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

Model Number 9-ASD-022

Device Problem Material Deformation (2976)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 22mm amplatzer septal occluder was selected for use with a 10fr delivery catheter.Upon deployment, the device formed into a cobra shape.The physician did not have complete visibility during the procedure, but states that the device did not sit properly so he resheathed the device twice in an attempt to fix the cobra shape, without success.The device was removed and deployed outside the patient, still taking on the cobra shape.Another physician resheathed the device and deployed it (outside the patient) and the occluder took on the proper shape.Tissue was noted on the device when initially removed from the patient.A new 24mm amplatzer septal occluder was used to successfully complete the procedure.The procedure was not significantly extended.The physician did see the deformation as a malfunction but reported it was not one that would result in patient harm.The patient was hemodynamically stable throughout the procedure and was discharged.

Manufacturer Narrative

The reported event of deformity upon deployment could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.Information from the field indicated that a 10f delivery sheath was used.Please note, per the instructions for use artmt100116885 ver a, the recommended delivery system size for this device is 9f.

• 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: 7879562
• MDR Text Key: 120379635
• Report Number: 2135147-2018-00151
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010182
• UDI-Public: 00811806010182
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/20/2018

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: 01/31/2023
• Device Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 6328573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• 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