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

Model Number B100-31M

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 05/26/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a biocor mitral valve (size unknown) was implanted.Following the procedure, the patient required a lengthy icu stay, however no information was provided beyond the patient developed an infection and endocarditis which resulted in a poorly functioning mitral prosthesis.On (b)(6) 2018, the valve was explanted and replaced with a 33 mm biocor valve.The patient was reported to be recovering.A request for the explanted valve was made by the local representative however the valve had been sent off to hospital pathology post explant.

Manufacturer Narrative

An event of endocarditis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2017, a mitral valve replacement was performed due to severe mitral valve regurgitation and a 31 mm biocor mitral valve (sn unknown) was implanted.The patient was stable throughout the procedure.The following year the patient developed presumed bacterial endocarditis of the biocor valve which resulted in a poorly functioning mitral prosthesis.On (b)(6) 2018, the valve was explanted and replaced with a 33 mm biocor valve.Closure of the left atrial appendage was performed during the same procedure.Post-procedure, the patient returned to the icu in a satisfactory and stable condition.A request for the explanted valve was made by the local representative however the valve had been sent off to hospital pathology post explant and is not expected to be returned for analysis.

• Brand Name: BIOCOR STENTED TISSUE VALVE
• 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: 7643459
• MDR Text Key: 112514850
• Report Number: 3001883144-2018-00057
• 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: 08/10/2018

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 Model Number: B100-31M
• Device Catalogue Number: B100-31M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention