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

Device Problems Biocompatibility (2886); Human-Device Interface Problem (2949)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/02/2021

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,"efficacy and safety of atrial septal defect closure using occlutech figulla flex ii compared with amplatzer septal occluder" was reviewed.The research article is a retrospective single center experience to examine the efficacy and safety of occlutech figulla flex ii (ffii) compared with amplatzer septal occluder (aso) for transcatheter atrial septal defect (asd) closure.Amplatzer septal occluder(abbott) and occlutech figulla flex ii(occlutech gmbh) were associated with the study.There is no allegation of malfunction of the abbott devices.The article concluded that there was no difference in the prevalence of procedural complications or the presence of a residual shunt between the ffii group and the aso group.The primary author is rie nakayama, department of cardiovascular medicine, okayama university graduate school of medicine, dentistry and pharmaceutical science, 2-5-1 shikata-cho, kita-ku, okayama 700-8558, japan.The correspondence author is yoichi takaya, department of cardiovascular medicine, okayama university graduate school of medicine, dentistry and pharmaceutical science, 2-5-1 shikata-cho, kita-ku, okayama 700-8558, japan with the email takayayoichi@okayama-u.Ac.Jp.

Manufacturer Narrative

As reported in a research article, between april 2013 and april 2019, 380 patients with a secundum atrial septal defect underwent transcatheter closure using an occlutech figulla flex ii (190) or an amplatzer septal occluder (190).Events of residual shunt and atrial fibrillation 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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11356678
• MDR Text Key: 234504703
• Report Number: 2135147-2021-00064
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• 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: 03/17/2021

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: 01/24/2021
• Initial Date FDA Received: 02/21/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR