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

Model Number	9-PDAP-03-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 (b)(6) 2025, a 3mm x 4mm amplatzer piccolo occluder was chosen for implant.The defect dimensions were reported as pulmonary artery end measuring 1.8 mm, aortic end measuring 3.3 mm, and a total defect length measuring 6.0 mm, with the mid-portion not measured.Device sizing was determined by aortogram fluoroscopic measurement, and fluoroscopy was used during the procedure as well as to identify the embolization.During the procedure, after deployment, the physician was dissatisfied with the size and positioning of the device.A stability check was reported as performed, and a residual leak was observed around the lobe of the device.The device reportedly shifted within the intended implant site and subsequently became fully dislodged.While attempting to retrieve the device using a snare in order to replace it with a larger device, the device became dislodged and embolized.The implanter attributed the embolization to attempts to retrieve the device via snare.There were no noted difficulties with implantation such as multiple recaptures or repositioning, and the embolized device did not cause obstruction of blood flow.The device ultimately embolized to the left pulmonary vein.No additional information was provided.
Additional Manufacturer Narrative
An event of residual shunt and device embolization 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported residual shunt could not be determined.The reported device embolization resulted from attempting to snare the device.An unexpected medical intervention was a result of case-specific circumstances, as the device was snared.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 24169053
• Report Number: 2135147-2026-00416
• Device Sequence Number: 9129434
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: (01)05415067030986(17)290430(10)10349586
• 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): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PDAP-03-04-L
• Device Catalogue Number: 9-PDAP-03-04-L
• Device Lot Number: 10349586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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