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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2016

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).Igtcfs-65-1-jug-tulip.Summary of investigational findings: it is stated that the deployment mechanism did not work properly, but not which portion of the mechanism.After repositioning with a loop snare the filter was placed in intended location.Ap view revealed the filter legs had appropriately opened, but the maximal distance between primary filter feet on lateral view measures less than one half of the max.Distance between primary filter feet on ap view, indicating the ivc is likely very oval.Also, a borderline significant (15°) tilt was noted on lateral x-ray.The tilt resulted in the filer hook abutting the left lateral ivc wall.Since no images of the filter deployment is provided, the exact reason for the deployment difficulties cannot be determined.However, it is known from the literature that excessive back tension could result in deployment difficulties/failure when pressing the release button.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Reference is made to ifu: while keeping slight back tension on the introducer, push the release button completely to ensure proper release of the filter.Repositioning of the filter is no longer possible.The filter is now released (fig.8).Warning: excessive tension during deployment may prevent the filter from releasing when the release mechanism is activated.Investigation found no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to study: the primary reason for the filter placement was history of prior vte and surgery.There was no vte present but the patient was at risk for vte and had a contraindication to anticoagulation.The filter placement was anticipated to be temporary and was accomplished with the use of a venacavagram.The ivc diameter at the intended filter location was 24.0 mm.There was no ivc anatomic anomaly or presence of thrombus in the ivc prior to filter placement.Using the right internal jugular vein as the access site, a gunther tulip filter (lot #e3420494) was deployed at the intended location in the ivc infrarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism.The filter did not deploy in intended location, per comments, "deployment mechanism didn't work properly, device repositioned using loop snare." the site indicated the filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, or migration.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.The filter angle of tilt was 6 - 11 degrees.Patient outcome: the filter was repositioned with a snare and the patient remains in the study.No clinical sequela has been reported.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5801627
• MDR Text Key: 49760374
• Report Number: 3002808486-2016-00749
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)190223(10)E3420494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Date Device Manufactured: 02/23/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 91