MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-MF-018-US

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

An event of embolization of a device implanted in 2013 and off label use of a cribriform device to close a pfo was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, artmt 600218-010 revision b "contraindications: treatment of patients with patent foramen ovale (pfo) defects.This device has not been studied in patients with pfo defects.".

Event Description

On an unknown date in 2013, a 18mm amplatzer asd mf occluder was implanted for a pfo.On an unknown date, the device embolized.There was no indication as to the time frame of the embolization.At the start of the procedure, the device was observed to be in the descending aorta under fluoroscopy.Access was gained via the femoral artery and a 6f gooseneck snare was used to grasp the embolized device.It was then observed under fluoroscopy that the device had epithelialized within the descending aorta tissues and removal of the 18mm asd mf was aborted.The pfo was closed using a 35mm pfo occluder successfully.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9866473
• MDR Text Key: 184662000
• Report Number: 2135147-2020-00133
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• 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-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2020
• 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
• Patient Age: 44 YR