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

Model Number	G21360
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: on (b)(6) 2021.The patient developed deep venous thrombosis (dvt) of lower limbs after procedure in the hospital, and a cook's vena cava filter was implanted.After more than one month of implantation, the patient went back to hospital where the plan was to remove the filter.They found that the filter was skewed, and there were many fibrous hyperplasia tissues attached to the filter.The hospital thought that the operation risk is high, if the removal process caused by vena cava rupture will lead to serious consequences.The hospital decided that closely observe the patient and give reexamination of blood routine, to know whether there is bleeding, shock and other symptoms.Patient outcome: the filter was tilted and adhered to the surrounding tissue and was difficult to remove.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): k172557.Investigation is still in progress.
Additional Manufacturer Narrative
Manufacturers ref # (b)(4).Summery of investigational findings: filter tilt and attached fibrous hyperplasia tissues noted approx.One month after placement caused difficulties with removal.However, the filter was successfully removed without immediate complications.No product was returned for analysis, but the venogram submitted at time of ivc filter deployment demonstrates the filter in the infrarenal ivc without evidence of significant tilt.Despite the tilt not being defined as significant, i.E.< 15 degrees, it was sufficient enough to place the hook of the ivc filter adjacent to the left lateral wall of the ivc.The angulation of the ivc filter mirrors the angulation of the deployment sheath positioned in the right common iliac vein indicating the ivc filter did not self-center upon deployment.Because the hook of the ivc filter was immediately adjacent to the wall of the ivc, this resulted in difficulty with retrieving the ivc filter due to neointimal hyperplasia that developed over the subsequent month.Eventually, the ivc filter was successfully retrieved endovascularly without immediate complication.The cause of the insignificant tilt is likely related to the patient's anatomy and angled junction of the iliac vein and the ivc.However, there was no discussion why a femoral approach was chosen over a jugular approach.There are adequate controls in place to ensure that 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 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 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 information received 03nov2021: the distributor learned that the filter was implanted on (b)(6) 2021 and angiography found that the filter was tilted after implantation.On (b)(6) 2021 the filter was removed.After the filter was removed, the patient's condition was stable and no obvious abnormality was observed.He was discharged on (b)(6) 2021.

• Brand Name: GUNTHER TULIP JUGULAR & 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 ; 56868686
• MDR Report Key: 12718094
• Report Number: 3002808486-2021-01934
• Device Sequence Number: 4444687
• Product Code: DTK
• UDI-Device Identifier: 10827002213606
• UDI-Public: (01)10827002213606(17)221116(10)E4041737
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2021

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: 11/16/2022
• Device Model Number: G21360
• Device Catalogue Number: IGTCFS-65-UNI
• Device Lot Number: E4041737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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: 68 YR
• Patient Sex: Male