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

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Prolapse (2475); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/15/2021

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, "a novel approach for transcatheter management of perimembranous ventricular septal defect with a subaortic ridge", was reviewed.This research article is a prospective single center experience to evaluate the safety and efficacy of the management of patients with perimembranous(pm) ventricular septal defect(vsd) and subaortic ridge with or without aortic regurgitation(ar) using transcatheter closure of the defect and compressing the subaortic ridge against the ventricular septum using an amplatzer ductal occluder type i(ado-i).Amplatzer duct occluder was associated to the study.There is no allegation of malfunction of the abbott device.The article concluded transcatheter management of patients with pm vsd and subaortic ridge is feasible and effective in protecting the aortic valve by ameliorating the blood flow disturbance across the left ventricular outflow tract(lvot) created by the left-to-right shunt across the vsd and the presence of subaortic ridge with regression of the preexisting ar.The primary and correspondence author of the article is hussein a.Wahab, department of cardiology, ibn albitar center for cardiac surgery, baghdad, iraq with the corresponding email: (b)(6).

Manufacturer Narrative

Remove medical device code 2993 - adverse event without identified device or use problem.As reported in a research article, 38 patients underwent closure of perimembranous ventricular septal defect (vsd) with subaortic ridge between (b)(6) 2014 and (b)(6) 2018; 5 failed procedures due to a deficient aortic rim in three patients, increased severity of the aortic regurgitation in two patients, 8 mild to moderate override(vsd with malalignment), 24 mild to moderate prolapsed noncoronary cusp or right coronary cusp, 13 mild to moderate aortic regurgitation, 9 left ventricular outflow tract obstruction and residual shunt were reported.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.Please note, per the amplatzer duct occluder instructions for use, artmt600157379 revision a "indications and usage: the amplatzer duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).".

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11625406
• MDR Text Key: 249446794
• Report Number: 2135147-2021-00129
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 20