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

Catalog Number 9-VSD-MUSC-012

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 12mm amplatzer muscular vsd occluder was chosen to close an esophageal fistula.The physician was aware that the usage of the product was off-label.The fistula was measured on computed tomography (ct) scan, and the device chosen was 30-40% larger than the implant site.The procedure was completed without difficulties.One month later, on follow up ct scan, it was noted that the device had moved inside the fistula.The patient did not have any symptoms.On (b)(6) 2023, the device was snared out easily with no complications for the patient.The device migration was believed to possibly due to the ct scan measurements being incorrect or that the device was too small for the defect.The patient was reported as stable.

Manufacturer Narrative

An event of device moved inside the fistula was reported.It was reported that the migrated device was snared with no complications.A returned device assessment could not be performed as the device was not returned for analysis.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, however could possibly related to incorrect sizing.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.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.

Event Description

N/a.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: 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: 18143001
• MDR Text Key: 328196789
• Report Number: 2135147-2023-05018
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011820
• UDI-Public: 00811806011820
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-VSD-MUSC-012
• Device Lot Number: 8996667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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): Required Intervention
• Patient Sex: Female