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

Model Number B10-27A-00

Device Problem Calcified (1077)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

An event of stenosis and dyspnea was reported.The reported calcification could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, calcification is a known event associated with tissue heart valves.Mitral and tricuspid regurgitation was also reported from the field.

Event Description

On (b)(6) 2007, a 27mm biocor valve was implanted in the aortic position.Leading up to the explant, the patient experienced dyspnea during normal activity.The patient was diagnosed with restenosis bioprosthetic aortic valve with critical aortic stenosis and the pre-op tee confirmed mitral valve regurgitation and tricuspid valve mild regurgitation.On (b)(6) 2018, the valve was explanted.The operative report indicated the leaflets were heavily calcified with poor mobility.The device was replaced with an onyx mechanical valve.

• Brand Name: BIOCOR VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8349392
• MDR Text Key: 136462686
• Report Number: 3001743903-2019-00002
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2019

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: 02/02/2011
• Device Model Number: B10-27A-00
• Device Lot Number: 0002101851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/19/2019
• Date Device Manufactured: 02/03/2007
• 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): Required Intervention
• Patient Age: 46 YR