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

Model Number 9-PFO-025

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Embolism (1829); Ischemia (1942); Numbness (2415)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2019, a 25mm amplatzer pfo was selected for implant.The patient was recently diagnosed of stroke on (b)(6) 2018.The device was implanted with a 8f troqvue delivery system through the right femoral vein.The physician noticed an unexpected positional adjustment/shift in positioning of the device upon removal of the delivery system.The patient was discharged on (b)(6) 2019 and did well on the one month follow up.On (b)(6) 2020, the patient experiences an ischemic stroke.The patient had left cheek numbness and slurred speech.Symptoms were sudden onset and present constantly for 15 minutes until they resolved on their own.Medication was administered.

Manufacturer Narrative

Additional information for g4, g7, h2, h6, and h10.The device remained implanted.Upon review of the device history records, there were no observed artifacts related to the design, or assembly, or device acceptance inspections that indicate the design or the manufacture of the present occluder is the root cause of the observed transient ischemic attack.The attack occurred four months after the implant procedure in a patient with a history of stroke 11 months prior to the procedure.

• 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: 10041530
• MDR Text Key: 190658970
• Report Number: 2135147-2020-00201
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7142532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR