|DRAP Alert No||No II/S/09-23-37|
|Action Date||10th October, 2023|
|Target Audience||• Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Cardiologists, Pharmacists, and Nurses.|
• People implanted with affected Trifecta Family Valves.
• Procurement Officers at Hospitals and Healthcare Institutions.
• Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
|Problem / Issue||Abbot Structural Heart (St.Jude Medical, USA) has initiated a market withdrawal for the Trifecta family of valves (TrifectaTM Valve and TrifectaTM Valve with Glide Technology see table below) and will be removing the limited remaining inventory from the field due to potential for early Structural Valve Deterioration (SVD). Accordingly, the manufacturing company is recalling all the defective products from the international market including Pakistan. The Medical Device Board has already suspended the product registration in its 61st Meeting and further course of action for deregistration is in process under the Medical Device Rules 2017.|
Therapeutic Goods Affected:-
|Brand Names and Description||Model No||GTN/UDI||Manufacturer and Distributor|
|TrifectaTM Valve 19mm|
TrifectaTM Valve 21mm
TrifectaTM Valve 23mm
TrifectaTM Valve 25mm
TrifectaTM Valve 27mm
TrifectaTM Valve 29mm
TrifectaTM Valve with Glide Technology 19mm
TrifectaTM Valve with Glide Technology 21mm
TrifectaTM Valve with Glide Technology 23mm
TrifectaTM Valve with Glide Technology 25mm
TrifectaTM Valve with Glide Technology 27mm
TrifectaTM Valve with Glide Technology 29mm
|M/s St. Jude Medical 11 county road b e saint paul, mn USA 55117|
Distributor in Pakistan:
M/s Verizon, 60-D, F.C.C Zahoor Elahi Road, Gulberg-IV, Lahore.
Products registration no. MDIR -0003639.
|Risk Statement:||The valves are intended to maximize valve opening and improve hemodynamic performance. Therefore, defective trifecta family heart valves pose a risk of patient harm which will compromise the hemodynamic performance of the valve and can lead to cardiac arrest, other serious injuries.|
|Action Initiated||-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.|
-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.
-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.
-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
|Advice for Healthcare Professionals||DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device. Patient using the affected device should immediately contact their doctors for further guidance. Furthermore, Abbott, USA provided patient management considerations for those patients implanted with the Trifecta and Trifecta GT valves. https://www.structuralheart.abbott/fileadmin/pdf/FINAL_Abbott_Letter_US_Trifecta_Abbott_Website_sig ned.pdf)|
Understanding that clinical decisions are shared between healthcare providers and patients, please consider the following post-implant:
· Patients should be reminded to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
· An initial post-procedural transthoracic echocardiogram (TTE) study is recommended for all patients within 1 to 3 months after the implant procedure to evaluate valve hemodynamics and ventricular function.
· Schedule annual follow-up visits beginning 1-year post-implant for clinical evaluation, including TTE to assess transvalvular gradients and valvular regurgitation grade.
· Patients presenting with changes in symptoms (e.g., shortness of breath or fatigue on exertion) or signs (e.g., murmur) indicative of potential SVD should undergo a TTE.
· Patients with evidence of hemodynamically significant SVD should be considered, in consultation with a heart team, for a possible valve intervention with either surgical aortic valve replacement (SAVR) or a trans catheter valve-in-valve intervention depending on individual patient risks and benefits.
· Patients being considered for a valve-in-valve intervention should undergo pre-procedure planning with imaging studies to ensure all potential procedure-related risks such as coronary obstruction are minimized. Additional information regarding future valve-in-valve considerations can be found in the Trifecta GT valve IFU. Please note that the titanium frame of the Trifecta GT valve cannot be fractured using a balloon. Actions Abbott is Asking You to Take:
· Please consider this information in your practice and share with relevant health care professionals (e.g., cardiac surgeons, cardiologists, primary care physicians) involved in the care of patients implanted with the Trifecta family of valves in your institution.
· Complete and return the provided Acknowledgement Form.
· Report any product incidents, regardless of procedure or patient outcome, to Abbott.
-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.
-Please click here for further information on problem reporting to DRAP.
|Advice for Consumers||-Consumers should stop using this product bearing the affected Model no and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to using this Medical Device and report the incident to National Pharmacovigilance Centre of Drug Regulatory Authority of Pakistan, through MedSafety Mobile Application, or online at Med Vigilance E Reporting System.|
-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.