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
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 5 week old patient born at 28 weeks¿ gestation.Bodyweight at the time of cardiac catheterization was 1.26 kg.Multiple dysmorphic features led to the diagnosis of cornelia de lange syndrome.Echocardiography demonstrated a hemodynamically significant patent ductus arteriosus (pda), perimembranous ventricular septal defect partially covered by pseudoaneurysmal tissue, and mild valvar pulmonary stenosis (peak gradient 25 mmhg).Due to the presence of pulmonary congestion and the inability to wean ventilatory support, the decision was made to close the pda using a transcatheter device.Angiography showed a type f-hockey-stick-shaped pda with a minimum diameter of 4 mm.A 5-2 amplatzer piccolo occluder device was deployed.After echocardiographic confirmation, the device was released.On release, the device embolized into the main pulmonary artery (mpa).Attempts to retrieve the device using a goose-neck snare were complicated by a moderate pericardial effusion requiring pericardiocentesis.A sternotomy was performed for recurrence of pericardial effusion and a perforation in the right ventricular outflow tract was repaired.Echocardiogram on the following morning revealed that the pda had closed; the embolized device was at the junction of mpa and left pulmonary artery (lpa) with mild lpa stenosis.At 17-month follow-up, the device remains in the mpa/lpa junction.The lpa has continued to grow with trivial lpa stenosis (doppler velocity.[the primary and corresponding author of the article is (b)(6) , division of pediatric cardiology, mcgovern medical school, university of texas health science center, (b)(6) , usa, with corresponding email: (b)(6).Related manufacturer reference number: 2135147-2022-02310-00, 2135147-2022-02309-00.
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.
Additional Manufacturer Narrative
Summarized patient outcomes/complications of piccolo occluder were reported in a research article in a subject population with multiple co-morbidities including multiple dysmorphic features leading to the diagnosis of cornelia de lange syndrome, mild pulmonary stenosis.Some of the complications reported were device embolization into the main pulmonary artery and moderate pericardial effusion requiring pericardiocentesis; 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 analysis.H6 device code 4580 removed.

• 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: 15901414
• Report Number: 2135147-2022-02311
• Device Sequence Number: 11833562
• 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,Health Professional
• 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: 5 WK
• Patient Sex: Female
• Patient Weight: 2 KG