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

Model Number 9-ASD-MF-025

Device Problem Entrapment of Device (1212)

Patient Problems Congestive Heart Failure (1783); Occlusion (1984); Ascites (2596)

Event Date 12/25/2013

Event Type  Injury  

Manufacturer Narrative

The results of this investigation are inconclusive because the product was not returned for analysis.Review of the device history record could not be performed because the lot number was not provided.The cause for the reported event remains unknown.

Event Description

On (b)(6), 2013, a 25mm amplatzer cribriform occluder (aco) was implanted to close two atrial septal defects (asd) approximately 5mm apart.On (b)(6), 2013, the patient presented to the implanting hospital with symptoms of congestive heart failure and ascites.A cardiac ct revealed the right atrial disc of the aco was partially occluding the ivc flow.The patient was transferred to a surgical hospital where the aco was surgically removed and the asds were surgically repaired.Review of the transesophageal echo showed that the left atrial disc apposed to the septum well but the right atrial disc appeared to be caught by the eustachian ridge.Fluoro imaging confirmed that there was a large separation between the two discs of the aco.

• 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: 3581990
• MDR Text Key: 11653530
• Report Number: 2135147-2013-00137
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2013
• 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