MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number	9-VSD-MUSC-014
Medical Device Problem Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 18mm amplatzer muscular vsd occluder was chosen for implant using a 9f amplatzer torqvue delivery system (itv) to treat a patients mitral paravalvular leak (pvl).The patient condition was not stable due to cardiogenic shock.During procedure, the device had a cobra deformation.There was no kink noticed on the delivery system but there was angulation on the delivery system due to angle of approach.The deformed device was never released from the delivery cable while inside the patient.A new 16mm amplatzer muscular vsd occluder and 8f amplatzer torqvue delivery system (itv) was selected, it had the same deformation.The deformed device was never released from the delivery cable while inside the patient.There was no kink noticed on the delivery system but there was angulation on the delivery system due to angle of approach.A new 14mm amplatzer muscular vsd occluder was chosen and successfully implanted using a amplatzer torqvue delivery system.The 14mm device didn't resolve the patients pvl.The patient was not hemodynamically stable during and after the procedure.On (b)(6) 2023, the patient was passed away due to sepsis.The patient had multiple co-morbidities, and the physician did not attribute device performance to the patient's death.
Additional Manufacturer Narrative
An event of paravalvular leak, device deformity and patient death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Possible causes of device deformity include use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment.Field indicated that here was an angulation on the delivery system due to angle of approach which may have contributed to the reported event of deformation.Multiple images from field showing deformation of the device after passage through a paravalvular leak channel and fluoroscopic images shown of the mitral valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.However, field noted that the device performance was not an attribute to the patient death.From medical review: four days post-implant the patient had a fatality due to sepsis.It remains unknown what was the cause for the sepsis, but it is possible that the sepsis was a result of active endocarditis.This vsd was used off-label to treat perivalvular leak, please note that per instructions for use, "indications and usage: the amplatzer¿ muscular vsd occluder and p.I.Muscular vsd occluder, are percutaneous, transcatheter, ventricular septal defect closure devices designed for the occlusion of muscular ventricular septal defects.".
Additional Manufacturer Narrative
An event of paravalvular leak, device deformity and patient death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Possible causes of device deformity include use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment.Field indicated that here was an angulation on the delivery system due to angle of approach which may have contributed to the reported event of deformation.Multiple images from field showing deformation of the device after passage through a paravalvular leak channel and fluoroscopic images shown of the mitral valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.However, field noted that the device performance was not an attribute to the patient death.From medical review: four days post-implant the patient had a fatality due to sepsis.It remains unknown what was the cause for the sepsis, but it is possible that the sepsis was a result of active endocarditis.Please note that, per instructions for use, "indications and usage: the amplatzer¿ muscular vsd occluder and p.I.Muscular vsd occluder, are percutaneous, transcatheter, ventricular septal defect closure devices designed for the occlusion of muscular ventricular septal defects.".

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17880496
• Report Number: 2135147-2023-04352
• Device Sequence Number: 15377347
• Product Code: MLV
• UDI-Device Identifier: 00811806011837
• UDI-Public: 00811806011837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-VSD-MUSC-014
• Device Lot Number: 8423372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 11/20/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/07/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 9-ITV08F180/80,9-ITV09F45/80,9-ITV09F45/80
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown