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

Catalog Number IGTCFS-65-1-JUG-CELECT-PT

Device Problems Premature Activation (1484); Failure to Unfold or Unwrap (1669); Malposition of Device (2616); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problems Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Investigation is still in progress.

Event Description

According to the physician he was trying to position the device and unsheathed it, but the primary struts did not open.At this point, the physician released it into the patient.At that point, they got an ensnare and tried to snare it but accidentally snared the secondary strut and proceeded to try to pull the filter out (filter would not budge).When the district manager got there, they had no other retrieval device, so the district manager provided a clover snare.The patient was no longer at the facility, so clover snare could not be attempted.Because it was not possible to retrieve the device on the first attempt, the physician decided to leave the device for the time being and discontinue the procedure.According to the technician the filter was deployed early and unintentionally, and is not in the right spot.Patient outcome: possibly new retrieval attempt.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Investigation is still in progress 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

Additional information received 16apr2019: "the facility removed the filter without incident.The lot number is e3621458.".

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that the primary struts did not open, when trying to position and unsheath the device.At this point, the physician says he released it into the patient.At that point, they got an ensnare and tried to snare it but accidentally snared the secondary strut and proceeded to try to pull the filter out (filter would not budge).Because device was unable to be retrieved on first attempt, physician determined to leave device for the time being and discontinue the procedure.The filter was successfully retrieved during a second attempt.Also, it was "thought that the filter was deployed early and unintentionally, and is not in the right spot." no harm to the patient reported.Only the used filter was returned and an investigation found two secondary filter legs wrapped, probably because they were "accidentally snared" with the ensnare.Hovewer, after removing the biological matter from the filter the legs unwrapped and were evenly distributed and no damages were noted on the filter hook.According to the video provided the celect platinum ivc filter was placed in the inferior vena cava with an insignificant leftward tilt (12 degrees).The hook terminates at the inferior endplate of the t12 vertebral body abutting the left lateral wall of the ivc.It is uncertain if the video submitted for review was taken immediately after deploying the ivc filter or after the attempted retrieval.It is also unclear why the physician released the device if he was uncertain if the primary legs had opened correctly.One of the advantages of deploying the filter from a jugular approach is the ability to recapture and reposition the filter.Assuming the video as taken prior to the attempted retrieval, the primary filter legs do appear somewhat clustered towards the right aspect of the ivc.Only 2 primary filter legs are appreciated, indicating the two sets of legs are oriented parallel to each other in the ap dimension/plane of the x-ray beam.If the ivc were collapsed/slit like at the time of unsheathing the primary filter legs, this would have resulted in the feet engaging with both the anterior and posterior walls of the ivc almost immediately, not allowing them to expand laterally, and would result in this appearance on the venogram.An oblique venogram could have been used to confirm this configuration.The secondary legs appear more evenly displaced throughout the ivc, and the overall efficacy of the filter would not likely have been decreased in this configuration.Furthermore, the ivc filter should not have been deployed in this location of the ivc.The primary filter feet are immediately adjacent to the ostium of the right renal vein, and several of the secondary filter legs extend into the left renal vein.The observed tilt is likely directly related to the secondary legs extending into the left renal vein.The difficulty in retrieving the ivc filter is related to the hook abutting the left lateral wall of the ivc, which again, is directly related to the tilt.Nothing on the limited images submitted for review suggests that the filter did not perform correctly, but rather the observed complaints are more likely related to deployment procedure, maybe because the filter "was deployed early and unintentionally." no evidence to suggest that this device 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 JUGULAR 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: 8309493
• MDR Text Key: 135387396
• Report Number: 3002808486-2019-00186
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Distributor Facility Aware Date: 01/25/2019
• Device Age: 17 MO
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1