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

Model Number G34505

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-fem-celect-pt.Investigation is still in progress.

Event Description

Description of event according to study: b)(6), site reported filter jump on deployment.During the index procedure on (b)(6) 2016, the patient received a celect® filter, lot # e3450532.The inferior vena cava (ivc) diameter at the intended filter location was 23 mm.There was no ivc anatomic anomaly or presence of thrombus 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 deploy prematurely but did jump upon deployment.There was no evidence of filter fracture, deformation or migration.Filter tilt was 6-< 11 degrees.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.Analysis of the placement procedure venacavagram is not yet available.Patient outcome: the patient discharge date is unknown at this time.

Manufacturer Narrative

(b)(4).Summary of investigational findings: investigation is based on description of event and review of provided imaging.According to the image review, the filter was positioned in an appropriate location of the ivc.The filter demonstrates 12deg of tilt with the hook at the midportion of the left renal ostium.The hook does not extend into the left renal vein.The follow-up imaging demonstrates "the deployment sheath ~33.6mm caudal to the inferior aspect of the filter feet, suggesting this is the distance traveled upon releasing the filter".However the imaging review states, that "the filter is still within an appropriate location of the ivc and should provide sufficient mechanical protection against pulmonary embolism".The exact reason why the filter "jumped at deployment" cannot be determined.However, it cannot be left out that the filter was pushed forward in stead of pulling the sheath back during filter placement.The ifu states (instruction for use section) "stabilize the introducer, and withdraw the introducer sheath and connect it to the handle.At this point the filter is expanded, still connected to the filter introducer".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 study: (b)(6), site reported filter jump on deployment during the index procedure on (b)(6) 2016, the patient received a celect® filter, lot # e3450532.The inferior vena cava (ivc) diameter at the intended filter location was 23 mm.There was no ivc anatomic anomaly or presence of thrombus 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 deploy prematurely but did jump upon deployment.There was no evidence of filter fracture, deformation or migration.Filter tilt was 6-< 11 degrees.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.Analysis of the placement procedure venacavagram is not yet available.Patient outcome: the patient discharge date is unknown at this time.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Additional information received 25aug2017: analysis of the placement procedure venacavagram revealed no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.The filter was placed in the ivc infrarenal site and the ivc diameter was 21.4 mm.There was no evidence of filter migration, deformation, extravasation of contrast, or filter legs appearing outside the column of contrast after placement.The angle of filter tilt in the ap view was 13.3 degrees.On the same day, the post procedure x-ray was performed and revealed no evidence of filter fracture, embolization, or migration.Filter tilt was 6 - < 11 degrees.Analysis of the post placement x-ray revealed no evidence of filter fracture, deformation, or embolization.Migration was not assessed.The angle of filter tilt in the ap view was 10.4 degrees.On (b)(6) 2016, the patient was discharged from the hospital.The 3 and 6 month follow-ups were completed and no device related adverse events were reported.On (b)(6) 2017, the 12 month follow-up clinical assessment, ct, x-ray, and ultrasound were completed.The filter is to be scheduled for retrieval.The ct revealed no evidence of filter embolization and a grade 1 filter leg interaction with the ivc wall.The x-ray revealed no evidence of filter fracture, embolization, or migration.Filter tilt = 16 degrees.The ultrasound revealed no evidence of thrombus in the ivc, pelvic veins or lower extremities.Patient outcome: the patient remains in the study.No adverse effects related to the procedure reported.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: complaint is reopened due to additional findings from one year follow-up.Investigation is based on additional information and image review.The impression from the november 2016 review stands unchanged.A review of the one year follow-up imaging demonstrate the celect pt filter in stable craniocaudal position with a significant anterior tilt.On previously submitted images, a lateral x-ray post filter deployment was not submitted for review, so this perceived anterior tilt cannot be compared to determine if this is new or a stable finding.More importantly, when compared with the sagittal images from the ct scan of the abdomen from same day, the anterior tilt seen on the x-ray images is a gross overestimation of the true anterior tilt, relative to the center line of the ivc.At the level of the l2 vertebral body, there is an intrinsic angle between the center line of the ivc and the anterior margins of the vertebral bodies measuring approximately 16° and as confirmed on the ct scan, this indicates that the true anterior tilt of the filter relative to the center line of the ivc is insignificant, measuring only a few degrees.Ct scan demonstrates a single grade 2 interaction between a secondary filter leg and the ivc wall.The remaining primary and secondary filter legs all demonstrate grade 1 interactions with the wall of the ivc.There is no comment of any symptoms potentially related to the perforations in the complaint report and the reason for the perforation cannot be determined.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.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.

• 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
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 5938418
• MDR Text Key: 54286263
• Report Number: 3002808486-2016-01035
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)190518(10)E3450532
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/16/2016
• Device Age: 3 MO
• Date Manufacturer Received: 12/11/2017
• Date Device Manufactured: 05/18/2016
• 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: 65 YR
• Patient Weight: 94