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

Model Number	G52917
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient of unspecified gender and age underwent a vena stenting in the iliac procedure and the physician concluded the patient would also need a vena cava filter.Therefore a gunther tulip navalign femoral vena cava filter set, g52917, was used.Upon deploying approximately one third of the filter hook stuck inside branch of the inferior vena cava but could not tell which one.At this point the district manager was called the procedure to assist with the removal.The filter was not totally detached.The physician tried to pull back on the filter, however could not as there was a previously placed stent there.Then tried re-sheathing with the filter sheath, however the side arms became tangled inside and could not pull the side arms in.The device was deployed where it was with the feet deployed inside the stent in the left iliac.The physician ballooned and opened the feet and some feet were also in the right iliac.The filter was also deployed where it was as the patient was having discomfort while attempting to pull the filter out.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Pma/510(k): k211874.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that during an iliac stenting procedure the physician concluded that the patient also would need a filter.During the filter placement it was observed that approximately one third of the filter hook was stuck inside a side branch.Because the stent had previously been placed the filter could not be pulled back and the physician attempted to resheath the filter, but the secondary legs became tangled.The physician decided to deploy the filter where it was which resulted in the filter got deployed inside the stent in the left iliac.The physician ballooned and opened the filter legs, and some filter legs was opened in the right iliac.The filter was left in the patient because the patient had discomfort while attempting to pull the filter out.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, 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.According to the instruction for use potential adverse events that may occur include, but are not limited to, the following: filter malpositioning there are adequate controls in place to ensure the device was manufactured to specifications.No device or images were provided for the investigation and with the information provided an exact cause for this event cannot be established.However, a possible cause is that during the filter procedure the filter somehow accidently ended up being led into a side branch of the ivc which resulted in the filter being placed in iliac, but this is purely speculation.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 or Problem Description
Additional formation received on 04oct2022: the filter deployed was partially deployed in accessory vein and rciv.The filter was inadvertently deployed in a venous side branch.

• Brand Name: GUNTHER TULIP NAVALIGN FEMORAL 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15453537
• Report Number: 3002808486-2022-00960
• Device Sequence Number: 20558537
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)241130(10)E4193342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 11/30/2024
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E4193342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Female