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

Catalog Number	9-PDAP-03-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
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 a 3mm x 4mm amplatzer piccolo occluder was selected for implant on (b)(6) 2025 for a 4 week old patient with a weight of 900 grams, a minimal ductus diameter of 1.9mm and a ductal length of 9mm.Sizing was determined through fluoroscopic angiogram.During the procedure, upon release of the occluder from the delivery cable, the occluder embolized to the left pulmonary artery.The occluder was snared and removed from the patient.A new 4mm x 2mm amplatzer piccolo occluder was successfully implanted.The patient did not present with any clinical signs or symptoms.There were no clinically significant delays in the procedure.The user believe a ductal spasm caused the occluder to embolize.The patient status was stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device was reported.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 and per event details, the cause of reported event could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as snaring of device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the instructions for use, ifu amplatzer piccolo occluder, it stated, " the amplatzer piccolo¿ occluder is contraindicated for patients with the following conditions: weight < 700 grams at time of the procedure.Age < 3 days at time of procedure.However, it was unable to determine if an improper or incorrect procedure or method contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.

• 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: 21345422
• Report Number: 2135147-2025-00650
• Device Sequence Number: 9078857
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: (01)05415067030986(17)271231(10)8834761
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/27/2025

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: 8834761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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: 24 DA
• Patient Sex: Male
• Patient Weight: 1 KG