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 Material Split, Cut or Torn (4008)

Patient Problems Mitral Insufficiency (1963); Mitral Regurgitation (1964)

Event Type  Injury  

Event Description

On (b)(6) 2013, double valve replacement (dvr) and tricuspid annuloplasty (tap) were performed for the treatment of rheumatic mitral stenosis (ms).The patient's native aortic annulus was noted to be bicuspid valve.A 25mm epic mitral valve (model number: e100-25m, serial number: (b)(4)) was implanted in the mitral position, a 19mm epic supra valve (model number: esp100-19, serial number: (b)(4)) in the aortic position and a 27mm tailor annuloplasty band (model number: tab-27, serial number: (b)(4)) in the tricuspid position.In 2018, during a follow-up visit, no findings were observed.In (b)(6) 2018, the patient presented at the hospital with symptoms of cardiac insufficiency.Medical examination revealed severe mr and torn leaflet was suspected.The regurgitation was controlled with diuretic and there was improvement.On (b)(6) 2019, a re-do mvr was performed, and the 25mm epic valve was explanted and replaced with a 27mm epic valve (sn unknown).Upon explant, leaflet tear was observed at the anterolateral commissure stent post extending toward the posterior leaflet.Post-operatively, the patient is reported to be stable.

Event Description

On (b)(6) 2013, double valve replacement (dvr) and tricuspid annuloplasty (tap) were performed.The patient had a bicuspid aortic valve, rheumatic mitral stenosis (ms) and tricuspid regurgitation.A 25mm epic mitral valve (model number: e100-25m, serial number: (b)(6) was implanted in the mitral position, a 19mm epic supra valve (model number: esp100-19, serial number: (b)(6) in the aortic position and a 27mm tailor annuloplasty band (model number: tab-27, serial number: (b)(6) in the tricuspid position.In 2018, during a follow-up visit, no findings were observed, however, in (b)(6) 2018, the patient presented at the hospital with symptoms of cardiac insufficiency.Medical examination revealed severe mr and torn leaflet was suspected, however medical intervention was implemented and the regurgitation was controlled with diuretic and there was improvement.As the patient condition did not remain stable, on (b)(6) 2019, a re-do mvr was performed, and the 25mm epic valve was explanted and replaced with a 27mm epic valve (sn unknown).Upon explant, leaflet tear was observed at the anterolateral commissure stent post extending toward the posterior leaflet.Post-operatively, the patient is reported to be stable.

Manufacturer Narrative

An event of cardiac insufficiency was reported, with the reported tear confirmed.Cusp 1 was torn at each stent post.Cusp 2 contained a puncture adjacent to an indentation in its tissue consistent with a surgical instrument.A thinning and loss of collagen fibers was noted on all 3 cusps.Cusp 3 contained a microcalcification.White tissue was noted over the commissure of cusps 2 and 3 at their free-edge, which may have contributed to cusp 3 remaining in the 'open' position and needing to be manipulated closed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, which confirmed that the device's in-production assessment fell within established manufacturing requirements and the valve met specifications prior to release.The cause of the torn cusp and resultant insufficiency could not be conclusively determined; however, the valve had been implanted for over 6 years, and the noted host to device reaction (white tissue and microcalcification) had the potential to induce increased stress on adjacent cusps and create an unbalanced stress relief distribution between all cusps 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. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8370931
• MDR Text Key: 137169843
• Report Number: 3001883144-2019-00012
• 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
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 04/05/2015
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Device Lot Number: 3491356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 40