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

Device Problems Backflow (1064); Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Dyspnea (1816); Foreign Body Embolism (4439); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"the article, "migration of pfo closure device and entrapment within tricuspid valve leading to tricuspid complication after transcutaneous pfo closure regurgitation: surgical correction of an extremely rare", was reviewed.This research article reported that a (b)(6) woman presented to a cardiology team with a thalamic cryptogenic stroke.Bubble echocardiogram confirmed the presence of a patent foramen ovale (pfo).Patient underwent transcatheter closure of a pfo with a amplatzer pfo closure device, without any complications.Post-procedural echocardiogram showed the device was well seated.Six months after the procedure, the patient presented to the cardiology team with periods of significant shortness of breath, especially on exertion and usually accompanied by occasional heavy chest pain.Patient developed paroxysmal nocturnal dyspnoea and could not lie flat.A repeat bubble echocardiogram showed pfo device migration onto the septal leaflet of the tricuspid valve with moderate to severe tricuspid regurgitation, device embolization, and reopening of the pfo.On examination the patient was hemodynamically stable.The patient was urgently transferred for open heart surgery.The pfo device was found to be deeply endothelialized and embedded in the septal leaflet of the tricuspid valve apparatus.A combination of extensive sharp and blunt dissection was carried out to remove the device without damage to the leaflet to preserve the native tricuspid valve.Due to distorted anatomy of the valvular apparatus, the septal and posterior leaflets of the tricuspid valve were bicuspidised to correct the regurgitation.The pfo was closed with simple continuous suture without the need for a patch.An intraoperative transesophageal echocardiogram was performed again and showed persistence of severe tricuspid regurgitation.A further attempt to repair the tricuspid valve was made to avoid replacing the tricuspid valve.The heart was put on bypass and the right atrium was opened again, the tricuspid valve was further bicuspidised.Subsequent echocardiogram showed significant improvement in tricuspid regurgitation.The patient noted resolution of the presenting symptoms.The patient had an uneventful recovery and was discharged from the hospital four days after the procedure.The article concluded that transcutaneous closure of patent foramen ovale is associated with rare, yet serious complications.Timely referral to the cardiothoracic surgical team is important to provide safe and effective patient care.Surgical retrieval of the migrated embolized device and repair of the tricuspid valve could be done safely.The primary and correspondence author is myat soe thet, md, department of cardiothoracic surgery, bartholomew's hospital, barts health nhs trust, london, united kingdom, w smithfield, london ec1a 7be, united kingdom, email: myatsoe.Thet@nhs.Net.

Manufacturer Narrative

As reported in a research article, a patient underwent closure of a patent foramen ovale with an amplatzer pfo occluder; an event of device embolization, shortness of breath, chest pain, paroxysmal nocturnal dyspnea, tricuspid regurgitation, and device explant was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11486269
• MDR Text Key: 248077247
• Report Number: 2135147-2021-00100
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR