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

Catalog Number 9-ASD-024

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 01/30/2024

Event Type  malfunction  

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) 2024, a 24mm amplatzer septal occluder was chosen for implantation utilizing a 12f amplatzer torqvue delivery system.During deployment, the occluder deformed into a cobra shape.The occluder was removed and a replacement 24mm amplatzer septal occluder (lot: 9031477) was attempted to be implanted with the same delivery system resulting in another cobra shaped deformation.The procedure was aborted and the patient underwent surgical intervention instead.There was no angulation or kink in the delivery system during either attempt.

Manufacturer Narrative

An event of device deformity during implant was reported.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Field indicated that a 12f amplatzer torqvue delivery system was used.Please note that per the amplatzer septal occluder instructions for use, the recommended size delivery system for use with a 24 mm septal occluder is an 9f.

Event Description

It was reported that on (b)(6) 2024, a 24mm amplatzer septal occluder (lot: 8937058) was chosen for implantation utilizing a 12f amplatzer torqvue delivery system.During deployment, the occluder deformed into a cobra shape.The occluder was removed and a replacement 24mm amplatzer septal occluder (lot: 9031477) was attempted to be implanted with the same delivery system resulting in another cobra shaped deformation.The procedure was aborted and the patient underwent a non-emergent surgical intervention instead.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.There was no angulation or kink in the delivery system or interaction with cardiac structures during either attempt.The patient is reported to be discharged.

• Brand Name: AMPLATZER SEPTAL 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: 18743480
• MDR Text Key: 335811032
• Report Number: 2135147-2024-00760
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000039
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 8937058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2023
• 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