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

Model Number 9-PDA2-03-04

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body Embolism (4439)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

An event of device dislodgement was reported.A more comprehensive 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.

Event Description

It was reported that on (b)(6) 2021, a 3mm/4mm amplatzer duct occluder ii was selected for implant for the patient's patent ductus arteriosus (pda).The device was successfully implanted in the pda, but immediately after the device was detached from the delivery cable, the occluder dislodged to the pulmonary artery side without causing a blockage.The device was removed from the patient percutaneously using a snare catheter (goose neck), which took approximately 30 minutes.After the device was successfully removed, the implant procedure was abandoned and there was no replacement device.The treatment for the patient will be reconsidered on a later date.There were no adverse health consequences to the patient.The patient remained hemodynamically stable throughout the procedure.According to the physician, the device was chosen appropriately based on morphological evaluation of the pda based on computerized tomography (ct) and angiography imaging, therefore the device dislodgement was related to the procedure and the patient's anatomy.No allegation to the sizing of the device was reported.No additional information was provided.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12162914
• MDR Text Key: 261710841
• Report Number: 2135147-2021-00277
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011172
• UDI-Public: 00811806011172
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDA2-03-04
• Device Catalogue Number: 9-PDA2-03-04
• Device Lot Number: 7365053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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: 26 YR