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

Model Number	9-PDAP-05-04-L
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.Report date 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 3 month old born at 28 weeks gestation.Bodyweight at the time of cardiac catheterization was 3.5 kg.The patient had residual tracheobronchomalacia after prior repair of tracheoesophageal fistula, with clinical signs of increased pulmonary blood flow and ventilator dependence.An echocardiogram showed moderate patent ductus arteriosus (pda) with a continuous left-to-right shunting.There was moderate left atrial and left ventricular enlargement associated with mild mitral regurgitation.Angiography (weight 3.5 kg) demonstrated a type c tubular pda.The minimum diameter of pda was 4.0 mm.The 5-4 amplatzer piccolo occluder was placed in an intraductal position in pda.Overnight, the patient remained sedated with dexmedetomidine.On chest radiograph and echocardiogram, the following morning, the device embolization to the left pulmonary artery (lpa) was evident.Repeat catheterization was performed, and the embolized device was retrieved.The pda appeared smaller, and a 6-4 amplatzer duct occluder was deployed but removed before release for unsatisfactory device position.Echocardiography the following day revealed a tiny pda.On echocardiogram, five days later, no pda was noted.Pda remained closed in the echocardiogram three weeks later.[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 : (b)(4).
Additional Manufacturer Narrative
As reported in a research article, a 5-4 amplatzer piccolo occluder device was deployed in a 3 month old born at 28 weeks gestation in an intraductal position in pda.The device embolization to the left pulmonary artery (lpa) was evident.Repeat catheterization was performed, and the embolized device was retrieved.The pda appeared smaller, and a 6-4 amplatzer duct occluder was deployed but removed before release since the position was unsatisfactory.Echocardiography the following day revealed a tiny pda.On echocardiogram, five days later, no pda was noted.Pda remained closed in the echocardiogram three weeks later.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.

• 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: 15899289
• Report Number: 2135147-2022-02309
• Device Sequence Number: 4285291
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• 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: Health Professional,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: 9-PDAP-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-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: 12/01/2022
• 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: 3 MO
• Patient Sex: Female
• Patient Weight: 3 KG