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

Model Number	9-PDA2-03-04
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12162914
• Report Number: 2135147-2021-00277
• Device Sequence Number: 19998492
• Product Code: MAE
• UDI-Device Identifier: 00811806011172
• UDI-Public: 00811806011172
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 9-PDA2-03-04
• Device Catalogue Number: 9-PDA2-03-04
• Device Lot Number: 7365053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR