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

Model Number E100-29M

Device Problems Perivalvular Leak (1457); Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 06/26/2017

Event Type  Injury  

Event Description

On (b)(6) 2016, a mitral valve replacement (mvr) was performed and this 29 mm epic valve was implanted in a patient with a history of chronic atrial fibrillation and a patent foramen ovale.Concomitantly, a complete biatrial maze procedure and patent foramen ovale (pfo) closure were performed.On (b)(6) 2017, the patient was hospitalized due to anemia and a diagnosis of sepsis was made.A tte revealed a highly mobile, 10 cm piece of vegetation was adhered to a cusp of the prosthetic valve.Blood cultures were positive for enterococcus faecalis and the patient was started on 8g of abpc (ampicillin) continuously for 24 hours and 60g of gentamicin for 4 weeks.On (b)(6) 2017, a subcutaneous hemorrhage from the right occipital lobe resulting in left-sided paresis occurred.Emergent hematoma evacuation was endoscopically performed with local anesthesia.Also, moderate paravalvular leakage (pvl) was newly-confirmed on a repeat tte and surgical intervention was considered.On (b)(6) 2017, a blood culture was negative.On (b)(6) 2017, signs of a cerebral hernia appeared resulting in a craniotomy to remove the hematoma.No cerebral artery aneurysm was observed by computed tomographic angiography (cta) or magnetic resonance angiography (mra) and a hemorrhagic cerebral infarction caused by infective embolism was suspected.On (b)(6) 2017, due to suspicion of drug fever, abpc was discontinued and vancomycin was started.On an unknown date of (b)(6) 2017, the stable patient was transferred to another hospital for a re-do mvr.On (b)(6) 2017, this epic valve was explanted and a second 29 mm epic valve was implanted.Ex vivo, stiffening of the leaflet due to prosthetic valve endocarditis (pve) was observed.Postoperatively, the patient was reported to be stable.

Manufacturer Narrative

The results of this investigation concluded that all three cusps contained calcifications and were fibrotically thickened.Cusp 1 contained a tear in the free edge.No acute inflammation was 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 causes of the calcification, fibrous thickening or tear were 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 of the reported event remains unknown.

Manufacturer Narrative

Describe event or problem -- updated to include size of vegetation (10 mm, not 10 cm).

Event Description

A tte revealed a 10 mm highly mobile piece of vegetation adhered to a cusp of the prosthetic valve.Blood cultures were positive for enterococcus faecalis and the patient was started on 8 g of abpc (ampicillin) continuously for 24 hours and 60 g of gentamicin twice/day x 4 weeks.

• Brand Name: EPIC STENTED PORCINE HEART 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: 6743634
• MDR Text Key: 81038903
• Report Number: 3001883144-2017-00046
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2016
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 3945276
• Other Device ID Number: 05414734027533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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): Required Intervention
• Patient Age: 76 YR