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

Model Number 9-PFO-018

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Thrombosis (2100)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019 a 18mm amplatzer pfo occluder was implanted.On (b)(6) 2020 the patient was admitted for abdominal pain and gi bleeding.Upon imaging, it was found that the device migrated to the distal aorta.The device remained implanted.In addition, imaging also subsequently found multiple deep vein thrombosis's (dvt), however the physician does not allege a relationship between the multiple dvt's and the migrated occluder.The patient is stable and discharged.

Manufacturer Narrative

An event of device migration and leaving the dislodged device in the patient reported.A more comprehensive assessment could not be performed as 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, arten600038249 revision a " embolized devices must be removed as they may disrupt critical cardiac functions".

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10897487
• MDR Text Key: 220969588
• Report Number: 2135147-2020-00501
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (y/n): N
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 9-PFO-018
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 6808958
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR