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

Model Number 9-ASD-MF-025

Device Problems Detachment Of Device Component (1104); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The 25 mm amplatzer cribriform occluder (aco) was delivered with a 9f amplatzer torque 45 delivery system ((b)(4)).The position was not satisfactory and during an attempt to recapture the aco, it prematurely detached from the delivery cable.The aco was captured with a snare and brought into the femoral vein.The patient underwent vascular surgery and the aco was explanted.A 35 mm amplatzer pfo occluder was successfully implanted with a 10f (b)(4).The patient was reported to be stable.

Manufacturer Narrative

(b)(4).The results of this investigation confirmed the amplatzer cribriform occluder (aco) and amplatzer torque delivery system delivery cable met all functional specifications when analyzed at sjm.A review of the device history records confirmed the aco and delivery cable met all visual, dimensional, and functional specifications at the time they were manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the aco or delivery cable, and the cause for the reported event remains unknown.

• 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: 5257533
• MDR Text Key: 32389604
• Report Number: 2135147-2015-00142
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P000039/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 5119043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• 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