MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (MITRAL); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-29M

Device Problems Patient-Device Incompatibility (2682); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Endocarditis (1834); Pulmonary Edema (2020)

Event Date 03/15/2024

Event Type  Injury  

Event Description

The article, "transcatheter mitral valve-in-valve explant: lessons learned", was reviewed.The article presented a case study of a 71-year-old male patient with pulmonary edema and decompensation heart failure.It was reported that on an unknown date, a 33mm epic valve was implanted.It was then reported 11 years post-procedure on an unknown date, the patient presented with acute severe mitral regurgitation and pulmonary edema.A decision was made to perform a transcatheter valve-in-valve procedure with a 29mm sapien valve.It was then reported two and a half years post-intervention, the patient developed recurrent bacterial endocarditis.A decision was made to surgically remove both 33mm epic valve with the embedded 29mm sapien valve.A 33mm epic plus valve was then implanted with no adverse patient consequences.The article concluded that mitral valve-in-valve explant is technically feasible.The authors recommended en bloc removal of both valves as the safest method of valve explant.[the primary and corresponding author was mohammad bashir, university of iowa carver college of medicine, department of cardiothoracic surgery, iowa city, iowa 52242, with corresponding email: mohammad-bashir@uiowa.Edu].

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: transcatheter mitral valve-in-valve explant: lessons learned.

Manufacturer Narrative

As reported in a research article, transcatheter mitral valve-in-valve explant: lessons learned.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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: 19098059
• MDR Text Key: 340041061
• Report Number: 2135147-2024-01672
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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 Catalogue Number: E100-29M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male