MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number 9-AVP2-012

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/20/2023

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had an amplatzer vascular plug ii implanted to close a patent ductus arteriosus off-label and the device deformed and caused left pulmonary artery stenosis.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 device deformation causing the stenosis was due to the device being oversized.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

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 5-month-old, 5.5kg patient with the following patent ductus arteriosus (pda) measurements: minimal ductus diameter = 4.2mm, ampulla diameter = 7.7mm, ductal length = 11.2mm.It was reported on an unknown date, a 12mm amplatzer vascular plug ii was chosen for implant to occlude a pda.After the device was implanted, it was noted there was an elongation of the device causing left pulmonary artery stenosis due to device oversizing.A decision was made to additionally implant a 10mm amplatzer vascular plug ii.The second device was implanted successfully with a reported mild residual shunting.[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].12mm amplatzer vascular plug ii, peri-procedural complications included surgical intervention, obstruction/occlusion, deformation, improper use.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 17543625
• MDR Text Key: 321100451
• Report Number: 2135147-2023-03548
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K071699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,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

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-AVP2-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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: 5 MO
• Patient Weight: 5 KG