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 Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under pma/510(k) # k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: due to the risk of pulmonary thromboembolism, of the pathology, and previous to surgery a celect filter was implanted, with small angulation (less than 15 %).In a control one of the secondary legs was bended in a big angle, predicting big risk on a future removal.Explant attempt: (b)(6) 2020.The situation is that they first tried the retrieval and discovered the abnormal placement of the filter, so it was decided to postpone the removal in order to study and decide the best approach.Patient outcome: the filter is still in place.According to the initial reporter the filter is working for the moment but risky future removal procedure prediction.

Manufacturer Narrative

Manufacturer ref#: (b)(4).Summary of investigational findings: the complaint investigation is based on a review of the image provided.It was reported that the filter was placed prior to surgery due to risk of pulmonary embolism.Upon attempting to retrieve the filter, it was noted that the filter placement was abnormal, so retrieval was postponed and the filter is still in situ.Video of a venogram demonstrates a pigtail catheter via a jugular approach positioned just caudal to a celect platinum ivc filter.The celect platinum ivc filter appears to be positioned below the inflow of the renal veins with approximately 13° of leftward tilt.The hook of the ivc filter abuts the left lateral wall of the ivc.One of the secondary legs is malpositioned and angled just over 90 ° relative to the long axis of the ivc filter, with the tip of the secondary leg located just cranial to the hook of the ivc filter.The additional fluoroscopic image confirms this configuration and does not add any additional information.The maximal distance between the primary filter legs measures approximately 22.5 mm.The remaining primary and secondary legs all appear intact and normally oriented.None of the primary or secondary legs appear to project outside the column of contrast.Presuming the celect platinum ivc filter was deployed via the jugular approach, although this is never specified in the report, it is hard to imagine a situation in which the secondary leg could achieve this configuration, unless the ivc filter was inadvertently pushed caudally after the filter's secondary legs had been unsheathed from the deployment system.If the implanting physician inadvertently pushed the entire filter assembly caudally after the primary and secondary legs were exposed, this could have resulted in the leftward tilt and caudal displacement of the filter legs.If one of the secondary legs engaged with the right lateral wall of the ivc as the entire filter was displaced caudally, this could have caused the secondary leg to flip into the current orientation.Additional potential explanations would be manipulating the pigtail catheter, seen in the venogram, through the ivc filter which have inadvertently pulled the secondary filter leg cranially.Finally, if the filter was in fact deployed from a femoral approach, after the secondary arms were exposed and prior to releasing the primary legs, the filter was displaced caudally, this could have also displaced a secondary filter leg in a similar configuration as described in the first scenario.Without the images during the actual deployment of the ivc filter, it is only speculation to which event led to the configuration observed.However, given the configuration of the secondary filter leg, it would not be possible for the filter leg to spontaneously acquired this configuration in this patient's ivc, even if the secondary filter leg was somehow malformed or malfunctioned, as the length of the secondary filter leg appears greater than the diameter of the ivc filter.Therefore, an extrinsic force had to be placed on the filter leg to result in its cranial displacement.Given the configuration, removing/replacing the ivc filter should be considered, as the hook abuts the left lateral wall will only result in challenges in retrieving the filter which tend to increase with longer dwell times.In addition, there is an increased likelihood of penetration with a mal-positioned secondary leg, and the associated issues encountered with penetrations.No evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 9669772
• MDR Text Key: 195561010
• Report Number: 3002808486-2020-00134
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)220717(10)E3876715
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E3876715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1