MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER VSD MUSCULAR 10MM PKG STER; CARDIAC OCCLUSION DEVICE

Model Number 9-VSD-MUSC-010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation are inconclusive because the 10mm amplatzer muscular vsd occluder was not returned to sjm for evaluation.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the embolization remains unknown.However, information from the field suggests the chosen device was too small for the defect.

Event Description

A 10mm amplatzer muscular vsd occluder (muscvsd) was successfully implanted.Sometime after the device had embolized to the pulmonary artery and was successfully snared.

• Brand Name: AMPLATZER VSD MUSCULAR 10MM PKG STER
• 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: 4085696
• MDR Text Key: 12567407
• Report Number: 2135147-2014-00085
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2017
• Device Model Number: 9-VSD-MUSC-010
• Device Catalogue Number: 9-VSD-MUSC-010
• Device Lot Number: 1205011877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2012
• 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