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

Model Number G34505

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: "first, physician encountered resistance when unsheathing the ivc filter, although ivc appeared to be normal.Second, after deployment a single secondary strut of the ivc filter was found to be splayed lateral to the filter.The rest of the struts were found to be normal and gained normal wall apposition.Discussed was the possibility that there was an accessory that the secondary strut may have found upon deployment." additional information received (b)(6) 2017: there was tilt.Patient outcome: 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.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description and image review.A follow-up fluoroscopic image following placement of a celect-pt filter demonstrates the filter with borderline significant leftward tilt and a secondary arm extending nearly perpendicular to the long axis of the ivc filter toward the right.This secondary filter leg is at the 9 level on the fluoroscopic tape, suggesting that it likely extends into the right renal vein ostium.The complaint report describes the deploying physician encountered resistance when unsheathing the ivc filter.Nothing on the provided images would account for this added resistance.Potentially, the sheath was not flushed prior to advancing the filter in the sheath and residual contrast or thrombus could have accounted for this resistance.Whatever the cause, this perceived resistance may have resulted in the inadvertent inferior displacement of the ivc filter after the secondary arms were deployed, allowing the right lateral most secondary filter leg to engage with the right renal vein.The leftward tilt is likely accentuated, if not entirely caused by, this engagement of the secondary leg with the renal vein ostium, altering the forces placed on the ivc filter displacing the hook of the filter toward the left.The filter tilt is not enough to decrease the efficacy of the filter.The exact reason for the difficulties encountered when attempting to place the filter cannot be determined, but this malpositioned secondary leg and leftward tilt could have been avoided if the filter was deployed only a few millimeters more caudal than its current location.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended during placement.Cook medical will continue to monitor for similar events.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 7082059
• MDR Text Key: 94197106
• Report Number: 3002808486-2017-02333
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)200807(10)E3616795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/11/2017
• Device Age: 3 MO
• Date Manufacturer Received: 03/02/2018
• Date Device Manufactured: 08/07/2017
• 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