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

Model Number E100-31M

Device Problems Backflow (1064); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  Injury  

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 Description

On (b)(6) 2020, a 31mm epic valve was selected for implant.During the procedure, it was observed that the carrier of the valve was defective.The valve was checked by the physician and deemed ok for implant.The valve was implanted, however, on examination by transesophageal ultrasound, major central leak was observed on the valve.The valve was exchanged and a new 31mm epic valve was successfully implanted.The physician alleges a 45-minute increased clamp time.The patient status was reported as unknown.Additional information has been requested.

Manufacturer Narrative

Additional information sections: an event that it was "impossible to set up the carrier of the valve" and forceps were needed, followed by regurgitation upon implant was reported.A more comprehensive assessment could not be performed as a valve-in-valve procedure was performed and the device was not accessible 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.

Event Description

On (b)(6) 2020, a 31mm epic valve was selected for implant.During the procedure, it was observed that the carrier of the valve was defective.The physician reported that it was "impossible to set up the carrier of the valve" and they had to use forcepts.The valve was checked by the physician and deemed ok for implant.The valve was implanted, however, on examination by transesophageal ultrasound, major central leak was observed on the valve.The valve was exchanged and a new 31mm epic valve was successfully implanted.The physician alleges a 45-minute increased clamp time.The patient is reported to be recovering.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• 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: 10459917
• MDR Text Key: 204566234
• Report Number: 3001883144-2020-00086
• 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: 11/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: E100-31M
• Device Lot Number: BR00024419
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention