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

Model Number E100-21A

Device Problem Material Puncture/Hole (1504)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 08/14/2019

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

On (b)(6) 2016, a 21mm epic stented porcine heart valve was implanted.On (b)(6) 2019, the valve was exchanged with a 21mm carpentier-edwards perimount rsr 2800tfx due to suspected stenosis and leakage of the original valve.Upon removal, a hole in the valve was noted.The patient was reported to have hypertrophic heart disease of valvular etiology.No patient consequences were reported.

Manufacturer Narrative

Explant was reported due to leakage and suspected stenosis.The investigation found that circumferential fibrous pannus ingrowth was present on the inflow surface.There was degenerative changes to all three cusps, with cusp 2 having severe degenerative changes, along with tears and microcalcifications.Cusp 1 was torn.Cusps 1 and 3 were fibrotically thickened.The base of cusp 2 was folded.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the tears, fibrous thickening, and folds could not be conclusively determined, however, the fibrous pannus ingrowth noted on the inflow surface 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.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8952914
• MDR Text Key: 156910917
• Report Number: 3001883144-2019-00081
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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 Expiration Date: 09/22/2019
• Device Model Number: E100-21A
• Device Catalogue Number: E100-21A
• Device Lot Number: BR00004911
• 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: 08/14/2019
• Initial Date FDA Received: 08/31/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 65