MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52917

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): k211874.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

Description of event according to initial reporter: on (b)(6) 2022 a tulip ivc filter was placed from fem vein per ifu.After unsheathing and releasing the filter the customer reported that the legs of the filter did not fully expand and it was as if the legs were tangled or intertwined with each other.He had to serial dilate the filter with balloons to open the filter back up.The filter remained in the patient and is going to be retrieved tomorrow and a new one placed.Patient outcome: the filter remained in the patient¿s body tilted until removed on (b)(6) 2022.

Manufacturer Narrative

Manufacturers ref# (b)(6).Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.This report is required by the fda under 21cfr 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 (b)(6) 2023: prior to inserting the filter the physician puts a bend or dog leg on the metal cannula prior to inserting the filter.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: after unsheathing and releasing the filter from femoral approach the filter legs did not fully expand and appeared tangled or intertwined.The filter was dilated with balloons and remained in the patient until successful retrieval the next day.The filter was not returned, but multiple fluoroscopic and venographic images from time of a gunther tulip inferior vena cava (ivc) filter placement via a right common femoral venous approach were submitted for review.The complaint report states the "legs of the filter did not fully expand." the images submitted for review at the beginning of the procedure suggest that the legs did not fully expand, however, this may be a misperception as a result of evaluating the filter primary foot expansion and the size of the inferior vena cava (ivc) in only projection from the initial venogram.Multiple venographic images were submitted while injecting contrast in the infrarenal ivc, as well as the right external iliac vein.These venograms clearly demonstrate very poor forward flow in the suprarenal ivc, and multiple paralumbar and internal iliac collaterals opacified with contrast.There is no reason why these paralumbar and internal iliac venous collaterals should be seen with an inferior venacavogram performed in the infrarenal ivc if the ivc is of normal caliber, and the flow through the ivc is normal.The presence of these collaterals suggests that the ivc is either collapsed due to hypovolemia, potentially mass effect, stenosis or some other cause and contrast is preferentially flowing through these collaterals instead of the ivc.The venogram in which the ivc diameter was measured shows the ivc in the frontal projection from right to left measures just under 20 mm, however, a lateral projection was not performed until much later in the case and this demonstrates the ivc diameter measuring at most 10 mm in anterior posterior projection, after ballooning this area with a 14 mm balloon.Based on the images, the ivc was likely collapsed in the anterior posterior dimension during the initial deployment of the filter.When the gunther tulip ivc filter was released from the deployment mechanism, the primary filter legs immediately engaged with the wall of the ivc anteriorly and posteriorly, preventing its lateral expansion in the more normal configuration.If a venogram was performed in the lateral projection prior to deploying the ivc filter, this may have been appreciated, and potentially the ivc filter could have been deployed in a different location to avoid this situation described above.After deploying the ivc filter, the operator was concerned about its overall appearance, and proceeded to angioplasty through the struts of the ivc filter using up to a 14 mm balloon with improved lateral distribution of the primary filter legs.However, these manipulations resulted in tilting of the ivc filter in both the rightward and anterior projection confirmed on multiple follow-up images.The hook of the ivc filter now appears to abut the right/anterior wall of the ivc which could cause challenges in removing the filter in the future and/or contribute to the potential perforation or other complications, but the filter was successfully removed six days later and a new filter was placed.The ivc filter configuration was likely not a result of the filter itself but is considered more related to the patient's underlying anatomy, or potential pathology resulting in collapse/stenosis of the ivc in the area of deployment.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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: GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16002194
• MDR Text Key: 305683954
• Report Number: 3002808486-2022-01054
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)250117(10)E4211273
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E4211273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/16/2023; 03/16/2023
• Supplement Dates FDA Received: 01/19/2023; 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male