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

Device Problems Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, the amplatzer duct occluder was protruding unto the aortic isthmus causing an gradient.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 duct occluder i that may be related to an intervention post procedure.Details are listed in the article, titled "a beneficial technique for preventing the device protrusion to the aorta during percutaneous patent ductus arteriosus closure: ¿balloon-assisted device releasing technique.¿ it was reported in the article that 155 infants underwent patent ductus arteriosus closure with an amplatzer duct occluder i device between january 2012 and december 2018.The mean age of the patient was 1.39 years old, with a mean weight of 8.75 kg.82 of the patients were female.All patients had a krichenko classification type a duct.Case 1: one of the patient has pulmonary hypertension and short ampulla/small isthmust.The physician had difficulty placing the device and a pulling maneuver technique was used for optimal device positioning.The device was found to be protruding into the aortic isthmus and causing a gradient of 10mmhg or more.The device was repositioned with low profile balloon catheter and a surgical intervention was performed.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10012432
• MDR Text Key: 189978266
• Report Number: 2135147-2020-00170
• 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: foreign,health professional,l
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 9