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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Transient Ischemic Attack (2109); Pericardial Effusion (3271)

Event Date 02/12/2021

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, "patent foramen ovale closure among patients with hypercoagulable states maintained on antithrombotic therapy" was reviewed.This research article is a retrospective single center experience to evaluate whether primary patent foramen ovale(pfo) closure is associated with lower incidence cryptogenic strokes among patients with clinically significant hypercoagulable states(hcs) of various types and who are maintained on antithrombotic therapy.Amplatzer pfo occluder(abbott) and occlutech figulla(occlutech gmbh) were associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that among patients with hcss maintained on anticoagulant or antiplatelet therapies, pfo closure was associated with a significantly lower risk of cerebrovascular accident(cva) or transient ischemic attack(tia).The primary and correspondence author of the article is jonathan buber, heart center, chaim sheba medical centre, tel-hashomer, israel with the corresponding email: (b)(6).

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10 as reported in a research article, 85 patients underwent transcatheter patent foramen ovale, 37 of those patients were implanted with an amplatzer pfo occluder; events of pericardial effusion, atrial fibrillation, large groin hematoma, residual shunt, cerebrovascular accident, stroke and transient ischemic attack.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: 11586855
• MDR Text Key: 249449072
• Report Number: 2135147-2021-00113
• 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: 04/14/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR