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

Model Number B10-31M

Device Problem Gradient Increase (1270)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 08/15/2017

Event Type  Injury  

Event Description

On (b)(6) 2005, a 31mm biocor valve was implanted in the mitral position in a patient with multiple co-morbidities.On (b)(6) 2017, the patient presented with fatigue, dyspnea, af and peripheral edema consistent with biventricular failure.The patient's pressure was 100/60mmhg and the patient demonstrated extended neck veins indicative of increased venous pressure.A resting ecg was normal and good left ventricular function with an ejection fraction of (b)(4) was noted on echo.Signs of pulmonary hypertension and tricuspid incompetence were present.Pulmonary pressure of more than 60mmhg was observed and severe mitral incompetence was noted on echo.On (b)(6) 2017, the biocor valve was explanted and replaced with a sorin pericarbon more valve.

Manufacturer Narrative

The results of the investigation concluded that cusps 2 and 3 contained tears at the stent post, and cusps 1 and 3 were folded and contained inflow fibrous pannus ingrowth and microcalcifications.All three cusps had thinning and loss of collagen fibers on their base.No acute inflammation was found to be present.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.There was no evidence found to suggest the cause of the tears, pannus, folds, microcalcifications or loss of collagen fibers was due to an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause for the reported event remains unknown.

• Brand Name: BIOCOR VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6850098
• MDR Text Key: 85263785
• Report Number: 3001743903-2017-00037
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

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: 05/04/2008
• Device Model Number: B10-31M
• Device Catalogue Number: B10-31M
• Device Lot Number: 2965286
• Other Device ID Number: A10078754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2004
• 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: 79 YR
• Patient Weight: 60