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

Catalog Number	IGTCFS-65-8.5-1-FEM-CELECT
Medical Device Problem Codes	Malposition of Device (2616); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Catalogue number: igtcfs-65-8.5-1-fem-celect.Investigation is still in progress.
Event or Problem Description
Description of event according to study: the inferior vena cava (ivc) diameter at the intended filter location was 22.0 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 (lot # e3110992) was deployed at the intended location in the ivc infrarenal 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.Evidence of filter fracture, deformation, tilt, migration, extravasation of contrast, or filter legs appearing outside the column of contrast is not assessable due intravascular ultrasound (ivus) filter placement.On (b)(6) 2016, post-procedure x-ray, (one day post-procedure): site: no evidence of filter fracture, embolization, migration (site queried), or tilt.On (b)(6) 2016, pre-retrieval x-ray, (106 days post-procedure): site: no evidence of filter fracture, embolization, or migration.Tilt = 16 degrees.Patient outcome: the patient remains in the clinical study and no other device related adverse events have been reported.
Additional Manufacturer Narrative
(b)(4).Catalog # igtcfs-65-8.5-1-fem-celect.Summary of investigational findings: investigation is based on event description and review of provided imaging.Image review confirms tilt (~18deg) measured in reference to the vertebral bodies (x-ray images).However tilt should be measured in reference to the longitudinal axis of the ivc.The imaging review states that given the degenerative changes present, using the vertebral body as a reference to tilt likely provides an overestimation in reference to the true lumen of the ivc.Furthermore, the image review found penetration of the ivc of two primary legs (venogram from time of ivc retrieval).The filter retrieval appeared straightforward and uneventful.No comments regarding symptoms related to the penetration.Based on the provided information, the root cause for the reported filter tilt and the found penetration is not possible to determine.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during filter placement or during filter implanting period.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.There is found 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 or Problem Description
Description of event according to study: the inferior vena cava (ivc) diameter at the intended filter location was 22.0 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 (lot # e3110992) was deployed at the intended location in the ivc infrarenal 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.Evidence of filter fracture, deformation, tilt, migration, extravasation of contrast, or filter legs appearing outside the column of contrast is not assessable due intravascular ultrasound (ivus) filter placement.On (b)(6) 2016, post-procedure x-ray, (one day post-procedure): site: no evidence of filter fracture, embolization, migration (site queried), or tilt.On (b)(6) 2016, pre-retrieval x-ray, (106 days post-procedure): site: no evidence of filter fracture, embolization, or migration.Tilt = 16 degrees.Patient outcome: the patient remains in the clinical study and no other device related adverse events have been reported.

• Brand Name: NAVALIGN COOK CELECT FEMORAL VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5777779
• Report Number: 3002808486-2016-00681
• Device Sequence Number: 16508127
• Product Code: DTK
• UDI-Device Identifier: 10827002037677
• UDI-Public: (01)10827002037677(17)160715(10)E3110992
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IGTCFS-65-8.5-1-FEM-CELECT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Weight: 96