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

Catalog Number	9-PDA2-06-06
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/07/2024
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.B3: event date is estimated as the date of embolization has not been provided.
Event or Problem Description
It was reported that on (b)(6) 2024, a 5mm/4mm amplatzer duct occluder was chosen for implantation utilizing an unknown abbott delivery system to treat a 3-4mm mitral valve leaflet perforation.When placed, a small residual shunt was noted so the occluder was removed and replaced with a 6mm/6mm amplatzer duct occluder utilizing the same delivery system.Device was placed successfully and with no shunt.Stability test performed.On an unknown date, a follow up echocardiogram was performed and the device had completely dislodged.There were no clinical signs or symptoms due to the dislodgement, and no blockage of blood flow.Device was retrieved percutaneously.
Additional Manufacturer Narrative
An event of migration or expulsion of device and residual shunt 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 reported device migration appears to be related to procedural conditions.The reported unexpected medical intervention was a result of case-specific circumstances as a device was snared and removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note that per the instructions for use, "indications and usage - the amplatzer¿ duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda)." please note that per the instructions for use, "precautions - handling - the amplatzer¿ duct occluder and 180° delivery system were sterilized with ethylene oxide and are for single use only.Do not reuse or resterilize.Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient." h6 medical device problem code: 2017 added.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: on (b)(6) 2024, a follow up echocardiogram was performed and the device had completely dislodged and had moved to the superficial femoral artery.There were no clinical signs or symptoms due to the dislodgement, and no blockage of blood flow.Device was retrieved percutaneously.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• 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: 20845844
• Report Number: 2135147-2024-06117
• Device Sequence Number: 17076228
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: (01)00811806011264(17)270430(10)8489930
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/05/2025

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-PDA2-06-06
• Device Lot Number: 8489930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2022
• 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 Sex: Unknown