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

Model Number B100-23A

Device Problem Gradient Increase (1270)

Patient Problems Death (1802); Pleural Effusion (2010)

Event Date 06/30/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a 23 mm biocor valve was implanted in a (b)(6) year-old female with severe calcific aortic stenosis (ppg/mpg - 192/115 mmhg) as part of a concomitant cabg and vsd closure.The procedure was uneventful but prolonged due to multiple procedural steps.On (b)(6) 2017, an echocardiogram showed good prosthetic valve function with acceptable gradients across the valve and normal lv function.However, a few days after, the patient was breathless, not mobilizing and noted to have a left pleural effusion which required drainage.An echo performed on (b)(6) 2017 showed severely increased gradients (108/53 mmhg) with suspicion of a membrane below the valve.A tee was performed and confirmed the higher gradients and an immobile left cusp.On (b)(6) 2017, the valve was explanted and replaced with a 25 mm regent heart valve.During explant, the native tissue was fragile and the annulus was completely destroyed which led to a root replacement.Per report, on 02 july 2017, the patient died due to low cardiac output, renal failure and bleeding after post-cardiotomy.

Manufacturer Narrative

The results of this investigation concluded there was fungal endocarditis in the returned 23 mm biocor valve.All three cusps contained vegetations with numerous fungal organisms and marked inflammation.All three cusps were fibrotically thickened and contained inflow and outflow thrombus.There was no significant calcifications present in the valve.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 fungal endocarditis, fibrin, or thrombus 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 reported event 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. (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 ; 6517564470
• MDR Report Key: 6719082
• MDR Text Key: 80245237
• Report Number: 3001883144-2017-00045
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

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: 10/05/2020
• Device Model Number: B100-23A
• Device Catalogue Number: B100-23A
• Device Lot Number: BR00010904
• Other Device ID Number: 05414734027410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• 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: 61 YR