MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-29M

Device Problems Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problems Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/25/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 29mm epic valve was successfully implanted in a patient with a history of endocarditis.On an unknown day in (b)(6) 2022, the patient went in for a routine follow up and there were no significant findings.On (b)(6) 2023, the patient returned to the hospital due to a chief complaint of worsening heart failure (palpitations and shortness of breath).An echocardiogram was performed and revealed a pressure gradient of 20 mmhg, due to mitral stenosis.The increased pressure gradient persisted and contributed to the patient's worsening heart failure.On (b)(6) 2023, the decision was made to explant and replace the 29mm epic valve with a 27mm sjm masters series heart valve with teflon cuff.It was noted during the explant procedure, that despite there being no clinical signs or symptoms of infection, there was a noticeable thickening of the 29mm epic valve's cusps.It was noted that the thickening of the leaflets was due to pannus.The patient was stable at the time of report.The direct cause of the patient's mitral stenosis, high pressure gradient and pannus are unknown.

Manufacturer Narrative

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

Manufacturer Narrative

Explant due to increased pressure gradient causing worsening heart failure and mitral stenosis was reported.It was also reported that there was thickening of the cusps due to pannus.The investigation found outflow thrombus on all cusps.There was fibrous thickening on cusps 1 and 2 and inflow pannus on cusp 1.There were folds observed in the free edges of cusps 1 and 2 with incomplete coaptation.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined, however the pannus and thrombus on the cusps could have contributed to the reported stenosis.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.B3: date of event.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16436525
• MDR Text Key: 310162282
• Report Number: 2135147-2023-00653
• 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: 04/12/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E100-29M
• Device Lot Number: BR00025609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• 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: 70 YR
• Patient Sex: Male