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

Model Number 9-PFO-025

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 35mm amplatzer pfo occluder (lot number: 6352588) was selected for implant, however, it was not used because it was too big.The device was exchanged for a 25mm amplatzer pfo occluder (lot number: 6300742).Upon release of the 25mm pfo occluder, the device immediately shifted out of place but remained in the defect.The user attempted to retrieve the device, but during retrieval, the device dislodged and embolized to the descending aorta.The occluder was removed percutaneously, and a 30mm amplatzer cribriform (lot number: 6311458) was successfully implanted.The patient is reported to be stable.

Manufacturer Narrative

An event of embolization was reported.Information from the field indicates the user released the 25mm device (pfo occluder) which shifted out of position and then while attempting to retrieve the device, it embolized into the aorta.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; it is reported the 25mm pfo device embolized and that the final implant was a 30mm cribriform.

• Brand Name: AMPLATZER PFO 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7702824
• MDR Text Key: 114453399
• Report Number: 2135147-2018-00090
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

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: 12/31/2022
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6300742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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