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

Catalog Number E100-29M

Device Problems Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article, "transcatheter mitral valve-in-valve explant: lessons learned", was reviewed.The article presented a case study of a 66-year-old male patient with von willebrand disease.It was reported that on an unknown date, a 29mm epic valve was implanted.It was then reported 10 years post-procedure on an unknown date, the patient presented with dyspnea due to severe mitral regurgitation.A decision was made to perform a transcatheter valve-in-valve procedure with a 26mm sapien valve.It was then reported one year post-intervention, the patient had elevated gradient.A decision was made to surgically remove both 29mm epic valve with the embedded 26mm sapien valve.A 27/29 on-x mechanical 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

Summarized patient outcomes/complications of epic valve was reported in a research article in a subject population with von willebrand disease.Some of the complications reported were surgical intervention (valve-in-valve, surgical explant), hospitalization, mitral regurgitation, dyspnea and mitral stenosis.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

Event Description

The article, "transcatheter mitral valve-in-valve explant: lessons learned", was reviewed.The article presented a case study of a 66-year-old male patient with von willebrand disease.It was reported that on an unknown date, a 29mm epic valve was implanted.It was then reported 10 years post-procedure on an unknown date, the patient presented with dyspnea due to severe mitral regurgitation.A decision was made to perform a transcatheter valve-in-valve procedure with a 26mm sapien valve.It was then reported one year post-intervention, the patient had elevated gradient.A decision was made to surgically remove both 29mm epic valve with the embedded 26mm sapien valve.A 27/29 on-x mechanical 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].

• 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: 19097809
• MDR Text Key: 340038708
• Report Number: 2135147-2024-01668
• 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: 05/22/2024

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: 05/17/2024
• Supplement Dates FDA Received: 05/22/2024
• 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: 66 YR
• Patient Sex: Male