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

Model Number 9-PFO-025

Device Problem Biocompatibility (2886)

Patient Problems Embolus (1830); Thrombus (2101)

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) 2018, a 25mm amplatzer pfo occluder was successfully implanted in a patient with a history of stroke.2 years post-procedure the patient presented with stroke.The echo revealed an obvious clot on the left disc, the presumptive site for the origin of the embolus.

Event Description

On (b)(6) 2018, a 25mm amplatzer pfo occluder was successfully implanted in a patient with a history of stroke, hypertension, diabetes, hyperlipidemia and tobacco user.2 years post-procedure the patient presented with stroke.The patient received a magnetic resonance imaging(mri) and computed tomography(ct) scan to confirm the stroke.The echo revealed an obvious clot on the left disc, the presumptive site for the origin of the embolus.The patient was placed on heparin drip and was given medication.The patient is currently discharged.

Manufacturer Narrative

Additional information for: b5, b7, g4, g7, h2, h6, and h10.An event of stroke two years after device implant was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, one video was received for analysis.Based solely on the aforementioned video, a clot did appear to be attached to the disc of the device.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the warnings section of the instructions for use, 600035-021 revision 1, stroke is a potential event due to device placement.

• 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: 10823080
• MDR Text Key: 215975909
• Report Number: 2135147-2020-00463
• Device Sequence Number: 1
• Product Code: MLV
• 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: 12/10/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR