MAUDE Adverse Event Report: ABBOTT MEDICAL STANDARD MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number M-101

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

At age (b)(6), an open mitral commissurotomy was performed due to rheumatic mitral stenosis.At age (b)(6), the patient underwent a mitral valve replacement (mvr), and a 29mm sjm mechanical heart valve implanted due to infectious endocarditis.At age (b)(6), a paravalvular leak (pvl) was noted, as well as aortic stenosis and regurgitation (asr) deterioration.A double valve replacement was performed for the aortic valve and the mitral valve.For the mitral valve replacement, the 29mm sjm mechanical heart valve was explanted and replaced with a 25mm non-abbott tissue valve.For the aortic replacement, a 21mm non-abbott tissue valve was implanted.One year after the double valve replacement surgery, prosthetic valve endocarditis (pve) occurred, and the patient was treated conservatively.Nineteen years the double valve replacement surgery at age (b)(6), there was structural valve deterioration (svd) of both non-abbott valves and cardiac insufficiency.The patient underwent another surgery, and the mitral valve, aortic valve, and tricuspid valve were replaced.A 27mm sjm epic valve was implanted in the mitral position, a 23mm sjm epic valve was implanted in the aortic position, and a 25mm sjm epic valve was implanted in the tricuspid position.

Manufacturer Narrative

An event of paravalular leak, aortic stenosis, and regurgitation after about seven years after implant was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: STANDARD MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14991195
• MDR Text Key: 295767368
• Report Number: 2135147-2022-00485
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006521
• UDI-Public: 05414734006521
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-101
• Device Catalogue Number: 29M-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 51 KG