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

Model Number	G52916
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: physician went to deploy the tulip from the jugular approach as he un-sheathed the filter he noticed the legs did not open up to the diameter of the ivc.He then decided to recapture it.He was able to get the filter halfway into the delivery sheath with the release mechanism broke.The filter was still halfway out the delivery sheath.The physician did not want to remove that way, so he decided to push the filter out of the sheath with a wire.The legs still did not open up.He was able to retrieve the filter using the cloversnare.Once the filter was retrieved it was placed into a specimen cup, the legs then opened up.He then placed an filter form another manufacturer to complete the procedure.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# pr393918 blank fields on this form indicate the information is unknown or unavailable.G4) 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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: attempts at deploying the tulip filter from right jugular approach resulted in the primary filter feet not fully expanding, and unsuccessful attempt to recapture the filter despite deploying it from a jugular approach and not purposely releasing from the deployment mechanism.The tulip filter was returned and an investigation found it fully expanded, symmetric, and nicely shaped.However, since the introducer system was not returned, it would be inappropriate to speculate at what may or may not have caused the release mechanism to break.Multiple fluoroscopic images, as well as venogram of the ivc were provided and there are several likely explanations for the behavior of the ivc filter, related to the patient's anatomy and the operators chosen location where to attempted to deploy the filter.Patient has a severe levoconvex curvature of the thoracolumbar spine with the apex of curvature centered at approximately the level of the left renal vein.It appears the operator attempted to deploy the filter just caudal to the apex of this curvature resulting in a significant rightward tilt of the filter relative to the center line of the ivc.In addition, attempting to deploy the filter in this location resulted in the filter feet likely abutting if not essentially extending into the left lateral wall of the ivc inhibiting their expansion, hence the complaint about the primary filter feet not fully expanding.If the filter was advanced out of the deployment sheath rather than the deployment sheath retracted, this could have also resulted in the primary filter feet engaging with a small vein ostium, or at least forcing the primary filter feet into the wall of the ivc, resulting in the same behavior of the filter feet.This hypothesis is somewhat supported as attempts at retracting the ivc filter into the retrieval sheath likely resulted in significant tension on the system causing the safety hook of the deployment mechanism to fail and detach within the deployment sheath.This resulted in the ivc filter being completely deployed in this abnormal configuration and necessitating retrieval using a clover leaf snare device successfully.Following retrieval of the gunther tulip, an an ivc filter from another manufacturer was deployed more caudally, in the straight segment of the ivc below the level of the renal vein.Despite the patient's severe scoliosis and curvature of the ivc, the situation could have been avoided if the operator would have chosen to deploy the ivc filter closer to the confluence of the iliac veins, in the straight segment of the ivc, as opposed to near the apex of the curvature of the ivc.The filter is not malleable, and attempting to retract the filter sheath right at the apex of curvature resulted in the filter being displaced towards the left lateral wall of the ivc resulting in the situation described above.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final release, there is evidence that the device history record 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 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: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: lissi walmann ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 16822066
• Report Number: 3002808486-2023-00122
• Device Sequence Number: 7014371
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)251212(10)E4345769
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2025
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E4345769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown