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

Model Number	DUCT OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/08/2023
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 5-4mm amplatzer duct occluder was chosen for implant for a 10 week old, 2 kg patient with the following patent ductal arteriosus (pda) measurements: pulmonary artery diameter of 3.8mm, aortic diameter of 4.4mm, and pda length of 7.9mm.The amplatzer duct occluder was chosen due to the minimum ductual diameter.An unknown abbott delivery system was utilized.Fluoroscopy and transesophageal echocardiogram (tee) were used during procedure for imaging.The patient was in sinus rhythm during procedure.The device was deployed, and it initially pulled through the duct into the pulmonary artery.The device was recaptured and repositioned.The device was evaluated closely prior to release, and it was positioned at the pulmonary artery end of the duct with mild left pulmonary artery obstruction and no aortic involvement.A stability check was performed prior to release.Upon release, the device moved forward in the duct towards the aorta.Post implant revealed an aortic obstruction with a peak gradient of 9mmhg.The patient was transferred to another hospital for evaluation.On (b)(6) 2023, the patient had open heart surgery to explant the device.A surgical ligation was performed to close the pda defect.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of device migration upon release towards the aorta causing aortic obstruction was reported.A returned device assessment could not be performed as the device 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 not be conclusively determined, however potentially be related to the user not following the the ifu.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.A 5-4 mm amplatzer duct occluder ii was used in patient weighting less than 6kg.Please note that per the instructions for use, "contraindications: ¿ patients weighing less than 6 kg ¿ patients less than 6 months of age".

• Brand Name: AMPLATZER DUCT OCCLUDER
• 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: 17199534
• Report Number: 2135147-2023-02748
• Device Sequence Number: 5540270
• Product Code: MAE
• UDI-Device Identifier: 00811806011103
• UDI-Public: 00811806011103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/15/2023

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: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 8854688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ABBOTT DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 10 WK
• Patient Sex: Female
• Patient Weight: 2 KG