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

Model Number	9-PDAP-05-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/11/2025
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 on (b)(6) 2025, a 5mm x 4mm amplatzer piccolo occluder was selected for implant.The occluder was sized as per the instructions for use.The dimension of the defect was 3.5mm.There was no rhythm change during procedure.A stability check was performed during procedure.There was no leak detected around the lobe of the device during the procedure.There was no difficulty with implanting the device, such as multiple recaptures/repositioning.Post-procedure it was noted via transthoracic echocardiogram, that the occluder embolized.The occluder embolized to the left pulmonary artery.The embolized occluder caused a partial obstruction/blockage of blood flow.The decision was made to perform percutaneous retrieval of the occluder.The patient did not have any clinical signs or symptoms during or after this event.There was no initial or prolonged hospitalization due to this event.The cause of the embolization is attributed to the patient being larger.The patient was noted to have recovered at the time of report.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization), obstruction/occlusion post procedure was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from field indicated that the sizing of the device was determined by following ifu.Field indicated that there was no difficulty implanting the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The occluder embolized to the left pulmonary artery.The embolized occluder caused a partial obstruction/blockage of blood flow.The physician mentioned the cause of embolization was due to physically larger patient.However, based on the available information, the cause of the reported embolization could not be conclusively determined.The reported occlusion, and lung infection appeared to be related to the reported device migration.The reported unexpected medical intervention was a result of case-specific circumstances as a device was snared.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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: 22482298
• Report Number: 2135147-2025-03790
• Device Sequence Number: 8499019
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: (01)05415067031044(17)290831(10)10510697
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/12/2025

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-05-04-L
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 10510697
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 09/06/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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: 1 MO
• Patient Sex: Unknown
• Patient Weight: 4 KG