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

Catalog Number IGTCFS-65-2-UNI-CELECT

Device Problems Failure to Capture (1081); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: evaluation is based on complainants description and available images.Images provided show that the filter appearance was normal after deployment.For the posterior leg to fracture in less than two and a half months, the perforation must have occured soon after implantation.Migration was minimal.The fractured primary leg fragment is in the right anterior paraspinal fat in between the spine and the right psoas muscle.It should be stable and asymptomatic.The other perforated legs touched but did not perforate important adjacent structures.From the literature it is known, that manipulation in the area of the filter may cause changes to the filter configuration and to the filter placement, thus causing stress and possibly fracture to the wires.This manipulation may place the filter in an unusual stressed position and result in fracture.Fracture of the wire is an uncommon, but known risk in relation to filter implant.There is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that this specific filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Furthermore, no other complaints were received on this lot.Based on the provided information it has not been possible to determine the exact root cause for this incident.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the issue has been that on screening prior to removal it was discovered that one of the primary struts had fractured and therefore was un-retrievable.Patient outcome: a section of the device did remain inside the patient's body.The device has been left in situ as cannot be removed, the photos clearly show a fractured leg.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• 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: 5887962
• MDR Text Key: 52504023
• Report Number: 3002808486-2016-00891
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)151031(10)E3002100
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2013
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR