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

Model Number 9-PFO-035

Device Problem Biocompatibility (2886)

Patient Problems Stroke/CVA (1770); Headache (1880); Visual Disturbances (2140); Thromboembolism (2654); Paresthesia (4421); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

In an research article an events of bilateral occipital, right fronto-parietal strokes, left upper limb weakness, paresthesia and thrombus were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "recurrent stroke secondary to late pfo-closure device thrombus: a case report", was reviewed.This research article presents a case study on a (b)(6) woman who developed late-onset recurrent embolic strokes.Patient's medical history included myelofibrosis with recurrent arterial and venous thromboembolism and a multifocal right occipital lobe infarct in 2018.It was reported that in april of 2020, the patient underwent percutaneous patent foramen ovale (pfo) closure.During the procedure a 25mm amplatzer pfo occluder was selected for implant, but was mis-sized.The device was exchanged and a 35mm amplatzer pfo occluder was successfully implanted in the patient.In september of 2020, the patient presented to the hospital with occipital headache and visual changes and was found to have bilateral occipital and right fronto-parietal strokes.Routine post-stroke transthoracic echocardiography (tte) demonstrated a mobile thrombus (1.8cm by 1.0cm) in the left atrium attached to the pfo device.There was separation of the left atrial disc of the pfo device from the inter-atrial septum adjacent to the thrombus and the patient was commenced on intravenous heparin anticoagulation.During the patient's hospital stay they experienced left upper limb weakness and paresthesia.Repeat magnetic resonance imaging (mri) demonstrated multifocal embolic infarcts in the right parietal and frontal lobes.Due to the patient's history of myelofibrosis and hypercoagulable state, surgical device explantation was too high risk and the patient was transitioned to subcutaneous enoxaparin anti-thrombotic therapy long-term.Repeat tte 6 days following the initial tte demonstrated a reduction in thrombus size and the patient was discharged home.Transesophageal echocardiogram 5 weeks after discharge showed residual device-associated thrombus with no significant change in size.On 6 month follow-up, the patient has not suffered any further neurological events.No additional information was provided.The article concluded that device-associated thrombus is an uncommon late complication of percutaneous pfo closure, as such, evidence as to the optimal management is lacking.Given this uncertain benefit of pfo closure in anticoagulated patients and the unclear risk profile, patient selection, and thorough pre-procedural evaluation are vital when assessing the appropriateness of percutaneous pfo closure.The primary and correspondence author of the article is lennox jerzyna, division of medicine, wollongong hospital, wollongong, nsw 2500, australia with the corresponding email: lennoxscott.Jerzyna@health.Nsw.Gov.Au.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12488796
• MDR Text Key: 272140039
• Report Number: 2135147-2021-00359
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR