MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number	IGTCFS-65-1-JUG-CELECT-PT
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: a female patient of undisclosed age underwent a filter placement procedure in which the cook celect platinum navalign jugular vena cava filter set, g34309, was used.The patient had bilateral clots in which one had dislodged.Patient has colon cancer and is scheduled to undergo colon resection on (b)(6) 2024 and the physician wanted the filter placed as a precaution for pulmonary embolism.During the filter placement procedure, the physician fired the filter into place and the tines did not expand.The filter then tipped where the physician intended to deploy the filter.After the filter tipped the tines expanded.Attempts were made to move and realign, however the tip of the filter was pointing into the vena cava wall and could not be moved, and the physician had to leave the filter in place.A retrieval wire could not be used as the filter tip was in the vena cava wall.A second filter was then deployed below the first filter that was tilted.The physician confirmed the patient is doing well, but there is concern of the tilted filter and the tip in the vena cava wall.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 19308520
• Report Number: 3005580113-2024-00028
• Device Sequence Number: 17751773
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)250824(10)E4297464
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• Report Date (Section F): 05/14/2024

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: 08/24/2025
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E4297464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2024
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Date Device Manufactured: 08/24/2022
• 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: Other
• Patient Sex: Female
• Date Report Sent to FDA: 05/14/2024