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

Model Number	ESP100-23-00
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 23mm epic supra valve was selected for implant.After implant, the physician observed that one of the leaflets was not closing properly, resulting in incomplete coaptation.The physician attempted unsuccessfully to free the leaflet by rotating the valve with the rotator to assess if underlying native tissue was interfering with coaptation.The site did not verify whether or not any such underlying native tissue was present.The valve was explanted, and a replacement 23mm epic supra valve was implanted.Per site, the explanted valve had been rinsed and handled at all times according to the ifu.The patient has been discharged.
Additional Manufacturer Narrative
An event of one of the leaflets not closing properly was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.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 cause of the reported event could not be conclusively determined.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• 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: 8595122
• Report Number: 3001883144-2019-00043
• Device Sequence Number: 19419482
• Product Code: LWR
• UDI-Device Identifier: 05414734055642
• UDI-Public: 05414734055642
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/14/2019

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: 10/28/2022
• Device Model Number: ESP100-23-00
• Device Catalogue Number: ESP100-23-00
• Device Lot Number: BR00018642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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: 52 YR