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 E100-25M

Device Problem Occlusion Within Device (1423)

Patient Problem Stenosis (2263)

Event Date 06/17/2015

Event Type  Injury  

Event Description

This 25 mm sjm epic valve was implanted on (b)(6) 2010 but within five years the patient returned with valve stenosis.The 25 mm epic valve was explanted and a 25 mm ats mechanical valve was implanted on (b)(6) 2015.

Manufacturer Narrative

Gtin number: unknown.

Manufacturer Narrative

(b)(4).The results of this investigation concluded there were calcifications and perforations in all three cusps, and tears in cusps 2 and 3.Degenerative changes, loss of collagen, mixed bacteria and fungal/yeast forms were observed on all three cusps.The mixed bacterial and yeast were present within disrupted tissue and not associated with fibrin or inflammation and most consistent with contamination.No acute inflammation was observed.No evidence was found to suggest the cause of the calcifications, perforations, tears, degenerative changes and loss of collagen was due to an intrinsic defect in the valve, as supported by the analysis performed.The cause of the reported event remains unknown.

• 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: 4909003
• MDR Text Key: 6837123
• Report Number: 3001883144-2015-00029
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 48