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

Model Number 9-VSD-MUSC-012

Device Problems Perivalvular Leak (1457); Positioning Problem (3009)

Patient Problem Embolism (1829)

Event Date 11/28/2014

Event Type  Injury  

Event Description

A 12mm amplatzer muscular vsd occluder (muscvsd) was selected to close a paravalvular leak (pvl) adjacent to the mitral valve; however, following release the muscvsd was knocked out of position when attempting to cross a second pvl adjacent to the mitral valve.The muscvsd was percutaneously snared and removed.A 12mm amplatzer vascular plug ii (avpii) was then selected; following release, it embolized while trying to cross the second pvl.The avpii was percutaneously retrieved and removed.The procedure was completed using a 14mm muscvsd.The patient was stable.

• 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: 4343175
• MDR Text Key: 5218084
• Report Number: 2135147-2014-00121
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 9-VSD-MUSC-012
• Device Catalogue Number: 9-VSD-MUSC-012
• Device Lot Number: 4199708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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