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

Model Number 9-ASD-008

Device Problem Material Deformation (2976)

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

Event Date 12/16/2021

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, an 8mm amplatzer septal occluder was selected for implant.During procedure, during deployment of the device inside the left atrium, the device deformed into a cobra shape and was removed from the patient prior to being released.The device was "reassembled, but the same problem was observed." a new 8mm amplatzer septal occluder was successfully implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

The reported event of device deformity 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
• 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: 13095070
• MDR Text Key: 283087450
• Report Number: 2135147-2021-00578
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010052
• UDI-Public: 00811806010052
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-008
• Device Catalogue Number: 9-ASD-008
• Device Lot Number: 7331754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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