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

Catalog Number	9-VSD-MUSC-006
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of right ventricular disc was trapped tricuspid valve and explant was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the device was noted to be oversized for the defect and successfully retrieved through transcatheter snare.Based on the information received, the cause of the reported incident could be by using larger device for the defect.However, it was noted that there was no indication of malfunction of the device.
Event or Problem Description
It was reported that on (b)(6) 2024, a 6mm amplatzer muscular vsd occluder was chosen for a high muscular ventricular septal defect (vsd) using an unknown size abbott delivery system.During procedure, when the device placed in the patient and released, but it was noted that the right ventricular (rv) disc was trapped tricuspid valve (tv) chordae tendinae.The device was noted to be oversized for the defect.The device removal via transcatheter snare was difficult as the defect was small, but the device was successfully retrieved.The patient remained hemodynamically stable throughout the procedure.The plan was made to later surgically close the defect.The patient was reported stable.

• 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: 18924024
• Report Number: 2135147-2024-01205
• Device Sequence Number: 18018692
• Product Code: MLV
• UDI-Device Identifier: 00811806011790
• UDI-Public: 00811806011790
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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: 9-VSD-MUSC-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/18/2024
• 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
• Patient Sex: Unknown