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

Model Number 9-ASD-MF-018

Device Problem Unintended Movement (3026)

Patient Problems Congenital Defect/Deformity (1782); Perforation (2001)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

An 18 mm amplatzer cribriform occluder (aco) was implanted in an atrial septal defect with little aortic rim.After released from the delivery cable, the aco embolized and came to rest in the abdominal aorta at the bifurcation which impeded flow into one of the legs.Attempts to remove the aco using a bioptome and a snare were unsuccessful and resulted in perforation of the aorta.The patient was taken to surgery for repair of the perforation and removal of the aco.The patient is stable and recovering.

• 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: 5161650
• MDR Text Key: 28745040
• Report Number: 2135147-2015-00123
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-018
• Device Catalogue Number: 9-ASD-MF-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• 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): Congenital Anomaly; Hospitalization; Required Intervention