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

Catalog Number E100-31M

Device Problem Device Stenosis (4066)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 12/09/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 31mm stented porcine,mit,epic was implanted in a patient.During an echocardiogram a severe mitral valve stenosis was detected.Device was explanted and a new 31mm stente porcine,mit,epic was implanted.Patient is stable, no additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of valve insufficiency and stenosis was reported.It was indicated that the valve was implanted and explanted on the same day.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.No photos were received for examination, and no information on if any anomalies were noted on the explanted valve was received.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

N/a.

• 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 (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: 16279988
• MDR Text Key: 308585029
• Report Number: 2135147-2023-00363
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: KZ
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: E100-31M
• Device Lot Number: BR00034079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female