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

Catalog Number IGTCFS-65-FEM-CELECT-PERM

Device Problem Occlusion Within Device (1423)

Patient Problems Pulmonary Embolism (1498); Death (1802); Pain (1994); Claudication (2550)

Event Date 09/10/2014

Event Type  Death  

Manufacturer Narrative

(b)(4). Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140. (b)(4). Summary of investigational findings: patient's medical records are unknown at this time and no imaging is provided. Therefore, no conclusion can be drawn based on the incomplete information provided regarding the leg pain and death of the patient more than 4 years after filter placement, nor on autopsy revealing "massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the ivc filter. " based on the limited information available in this complaint, it remains unknown if the filter performance was related to this occurrence and therefore the exact root cause is unknown. However, pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. 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 medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009 prior to a spinal procedure. " "on or about (b)(6) 2014, [pt] complaining of leg pain, while walking. There, he was admitted and found to have symptoms consistent with neurogenic claudication likely secondary to an exacerbation of his lumbar spinal stenosis. Pain management and physical therapy was started. After a physical therapy session, the [pt] became unexpectedly lightheaded while climbing the stairs. He then became unresponsive and ultimately died on (b)(6) 2014. " "the final pathologic findings of an autopsy performed at the (b)(6) revealed massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the ivc filter. " patient outcome: patient deceased on (b)(6) 2014.

Manufacturer Narrative

(b)(4). The patient involved was reported to be deceased without further details, therefore this report is being submitted as ¿death¿ related as a cautionary measure. The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 04/28/2017 as follows: the patient allegedly received the filter implant on (b)(6) 2009 for dvt. The patient died on (b)(6) 2014. The patient¿s estate alleges death due to caval thrombus, dvt of left iliac vein, and massive bilateral pe.

Manufacturer Narrative

(b)(4). Corrected data based on new information received: adverse event and product problem to adverse event. Complaint was reopened since lot# was provided. However, since this is the only additional information received the below investigation information is still valid and remains unchanged: patient's medical records are unknown at this time and no imaging is provided. Therefore, it is impossible to comment on the reported leg pain and death of the patient more than 4 years after filter placement. Also, it is impossible to comment on autopsy revealing "massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the ivc filter. " based on the limited information available in this complaint, it remains unknown if the filter performance was related to this occurrence and therefore the exact root cause is unknown. However, pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. 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.

• Brand Name: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov 4632, IN 47404 ; 8004574500
• MDR Report Key: 6016287
• MDR Text Key: 56909535
• Report Number: 3002808486-2016-01199
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 09/15/2016
• Device Age: 67 MO
• Event Location: No Information
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/18/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/11/2016 Patient Sequence Number: 1