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

Model Number 9-ASD-022

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  Injury  

Event Description

During an atrial septal defect closure procedure, the defect was measured via balloon sizing, sizing plate and echo measurements and measured 19 mm.A 22 mm amplatzer septal occluder (aso) was chosen along with a 9f amplatzer torqvue 45 delivery system (dtv45).The aso was attempted to be correctly positioned several times without success as the 5mm anterior edge of the defect had floppy tissue and the aso was not able to be deployed in a stable position.The 22 mm aso was removed and a larger 26 mm aso was attempted through a larger 10f dtv45.The 26mm aso was also not able to be positioned and the procedure was aborted.There were no patient consequences reported; however, the procedure was delayed 40 minutes due to this event.Patient information cannot be provided due to personal data privacy legislation/policy.

Manufacturer Narrative

The device was returned due to a positioning issue of the 22 mm amplatzer septal occluder due to patient anatomy.The investigation confirmed the device met all functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event 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: 7120222
• MDR Text Key: 94932376
• Report Number: 2135147-2017-00171
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 5872452
• Other Device ID Number: 00811806010182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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): Hospitalization