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

Model Number E100-29M

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

Patient Problems Mitral Valve Stenosis (1965); Low Cardiac Output (2501); Thrombosis/Thrombus (4440)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6)2021, that a 29 mm epic stented porcine heart valve w/flexfit system was implanted in a patient with mitral regurgitation leading to cardiac insufficiency.It was also suspected that the patient had sarcoidosis.Three months after the surgery, echo was performed and showed no issue.Earlier in january 2022, the patient presented for a follow-up and mitral stenosis was revealed.On (b)(6) 2022, the epic device was explanted and replaced with a 25 mm non-abbott device.After the surgery the patient has been hemodynamically unstable due to cardiac insufficiency.Examination of the explanted valve revealed that thrombi had become adhered to the outflow surfaces of all three cusps, likely resulting in the limited mobility.

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6)2021, that a 29 mm epic stented porcine heart valve w/flexfit system was implanted in a patient with mitral regurgitation leading to cardiac insufficiency.It was also suspected that the patient had sarcoidosis.Three months after the surgery, echo was performed and showed no issue.Earlier in (b)(6) 2022, the patient presented for a follow-up and mitral stenosis was revealed.On (b)(6) 2022, the epic device was explanted and replaced with a 25 mm non-abbott device.After the surgery the patient has been hemodynamically unstable due to cardiac insufficiency.Examination of the explanted valve revealed that thrombi had become adhered to the outflow surfaces of all three cusps, likely resulting in the limited mobility.

Manufacturer Narrative

Explant due to mitral stenosis was reported.The investigation found that there was fibrous thickening of cusp 2.Cusp 1 and cusp 3 had thrombus on the outflow.There was a distal fold in cusp 2 that was tethered by pannus.The sewing cuff was fractured in processing.There was no inflammation or significant calcifications.The device history record was reviewed to ensure each manufacturing and inspection operation was performed, and the product met all specifications.The immobilizing thrombus on the outflow of the cusps 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13492182
• MDR Text Key: 285323277
• Report Number: 3005334138-2022-00084
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: E100-29M
• Device Lot Number: BR00020615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2019
• 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; Other
• Patient Age: 73 YR
• Patient Sex: Female