MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-29M

Device Problems Material Puncture/Hole (1504); Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008)

Patient Problems Fatigue (1849); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/07/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, a 29mm epic valve was successfully implanted in the mitral valve of a patient.On 07 june 2022, the 29mm epic valve was explanted due to patient becoming easily fatigued and echography showing signs of mitral regurgitation.During the explant procedure it was noted that a cusp on the 29mm epic valve was perforated.Pannus was also noted on the posterior leaflet of the 29mm epic valve.A non-abbott replacement device was successfully implanted.The patient remained hemodynamically throughout the procedure.There was no clinically significant delay in procedure reported.The patient was stable and starting rehabilitation at the time of report.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Explant due to patient fatigue and signs of mitral regurgitation was reported.The investigation found that cusp 1 and 2 were torn.Information from the field confirmed that one cusp was observed to be perforated upon explant.There was circumferential fibrous pannus ingrowth on the inflow and outflow surfaces which extended onto cusp 2.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.The cause of the perforation could not be conclusively determined; however, the tears in cusp 1 and cusp 2 were associated with degenerative changes at the tear site including a denatured appearance in collagen and a marked thinning and loss of collagen fibers at the test site of the tear.In addition, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent cusps and create an unbalanced stress relief distribution between all cusps during coaptation, leading to cusp tears and reduced durability.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6.Medical device problem code 4008 a0414 material split, cut or torn was removed.

Event Description

N/a.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14893183
• MDR Text Key: 295227117
• Report Number: 2135147-2022-00466
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2017
• Device Catalogue Number: E100-29M
• Device Lot Number: 4307318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• 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
• Patient Age: 78 YR
• Patient Sex: Male