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

Model Number 9-ASD-017

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 06/26/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2021, a 17mm amplatzer septal occluder was selected for implant.During device preparation, it was noted that it was tough to pull the device into the loader.When pushed back out, the occluder deformed into a cobra shape and then returned to normal.It was decided to test the occluder inside the patient.The left disc was normal and positioned well, however the right disc continued to deform; the right disc was sitting oddly to the atrial septum.The physician attempted to reposition the occluder, however the issue persisted and the occluder was removed from the patient.A new 16mm amplatzer septal occluder was successfully implanted.No patient consequences were reported.

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 under non-physiological conditions.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 event 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: 12150069
• MDR Text Key: 261022648
• Report Number: 2135147-2021-00265
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010144
• UDI-Public: 00811806010144
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-017
• Device Catalogue Number: 9-ASD-017
• Device Lot Number: 7260675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1