MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-024

Device Problem Material Deformation (2976)

Patient Problem Tissue Damage (2104)

Event Date 09/19/2017

Event Type  Injury  

Event Description

A 24 mm amplatzer septal occluder (aso) deployed cobra shape in the patient.During removal of the aso, tee revealed damage to the eustachian valve or atrial wall.The patient was referred to surgery due to challenging anatomy as the user reported a successful aso closure was not likely.Of note, it was well established prior to the procedure that the patient may not have been a successful aso implant candidate and would require surgical intervention.

Manufacturer Narrative

The reported event of deformation upon deployment could not be confirmed.The results of this investigation confirmed the 24 mm amplatzer septal occluder met all functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.A cause for the reported deformation remains unknown.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6952301
• MDR Text Key: 89409213
• Report Number: 2135147-2017-00123
• Device Sequence Number: 1
• Product Code: MLV
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

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: 01/31/2022
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 5874940
• Other Device ID Number: 00811806010199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2017
• 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