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

Model Number E100-27M

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Asthma (1726); Chest Pain (1776); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Decreased Appetite (4569)

Event Date 07/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2014, a 27mm epic stented porcine valve was implanted.On (b)(6) 2021, mitral valve insufficiency was observed.On (b)(6) 2021, the valve was explanted due to mitral valve insufficiency with associated symptomatic chest tightness, asthma, and poor appetite; the valve was considered to be "decayed", further described as heart failure.A new unknown manufacturer device was successfully implanted.The patient was reported to be in stable condition.

Event Description

It was reported that on (b)(6) 2014 a 27mm epic stented porcine valve was implanted.On (b)(6) 2021, mitral valve insufficiency was observed.On (b)(6) 2021, the valve was explanted due to mitral valve insufficiency with associated symptomatic chest tightness, asthma, and poor appetite; the valve was considered to be "decayed", further described as heart failure.A new unknown manufacturer device was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to the valve being "decayed".The investigation found that cusp 1 was torn.Cusp 1 and 2 had marked thinning and loss of collagen fibers throughout, while cusp 3 had thinning and loss of collagen fibers at the base.There was fibrous pannus ingrowth on the inflow surface of cusp 1 and on the outflow surface of cusp 2.A calcification was present on the sewing cuff.No 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 in the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12422514
• MDR Text Key: 269807350
• Report Number: 3001883144-2021-00123
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: E100-27M
• Device Lot Number: 3620348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention