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

Model Number	OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Obstruction/Occlusion (2422)
Date of Event	04/18/2023
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) 2023, a 4mm x 2mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue delivery system and a 4f non-abbott introducer.The patent ductus arteriosus (pda) minimal diameter was measured as 1.6mm, the pda diameter at the aortic ampulla was 4.5mm, and the pda length was 5.6mm.The device was placed intraductally, tested and optimally positioned.After it was released, the user pushed the occluder into the aorta with the sheath.It was reported that 75% of the device remained inside the ductus but the remaining 25% was protruding into the aorta.After being pushed, the occluder blocked arterial flow and the patient's vital signs were compromised.The patient's oxygenation decreased, blood pressure increased, and the patient's pulse was no longer felt.A snare was used to emergently capture the occluder and remove it from the patient.The delivery sheath and introducer were replaced and the occluder was reloaded.The device was implanted without complications.The patient was reported as stable.
Additional Manufacturer Narrative
An event of device shift in position within the intended implant site was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could potentially be related to the user not following the recommended sizing chart provided in the ifu.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, artmt600061587-c, sizing chart t3, the recommended size device is 03-02 mm.Please note that, per the instructions for use, "this device was sterilized with ethylene oxide and is for single-use only.Do not reuse or resterilize this device.¿.

• 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: 16915837
• Report Number: 2135147-2023-02061
• Device Sequence Number: 20427045
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/20/2023

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-04-02-L
• Device Lot Number: 8254743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: Male
• Patient Weight: 1 KG