MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES; TRANSCATHETER SEPTAL OCCLUDER

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body Embolism (4439)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, an amplatzer duct occluder 2 additional sizes embolized after release of the device.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.

Event Description

The article, "catheter closure of clinically silent patent ductus arteriosus using the amplatzer duct occluder ii-additional size: a single-center experience", was reviewed.This research article is a retrospective single center experience to determine immediate and long-term follow-up of transcatheter closure of patent ductus arteriosus (pda) in children.Amplatzer duct occluder ii additional sizes (ado ii-as) were associated with the study.The article concluded that device closure of silent pda is safe and effective using an ado ii-as device with minimal risk of embolization and a low residual shunt rate.The primary and correspondence author of the article is yasser a.Bhat, department of pediatric cardiology, prince sultan cardiac centre, buraidah, sau with the corresponding author: bhatyasser26@gmail.Com.

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12639536
• MDR Text Key: 276655944
• Report Number: 2135147-2021-00410
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• 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: 1 YR