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

Catalog Number 29MJ-501

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2023

Event Type  Injury  

Event Description

The article, "3d printing from transesophageal echocardiography for planning mitral paravalvular leak closure: feasibility study", was reviewed.The article presented a case study of a patient the underwent mitral valve replacement surgery.It was reported that on an unknown date, a 29mm sjm masters series mechanical heart valve was implanted.It was reported on an unknown date, the patient presented with paravalvular leak of the mitral prosthesis valve.A decision was made to implant a 4-2mm occlutech paravalvular leak device.The patient status was reported stable after one year follow up.The article concluded 3d-printing from 3d-tee is technically feasible.Both shape and location of pvls are preserved during model preparation and printing.It remains to be tested whether 3d printing would improve outcomes of percutaneous pvl closure.[the primary and corresponding author was marek jedrzejek, department of cardiology and structural heart diseases, medical university of silesia, katowice, poland, with corresponding e-mail: marek.Jedrzejek@poczta.Fm].

Manufacturer Narrative

As reported in a research article, "3d printing from transesophageal echocardiography for planning mitral paravalvular leak closure: feasibility study", a patient underwent mitral valve replacement surgery and a 29mm sjm masters series mechanical heart valve was implanted.Some of the post-procedural complications reported were paravalvular leak, surgical intervention, and hospitalization.There were no peri-procedural complications.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.There is no indication of a product quality issue with regards to manufacture design or labeling.

• Brand Name: MASTERS SERIES 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: 18331159
• MDR Text Key: 330545468
• Report Number: 2135147-2023-05530
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• 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): Hospitalization; Required Intervention