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

Model Number B100-23A

Device Problem Occlusion Within Device (1423)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 09/30/2014

Event Type  Injury  

Event Description

The valve was explanted due to aortic stenosis.A 23 mm sjm masters series valve was implanted as a replacement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded fibrous thickening on all cusps, and outflow thrombus on all cusps with retraction of cusp 3.Special stains were negative for organisms, and no significant calcifications were present.A focus of intact and degenerating acute and chronic inflammatory cells was present on cusp 2.There was no acute inflammation on cusps 1 and 3.There was no evidence found to suggest the cause of fibrin and thrombus formation was 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 and thrombus formation remains unknown.

• Brand Name: BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4211624
• MDR Text Key: 15120896
• Report Number: 3001883144-2014-00025
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: PP040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

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: 07/12/2016
• Device Model Number: B100-23A
• Device Catalogue Number: B100-23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR