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

Model Number G52917

Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Perforation (2001)

Event Date 03/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-fem-tulip.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: (b)(6): pulmonary embolism probably related to the ivc filter.During the index procedure on (b)(6) 2016, the patient received a g¿nther tulip filter.The primary reason for filter placement was a current deep vein thrombosis with a complication of anticoagulation.The inferior vena cava (ivc) diameter at the intended filter location was 16.5 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 g¿nther tulip filter was deployed at the intended location in the ivc suprarenal site and in a location suitable to provide sufficient mechanical protection against pulmonary embolism (pe).The filter neither deployed prematurely nor did the filter jump upon deployment.There was no evidence of filter fracture, deformation, migration, or extravasation of contrast.Filter legs did not appear outside the column of contrast after filter placement.Filter tilt was 11 - < 16 degrees.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.The ivc diameter at the filter location was 17.3 mm.The angle of filter tilt in the ap view was 5.0 degrees.There was no evidence of deformation, extravasation of contrast, or migration.Filter legs did appear outside the column of contrast after placement.On the same day, the post-placement x-ray was performed.There was no evidence of filter fracture, embolization, or migration.Filter tilt was 6 - < 11 degrees.Analysis revealed no evidence of filter fracture, deformation, or embolization.Filter migration was not assessed.The angle of filter tilt in the ap view was 10.7 degrees.On (b)(6) 2017 (131 days post-procedure), the patient was diagnosed with a new pe.The investigator determined that the pe was probably related to the study device and the patients pre-existing interstitial lung disease caused or contributed to the event.The device did not malfunction or deteriorate in characteristics or performance.On (b)(6) 2017(199 days post-procedure), the filter was retrieved with minimal difficulty via the right internal jugular vein.Patient outcome: on (b)(6) 2017 (248 days post-procedure), the patient exited the study.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and image review.A tulip filter was deployed in a normal infrarenal location with no evidence of immediate perforation or significant tilt.Ct scan of the chest, performed 131 days later demonstrates what appears to be chronic, nonocclusive thrombus within the left main pulmonary artery extending into the upper and lower lobar branches.There is remodeling of the thrombus which appears adherent to the wall of the vessel with significant interstitial thickening throughout much of the left lung, resulting in significant volume loss and compensatory hypertrophy of the right lung with a right to left shift of the mediastinum.The complaint report describes this as a new pe, but does not have imaging of the chest included performed prior to the implantation of the gunther tulip ivc filter.In addition, the clinical history provided states the patient had a prior history of dvt and pe prior to ivc filter placement.Given the remodeled appearance of the thrombus and the interstitial changes which appeared to be more chronic than acute, it would be very unlikely this pulmonary embolism was new, but rather was present prior to placement of the gunther tulip ivc filter.Furthermore, given the size of the thrombus that is present, it is difficult to envision a clinical scenario where this thrombus passed through the ivc filter.The retrieval venogram approx.2 months later demonstrated penetration of the walls of the ivc filter by two of the primary legs, which did not appear to impede the retrieval success.Furthermore, there was no comment in the complaint report regarding any symptoms related to the observed penetration and the cause of penetration, at this point, is indeterminate.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.Cook medical will continue to monitor for similar events.

• Brand Name: GUNTHER TULIP 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 Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6787402
• MDR Text Key: 82452081
• Report Number: 3002808486-2017-01601
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)190426(10)E3443066
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G52917
• 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: 07/18/2017
• Device Age: 11 MO
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/12/2017
• Date Device Manufactured: 04/26/2016
• 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): Life Threatening
• Patient Age: 66 YR
• Patient Weight: 94