MAUDE Adverse Event Report: ST. JUDE MEDICAL BIOCOR; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that a transcatheter bioprosthetic valve was implanted into a failed biocore 19 mm valve.The failure mechanism of the biocore valve was stenosis.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BIOCOR
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17535450
• MDR Text Key: 321287938
• Report Number: MW5142347
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1