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

Catalog Number UNK AMPLATZER PICCOLO

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information literature attachment: transcatheter closure of patent ductus arteriosus in infants between 2-10 kg.

Event Description

The article, "transcatheter closure of patent ductus arteriosus in infants between 2-10 kg", was reviewed.The article presented a retrospective, single center study on transcatheter patent ductus arteriosus (pda) closure with different devices, mostly the amplatzer piccolo occluder, in infants weighing between 2-10 kg.Devices included in this study were amplatzer piccolo occluder, amplatzer duct occluder i, amplatzer duct occluder ii, and lifetech multifunctional occluder device.The article concluded that transcatheter treatment of pda with the amplatzer piccolo occluder device which was their first choice for appropriate duct anatomy and size in infants weighing between 2-10 kg, is safe and effective.[the primary and corresponding author was (b)(6).] the time frame of the study was from (b)(6) 2019 to (b)(6) 2022.A total of 31 patients were included in this study, of which 97% received an abbott device.The average age was 10.7 months, the average gender was female, the average weight was 6.6 kg, the average smallest diameter of the ductus was 2.2mm, and the average ductus length was 6mm.Comorbidities included patent ductus arteriosus.

Manufacturer Narrative

Summarized patient outcomes/complications of transcatheter closure of patent ductus arteriosus in infants between 2-10 kg were reported in a research article in a subject population with multiple co-morbidities including device embolization, obstruction/occlusion, unexpected medical intervention, improper or incorrect use or method.One of the complication reported was residual shunt this complication is anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• Brand Name: AMPLATZER PICCOLO
• 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: 18827285
• MDR Text Key: 337072368
• Report Number: 2135147-2024-00960
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER PICCOLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• 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