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

Model Number 9-VSD-MUSC-010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Regurgitation (2259)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information was obtained from a 2017 literature article titled, "percutaneous closure of left ventricular pseudoaneursym with septal occluder device and coils: a multimodality imaging approach." a patient presented to the hospital for a two week follow up after a myocardial infarction.An echocardiogram (ecg) diagnosed a left ventricular pseudoaneurysm.A 10mm amplatzer muscular vsd occluder (muscvsd) was successfully deployed via a retrograde transaortic approach.A follow up ecg showed continued flow into the pseudoaneurysm.The patient was brought back to the cath lab three days later for direct chest wall entry into the pseudoaneurysm to deploy three coils (boston scientific, 0.018 inch interlock 2d coils).The residual flow was resolved and the patient was discharged.Conclusion: multimodality imaging is essential for diagnosis, to completely understand the pseudoaneurysm anatomy, for procedural planning, and ultimately to guide the intervention.Doi: 10.1016/j.Jcin.2017.06.033.

• 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: 6853350
• MDR Text Key: 85465881
• Report Number: 2135147-2017-00104
• 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: company representative,litera
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSD-MUSC-010
• Device Catalogue Number: 9-VSD-MUSC-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 79 YR