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

Model Number 9-ASD-034

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2014

Event Type  Injury  

Event Description

Using a 12f amplatzer torqvue 45 delivery system (dtv45) to implant a 34mm amplatzer septal occluder (aso), the aso became detached from the dtv45 delivery cable as the aso was retracted into the delivery sheath following multiple attempts to reposition the aso.The delivery cable reportedly prematurely detached from the device causing the aso to embolize into the right atrium where it was snared and removed.No adverse patient effects were reported and a new dtv45 was used to implant a larger aso.

Manufacturer Narrative

The 12f dtv45 delivery system, delivery cable, and 34mm aso were returned to sjm and decontaminated.The results of this investigation confirmed the dtv45 delivery cable and aso met all functional and dimensional specifications when analyzed at sjm.There was no evidence to suggest there was an intrinsic defect in the delivery cable or aso, and the cause for the premature release of the aso during the procedure remains unknown.The device history record for both products was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.Information from the field indicated there were multiple attempts to re-position the aso during which turning of the delivery cable can potentially cause it to unscrew from the device.

• 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: 3726791
• MDR Text Key: 4309921
• Report Number: 2135147-2014-00032
• Device Sequence Number: 1
• Product Code: MLV
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: 9-ASD-034
• Device Lot Number: 4452311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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
• Treatment: MODEL 9-ITV12F45/80, LOT 4410640
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 57