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

Model Number 9-ASD-022

Device Problem Material Deformation (2976)

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

Event Date 12/01/2021

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 a 22mm amplatzer septal occluder was chosen for implant.During the procedure, a sizing balloon was used to size the defect.The device was prepped and inserted for placement.During the deployment, the device did not remain flat and presented in a "bulbous" shape.The device was never released from the cable and the device was removed from the patient.The device was exchanged with a 20mm amplatzer septal occluder.The device was deployed and was successfully released.There is no allegation against the sizing of the 22mm.There were not consequences to the patient as the patient remained stable throughout procedure, the patient is recovering.No additional product experience other than the reported deformation occurred.The event did not cause a delay in procedure.No additional information has been provided.

Manufacturer Narrative

The reported event of bulbous deformation 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: 13085757
• MDR Text Key: 282776235
• Report Number: 2135147-2021-00541
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010182
• UDI-Public: 00811806010182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

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-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 7695144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/26/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White