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

Model Number DUCT OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, an 8-6mm amplatzer duct occluder was chosen for implant.Prior to the procedure, the dimensions of the defect were measured to be 5mm-7mm via an echocardiogram imaging and during an angiogram.The device was implanted in the defect and was properly seated until it embolized towards the pulmonary artery.The device was snared and attempted to re-implant in the defect two times but each time the device embolized towards the pulmonary artery.The device was not able to be successfully implanted and the device was removed from the patient using a transcatheter snare.It is unknown if a replacement device was implanted.No patient consequences were reported.The patient was reported as discharged.The implanted believes the cause of the embolization was from mis-sizing.No additional information was provided.

Manufacturer Narrative

An event of device embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined but could have been due to the use of an occluder of the wrong size during the procedure.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.Please note per the instructions for use, refer to table t1.Select an occluder with a dimension b that is at least 2 mm larger than the narrowest portion of the ductus.H6: clinical code 4582 removed.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: 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: 16279348
• MDR Text Key: 308574228
• Report Number: 2135147-2023-00355
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 8584994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female