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

Device Problem Off-Label Use (1494)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Cardiac Tamponade (2226)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 800 consecutive patients underwent transcatheter patent foramen ovale closure between january 1995 and may 2010; amplatzer pfo occluder and amplatzer cribriform occuder (abbott), cardioform and helex pfo occluder (w.L.Gore and associates) and cardioseal starflex septal occluder(nitonal medical technologies) were associated with the study.Events of stroke, transient ischemic attack, tamponade, device embolization, deep venous thrombosis, tricuspid valve damage, residual shunt, and re-intervention were 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.Please note, per the amplatzer cribriform occluder instructions for use, 600218-010 revision b "contraindications: treatment of patients with patent foramen ovale (pfo) defects.This device has not been studied in patients with pfo defects.".

Event Description

Related manufacturing reference number: 2135147-2021-00303.The article, "efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder", was reviewed.This research article is a retrospective single center experience to compare the safety and efficacy of percutaneous patent foramen ovale (pfo) closure in patients with and without a hypercoagulable state.Amplatzer pfo occluder and amplatzer cribriform occluder (abbott), cardioform and helex pfo occluder (w.L.Gore and associates) and cardioseal starflex septal occluder(nitonal medical technologies) were associated with the study.The article concluded that percutaneous pfo closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.The primary and correspondence author of the article is eyal ben-assa bsc, md, 1 cardiology division, department of medicine, massachusetts general hospital, harvard medical school, boston, massachusetts, usa with the corresponding email: eyalbenassa@gmail.Com.

• Brand Name: AMPLATZER CRIBRIFORM 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: 12277329
• MDR Text Key: 265167136
• Report Number: 2135147-2021-00304
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• 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): Required Intervention
• Patient Age: 50 YR