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

Model Number 9-ASD-024

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event of an amplatzer septal occluder deploying with a cobra deformation 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.An initial review of complaints data was reviewed on 13 november 2020 as a component of the complaint handling risk review per, (b)(4).The medical device problem and aho codes are consistent with the hazards/harms identified for this product family, and no new hazards, or harms were identified.

Event Description

On (b)(6) 2020, a 24mm amplatzer septal occluder(aso) was selected for implant.When the aso was deployed in the patient's defect, the aso deformed into a cobra head shape although several implant attempts were made.The physician removed the aso from the patient once to restore its shape, but the axis on the la disk appeared shifted from that on the ra disk side.The physician decided it was impossible to restore the shape.The aso was replaced with another same-sized aso, and the implant procedure was completed safely with no adverse consequence to the patient.The physician thought the issue was due to the aso, for the procedure was completed without any problem after replacement.

• 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: 10874835
• MDR Text Key: 219564293
• Report Number: 2135147-2020-00500
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

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-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 7238490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention