MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER II; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number UNK AMPLATZER DUCT OCCLUDER II

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Literature article attached: safety and efficacy of amplatzer duct occluder ii and konar-mftm vsd occluder in the closure of perimembranous ventricular septal defects in children weighing less than 10 kg.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.As reported in a research article, amplatzer duct occluder ii's were placed off label to close pmvsd.Complications of the implant included device embolization and residual shunt.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.

Event Description

The article, "safety and efficacy of amplatzer duct occluder ii and konar-mftm vsd occluder in the closure of perimembranous ventricular septal defects in children weighing less than 10 kg", was reviewed.The article presented a retrospective, multicenter study to report and compare the outcomes of pmvsd closure in children weighing less than 10 kg using amplatzer duct occluder ii (adoii) and konar-mf vsd occluder (mfo) devices.The article concluded both the mfo and adoii are effective closure devices in appropriately selected pmvsds.Cavb can occur with both devices.The mfo is inherently advantageous for defects larger than 6 mm and subaortic rims smaller than 3 mm.In the literature, the series represents the first study comparing the mid-term outcomes of mfo and adoii devices in children weighing less than 10 kg.[the primary and corresponding author was kaan yildiz, sbu tepecik training and research hospital, izmir, türkiye, with corresponding email: drkaanyildiz@gmail.Com].The time frame of the study was from january 2018 to january 2023.A total of 52 patients were included in this study, of which 22 (42.3%) received an abbott device.The average age was 10.8 months and the average gender was female.Comorbidities included down syndrome, aneurysm, and perimembranous ventricular septal defect.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 18366892
• MDR Text Key: 331330624
• Report Number: 2135147-2023-05615
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER DUCT OCCLUDER II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• 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