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 E100-29M

Device Problems Backflow (1064); Material Split, Cut or Torn (4008)

Patient Problem Mitral Regurgitation (1964)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

In (b)(6) 2017, patient underwent mitral valve replacement at (b)(6) hospital, (b)(6).The bio prosthesis used in this case was an epic stented porcine heart valve w/flexfit system.On (b)(6) 2020, the patient went to a follow up check in (b)(6).After doing tee the physician found that one of the leaflets was degenerated/torn.In the last few months the patient was hospitalized twice , due to repeated severe mr.On (b)(6) 2020 the surgeon explanted the valve and replaced it with another mechanical heart valve.

Event Description

In (b)(6) 2017, patient underwent mitral valve replacement at (b)(6) hospital, new delhi.The bio prosthesis used in this case was an epic stented porcine heart valve w/flexfit system.On (b)(6) 2020, the patient went to a follow up check in patna, bihar.After doing tee the physician found that one of the leaflets was degenerated/torn.In the last few months the patient was hospitalized twice ,due to repeated severe mitral regurgitation(mr).On (b)(6) 2020 the surgeon explanted the valve and replaced it with a mechanical heart valve.

Manufacturer Narrative

The reported tear and regurgitation was confirmed.While a more comprehensive assessment could not be performed since the device was not returned for analysis, videos of echo imaging the valve following explant appeared to document mitral regurgitation and a torn cusp.There was circumferential white tissue present on the inflow surface; however, it was not clear if this tissue encroached onto the cuspal tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The tear noted is consistent with the reported regurgitation.If the aforementioned tissue did encroach onto the inflow base of the cusps, it would have 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. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9920755
• MDR Text Key: 186303610
• Report Number: 3001883144-2020-00024
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: E100-29M
• Device Lot Number: BR00009606
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention