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

Model Number	DUCT OCCLUDER II
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm by 6mm amplatzer duct occluder ii was chosen for implant.Prior to the procedure, the defect was measured to be 4mm-6mm via echocardiogram and angiogram imaging.The occluder was implanted.Immediately after the procedure, it was seen via angiogram and echocardiogram that the device embolized out of the defect.The device was then explanted in a non-emergent surgery on the same day.The patient was reported as discharged.The implanter alleges the embolization to be due to a mis-sizing of the occluder.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of occluder embolization after the procedure was reported.The device was returned to abbott for investigation and the device met dimensional and functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 16279292
• Report Number: 2135147-2023-00353
• Device Sequence Number: 6992989
• Product Code: MAE
• UDI-Device Identifier: 00811806011240
• UDI-Public: 00811806011240
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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 Expiration Date: 03/31/2026
• Device Model Number: DUCT OCCLUDER II
• Device Catalogue Number: 9-PDA2-05-06
• Device Lot Number: 7937650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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 Age: 8 YR
• Patient Sex: Female