MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-020

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The reported event of the device not sitting properly and deploying deformed could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 20mm amplatzer septal occluder was selected for implant.During the procedure, the physician unsheathed the left atrial disc and was pulling back the device in order to un-sheath the right disc.Since the device was not aligning to the septum properly, the physician decided to re-sheath the left atrial disc and rotate the sheath in effort to adjust the angle in which the device would align to have a better orientation once it was completely unsheathed.This was attempted 3 times, in which the device would not sit properly.On the 4th time, when the physician rotated the sheath to change angles, the device was deployed and formed a cobra shape.The device was retracted, removed from the patient, and exchanged for another 20mm amplatzer occluder (lot # 6674420).The second device was successfully implanted.The delivery system was not exchanged when the device was exchanged.There was no negative impact on the patient and there were no significant delays in the procedure.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10901592
• MDR Text Key: 218206177
• Report Number: 2135147-2020-00511
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: 00811806010175
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 6178005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 4 YR