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

Model Number	Occluder
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2135147-2022-02310
• Device Sequence Number: 4285292
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 WK
• Patient Sex: Female