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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Type  Death  

Manufacturer Narrative

An event of death following aortic dissection 10 years following implant was reported.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; however, no evidence was provided of a device malfunction.

Event Description

Ten years following implant of an amplatzer duct occluder, the patient expired suddenly and unexpectedly due to aortic dissection.Additional information has been requested regarding device, hospital, date of implant, date of death, autopsy report and initial implant medical reports.

Event Description

On (b)(6) 2007, a 10/8mm amplatzer duct occluder was successfully implanted in a 54 year old female with a history of hypothyroidism.12 years later, the patient at 66 years old collapsed suddenly at home and could not be resuscitated.Based on the non-contrast post-mortem ct scan images it was difficult to determine with certainty the exact cause for the aortic dissection.The presence of an aortic calcification suggests underlying aortic disease which may represent a risk factor for aortic dissection in the setting of an acute hypertensive episode.Additional information was received from the following article, "acute aortic dissection as a late and fatal complication of transcatheter persistent ductus arteriosus occlusion: a case report" stating that the cause of death was confirmed by post-mortem.The patients cause of death was a pericardial tamponade complicating an acute aortic dissection, with a large intimal tear identified adjacent to the pda occluder.

Manufacturer Narrative

The reported aortic dissection in a patient where "presence of an aortic calcification suggests underlying aortic disease" was confirmed via post-mortem ct scan images.Further information indicated that the cause of death was "pericardial tamponade complicating an acute aortic dissection, with a large intimal tear identified adjacent to the pda occluder".The results of the investigation are inconclusive since the device remains implanted was not returned for analysis; however, the aforementioned images were received from the field and reviewed by an abbott medical director.This review concluded that "the impact of the implanted ado on the suspected aortic dissection cannot be determined with certainty.".

• Brand Name: AMPLATZER DUCT OCCLUDER (UNKNOWN)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8503722
• MDR Text Key: 141649714
• Report Number: 2135147-2019-00103
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• 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: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 66 YR