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

Model Number ESP100-23

Device Problems Calcified (1077); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Calcium Deposits/Calcification (1758); Valvular Stenosis (2697)

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) 2013, a 23mm epic supra valve was implanted.Two years post-implant, severe valve stenosis was observed.Four years post-implant, ct scan showed calcification and presence of pannus.On an unknown date, re-operation for heart failure due to severe valve stenosis was reported.The patient was reported to be in unstable condition.Additional information has been requested and is pending.

Event Description

It was reported that on (b)(6) 2013, a 23mm epic supra valve was implanted.Two years post-implant, severe valve stenosis was observed.Four years post-implant, ct scan showed calcification and presence of pannus.On an unknown date, re-operation for heart failure due to severe valve stenosis was planned, however, the physician changed their mind and the operation was not performed.The patient is being treated with medication.The patient was reported to be in unstable condition.

Manufacturer Narrative

An event of severe stenosis caused due to calcification were reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident 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
• MDR Report Key: 12558190
• MDR Text Key: 274433585
• Report Number: 3001883144-2021-00136
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESP100-23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR