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

Model Number 9-ASD-MF-025

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 10/31/2014

Event Type  Injury  

Event Description

After a 25mm amplatzer cribriform occluder (aco) was released from the cable, the device position was not ideal and the aco was too small so the aco was percutaneously snared and a 30mm aco was implanted.

Manufacturer Narrative

(b)(4).

• Brand Name: AMPLATZER CRIBRIFORM 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: 4246094
• MDR Text Key: 5014407
• Report Number: 2135147-2014-00106
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039/S013
• 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,Followup
• Report Date: 10/31/2014

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: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 3992971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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