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

Catalog Number	9-PDAP-03-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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.
Event or Problem Description
It was reported that on (b)(6) 2024, a amplatzer piccolo occluder 3 mm x 4 mm was selected for an implant.The pda minimal diameter was 3.4mm, the pda diameter at aortic ampulla was 3.5mm.The length of the pda was 7mm.The device was successfully implanted intraductal, no residual flow and no obstruction via transthoracic echocardiogram (tte).Post device release tte revealed device had embolized to left pulmonary artery with no obstruction and patient tolerated well with no hemodynamic changes.Device was snared and removed without consequence.The implanter believe the cause of embolization was possible duct spasm causing incorrect measurements.The physician then placed a amplatzer piccolo occluder 4mm x 2mm with good placement, no residual flow and no obstruction via tte.No patient consequences and no hemodynamic changes throughout procedure.Patient is stable,.
Additional Manufacturer Narrative
An event of device embolization to left pulmonary artery with no obstruction was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the ductal measurements as reported from the field was performed.Please note that per the sizing table in the instructions for use, artmt600061587 rev c, sizing chart t3, the recommended size device for provided measurements is 05-02 amplatzer piccolo occulder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could potentially be related to the user not following the recommended sizing chart provided in the ifu.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on 02 april 2024, a amplatzer piccolo occluder 3 mm x 4 mm was selected for an implant.The pda minimal diameter was 3.4mm, the pda diameter at aortic ampulla was 3.5mm.The length of the pda was 7mm.The device was successfully implanted intraductal, no residual flow and no obstruction via transthoracic echocardiogram (tte).Post device release tte revealed device had embolized to left pulmonary artery with no obstruction and patient tolerated well with no hemodynamic changes.Device was snared and removed without consequence.The implanter believe the cause of embolization was possible duct spasm causing incorrect measurements.The physician then placed a amplatzer piccolo occluder 4mm x 2mm with good placement, no residual flow and no obstruction via tte.No patient consequences and no hemodynamic changes throughout procedure.Patient is stable.

• 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: 19166792
• Report Number: 2135147-2024-01817
• Device Sequence Number: 20604360
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: (01)05415067030986(17)280731(10)9182414
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/09/2024

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 Catalogue Number: 9-PDAP-03-04-L
• Device Lot Number: 9182414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: 28 DA
• Patient Sex: Female
• Patient Weight: 1 KG