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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article "comparison of transcatheter patent ductus arteriosus closure between children and adults" was reviewed.This article was a retrospective study to evaluate the differences in the clinical characteristics and hemodynamic changes after transcatheter pda closure between children and adults.The physicians extracted and analyzed the data of 54 consecutive patients who underwent a transcatheter pda device closure between april 2009 and april 2018.The devices associated with this study are amplatzer duct occluder (ado) and amplatzer vascular plug ii (avp-ii).There are no allegations of malfunction against the abbott devices.The primary author is jun yasuhara.The corresponding author is naokata sumitomo of department of pediatric cardiology, saitama medical university international medical center, yamane, hidaka city, saitama, japan.The corresponding email is: sumitomo@saitama-med.Ac.Jp.

Manufacturer Narrative

As reported in a research article, two patients had hypertension after the procedure and one patient had a arteriovenous fistula.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
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10277501
• MDR Text Key: 200813486
• Report Number: 2135147-2020-00317
• 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: 07/15/2020
• 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: 4 YR