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

Model Number G34502

Device Problems Difficult to Remove (1528); Structural Problem (2506)

Patient Problems Arrhythmia (1721); Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Date 08/01/2020

Event Type  Injury  

Event Description

Description of event according to initial reporter: patient experience extreme shortness of breath, hypertension and rapid heart beat right after having surgery for the filter placement.The device was removed as a result of her complications and the device was embedded in the wall.Two attempts were made to remove the device, first attempt was on (b)(6) 2020 and the cardiologist was having complications removing the device so a cardiac catheter was inserted and the patient reports being transferred to the hospital.The second attempt for removal was on (b)(6) 2020 by the interventional radiologist and the removal was successful.However, the physician told the patient the surgery to remove the filter was very complicated because the filter was embedded.Patient outcome: patient reports after one week of having the device removed she is now feeling much better.

• Brand Name: COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10919177
• MDR Text Key: 218689491
• Report Number: 3005580113-2020-00451
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)230609(10)E3989523
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2020,11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3989523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2020
• Date Device Manufactured: 06/09/2020
• 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