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

Model Number CVD0095

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dysphagia/ Odynophagia (1815); Perforation of Esophagus (2399)

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 "late esophageal perforation due to an amplatzer device in scimitar syndrome" that a (b)(6) man with scimitar syndrome with 2 large aortopulmonary collaterals that were causing a significant shunt.He was sent for percutaneous embolization using an amplatzer duct occluder ii device for the superior collateral and an amplatzer vascular plug for the inferior collateral, without complications.The patient remained asymptomatic for approximately 2 years with clinical follow-up every 6 months.He then reported a 3-month history of progressive dysphasia, and chest computed tomography showed partial blockage of the esophagus with the amplatzer duct occluder ii, which was completely expanded.An upper gastrointestinal endoscopy was performed, which showed that the mesh of the device was partially blocking the esophageal lumen such that the endoscope could not be advanced.Endoscopic removal of the device was performed, and a provisional esophageal stent was implanted to treat the residual stenosis.The procedure occurred without complications with no bleeding from the collaterals, which were completely occluded.The esophageal stent was removed at 3 weeks, with no residual esophageal stenosis, and the patient remained asymptomatic after discharge from hospital and at follow-up.

Manufacturer Narrative

As reported in a research article, a patient had the amplatzer duct occluder implanted to close a aortopulmonary collateral, which embolized after 2 years and partially blocked the esophagus.The device was removed.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.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10084780
• MDR Text Key: 192153918
• Report Number: 2135147-2020-00224
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0095
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 16 YR