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

Catalog Number	27MJ-501
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 27mm 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 12-5mm 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].
Additional Manufacturer Narrative
Literature article attached: 3d printing from transesophageal echocardiography for planning mitral paravalvular leak closure ¿ feasibility study.As reported in a research article, paravalular leak was noted after an unknown length of implant.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
• Common Device Name: 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: 18356646
• Report Number: 2135147-2023-05575
• Device Sequence Number: 20434982
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown