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

Model Number 9-VSD-MUSC-004

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 06/17/2014

Event Type  Injury  

Event Description

A 4mm amplatzer muscular vsd occluder (muscvsd) was released from the cable then embolized from the ventricular septal defect.The muscvsd was snared and removed.No adverse patient effects were reported.

Manufacturer Narrative

The 4mm muscvsd was returned to sjm and decontaminated.The muscvsd was removed from the snare, grossly and microscopically examined, and no anomalies were found.The muscvsd met dimensional specifications when measured with a caliper.The muscvsd was loaded into a test loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.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.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the embolization remains unknown.

• 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 ; 6517565400
• MDR Report Key: 3999374
• MDR Text Key: 4775376
• Report Number: 2135147-2014-00074
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/24/2017
• Device Model Number: 9-VSD-MUSC-004
• Device Lot Number: 1211271042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2012
• 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