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

Model Number G34309

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according initial reporter: "went to place filter in standard fashion.Upon deployment, device appears to not have fully opened.Retrieved device and placed another to successfully complete procedure." 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.

Event Description

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

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# pr241058.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Summary of investigational findings: investigation is based on event description and image review.It was reported that the filter appeared to have not fully opened upon deployment.The filter was retrieved and procedure was successfully completed with another device.No consequence or impact to the patient was reported.A celect-pt filter and a günther retrival device (gtrs) were returned - the retrieval loop holding on to the filter.Investigation found two secondary filter legs placed on the opposite side of the primary filter legs, but the primary filter leg diagonals were still within specifications.Per the complaint report, "initial deployed filter appears to not have fully opened".This first filter was retrieved and another filter was placed successfully.The images submitted for review are reportedly of the second filter, and no images of the first unsuccessful deployed filter were submitted for review to better help to determine what the issue was.On the submitted images, if this is indeed the second filter, this does not appear to have been deployed in a normal infrarenal ivc.Given the pre and post deployment images, it is suspected that the ivc filter was deployed in the gonadal vein and not the ivc.This is based on several findings; the size of the vessel which measures between 5 and 10 mm in diameter, the origin of this vessel appears to be from the right renal vein or immediately caudal to the right renal vein, and the fact that the post-deployment venogram demonstrates faint contrast opacification of what is presumed to be the infrarenal ivc with contrast seen extending along the left lateral margin in a slightly different course than where the ivc filter has been deployed.The ivc filter is angled approximately 45° relative to the center line of the ivc cranial to the renal veins.The maximal distance between the primary filter legs measures approximate 9.5 mm.The hook of the ivc filter appears to extend into the central portion of the right renal vein.The caveat is that the patient has a severe s-shaped scoliosis of the lumbar spine which notably will distort the normal course of the ivc.In addition, if this was indeed the patient's ivc, placement of a infrarenal ivc filter would not follow the recommendations of the ifu given the small size of this vessel measuring less than 15 mm in diameter.If the pictures are mislabeled, and this was indeed the first filter that did not open fully, this would be explained by deploying the filter in the gonadal vein.If this is indeed the second deployed filter, this filter is not within the ivc and will provide the patient no benefit in its current location.This could be confirmed with cross-sectional imaging if made available.No evidence to suggest that this filter was not manufactured according to specifications and nothing indicates that it did not perform as intended upon deployment.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.

• 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: 7955210
• MDR Text Key: 125931735
• Report Number: 3002808486-2018-01178
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)210524(10)E3729356
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3729356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Distributor Facility Aware Date: 09/24/2018
• Device Age: 4 MO
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1