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

Device Problem Off-Label Use (1494)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article titled "recurrent cerebrovascular events in patients after percutaneous closure of patent foramen ovale" that 282 consecutive patients with pfo who were referred underwent pfo closure from october 2006 to march 2014.The devices implanted include amplatzer pfo occluder (153), amplatzer asd occluder (32), amplatzer cribiform occluder (31), solysafe septal occluder (4), gore helex septal occluder (8), gore septal occluder (24), biostar (29), and starflex cardioseal (1).Complications reported include temporary st- elevation (4), thrombus on catheter during operation (4), minor bleeding (5), device dislocation (5), atrial fibrillation (18), heart block (4), residual shunting (64), recurrent cve (9).It was no stated what devices were associated with the reported events and there are no allegations against the abbott devices.No additional information was obtained.

Manufacturer Narrative

Additional information sections: as reported in a research article, complications from having an amplatzer cribriform occluder implanted off label to close a pfo defect included temporary st elevation, thrombus on the catheter during the operation, bleeding, device dislocation, atrial fibrillation, heart block, residual shunt, and recurrent cve.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 instructions for use 600317-004 revision a "contraindications: treatment of patients with patent formen ovale (pfo) defect.This device has not been studied in patients with pfo defects.".

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10111990
• MDR Text Key: 194122995
• Report Number: 2135147-2020-00235
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention