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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Bent (1059)

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

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Catalog# igtcfs-65-2-uni-celect-pt.(b)(6).No known impact or consequence to patient; bent.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the physician implanted the filter in the patient without difficulty.Suddenly he saw the wire not in place one secondary leg is pointing outwards.He decided to take it out and put a new one in.One of the leg of filter pulled up in ivc.Filter was removed with snare and a new celect filter was inserted instead.Patient outcome: prolonged procedure time and radiation.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).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description, returned product, and image review.Only the filter was returned and investigation found a secondary filter leg almost wrapped around the primary filter leg.The secondary leg was kinked in two areas, probably caused by manipulation during filter placement or during filter removal.The single image from a venogram with a celect platinum ivc filter in an infrarenal location demonstrates significant distortion and displacement of a single secondary leg with the tip located cranial to the hook of the ivc filter, and also extending into the left renal vein laterally.Given the diameter of the ivc measures only 18 mm, it would not be plausible for the secondary filter leg to expand into the ostium of the renal vein and be displaced cranially on its own accord, even if there was a kink where the secondary leg joined the filter body.Furthermore, the picture of the ivc filter after retrieval demonstrates, at most, a 90° angle between the secondary filter leg and the long axis of the ivc filter body, indicating there was not a kink present in the secondary filter leg.There are several potential explanations for this configuration, the most plausible of which would be inadvertent caudal displacement of the ivc filter once the secondary legs were partially unsheathed.If the secondary filter leg engaged the ostium of the left renal vein when the filter was pushed forward out of the sheath, instead of retracting the sheath, this would have resulted in the cranial displacement of the secondary filter leg.A slightly less plausible event would have been the inadvertent snagging of the secondary filter leg with the deployment hook of the ivc filter deployment sheath.If the operator retracted the sheath, unaware that the small hook had engaged a secondary filter leg, this may have pulled the leg cranially into the observed configuration.A final, but less likely explanation would be the fact that this was a uni configuration, and potentially, though highly unlikely, the secondary filter leg could¿ve been loaded into the deployment sheath oriented parallel to the long axis of the ivc filter, but directed towards the hook instead of towards the filter feet.When the filter was deployed, this secondary filter leg was then in an opposite orientation when compared to the remaining filter legs.It is difficult to foresee a mechanism in which the secondary filter leg resided in this configuration without some form of deployment error introduced by the deploying physician.Fortunately, the filter was retrieved in its entirety and there were no symptoms described in the complaint report caused by this mal aligned secondary leg.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.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: 6867816
• MDR Text Key: 86843242
• Report Number: 3002808486-2017-01820
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• 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-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/25/2017
• Device Age: 4 MO
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1