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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problems Malposition of Device (2616); Material Twisted/Bent (2981)

Patient Problem Thrombus (2101)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Similar to device under 510(k): k121629.Investigation is still in progress.

Event Description

Description of event according to initial reporter: uncomplicated placement of ivc filter on friday (b)(6) 2018, via right femoral approach.Imaging at end of procedure shows position.Patient admitted for procedure and later discharged.Patient subsequently collapsed at some point over the weekend and was readmitted.Collapsed again.Ct scan on tuesday (b)(6) 2018, shows tilted filter with 4 legs bent up at acute angles.Scan also showed extensive thrombus within ivc below filter extending into iliac veins.Patient now ventilated on itu.(no surgical procedures known of between (b)(6) (deployment) and (b)(6) (ct scan).Physician unsure at this point as to whether the filter contributed to the patient's current condition.Patient outcome: no extra procedures reported.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).(b)(4).Summary of investigational findings: investigation is based on event description and image review.It was reported that the filter tilted with four legs bent up at acute angles and extensive thrombus within ivc.Imaging showed appropriate placement of the filter without evidence of tilt or perforation.Imaging four days later demonstrate significant change in orientation of multiple secondary filter legs to a near perpendicular orientation to the long axis of the filter.There was also subsequent development of increase in rightward tilt, and per the complaint report, there is extensive thrombus below the ivc filter extending into the iliac veins.There is no comment regarding potential pulmonary emboli to indicate the filter did not perform adequately.Given the short time interval between the placement and these followup images it is assumed that given the patient had collapsed and was in the icu ventilated, an internal jugular central line was placed at bedside and the j-wire inadvertently engaged with the filter as it was being removed and resulted in the significant distortion of the filter configuration.This has been described in the literature, and is not a fault of the filter.The complaint report specifies the patient had "no surgical procedures" between the 2 dates, but this does not likely include the placement of central lines which are commonly performed in the icu and are almost inevitably in place for patients who are intubated, as this patient was.Without additional images from the ct scan, it is uncertain whether or not the secondary legs penetrate through the ivc wall or potentially extend into the left renal vein ostium.If the filter is deployed in such a manner that the secondary leg engaged with the ostium of a renal vein, this can contribute to contralateral tilt and extension of the secondary legs into the renal vein ostium, however, on the placement venogram images, the primary nor secondary legs appear close to the renal vein ostium indicating this is less probable than the first theory.The submitted images do not confirm the development of caval and iliac venous thrombus, nor do they help elucidate a potential cause.The extensive thrombus may have been related to a pre-existing condition especially if the filter was placed for extensive thrombus with inability to anticoagulate.Unfortunately, this clinical information was not submitted in the complaint report.Ivc filters have been known to slightly increase the risk of caval and lower extremity deep venous thrombosis even in the setting of anticoagulation, but without further understanding of the patient's indication for ivc filter, it is difficult to determine if this was spontaneous caval thrombosis related to the presence of the ivc filter, or if this was capture of an embolizing thrombus from the lower extremities with inferior clot propagation.There is 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.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 information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 7867763
• MDR Text Key: 119928297
• Report Number: 3002808486-2018-01066
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)210523(10)E3728619
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2021
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E3728619
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/24/2018
• Device Age: 3 MO
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening