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

Model Number 9-ASD-MF-025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 02/26/2015

Event Type  Injury  

Event Description

A 25mm amplatzer cribriform occluder (aco) was successfully implanted on (b)(6) 2014.On (b)(6) 2015, the patient was admitted to the emergency room with acute chest pain.The mr images were not clear; however, reportedly the transesophageal echocardiogram confirmed a device erosion.The aco was endothelialized and was against the right atrium and aortic root.The patient was sent to surgery where the aco was removed.The patient was reported to be recovering and has been discharged.

Manufacturer Narrative

(b)(4).The results of this investigation are inconclusive because the aco was not returned for evaluation.A review of the device history record confirmed the aco met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the aco, and the cause for the reported event remains unknown.

Event Description

A 25mm amplatzer cribriform occluder (aco) was successfully implanted on (b)(6) 2014.On (b)(6) 2015, the patient was admitted to the emergency room with acute chest pain.The mr images were not clear; reportedly the transesophageal echocardiogram confirmed device erosion.The aco was endothelialized and was against the right atrium and aortic root.The patient was sent to surgery where erosion of the right atrial wall and partial erosion of the aortic wall (non-coronary sinus) was confirmed.The aco was removed and the wound and defect were repaired.The patient was reported to be recovering and has been discharged.

• 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: 4625712
• MDR Text Key: 19405132
• Report Number: 2135147-2015-00039
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P000039/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2015

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: 04/30/2019
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 4631278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR