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

Catalog Number UNK AMPLATZER PICCOLO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 04/01/2016

Event Type  Injury  

Event Description

The article, ¿percutaneous closure of the patent ductus arteriosus in infants #2 kg: impact registry insights¿, was reviewed.The article presents a retrospective, multicenter experience to assess safety and feasibility of percutaneous pda closure in patients #2 kg.Devices included in this study are amplatzer piccolo occluder, medtronic microvascular plug, amplatzer ductal occluder ii, and amplatzer vascular plug ii.The article concluded percutaneous pda closure appears to be safe and feasible procedures in infants #2 kg.The incidence of major adverse events has continued to decline over the years and seems to have a strong correlation with individual center case volumes and expertise.[(b)(6)].The time frame of the study was from april 2016 through june 2021.A total of 1587 patients were included.The average age and weight at intervention was 37 days and 1.2kg and the average gender was male.Comorbidities included necrotizing enterocolitis, sepsis, and genetic/chromosomal syndrome.

Manufacturer Narrative

Literature article: percutaneous closure of the patent ductus arteriosus in infants #2 kg: impact registry insights b3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effects of death and malfunctions reported in the article are captured under separate medwatch reports.Summarized patient outcomes/complications of closure of patent ductus arteriosus defects with occlusion devices including including amplatzer piccolo devices were reported in a research article in a subject population with multiple co-morbidities including necrotizing enterocolitis, sepsis, and genetic/chromosomal syndrome.Some of the complications reported were device embolization, unplanned cardiac or vascular surgery, cardiac arrest, cardiac tamponade, device malposition, thrombus, arrhythmia, bleeding, airway escalation of care and death.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.The root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17632808
• MDR Text Key: 322072778
• Report Number: 2135147-2023-03747
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/03/2023
• 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): Life Threatening; Required Intervention