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

Model Number B10SP-21

Device Problems Material Perforation (2205); Obstruction of Flow (2423)

Patient Problems Aortic Insufficiency (1715); Death (1802)

Event Date 09/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation concluded the cusps were received fragmented with all cusps partially excised; there was mild fibrous thickening of the undesignated detached cusps, perforations measuring 1-2 mm on the two undesignated cusps, and a thin layer of fibrin on all cusps.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the fibrin formation and perforations were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin formation and perforations remains unknown.

Event Description

The valve was explanted due to stenosis.During the explant procedure, two perforations in the cusps were observed which were thought to be the cause of the aortic insufficiency.It was reported the stenosis likely to be due to subvalvular inflammatory tissue growth.The patient expired postoperatively (date and cause unknown).

Manufacturer Narrative

(b)(4).

• Brand Name: BIOCOR SUPRA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA.; caixa postal 106; belo horizonte 3400 0-00; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4200555
• MDR Text Key: 13225421
• Report Number: 3001743903-2014-00051
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2009
• Device Model Number: B10SP-21
• Device Catalogue Number: B10SP-21
• Device Lot Number: 0002105543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 71 YR