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

Model Number	G52914
Medical Device Problem Codes	Difficult to Remove (1528); Structural Problem (2506); Device Tipped Over (2589)
Health Effect - Clinical Codes	Abdominal Pain (1685); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2012 prior to undergoing a surgery.Approximately eight years and seven months later, the patient underwent a computed tomography (ct) which showed multiple legs perforated through the ivc, perforated through the vertebrae causing boney reactive changes - causing abdominal pain, and perforated the ivc between 10mm and 12mm.Hospital and medical records have been requested, but not yet provided.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Section e3: non-healthcare professional.Investigation: the following allegations have been investigated: organ/vena cava (vc) perforation, abdominal pain.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.Unknown if the reported abdominal pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, the alleged filter is manufactured and inspected according to controls.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.
Additional Manufacturer Narrative
Investigation: the following allegations have been investigated: organ/vena cava (vc) perforation, embedded, difficult removal, tilt, abdominal/back pain, limited activity.Investigation is reopened due to additional information provided.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications the filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported abdominal pain, back pain and limited activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No relevant notes on work order.The 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
The patient allegedly received an implant on (b)(6) 2012 via the right common femoral vein due to post trauma.The patient additionally alleges a failed filter retrieval attempt on (b)(6) 2013 followed by a successful percutaneous retrieval on (b)(6) 2023.The patient alleges lower back pain, vertebrae penetration, and limited activity.(b)(6) 2013, per a report from retrieval report (attempted); ¿findings: iliac venogram and inferior venacavogram demonstrates no iliac or renal venous anomalies, and no caval anomalies.Caval diameter is within normal limits.There is no thrombus in the iliac veins or inferior vena cava.However, there is significant filter tilt, with the nose of the cook celect filter abutting the left aspect of the inferior vena cava at the level of the superior l3 vertebral body.Because of the significant tilt, retrieval was not possible.¿ (b)(6) 2021, per a report from computed tomography 2; ¿the filter is tilted 45 degrees to the left with its proximal cone against the ivc wall.The anterior strut penetrates 11 mm through the ivc wall.The left strut penetrates 10 mm though the ivc wall.The posterior strut penetrates 12 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes.The right strut penetrates 5 mm through the ivc wall.¿ (b)(6) 2023, per a report from retrieval report (successful), ¿impression: right common femoral vein access for venogram.Right internal jugular vein access for ivc filter retrieval.Successful embedded ivc filter retrieval via antegrade and retrograde loop snares using laser atherectomy.Mynx vascular closure device for hemostasis of right common femoral vein access site.Manual compression for hemostasis of right internal jugular vein access site.¿.

• Brand Name: COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 17009582
• Report Number: 3002808486-2023-00158
• Device Sequence Number: 7493181
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)150918(10)E2979719
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• 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): 06/14/2023

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: 09/18/2015
• Device Model Number: G52914
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2979719
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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: 69 KG