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

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem Internal Organ Perforation (1987)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-fem-celect-pt.(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 25.0 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 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 angle of 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 placement site was infrarenal, and the ivc diameter at the filter location was 22.2.There was no evidence of filter migration, extravasation of contrast, or deformation.Filter leg(s) did appear outside the column of contrast after filter placement.From the venacavagram, the angle of filter tilt in the ap view was 2.4 degrees.On (b)(6) 2015 (day of procedure), the post- procedure x-ray was completed.Site report of tilt was 0 degrees.Analysis revealed filter tilt of 15.6 degrees in the ap view and 16 degrees in the oblique view.On (b)(6) 2016 (375 days post-procedure), the 12-month follow-up ct scan was performed and the site indicated no filter embolization and no filter leg interaction with the ivc wall.Analysis of the ct scan revealed 11 filter legs with grade 1 interaction with the ivc wall and 1 filter leg with grade 3 interaction with the ivc wall.The organ affected was the iliac artery.There was no hemorrhage, hematoma, or other clinical findings observed at the perforation/puncture site.On (b)(6) 2016 (429 days post-procedure), the 12-month follow-up clinical assessment was completed.The site indicated that due to ongoing risk for pe, the filter would not be removed.Patient outcome: the patient remains in the study.

• Brand Name: COOK CELECT® PLATINUM 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: 6144366
• MDR Text Key: 61437911
• Report Number: 3002808486-2016-01467
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345024
• UDI-Public: (01)10827002345024(17)180619(10)E3340715
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/22/2016

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 Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/05/2016
• Date Device Manufactured: 06/19/2015
• 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 Outcome(s): Life Threatening
• Patient Age: 93 YR
• Patient Weight: 67