MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/08/2024

Event Type  Injury  

Event Description

Description of event according to initial reporter: the filter was fractured.One primary leg is located down somewhere in the pelvis.Two other primary legs penetrated through caval wall.There is acute deep vein thrombosis bilaterally and in the cava probably as a result of the indwelling filter.They could not explant it.They ended up ballooning and stenting across it.The complaint device had been implanted 13 years ago.Patient outcome: patient was hospitalized because of deep vein thrombosis and underwent ballooning and stenting.

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) catalog# is unknown but referred to as cook celect filter.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: 13 years after placement more filter legs had fractured/penetrated.Acute bilateral deep vein thrombosis (dvt) and in the cava probably as a result of the indwelling filter.The filter could not be explanted and they ended up ballooning and stenting across it.The celect filter was not returned for analysis.Multiple poor-quality images and movie from a ct of the abdomen and pelvis, along with a single fluoroscopic image during attempted retrieval were submitted for review and demonstrated more fractured/penetrated primary or secondary filter legs.The hook of ivc filter is positioned adjacent to the ostium of the left renal vein.Adjacent to the hook/neck of the ivc filter is a primary filter leg, oriented parallel to the long axis of the ivc filter, but not attached to the ivc filter neck.Just below the level of the filter neck, the ivc is severely stenotic.Below this level the density within the lumen of the ivc is much less, suggesting the entire ivc is thrombosed from the level of stenosis, caudally.In addition, the primary filter leg at the 12 o¿clock position demonstrates a grade 3 interaction, abutting the duodenum, while the primary leg at the 4 o¿clock position demonstrates a grade 3 interaction with the vertebral body.Several secondary legs appear clustered with the primary legs, resulting in a thickened appearance on the ct.Two secondary legs are seen at the 6 and 8 o¿clock regions also demonstrating grade 3 interactions with the vertebral body and the right psoas muscle.Both of these secondary filter legs are no longer attached to the filter, and appear predominantly entirely outside the ivc.The last primary filter leg is located several vertebral bodies more caudally, deeply embedded in the right psoas muscle.A single fluoroscopic image of the filter during attempted retrieval demonstrates the filter hook terminating at the superior endplate of the l2 vertebral body.There is 6 degrees of leftward tilt present.There are 2 primary leg fractures, as described above.The superior fracture fragment measures 3 cm, while the caudal fragment measures 2.7 cm.Both fracture fragments are oriented parallel to the long axis of the ivc filter.There are at least two fractured secondary filter legs with the fractured fragments measuring just over 1 cm each.Four intact secondary legs are appreciated and normally aligned.The last 2 secondary legs are not clearly appreciated, but may be a result of the resolution of the image.There is a catheter approaching the caudal aspect of the filter, but does not traverse the ivc filter.With an ivc filter dwell time of 13 years and no other additional imaging submitted to determine the time line for development of multiple primary and secondary filter leg fractures as well as a severe ivc stenosis, the exact mechanism and temporal relationship remains unknown.Several known factors increase the likelihood of developing an ivc filter fracture including long dwell time, small ivc, ivc filter tilt, and conical design of the ivc filter.Determine which of these factors was most contributory for the development of the ivc perforation and the eventual fractures remains unknown.These fractures and perforations likely directly contributed to the ivc stenosis.Ivc thrombosis and deep vein thrombosis is at a slightly higher risk in the setting of an ivc filter, even in the setting of anticoagulation.In this case there is current ivc stenosis at the level of the filter, which is likely a result of the long dwell time, perforations and fractures of the ivc filter causing scarring of the ivc.This severe stenosis resulted in slow flow in the ivc, setting the patient up for ivc and lower extremity thrombosis.Inability to retrieve the ivc filter is likely in part due to the endothelialization of the filter hook which abuts the wall of the ivc, as well as the ivc stenosis, ivc filter penetration and thrombosis all complicate the potential retrieval attempts making it a challenge, if not impossible as was in this case.Patient underwent thrombectomy and thrombolysis, and in the setting of inability to retrieve the ivc filter, the filter was angioplastied and stented out of the way in order to reestablish direct in-line flow in the ivc.In this setting where the filter cannot be retrieved, this is a clinically appropriate approach.Presumably advanced retrieval techniques were attempted, but these were not discussed in the complaint report and no images of these retrieval attempts were submitted for review.There is no comment on any symptoms related to the grade 3 interaction's between the filter legs and the adjacent structures.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.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.There are adequate controls in place to ensure this type of device was manufactured to specifications.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.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: UNKNOWN
• Type of Device: 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: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18746624
• MDR Text Key: 335817217
• Report Number: 3002808486-2024-00036
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 125 KG