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

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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, "transcatheter closure of atrial septal defect associated with pulmonary artery hypertension using fenestrated devices", was reviewed.This research article is a retrospective single center experience to evaluate the safety and efficacy of transcatheter closure of atrial septal defect(asd) in selected patients with pulmonary artery hypertension (pah) using a fenestrated device followed by pulmonary vasodilator therapy.Amplatzer septal occluder(abbott) was associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that asd patients with moderate-to-severe pah can be managed by using a fenestrated device and followed by vasodilator treatment.The strategy of partial closure with a fenestrated device followed by vasodilator treatment was effective in majority of the patients.The primary and correspondence author of the article is jou-kou wang, md, phd, department of pediatrics, national taiwan university hospital, and medical college, national taiwan university, taipei, taiwan with the corresponding email: jkww@ntuh.Gov.Tw.

Manufacturer Narrative

As reported in a research article, 51 patient underwent secundum type atrial septal defect closure with an amplatzer septal occluder between (b)(6) 2002 and (b)(6) 2017; events of 35 patients receiving vasodilator therapy, fenestrations still patent in 15 patients, and left-to-right shunt across the fenestrations observed on precordial echocardiography in 21 patients 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: 11697966
• MDR Text Key: 246430076
• Report Number: 2135147-2021-00146
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR