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

Catalog Number IGTCFS-65-1-FEM-CELECT

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Perforation of Vessels (2135); Vomiting (2144); No Information (3190)

Event Type  Injury  

Event Description

It is alleged that the patient received a cook celect filter on (b)(6) 2012.The patient alleges to have been injured without further explanation.

Event Description

Patient allegedly received an implant on (b)(6) 20112 via right common femoral vein due to deep vein thrombosis (dvt).Patient is alleging vena cava perforation.Patient notes and further alleges experiencing "unexplained nausea and vomiting.Per the (b)(6) 2012 ivc (inferior vena cava) filter placement: "impression: ivc filter placed with ultrasound and fluoroscopic guidance below the renal veins".Per the (b)(6) 2019 ct (computed tomography) abdomen: "there is an ivc filter without significant tilt.The tip of the filter is at the level of the left renal vein.There is no evidence of strut fracture or bending.There is no evidence of ivc stenosis.There is strut penetration of the anterior strut by 1mm, the posterior strut by 3mm, the lateral strut by 4mm, and the medial strut by 5mm.There is no evidence of penetration of surrounding organs".

Manufacturer Narrative

This event has been reported by the manufacturer under mdr# 3002808486-2019-01150.

• Brand Name: COOK CELECT 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: 8860894
• MDR Text Key: 153284323
• Report Number: 3005580113-2019-00156
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2014
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2834053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Distributor Facility Aware Date: 09/11/2019
• Event Location: Other
• Date Report to Manufacturer: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 125