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

Model Number 9-ASD-014

Device Problems Retraction Problem (1536); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Pre-implant, the patient's atrial septal defect (asd) measured 8-10 mm following a pre-op and intraoperative tee and was balloon-sized to 12 mm.A 14 mm amplatzer septal occluder (aso) was deployed and placement appeared favorable on echo; however, as the aso was released it embolized to the descending aorta.A 12f amplatzer torqvue sheath was placed in the artery via arterial access in the groin and a gooseneck snare was advanced.The aso was snared but would not collapse and, therefore, could not be retracted within the sheath so the 12f sheath was exchanged for a non-abbott 18f sheath allowing the aso to be snared and removed.The asd was re-examined and it was found that the defect was more complex than expected so the procedure was abandoned and the patient will be re-evaluated.Per report, secondary to the use of a unknown mechanical closure device the patient sustained an unspecified injury to the groin area.Despite multiple requests, additional details were not made available.

• Brand Name: AMPLATZER SEPTAL 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: 6820371
• MDR Text Key: 83640963
• Report Number: 2135147-2017-00098
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 5721823
• Other Device ID Number: 00811806010113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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