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

Model Number G34502

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to study: at the index procedure on (b)(6) 2015 the patient received a celect filter.The inferior vena cava (ivc) diameter at the intended filter location was 23 mm.There was no ivc anatomic anomaly or presence of thrombus noted in the ivc prior to filter placement.Using the right common femoral vein as the access site, a celect filter was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pe.The filter did not filter jump upon deployment and there was no evidence of filter fracture, deformation, or migration.The filter did release prematurely.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.Analysis of the placement procedure venacavagram reported no ivc anatomic anomaly or thrombus present.The filter was placed in the ivc infrarenal site, and the ivc diameter at the filter location was 23.5 mm.There was no evidence of filter fracture, deformation, or migration.Filter tilt was 1.5 degrees in the ap view.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.On (b)(6) 2016 (73 days post-procedure), the filter was no longer clinically needed and the pre-retrieval x-ray was performed.There was no filter fracture, embolization, migration, or filter tilt.On the same day, the filter was retrieved endovascularly with a cloversnare¿ retrieval set via the right internal jugular vein.The physician reported ¿minimal¿ difficulty retrieving the filter.No additional devices used.Filter legs did not appear outside the column of contrast and there was no thrombus present in the filter prior to filter retrieval.Analysis of the pre-retrieval x ray revealed no thrombus present.There was no evidence of filter fracture or deformation.Filter legs did appear outside the column of contrast before retrieval.There was no extravasation of contrast after filter retrieval.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description and image review.A review of imaging provided found the celect-pt filter placed in infrarenal location without evidence of immediate penetration or significant tilt.The complaint report states "filter did release prematurely", but does not elaborate further on this statement.As the filter appears to have been deployed in the intended location, the exact mechanism or implication of premature release is indeterminate.In all likelihood, if the filter did indeed become detached from the deployment mechanism, this was likely due to advertent depression of the release button while the filter was being advanced through the sheath.In addition, on the lateral projection, there appeared to be borderline significant anterior tilt relative to the bony landmarks.This was a gross overestimation of the anterior tilt based on the divergent course of the ivc and anterior margins of the vertebral bodies, confirmed on sagittal reformats on a prior ct scan.The intrinsic angle between the ivc and anterior margins of the vertebral bodies at this level, measures approximately 12°, indicating the true anterior tilt relative to the central line of the ivc would be only 2°.Follow-up x-rays and venogram, at the time of filter retrieval 73 days later, demonstrate cranial shift of the filter by approximately 1 cm, likely related to projection and does not denote true cranial migration by definition.Venogram confirmed no evidence of significant tilt, but there was development of perforation by 2 of the secondary filter legs both extending approximately 5 mm outside of the column of contrast.The exact reason for the perforations cannot be determined, but there was no discussion of the complaint report regarding any symptoms related to this perforation and the filter was removed without difficulty.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.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.

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 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 DK-46 32; DA DK-4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7760924
• MDR Text Key: 116402913
• Report Number: 3002808486-2018-00891
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)181015(10)E3376764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2018
• Device Model Number: G34502
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3376764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/17/2018
• Device Age: 2 MO
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• 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 Age: 63 YR
• Patient Weight: 70