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

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article out of 110 patient had pfo closure using either cardioseal occluder, an amplatzer pfo occluder, an amplatzer septal occluder, or an amplatzer cribriform one patient had a device embolize, and four had a shunt requiring reoperation.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

Reference manufacturing report 2135147-2020-00078.It was reported through a research article identifying amplatzer devices that may be related to a complications post procedure.Details are listed in the article, titled "effect of residual interatrial shunt on migraine burden after transcatheter closure of patent foramen ovale." it was reported in the article that 110 patients underwent pfo closure using either: cardioseal occluder device, or any of the amplatzer pfo occluder, septal occluder, or cribiform devices.The average age of the patients was 42.7 years, with 74 of them being female.The comorbidities include: hypertension, diabetes, hypercoagulability, history of smoking, arrhythmias, and migraines.Post procedural complications includes: device embolization (1), reoperation due to shunt (4).

• Brand Name: AMPLATZER OCCLUDER (UNKNOWN)
• 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: 9759137
• MDR Text Key: 181826245
• Report Number: 2135147-2020-00080
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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: 02/09/2020
• 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: 43 YR