MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)

Patient Problems Embolism (1829); Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 245 patients were implanted with amplatzer septal occluder and complications during or after the procedure including two patients which had the device embolize, three where the device migrated, eleven patients had a residual shun and four patients had a transient ischemic attack and stroke.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying amplatzer septal occluders that may be related to a complications post procedure.Details are listed in the article, titled "transcatheter closure vs totally endoscopic robotic surgery for atrial septal defect closure: a single-center experience." between january 2011 and may 2019, amplatzer septal occluders were implanted in 245 patients.The median age was 39, with 180 of them being women.The patients had the following comorbidities: atrial fibrillation, transient ischemic attack (tia), stroke, lung disease, hypertension, coronary artery disease, and diabetes.Complications during and post procedure includes: residual shunt (11), device migration (3), device embolization (2), tia and stroke (4).

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9850642
• MDR Text Key: 184069440
• Report Number: 2135147-2020-00118
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/18/2020
• 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): Other; Required Intervention
• Patient Age: 39 YR