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

Catalog Number 9-VSD-MUSC-010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/20/2023

Event Type  Injury  

Event Description

The article, ¿a challenging interventional procedure: transcatheter closure of tubular patent ductus arteriosus in patients with pulmonary hypertension¿, was reviewed.The article presents a case study of an 9-month-old, 7.5kg patient with the following patent ductus arteriosus (pda) measurements: minimal ductus diameter = 9.2mm, ampulla diameter = 13.4mm, ductal length = 9.8mm.It was reported on an unknown date, a 10mm amplatzer muscular ventricular septal duct was chosen for implant to occlude a pda.After implant, it was noticed the patient had a left pulmonary artery (lpa) stenosis that was resistant to balloon dilation.A decision was made to implant a stent in the lpa to treat stenosis.[the primary and corresponding author is ilker kemal yucel, department of pediatric cardiology, university of health sciences dr.Siyami ersek thoracic and cardiovascular surgery training and research hospital, istanbul, turkey, ilkerkemalyucel@yahoo.Com].Periprocedural complications included surgical intervention, pulmonary occlusion, improper use.

Manufacturer Narrative

As reported in a research article, a muscular ventricular septal occluder was implanted off-label in a patent ductus arteriosus and afterwards it was noted the patient had left pulmonary artery stenosis which was treated with a stent.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17541366
• MDR Text Key: 321182319
• Report Number: 2135147-2023-03531
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011813
• UDI-Public: 00811806011813
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2023

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
• Device Catalogue Number: 9-VSD-MUSC-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO