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 Codes	Obstruction of Flow (2423); Structural Problem (2506); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: non-healthcare professional.(510k): k211874.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.20 devices in lot.No relevant notes on wo for neither device (igtcfs-65-1-fem-tulip) lot: e2995015, nor filter (igtf-30) lot: e2991536 and e2991506.Three other complaints ((b)(4), different issue, occasional cramps on right side, pr361557, different issue, ivc filter perforation ivc unfiled claims and (b)(4), different issue, ivc filter perforation ivc unfiled claims) on lots.Product is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.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
It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2013, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, b7, h6.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ/ vena cava (vc)/ vertebra perforation, deep vein thrombosis (dvt), fear.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported fear is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, three (3) other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Patient allegedly received an implant on (b)(6) 2013 via the right common femoral vein due to pulmonary emboli (pe).Patient is alleging organ and vena cava perforation, vertebral perforation.Patient further alleges "fear that the filter might cause further damage as it has not yet been removed" and deep vein thrombosis of left leg after filter placement.Per ct report, "3 mm aortic, 5 mm vertebral, and 4 mm mesenteric perforation.No fracture, tilting, migration, or stenosis".Per ct report, "an ivc filter was identified.The tip of the filter is not in contact with the wall of the ivc.The metallic struts appeared to be intact.Only 1 of the struts perforates the wall of the ivc by strict definition.It is the strut in the 4 o'clock position and it perforates the wall by approximately 1.5 mm.The struts do not extend into any vital structures.The superior tip of the ivc filter is 2.4 cm below the right and left renal vein orifices.".

• 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: 14846983
• Report Number: 3002808486-2022-00864
• Device Sequence Number: 4640039
• Product Code: DTK
• UDI-Device Identifier: 10827002529172
• UDI-Public: (01)10827002529172(17)151018(10)E2995015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 10/18/2015
• Device Model Number: G52917
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Device Lot Number: E2995015
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: Life Threatening
• Patient Sex: Female
• Patient Weight: 97 KG