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

Model Number	OCCLUDER
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/30/2022
Type of Reportable Event	Death
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) 2022, a 4mm x 4mm amplatzer piccolo occluder was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.After implant of the device but during the procedure, that the patient suffered cardiac arrest.Chest compressions were initiated.Ultimately, the patient was pronounced deceased.There was no difficulty with implanting the device.It was thought that the proximal disc caused a coarctation into the aorta.The dimensions of the patient's patent ductus arteriosus was reported as aortic ampulla- 5.4mm, middle of duct-2.5mm, narrowest portion-1.5mm, length-10.5mm.It was noted that prior to the procedure the patient was noted in stable condition.
Additional Manufacturer Narrative
An event of death after the device implant was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information relating to the operative notes, and procedure imaging was requested but was not received from the field.Information from the field indicated that the abbott delivery system was used to deliver the device and no difficulty was experienced when implanting the device.The field also indicated that the proximal disc caused a device to stretch too long due to the size of the duct causing the into the coarct.The device history record could not be reviewed as lot/batch details were not provided.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 15695144
• Report Number: 2135147-2022-01847
• Device Sequence Number: 12580784
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/13/2023

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-04-04-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: 09/30/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Weight: 1 KG