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

Catalog Number	9-PDAP-05-02-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	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 5 mm x 2 mm amplatzer piccolo occluder was chosen for a procedure.The patent ductus arteriosus (pda) minimal diameter was 2.8mm, pda diameter at aortic ampulla was 5mm, pda length was 6mm and the dimension of the defect was 2.8mm x 6mm.The sizing of the device was determined by angiogram and the device was implanted.The physician confirmed piccolo pulse checklist was used and stability check was performed.On (b)(6) 2024, a transthoracic echocardiogram (tte) was conducted and it was noted that the device was embolized into left pulmonary artery (lpa) and it got retrieved percutaneously through left femoral vein ( lfv) access via transcatheter snare.The procedure took less than 10 minutes from access to close.The physician mentioned the cause of embolization was possible spasm.
Additional Manufacturer Narrative
The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization) was reported.A returned device assessment could not be performed as the device was not returned for analysis.An transthoracic echocardiogram (tte) was conducted and it was noted that the device was embolized into left pulmonary artery (lpa) and it got retrieved percutaneously through left femoral vein ( lfv) access via transcatheter snare.Based on the information received, the cause for the reported device embolization could not be conclusively determined.The reported unexpected medical intervention was results of case-specific circumstances as the physician used a snared to retrieve the device.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: 20257252
• Report Number: 2135147-2024-04606
• Device Sequence Number: 7742717
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: (01)05415067031037(17)280229(10)8956109
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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 Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 8956109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 3 KG