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 Device Interaction Problem (4001)

Patient Problems Aortic Valve Stenosis (1717); Pulmonary Valve Stenosis (2024)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Literature: piccolo in transcatheter pda closure multicentre study from premature to adolescent children.Summarized patient outcomes/complications of closure of patent ductus arteriosus with an amplatzer piccolo device were reported in a research article in a subject population with multiple co-morbidities including secundum atrial septal defect, ventricular septal defect, coarctation, pulmonary stenosis, endocardial cushion defect and prior surgical ductus ligation with a residual duct.Some of the complications reported were device embolization, malposition, improper use (wrong measurement), iatrogenic coarctation of the aorta, surgical intervention, pulmonary valve stenosis, aortic valve stenosis, iatrogenic coarctation of the aorta 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 or individual patient information was received for analysis.

Event Description

The article, "piccolo in transcatheter pda closure multicentre study from premature to adolescent children", was reviewed.The article is a prospective, multi-center study with a focus on mid- to long-term efficacy and safety of the amplatzer piccolo occluder in patent ductus arteriosus closure in premature and term infants as well as children.The article concluded the piccolo device can be considered as close an ideal occluder.The lower profile, smaller delivery catheter size, and symmetry of this device allow for a venous or arterial approach.[the primary and corresponding author is osman baspinar, pediatric cardiology, gaziantep university medical faculty, gaziantep, turkey, with corresponding email: osmanbaspinar@hotmail.Com].The time frame of the study was from 2016 through 2021.A total of 645 patients were included in this study, with 152 patients less than 1 month old.Patients were divided into three groups dependent on their weight: less than or equal to 1.5kg, between 1.5kg and 3kg, and greater than 3kg.For patients who weighed less than 1.5kg, the average age was 0.80 months, average gender was female, average weight was 1.200kg, average pda length 6.62mm, average pda aortic diameter 3.91mm, and average pda pulmonary diameter 2.720mm.For patients who weighed 1.5kg to 3kg, the average age was 2.27 months, average gender was male, average weight was 2.340kg, average pda length 8.33mm, average pda aortic diameter 4.91mm, and average pda pulmonary diameter 2.750mm.For patients who weighed greater than 3kg, the average age was 34.544 months, average gender was female, average weight was 13.0611kg, average pda length 8.13mm, average pda aortic diameter 5.92mm, and average pda pulmonary diameter 1.660mm.Comorbidities included secundum atrial septal defect, ventricular septal defect, coarctation, pulmonary stenosis, endocardial cushion defect, prior surgical ductus ligation with a residual duct.

• 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: 17192925
• MDR Text Key: 317813893
• Report Number: 2135147-2023-02726
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER PICCOLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/23/2023
• 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): Hospitalization; Required Intervention