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

Model Number	9-PFO-018
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Abdominal Pain (1685); Thrombosis (2100)
Date of Event	10/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
Event or Problem 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.
Additional 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10897487
• Report Number: 2135147-2020-00501
• Device Sequence Number: 14088969
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR