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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 5mm x 6mm amplatzer piccolo occluder was chosen for implant.The sizing of the device was determined via echocardiography and fluoroscopy imaging.Roughly 7 minutes after release, the occluder embolized into the pulmonary artery.The implanter believes the pliable duct didn't allow for an accurate measurement of the defect.The measured dimensions of the defect are: 8mm length x 3.4mm diameter.There was an attempt to snare the device but it was unsuccessful and the patient underwent surgery to remove the device.This was considered an emergency procedure.It was noted that the patient's status was noted as stable and the surgery was successful.The patient remained hemodynamically stable throughout the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
An event of device embolization was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient was at least 3 days old and was over 2kg at the time of the procedure.The device was placed extraductal.

• 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: 15831476
• Report Number: 2135147-2022-02115
• Device Sequence Number: 5298710
• Product Code: MAE
• UDI-Device Identifier: 05415067031051
• UDI-Public: 05415067031051
• 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: 2022
• Device Explanted Year: 2022
• 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): 01/18/2023

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 Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-06-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 11/20/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 DA
• Patient Sex: Unknown
• Patient Weight: 2 KG