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

Model Number	9-PDAP-04-04-L
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported (b)(6) 2025, a 4x4 amplatzer piccolo occluder was chosen for implant using a 4f tvlp catheter.During the procedure, the defect was measured to be 4.1 mm at the aorta, 2.7 mm at the pulmonary end, and 7.5 mm in length.The sizing of the device was determined using angiography and transesophageal echocardiography, which were also the imaging modalities utilized during the procedure.The migration of the device was identified through angiography.It was noted that the device completely dislodged from the intended implant site.According to the implanter, the cause of embolization was attributed to difficulty in releasing the prosthesis, with twisting of the prosthesis within its own axis.The embolization was recognized during the procedure.There were no rhythm changes and no leak detected around the lobe of the device during the procedure.The patient did not experience any clinical signs or symptoms such as arrhythmia, valve interaction, or hemodynamic instability.There was no difficulty with implanting the device, such as multiple recaptures or repositioning.To address the embolization, a percutaneous recapture attempt with a snare was performed.The embolized device caused a partial obstruction of blood flow and migrated to the distal branch of the right pulmonary artery.It was clarified that the embolized device, which could not be retrieved, does not pose risk or harm to the patient.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay.Additionally, it was noted that there was difficulty during separation of the delivery system and the device, but not premature separation.The device was attempted to be retrieved using a percutaneous snare.Following this event, a new device 6-4mm amplatzer pda occluder had to be opened to close the ductus arteriosus.
Additional Manufacturer Narrative
An event of difficult separation, device embolization, and foreign body in patient.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information and cine review, the cause for the reported difficult separation is likely related to procedural circumstances (device being tightly attached to the screw), however this cannot be determined.The reported device embolization likely resulted from the difficulty to separate the device.An unexpected medical intervention and foreign body in patient was a result of case specific circumstances, as an attempt to snare the device was performed, however was unsuccessful.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed h6 health effect - clinical code: 4582.

• 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: 23950589
• Report Number: 2135147-2026-00031
• Device Sequence Number: 7844973
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: (01)05415067031013(17)290630(10)10430737
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 10430737
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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 Sex: Unknown