MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA2AS-04-02-L

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient required coarctation repair after device implant due to an aortic arch obstruction caused by protrusion of the device.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.Please note, per the instructions for use, 600419-004 revision a "the amplatzer duct occluder ii additional sizes is contraindicated for patients who weigh less than 6 kgs.".

Event Description

It was reported through a research article identifying amplatzer ado ii that may be related to a complications post procedure.Details are listed in the article, titled "improved ventilation in premature babies after transcatheter versus surgical closure of patent ductus arteriosus." it was reported in the article that one 1000 grams patient implanted with a 4/2mm amplatzer duct occluder ii requiring re-intervention had aortic arch obstruction due to protrusion of the device.The patient made good clinical progress following the procedure.However serial echocardiograms showed increasing aortic arch obstruction.He underwent successful coarctation repair 118 days following initial catheter intervention.This was performed via a posterolateral thoracotomy, with end-to-end anastomosis and with removal of the aortic disc of the device.

Manufacturer Narrative

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

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9981673
• MDR Text Key: 188406974
• Report Number: 2135147-2020-00165
• 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: Modification/Adjustment
• 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: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDA2AS-04-02-L
• 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 Weight: 1