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

Model Number 9-ASD-020

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a 20mm amplatzer septal occluder was selected for implant in the patient.During the procedure, the physician attempted to place the amplatzer septal occluder into the left atrium.As the device exited the delivery sheath into the left atrium a cobra head malformation was observed.The device was removed from the body prior to release from the cable, flushed, and a second attempt to place the device was taken, at which point the device took a cobra head shape again.The device was removed without being released from the cable and exchanged for a 19mm amplatzer septal occluder.The 19mm amplatzer septal occluder was placed in the atrial septum.This device originally captured the atrial septum, however, further manipulation revealed right disc prolapse into the left atrium, and that the device was too small.The 19mm amplatzer septal occluder was removed from the patient prior to release from the cable and was exchanged for a 22mm amplatzer septal occluder.The 22mm amplatzer septal occluder was placed and released effectively.The patient was not impacted by these events, the procedure was completed without patient impact and the patient remained hemodynamically stable.Although the procedure was extended, there was no significant delay in patient care.The physician did not attribute the concern to any device related contributions, and rather felt that the device malformations and sizing concerns were the result of a challenging anatomy.No additional information was provided.

Manufacturer Narrative

The reported event of deformity of device could not be confirmed.The investigation confirmed, the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed, to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12199639
• MDR Text Key: 262638437
• Report Number: 2135147-2021-00292
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: 00811806010175
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 7372550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR