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

Model Number	E100-33M-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 33mm epic stented porcine valve was implanted approximately 4 years ago.On (b)(6) 2022, the valve was explanted because "it was defective." the defect is unknown.No patient consequences were reported.
Additional Manufacturer Narrative
Explant due to device being defective was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determinedh6 health effect - impact code: code 4624 removed and code 4648 added.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• Common Device Name: 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: 15464896
• Report Number: 2135147-2022-01297
• Device Sequence Number: 6897025
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: E100-33M-00
• Device Catalogue Number: E100-33M-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown