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

Model Number 9-ASD-026

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date, an 18mm amplatzer septal occluder was implanted.Following the procedure, on (b)(6) 2019, the device was reported to have embolized.On (b)(6) 2019, the device was removed from the patient percutaneously by snaring and re-sheathing.The defect was balloon-sized to 18mm using a 30mm pts sizing balloon (lot number: unknown) and the physician attempted closure with a 22mm amplatzer septal occluder (lot number: 6821072) and 26mm amplatzer septal occluder (lot number: 5562243).Both devices were reported to be mis-sized.Of note, the 26mm amplatzer septal occluder was impinging on the mitral valve.The physician elected to abandoned the procedure and surgical closure is planned for a future time.

Manufacturer Narrative

Additional information: supplemental report needed to address analysis.Supplemental report needed for implant date and anatomical difficulties.Investigation will not be performed as the event did not indicate a malfunction.Correction: upon review, the septal occluder should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

Event Description

On (b)(6) 2019, an 18mm amplatzer septal occluder was implanted.Following the procedure, the device was reported to have embolized.On (b)(6) 2019, the device was removed from the patient percutaneously by snaring and re-sheathing.The defect was balloon-sized to 18mm using a 30mm pts sizing balloon (lot number: unknown) and the physician attempted closure with a 22mm amplatzer septal occluder (lot number: 6821072) and 26mm amplatzer septal occluder (lot number: 5562243).Both devices were reported to be mis-sized.Of note, the 26mm amplatzer septal occluder was impinging on the mitral valve.Additionally, the patient had multiple asds and challenging anatomical features which caused the mis-sizing.The physician elected to abandoned the procedure and surgical closure is planned for a future time.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8697308
• MDR Text Key: 148003085
• Report Number: 2135147-2019-00160
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019318
• UDI-Public: 05415067019318
• 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
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

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: 06/30/2021
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 5562243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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