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

Model Number 9-ASD-032

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895); Material Deformation (2976); Material Protrusion/Extrusion (2979)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2021, a 32mm amplatzer septal occluder was selected for implant.Upon deployment a cobra deformation was noted.The device was removed and rinsed or "smudged" and loaded again however, the device would still deform and it was noted that the polyester coating was coming off as well.The device looked darker and less bluish than the usual amplatzer septal occluder that has undergone the intaglio treatment.A 34mm amplatzer septal occluder, was selected for implant however, wouldn't stay in the defect as the rims were insufficient for deployment.The device was withdrawn from the sheath and it was noted that the polythene stands were deformed and protruding out the device.The procedure was postponed for a coinvent slot for a surgical closure.There were no patient consequences reported.The patient was reported to be in stable condition.

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

The reported event of device deformation, the device appearing darker and "less blue" and "the polyester coating coming off" could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.Differences in the color of the nitinol wire in device is a normal and acceptable characteristic of the occluder.A range of colors is possible due to the thermal set in the manufacturing process, where the color will differ due to the oxide thickness that develops during thermal set.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
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12967788
• MDR Text Key: 282776345
• Report Number: 2135147-2021-00554
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010236
• UDI-Public: 00811806010236
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-032
• Device Catalogue Number: 9-ASD-032
• Device Lot Number: 7614602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• 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