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

Model Number BSP100-19

Device Problem Microbial Contamination of Device (2303)

Patient Problems Abscess (1690); Death (1802); Endocarditis (1834); Fever (1858); Staphylococcus Aureus (2058); Chills (2191)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Three months post procedure, the patient presented with chills and fever and was diagnosed with subacute (b)(4) endocarditis with aortic root abscess.Reoperation was performed where the tissue valve was explanted and replaced with a 19 mm mechanical valve from another manufacturer.During the explant procedure, the infection was noted to extend into the annulus.The annulus was badly damaged and would not hold sutures properly.The endocardium was also diseased.The patient expired the next day due to complications of extensive infective endocarditis.

Manufacturer Narrative

Gtin number: not available.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: BIOCOR SUPRA 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
• Manufacturer (Section G): 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4773080
• MDR Text Key: 18997884
• Report Number: 3001883144-2015-00017
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2015

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: 04/24/2017
• Device Model Number: BSP100-19
• Device Catalogue Number: BSP100-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• 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: 78 YR