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

Model Number G48372

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

This mdr is related to mfr report #3002808486-2017-01868.Non-healthcare professional the investigation is in progress.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2011 via the right internal jugular vein due to deep vein thrombosis (dvt).Successful percutaneous filter removed on (b)(6) 2011 due to it being a temporary placement.(b)(6) 2011 , per a report from implant report; "angiographic findings: the suprarenal inferior vena cava is patent.There is thrombus extending from the left superficial femoral vein and the right common femoral vein to the inferior vena cava bilaterally.The thrombus is occlusive of the iliac veins.The thrombus extends cephalad to the previous inferior vena cava filter extending 2 cm proximal to the filter tip.This is consistent with the ct angiogram findings of clot extending above the right renal vein but below the left renal vein." (b)(6) 2011 , per a report from retrieval report; "angiogram findings: the superficial femoral, common femoral, iliac veins and inferior vena cava are free of filling defects.There was complete resolution of the thrombus within these veins.Infrarenal inferior vena cava filter is also free of thrombus.The suprarenal inferior vena cava filter is free of thrombus.Successful removal of the suprarenal inferior vena cava filter was performed.".

Manufacturer Narrative

Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional event information has been provided at this time.

• Brand Name: COOK CELECT JUGULAR 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: 11757329
• MDR Text Key: 249030046
• Report Number: 3002808486-2021-01165
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002483729
• UDI-Public: (01)00827002483729(17)130411(10)E2731511
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2013
• Device Model Number: G48372
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2731511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening