MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER

Model Number CVD0091

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Information was received that following the implant of an amplatzer septal occluder for treatment of an atrial septal defect, the patient was noted to have a pulmonary vein perforation.The patient reportedly had hemolysis as well.The exact implant and event date remain unconfirmed but were reportedly in (b)(6) 2017.No additional details were made available on the device or patient status however it has been requested.

Event Description

Information was received that in (b)(6) 2017, following the implant of an amplatzer septal occluder for atrial septal defect closure, the patient was noted to have a pulmonary vein perforation and had hemolysis.Repeated request for additional details were made however no additional information was provided.The implanting physician was not the physician who reported the event.

Manufacturer Narrative

An event of pulmonary vein perforation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: AMPLATZER SEPTAL OCCLUDER
• 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: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7134045
• MDR Text Key: 95376589
• Report Number: 2135147-2017-00174
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• 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