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

Model Number ESP100-21

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2017, a 21mm epic supra valve was implanted in the patient's aortic position.On (b)(6)2021, the valve was explanted due to thrombus on the valve and a new non-abbott valve was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to "thrombus on the valve".The investigation found that there was thrombus on the outflow of all three cusps.There was fibrous pannus ingrowth on the inflow surface of cusp 1 and cusp 2.Cusp 1 and cusp 2 contained folds/retraction.There was no inflammation or significant calcifications.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.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12277236
• MDR Text Key: 265057414
• Report Number: 3001883144-2021-00113
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: ESP100-21
• Device Lot Number: BR00008268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2016
• 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): Hospitalization; Required Intervention