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 Codes	Dyspnea (1816); Fatigue (1849)
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 23mm trifecta gt valve was implanted in aortic position and a 29mm epic valve was implanted in the mitral position.On an unknown date the patient presented with shortness of breath and fatigue.On (b)(6) 2020, the trifecta valve was explanted due to 2 small leaflet holes and was replaced with a medtronic ultra valve.The epic valve seemed to be okay but on an echocardiogram it was reported to have posterior prolapsed leaflet and it was explanted and exchanged for a mosaic ans valve.The patient was reported to be stable condition.Manufacturer report number: 3001883144-2020-00025.
Additional Manufacturer Narrative
Additional information: d10, h3, h6.Explant was reported due to a prolapsed leaflet.The investigation found that there were previous incisions in all three cusps, with some portions of cusp tissue not received at abbott.There was thinning and loss of collagen fibers in cusps 1 and 3.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 prolapsed leaflet could not be conclusively determined.

• 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: 9851285
• Report Number: 3001883144-2020-00026
• Device Sequence Number: 2664037
• Product Code: LWR
• UDI-Device Identifier: 05414734055598
• UDI-Public: 05414734055598
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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 Expiration Date: 03/13/2023
• Device Model Number: E100-29M-00
• Device Catalogue Number: E100-29M-00
• Device Lot Number: BR00019403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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: 58 YR
• Patient Weight: 87