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

Model Number 9-VSD-MUSC-010

Device Problem Positioning Problem (3009)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/07/2014

Event Type  Injury  

Event Description

A (b)(6)-old patient had a percutaneous closure of her vsd but the device was recaptured and the vsd was surgically closed with a patch.A residual leak remained and on (b)(6) 2014, the patient returned to the cath lab to close the residual leak with a 10mm amplatzer muscular vsd occluder (muscvsd).The muscvsd embolized to the left ventricle and was surgically removed and the residual vsd was repaired with a patch.The patient was noted to be recovering.

Manufacturer Narrative

The device history record for this product 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.

• Brand Name: AMPLATZER MUSCULAR VSD 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: 3761349
• MDR Text Key: 4551605
• Report Number: 2135147-2014-00035
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040040
• 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
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2017
• Device Model Number: 9-VSD-MUSC-010
• Device Catalogue Number: 9-VSD-MUSC-010
• Device Lot Number: 1201256641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• 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
• Patient Age: 21 MO