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

Catalog Number IGTCFS-65-1-FEM-TULIP

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Perforation of Vessels (2135)

Event Date 11/22/2016

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 gunther tulip 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 in the ivc prior to filter placement.Using the right common femoral vein as the access site, a gunther tulip 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 neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, or migration.Filter tilt was reported as < 6 degrees by the investigative site.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.Analysis of the placement procedure venacavagram noted an ivc diameter of 21.1 mm at the filter location.There was no evidence of filter deformation or migration.Filter tilt was 5.9 degrees in the ap view.There was no extravasation of contrast but filter legs did appear outside the column of contrast after placement.On (b)(6) 2015 (day of procedure), the post-procedure x-ray was completed which revealed filter tilt of < 6 degrees by the investigative site.There was no evidence of filter fracture or migration.Analysis showed filter tilt of 1.3 degrees in the ap view and 4.5 degrees in the lat view.There was no evidence of filter fracture or deformation.On (b)(6) 2016 (335 days post-procedure), the 12-month follow-up ct scan revealed grade 2 filter leg interaction with the ivc wall.A x-ray performed on the same day revealed evidence of filter fracture.There was no evidence of filter embolization or migration, and filter tilt was 0 degrees.Patient outcome: no clinical sequelae were associated with this event, and no intervention has been performed.The patient remains in the study.

Manufacturer Narrative

(b)(4).Summary of investigational findings: a tulip filter was deployed in an infrarenal location with insignificant tilt and no perforation.At the twelve months follow-up all four primary legs demonstrate at least grade 1 interaction with the ivc wall, but two of these have a borderline grade 2 interaction present.However, it is difficult to determine if the filter feet project completely outside of the ivc wall or if there is just severe tenting of the wall.The reason for the filter legs to perforate the ivc wall cannot be determined.The reported filter fracture cannot be confirmed.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.

Event Description

Description of event according to study: at the index procedure on (b)(6) 2015 the patient received a gunther tulip 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 in the ivc prior to filter placement.Using the right common femoral vein as the access site, a gunther tulip 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 neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, or migration.Filter tilt was reported as < 6 degrees by the investigative site.There was no extravasation of contrast or filter legs appearing outside the column of contrast after filter placement.Analysis of the placement procedure venacavagram noted an ivc diameter of 21.1 mm at the filter location.There was no evidence of filter deformation or migration.Filter tilt was 5.9 degrees in the ap view.There was no extravasation of contrast but filter legs did appear outside the column of contrast after placement.On (b)(6) 2015 (day of procedure), the post-procedure x-ray was completed which revealed filter tilt of < 6 degrees by the investigative site.There was no evidence of filter fracture or migration.Analysis showed filter tilt of 1.3 degrees in the ap view and 4.5 degrees in the lat view.There was no evidence of filter fracture or deformation.On (b)(6) 2016 (335 days post-procedure), the 12-month follow-up ct scan revealed grade 2 filter leg interaction with the ivc wall.A x-ray performed on the same day revealed evidence of filter fracture.There was no evidence of filter embolization or migration, and filter tilt was 0 degrees.Patient outcome: no clinical sequelae were associated with this event, and no intervention has been performed.The patient remains in the study.

• Brand Name: GUNTHER TULIP NAVALIGN FEMORAL 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: 6180032
• MDR Text Key: 62543067
• Report Number: 3002808486-2016-01487
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)181105(10)E3384069
• 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,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/23/2016
• Device Age: 12 MO
• Date Manufacturer Received: 11/28/2016
• Date Device Manufactured: 11/05/2015
• 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: 56 YR
• Patient Weight: 88