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

Model Number 9-VSD-MUSC-008

Device Problems Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 02/16/2021

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, "transcatheter patent ductus arteriosus closure: what have we learned after over 25 years? a single-center experience with 1036 patients", was reviewed.This research article reported that 1,036 consecutive patients underwent transcatheter closure of patent ductus arteriosus(pda) between october 1993 and february 2020.It was reported that a 7kg, male patient with a 6 mm diameter pda type c(tubular) and mean pulmonary pressure(mpap) of 65 mmhg developed a moderate left pulmonary artery stenosis after a 8 mm amplatzer muscular vsd occluder was implanted.After a 5-year observation period, the patient underwent stent implantation to the narrowed vessel.The article concluded transcatheter pda closure with all types of nitinol duct occluders is safe and effective, with no residual shunting at one-year follow-up.The primary and correspondence author of the article is michal galeczka md, department of congenital heart defects and pediatric cardiology, fms in zabrze, medical university of silesia in katowice, silesian center for heart diseases, 9 curie-sklodowskiej st., 41-800 zabrze, poland with the corresponding email: (b)(6).

Manufacturer Narrative

As reported in a research article, a patient underwent patent ductus arteriosus with an amplatzer muscular vsd occluder; an event of moderate left pulmonary artery stenosis was 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 muscular vsd occluder instructions for use, artmt600034253 revision b "indications and usage: the amplatzer¿ muscular vsd occluder and p.I.Muscular vsd occluder, are percutaneous, transcatheter, ventricular septal defect closure devices designed for the occlusion of muscular ventricular septal defects.".

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11625174
• MDR Text Key: 249446655
• Report Number: 2135147-2021-00123
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P040040
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSD-MUSC-008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 7