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

Model Number 9-ASD-030

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

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

Event Date 11/27/2021

Event Type  malfunction  

Event Description

It was reported a 30mm amplatzer septal occluder was chosen for procedure.During procedure, there had been no difficulty loading the device after the flushing was performed, however when the user attempted to deploy, and resistance was felt.The user withdrew the device from the patient and inspected the device, while attempting to redeploy the device, the device presented in cobra formation.The device was removed and exchanged with a new device.The patient remained stable throughout the procedure and has been discharged.

Manufacturer Narrative

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

Manufacturer Narrative

An event of cobra deformation and resistance upon deployment was reported.The investigation confirmed the device met visual, dimensional 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.Please note, per the amplatzer septal occluder instructions for use, artmt600034451 revision c "warnings: do not release the device from the delivery cable if the device does not conform to its original configuration or if the device position is unstable or if the device interferes with any adjacent cardiac structure, such as superior vena cava (svc), pulmonary vein (pv), mitral valve (mv), coronary sinus (cs) or aorta (ao).Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace with a new device.".

• 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: 13052927
• MDR Text Key: 282775693
• Report Number: 2135147-2021-00570
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: 00811806010229
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 7212956
• 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: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2019
• 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