MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-21A

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Valve Stenosis (1717); Chest Pain (1776); Fatigue (1849)

Event Date 12/15/2021

Event Type  Injury  

Event Description

It was reported on (b)(6) 2015, a 21mm epic stented porcine heart valve w/flexfit system was implanted.In 2017 moderate aortic stenosis was observed.In (b)(6) 2020, the mean gradient was 49mmhg and velocity 4.5m/s was noted.In (b)(6) 2021, the peak gradient was 50mmhg and peak pg 82.2mmhg and velocity 5m/s and the patient was complaining of fatigue during exertion and feeling chest oppression.On (b)(6) 2021, the valve was explanted and replaced with a non-abbott valve.Upon explant pannus ingrowth was observed circumferentially on the inflow surface and inflow diameter had become narrowed.The patient was reported to be in stable condition.

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

Explant was reported due to fatigue upon exertion, chest "oppression", and stenosis.The investigation found that there was a tear in cusp 3.Degenerative changes were present in cusps 1 and 3, and the changes were present in the tear site in cusp 3.There was circumferential fibrous pannus ingrowth on the inflow surface which extended onto the bases of all three leaflets and narrowed the inflow diameter.The inflow pannus also caused limited mobility of cusps 2 and 3.There was a calcification in the pannus on cusp 2.No inflammation was present.The cause of the tear could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.The circumferential pannus restricting the cusp mobility and narrowing the inflow diameter could have contributed to the reported stenosis.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13193615
• MDR Text Key: 283417316
• Report Number: 3007113487-2022-00004
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• 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: 02/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: E100-21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 79 YR
• Patient Weight: 60 KG