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

Model Number	E100-29M-00
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
On (b)(6) 2019, a 29mm epic valve was selected for implant.During procedure preparation, one of the leaflets was observed to be folded and not coapting properly.The physician placed sutures and tested the valve inside of the patient; however, the issue of coaptation persisted.The valve was removed and exchanged for a 31mm epic valve.Per the site, there was a clinically significant extension in procedure time.The patient is reported to be discharged.
Additional Manufacturer Narrative
The reported event that one of the leaflets was folded and did not coapt properly could not be confirmed.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, a 29mm epic valve was selected for implant.During procedure preparation, one of the leaflets was observed to be folded and not coapting properly.The physician placed sutures and tested the valve inside of the patient; however, the issue of coaptation persisted.The valve was removed and exchanged for a 31mm epic valve.Per the site, there was a clinically significant extension in procedure time.The patient is reported to be discharged.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8640919
• Report Number: 3001883144-2019-00051
• Device Sequence Number: 16616738
• Product Code: LWR
• UDI-Device Identifier: 05414734055598
• UDI-Public: 05414734055598
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2022
• Device Model Number: E100-29M-00
• Device Catalogue Number: E100-29M-00
• Device Lot Number: BR00018061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR