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

Model Number G34505

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/21/2017

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: "during a routine deployment of the filter, two of the legs prolapsed.The filter was implanted and the physician plans on retrieving it soon." 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).Manufacturers ref# (b)(4).(b)(4).Summary of investigational findings: investigation is based on description of event stating "during a routine deployment of the filter, two of the legs prolapsed.The filter was implanted and the physician plans on retrieving it soon." and a single fluoroscopic image with no additional clinical information.The image demonstrates a celect-pt filter that came as a uni set.The complaint report does not specify if this was deployed from a femoral or jugular approach.In all likelihood, given the orientation of the malpositioned secondary legs, this was deployed from a femoral approach.The filter demonstrates two secondary legs displaced cranial to the filter hook, in an orientation which is nearly opposite to that of the intended orientation.This abnormal configuration results in a rightward force on the hook of the ivc filter, resulting in a tilt of ~12deg relative to the posterior spinous processes.The remaining primary and secondary legs are normally aligned.Assuming this filter was deployed from a femoral approach, the likely explanation is the secondary filter legs were under sheathed and the filter was retracted in the ivc causing these two secondary legs to engage with the wall of the ivc and flip them cranially as caudal retraction was performed.The ifu for the filter states that once the secondary legs are expanded, ¿retracting the filter could damage the secondary legs or caval wall¿.This is a complication of the use, or rather misuse, of the device, by not following the ifu.No evidence to suggest that this device was not manufactured according to specifications.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: 6705116
• MDR Text Key: 80035764
• Report Number: 3002808486-2017-01506
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)200426(10)E3577782
• 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: user facility
• Reporter Occupation: Other
• 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: 07/12/2017
• 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?: No
• Distributor Facility Aware Date: 06/21/2017
• Device Age: 2 MO
• Date Manufacturer Received: 12/11/2017
• Date Device Manufactured: 04/26/2017
• 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