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 Codes	Aortic Valve Stenosis (1717); Hemorrhage/Blood Loss/Bleeding (1888); Obstruction/Occlusion (2422); Convulsion/Seizure (4406); Tricuspid Valve Insufficiency/ Regurgitation (4453); Respiratory Insufficiency (4462)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that 58 patients underwent patent ductus arteriosus (pda) closure in premature infants between (b)(6) 2018 to (b)(6) 2021, and 8 patients were implanted using a piccolo.Summarized patient outcomes/complications of piccolo were reported in a research article in a subject population with multiple co-morbidities, beckwith weidman syndrome, ruptured omphalocele, sepsis, renal failure, large pda, grade iii intraventricular hemorrhage.Some of the complications reported were embolization, aortic obstruction, surgical intervention, aortic valve stenosis, tricuspid regurgitation, hemorrhage, respiratory failure, seizures, and declining neurologic status.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 or Problem Description
The article, "institutional trend in device selection for transcatheter pda closure in premature infants", was reviewed.This article is a retrospective single study experience with transcatheter patent ductus arteriosus (pda) closure in premature infants and compare patients grouped by the device used for closure and also report trends in device selection over time.The devices associated with this study included the microvascular plug, ¿mvp¿ (medtronic, minneapolis, mn); micro plug set, ¿micro plug¿ (ka medical, minneapolis, mn); and amplatzer piccolo occluder, ¿piccolo¿ (abbot, santa clara, ca).Closure of a pda in 58 premature infants was successful using three commercially available devices, all with a favorable safety profle.Over time, the group gravitated towards selecting the micro plug device in most cases because it was short, visible, trackable, delivered through a soft microcatheter, and relatively inexpensive.This comparison of three devices is based on a retrospective analysis with small numbers and thus should be interpreted with caution.[the primary and corresponding author of this study is (b)(6), (b)(6).].

• 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: 17009759
• Report Number: 2135147-2023-02338
• Device Sequence Number: 6975865
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: Occluder
• Device Catalogue Number: 9-PDAP-03-02-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: 05/09/2023
• Initial Report FDA Received Date: 05/26/2023
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown