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

Catalog Number UNK AMPLATZER PICCOLO

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The article, "changes in left ventricular systolic function after transcatheter patent ductus arteriosus closure in premature infants", was reviewed.The article presented a retrospective, single center study to describe changes in left ventricular (lv) systolic function after transcatheter patent ductus arteriosus (pda) closure in a group of premature infants and to identify variables associated with the development of abnormal lv systolic function after closure.Devices included in the study were amplatzer piccolo occluder, amplatzer vascular plug ii, and microvascular plug.The article concluded in preterm neonates who underwent successful transcatheter pda closure, 23% developed abnormal lv ejection fraction (lvef) after closure and those with significant lv dilation prior to the procedure were at increased risk for the development of lvef < 55% after closure.[the primary and corresponding author was aravinth karunanandaa, children¿s hospital of los angeles, akarunanandaa@chla.Usc.Edu] the time frame of the study was from 01 january 2015 to 31 january 2021.A total of 23 patients were included in the study, of which 20 received an abbott device.The average age was 65 days, the average weight at procedure was 1.894kg, and the average gender was female.Comorbidities included patent ductus arteriosus and pre-term birth.

Manufacturer Narrative

Summarized patient outcomes/complications of changes in left ventricular (lv) systolic function after transcatheter patent ductus arteriosus (pda) closure in a group of premature infants and to identify variables associated with the development of abnormal lv systolic function after closure were reported in a research article "changes in left ventricular systolic function after transcatheter patent ductus arteriosus closure in premature infants", in a subject population with multiple co-morbidities including patent ductus arteriosus and pre-term birth.Some of the complications reported were blood transfusion (unexpected medical intervention), heart failure, hypotension, residual shunt; these complications are 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 analysisna.

• 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: 18669505
• MDR Text Key: 336077549
• Report Number: 2135147-2024-00584
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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: 01/22/2024
• 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