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

Model Number 9-PFO-025

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

On (b)(6) 2018, a 25mm amplatzer pfo occluder was selected for implant.After performing a stability check, the device was released, and subsequently, the device prolapsed into the defect.The physician attempted to retrieve the device, and during retrieval, the device embolized to the aorta.The device was successfully snared and removed.Then a 35mm amplatzer pfo occluder (lot number: 5883872) was implanted.Post-implant tee was performed to ensure there were no issues associated with the embolized device and its retrieval.The patient was discharged on (b)(6) 2018 without any complications.

Manufacturer Narrative

An event that the device "prolapsed into the defect" and embolized during an attempt at retrieval was reported.The investigation confirmed the occluder met all functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER PFO 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8177057
• MDR Text Key: 130773279
• Report Number: 2135147-2018-00240
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6667186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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
• Patient Age: 78 YR