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 Hematoma (1884); Hemolysis (1886); Thrombosis (2100); Loss Of Pulse (2562)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article "comparison of isolated venous approach with the standard approach in children undergoing patent ductus arteriosus device closure" published on 29 september, 2020 was reviewed.This research article is a prospective single center experience to compare the two vascular approaches of pda device closure in pediatric patients and have also studied the feasibility of this approach in young children with weight < 6 kg.Amplatzer duct occluder (ado), cocoon duct occluder, lifetech duct occluder were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that the isolated venous approach is a pragmatic approach for pda device closure.The primary author of the article is lipi uppal, md of department of cardiology, post graduate institute of medical education and research, chandigarh, india with the email cardiopgimerchd@gmail.Com.

Manufacturer Narrative

As reported in a research article, complications of device placement for patent ductus arteriosus closure included hematoma, thrombosis, transient loss of pulse, and hemolysis.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: 10881980
• MDR Text Key: 217675684
• Report Number: 2135147-2020-00507
• 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
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2020
• 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: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 17