MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK TRIFECTA GT VALVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Angina (1710); Endocarditis (1834)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided summarized patient outcomes/complications of patient prothesis miss-match on long term survival and quality of life were reported in a research article.Some of the complications reported were endocarditis, redo surgery, and angina.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, "clinical impact of patient-prosthesis mismatch after aortic valve replacement with a mechanical or biological prosthesis", was reviewed.The article presented a prospective, single center study to investigate the impact of patient-prosthesis mismatch (ppm) on long-term survival and quality of life after mechanical and biological aortic valve replacement.Devices included in this study were sjm masters, sjm regent, medtronic ats open pivot, cyrolife on-x, livanova carbomedics, medtronic hancock ii, abbott epic, abbott trifecta gt, livanova crown prt, livanova solosmart, and livanova perceval s.The article concluded mismatch is common after biological valve implantation and statistically significantly affects long-term survival and quality of life.If the risk of ppm after implantation of a biological prosthesis is suspected, adopting strategies to avoid ppm at the time of surgery is warranted.[the primary and corresponding author was (b)(6).

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18150993
• MDR Text Key: 328306128
• Report Number: 2135147-2023-05059
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TRIFECTA GT VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization