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

Catalog Number	9-VSD-MUSC-012
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 16mm amplatzer muscular vsd occluder was chosen to close the post-infarct ventricular septal defect (pi-vsd) using an unknown delivery system.During procedure, the physician was unable to cross the defect due to advancement difficulty through patient anatomy with the delivery system.The 16mm plug was not released from the delivery cable.A new 12mm amplatzer muscular vsd occluder was chosen and the sizing was determined by transesophageal echocardiogram (tee).The 12mm was implanted and the fluoroscopy showed the device was completely dislodged from the implant site.The device was travelled to right ventricle.The device was removed using a transcatheter snare.There was no blockage of blood flow.A new 18mm amplatzer vascular plug ii was chosen and successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported recovering.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device migrated to right ventricle was reported.A returned device inspection, to rule out any device-related causes could not be performed as the device was not returned for analysis.Field indicated that patient had anatomy which may have contributed to the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2023, a 16mm amplatzer muscular vsd occluder was chosen to close the post-infarct ventricular septal defect (pi-vsd) using an unknown delivery system.During procedure, the physician was unable to cross the defect due to advancement difficulty through patient anatomy with the delivery system.The 16mm plug was not released from the delivery cable.A new 12mm amplatzer muscular vsd occluder was chosen and the sizing was determined by transesophageal echocardiogram (tee).The 12mm occluder was implanted, and fluoroscopy showed that the device completely dislodged from the implant site and had travelled to the right ventricle.There was no blockage of blood flow.The device was removed using a transcatheter snare.A new 18mm amplatzer vascular plug ii was chosen and successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient was reported to be recovering.

• 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: 17773801
• Report Number: 2135147-2023-04004
• Device Sequence Number: 18015167
• Product Code: MLV
• UDI-Device Identifier: 00811806011820
• UDI-Public: 00811806011820
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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-012
• Device Lot Number: 8624632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown