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

Model Number E100-31M

Device Problem Material Perforation (2205)

Patient Problem Mitral Regurgitation (1964)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

The results / method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2012, a 31 mm epic mitral valve was implanted.Since 2016, mitral regurgitation has been observed.The patient was prescribed a diuretic agent and monitored closely, however, cardiac insufficiency worsened.Therefore, the patient was referred for redo mvr.On (b)(6) 2019, redo mvr was performed.The valve was explanted and a competitor's unknown sized edwards magna mitral was successfully implanted.Upon explant of the epic valve, perforation was observed in one leaflet.The physician commented: there was neither calcification nor pannus observed on the explanted valve.Therefore, mitral regurgitation might have been caused by the product itself not by the patient related factor.

Manufacturer Narrative

The perforation seen at explant was confirmed.Cusp 1 contained a tear in the base of the cusp.There were degenerative changes to all three cusps.Thrombus was present on the outflow surface of cusps 2 and 3.There was circumferential fibrous pannus on the inflow surface which extended onto the bases of all three cusps.Fibrous pannus was present on the outflow surface of cusps 1 and 3.There was a horizontal fold in cusp 3.No acute inflammation or significant calcifications were 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 thrombus, fold, and tear 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

On (b)(6) 2012, a 31mm epic mitral valve was implanted.Since 2016, mitral regurgitation has been observed.The patient was prescribed a diuretic agent and monitored closely, however, cardiac insufficiency worsened.Therefore, the patient was referred for redo mvr.On (b)(6) 2019, redo mvr was performed.The valve was explanted and a competitor's unknown sized edwards magna mitral was successfully implanted.Upon explant of the epic valve, perforation was observed in one leaflet.The physician commented: there was neither calcification nor pannus observed on the explanted valve.Therefore, mitral regurgitation might have been caused by the product itself not by the patient related factor.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9135750
• MDR Text Key: 160673555
• Report Number: 3001883144-2019-00094
• 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: 10/29/2019

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: 02/22/2016
• Device Model Number: E100-31M
• Device Catalogue Number: E100-31M
• Device Lot Number: 3694599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR