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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problems Perivalvular Leak (1457); Patient-Device Incompatibility (2682)

Patient Problems Endocarditis (1834); Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

The case study, surgical treatment for prosthetic valve infection infective endocarditis caused by candida albicans", was reviewed.The patient was a 55-year-old man.Five years ago, the patient had undergone right small full thoracotomy aortic valve replacement with a trifecta tissue valve for aortic valve insufficiency at another hospital.Giant vegetation, paravalvular leakage was found in the prosthetic valve and the patient was referred to our hospital for surgical treatment.The patient was approached through a median sternotomy, and artificial heart and lung were established through ascending blood delivery and superior and inferior vena cava demyelination.After aortic blockade, the prosthetic valve was observed, and a giant vegetation was found to be lodged in the prosthetic valve.The prosthetic valve on lcc side was dehiscent, the aorta that had formed the pseudoaneurysm was transected, and the prosthetic valve was explant after the right and left coronary arteries were boutoned and held.The infected valsalve tissue was resected, debrided and well washed.In order to prevent postoperative paravalvular leakage, the thread was applied to tesdesser thread applied to the left ventricular outflow tract and composite graft skirt made of valsalva graft 28mm and non-abbott 25mm bioprosthesis seating between the left ventricular outflow tract and composite graft by dividing the band-trimmed autologous pericardium into the whole circumference.The thread was placed in aortic valve position, and the thread was tied and composite graft was sutured.The right and left coronary arteries were sutured to the artificial blood vessel, and after the peripheral anastomotic of the artificial blood vessel was carried out, air was extracted, and the blockage was released.The heart-lung machine was weaned under pacing.The operation time was 6 hours and 36 minutes, the heart-lung machine time was 245 minutes, and the aortic interception time was 211 minutes.Candida albicans was detected from the tissue culture submitted to the surgical band.[the author of this case study is shigefumi matsuyama, md, dept of surgery, cardio center, toranomon hospital].

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including median sternotomy, and artificial heart and lung.Some of the complications reported were perivalvular leak, aortic blockade, giant vegetation, pseudoaneurysm and endocarditis these complications are anticipated for the procedure and subject population.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.

• Brand Name: SJM TRIFECTA 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: 16021425
• MDR Text Key: 305878012
• Report Number: 2135147-2022-02657
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/17/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male