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

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.(b)(4).Investigation is still in progress.

Event Description

"leg of device observed to be fractured; noticed during removal procedure (but didn't occur as a result of the retrieval).Device and leg could not be retrieved.Leg is embedded next to existing filter, did not appear to have perforated anything." "filter hook was embedded in caval wall".Filter could not be retrieved, risk was deemed too great.

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: a celect ivc filter was placed in prevention of upper extremity thrombus approximately 10 years ago with reversed orientation and in the superior vena cava (svc).Before retrieval was initiated, the physician noticed that one of the primary filter legs had fractured and retrieval of both filter and leg was unsuccessful.There is no information about patient harm.Single poor quality screen shot from a venogram obtained at time of ivc filter removal demonstrates a celect ivc filter with a fracture of one of the primary filter legs.The fractured fragment measures approximately 18 mm in length and is just superior and posterior to the donor segment of the ivc filter.The venogram is a subtracted image lending to difficulty with exact anatomic location, but the ivc filter appears to be in the svc.The image was acquired in an oblique projection, but there does not appear to be any significant tilt relative to the sheath positioned from the femoral approach located just caudal to the filter.The hook of the filter does appear to abut the wall of the svc, but without the placement images, it is not possible to determine if the filter was placed in this position or if this configuration developed over time.There is no contrast opacification of the svc cranial to the ivc filter, to help assess for penetration.The remaining primary and secondary legs appear intact.There is no discussion of any advanced filer retrieval techniques potentially used to attempt to remove the filter and overcome the embedded filter hook.The exact reason for the fractured filter leg cannot be determined, but the forces experienced in the svc from cardiac and respiratory motion are dramatically increased when compared to those experienced in a subdiaphragmatic location and inevitably contributed to the development of the suspected penetration and fracture of the filter leg in this case.With reference to the instructions for use 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).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.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.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.No evidence to suggest the product was not manufactured according to specifications 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
• MDR Report Key: 8407051
• MDR Text Key: 138347521
• Report Number: 3002808486-2019-00288
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/25/2019
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR