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

Catalog Number	9-VSD-MUSC-010
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2135147-2023-03531
• Device Sequence Number: 6370140
• Product Code: MLV
• UDI-Device Identifier: 00811806011813
• UDI-Public: 00811806011813
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 9-VSD-MUSC-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 MO
• Patient Sex: Unknown