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

Model Number Occluder

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Implant date & explant date are unknown as this is a literature article.Date of event is unknown as this is a literature article.

Event Description

The article, "spontaneous closure of patent ductus arteriosus in preterm babies after failed attempts at transcatheter device closure", was reviewed.This research article reported a case study on a 4 week old patient at 30 weeks gestation.Weight at the time of cardiac catheterization was 1.86 kg.The patient was transferred from an outside hospital for transcatheter device closure of the patent ductus arteriosus (pda) after failure of ibuprofen therapy.Echocardiography demonstrated a large pda (diameter 3 mm) with a left-to-right shunting, moderate left heart enlargement, and mild mitral regurgitation.An angiogram demonstrated a type c tubular pda with a minimum diameter of 3.5 mm.First, an 5-4 amplatzer piccolo occluder device (5¿4 size) was deployed.As the device was too long and encroached on the aorta and lpa, the device was removed before release.A second amplatzer piccolo occluder (5-2) device was attempted.On release, the device embolized to the right pulmonary artery.The device was successfully retrieved using a 10-mm goose-neck snare.The next morning, an echocardiogram showed that the pda was significantly smaller.On repeat echocardiogram 3 days later, pda had closed.Pda remained closed in follow-up echocardiogram after 10 weeks.[the primary and corresponding author of the article is ahmed deniwar, md, division of pediatric cardiology, mcgovern medical school, university of texas health science center, houston, texas, usa, with corresponding email: deniwar.Ahmed@gmail.Com.] related events : cn-140987, cn-140984.

Manufacturer Narrative

As reported in a research article, a 5-4 amplatzer piccolo occluder device was deployed in a 4 week old patient at 30 weeks gestation.The device was too long and encroached on the aorta and lpa, and thus was removed before release.A second amplatzer piccolo occluder (5-2) device was attempted.On release, the device embolized to the right pulmonary artery.The device was successfully retrieved using a 10-mm goose-neck snare.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 15902336
• MDR Text Key: 304696667
• Report Number: 2135147-2022-02310
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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 Model Number: Occluder
• Device Catalogue Number: 9-PDAP-05-02-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/26/2023
• 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): Required Intervention
• Patient Age: 4 WK
• Patient Sex: Female