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

Catalog Number	9-PDAP-03-02-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	03/25/2024
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 25 march 2024, a amplatzer piccolo occluder 3 mm x 2 mm was selected for an implant.The pda minimal diameter was 1.5mm and 5.0mm pda diameter at aortic ampulla.The pda length was 7.0mm.During the procedure, the device embolized in the pulmonary artery during deployment and was retrieved from the patient.Device was replaced with amplatzer piccolo occluder 5 mm x 4 mm device that completed the procedure.The patient is stable.
Event or Problem Description
It was reported that on 25 march 2024, a amplatzer piccolo occluder 3 mm x 2 mm was selected for an implant.The pda minimal diameter was 1.5mm and 5.0mm pda diameter at aortic ampulla.The pda length was 7.0mm.During the procedure, the device embolized in the pulmonary artery during deployment and was retrieved from the patient.Device was replaced with amplatzer piccolo occluder 5 mm x 4 mm device that completed the procedure.The patient is stable,.
Additional Manufacturer Narrative
An event of embolization of a piccolo occluder was reported.Potential causes of embolization may include inadequate sizing or placement of occluder (anatomical or user technique) or patient related factors (physiological factors resulting in sudden increase in blood flow or ductal spasm).Information from the field indicated that the cause of the embolism is believed to be under sizing.A returned device assessment could not be performed as the device was not returned for analysis.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 undersizing of the defect.There were no complaints associated with any other devices from the lot.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: 19116673
• Report Number: 2135147-2024-01711
• Device Sequence Number: 7699067
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: (01)05415067030979(17)241231(10)9041008
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 9041008
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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: 3 MO
• Patient Sex: Female
• Patient Weight: 3 KG