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 Biocompatibility (2886)

Patient Problems Aortic Regurgitation (1716); Mitral Regurgitation (1964); Tricuspid Regurgitation (2112)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

In 2016, an double valve replacement procedure and a tricuspid annuloplasty were conducted.On (b)(6) 2019, the patient was referred to the hospital for heart failure.The patient was noted to have aortic regurgitation, mitral regurgitation and tricuspid regurgitation.On (b)(6) 2019, a re-do dvr and tap were performed and both valves were replaced with mechanical valves (serial number unknown).The physician reported endocarditis and pannus on the right coronary cusp.Since the procedure was performed at another hospital, the physician is unable to determine if the reported event was due to the initial procedure or patient condition.Additional information has been requested.

Manufacturer Narrative

Explant was reported due to mitral regurgitation.The investigation found that all three cusps were fibrotically thickened.There was a tear in the free edge of cusp 2.Both cusps 2 and 3 contained folds, resulting in incomplete coaptation.There was fibrous pannus ingrowth on the inflow surface of all three cusps.Focal calcifications were present in cusp 1.No acute inflammation was present.The cause of the fibrotic thickening, tear, folds, and calcification could not be conclusively determined, however, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

Event Description

In 2016, an double valve replacement procedure and a tricuspid annuloplasty were conducted.On (b)(6) 2019, the patient was referred to the hospital for heart failure.The patient was noted to have aortic regurgitation, mitral regurgitation and tricuspid regurgitation.On (b)(6) 2019, a re-do dvr and tap were performed and both valves were replaced with mechanical valves (serial number unknown).The physician reported endocarditis and pannus on the right coronary cusp.Since the procedure was performed at another hospital, the physician is unable to determine if the reported event was due to the initial procedure or patient condition.

• 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
• MDR Report Key: 8945603
• MDR Text Key: 155986919
• Report Number: 3001883144-2019-00089
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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 Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 40