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

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Internal Organ Perforation (1987); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: fracture, organ/vc perforation, embedment, complex removal, hospitalization.The reported allegations have been investigated based on the information provided to date.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, vena cava perforation, vena cava penetration.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.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.Catalog number and lot number are unknown.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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2010.The patient's ivc filter had perforated the ivc with all of the prongs incorporated within the duodenal lumen, a medial strut perforated the right aortic wall, and two posterior struts embedded within adjacent osteophyte at l3-4.Approximately nine years later, the patient was admitted to the hospital for issues with the implanted ivc filter.Within the week, the patient underwent a successful open surgery for removal of the ivc filter via bilateral subcostal incisions.The filter had fractured and one of prongs was embedded in an osteophyte or vertebral body.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: occluded, hematoma.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: occluded, hematoma.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 hematoma is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot number are unknown.The alleged celect 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 Description

Patient allegedly received an implant on (b)(6) 2010 via the right internal jugular vein due to deep vein thrombosis (dvt).Patient is alleging fracture, organ and vena cava perforation.Patient further alleges "had a device that was broken removed from my body where a piece of the filter is still lodged in my body." the patient allege to have an open procedure to have the filter removed on (b)(6) 2019 due to ivc filter penetration.Per computed tomography (ct) report, "the ivc strut enters the third portion of the duodenum.There is mild thickening of the duodenal wall anteriorly.A focal perforation cannot be entirely excluded though there is no periduodenal collection or even in periduodenal inflammatory stranding, but only a mildly thickened wall this site." "several of the inferior vena caval struts extend deeply into the pericaval fat." per retrieval report, "the inferior vena cava distally above the ivc bifurcation was dissected out as well." "the inferior vena cava was then occluded with clamps.Lumbar veins were controlled with clips.The inferior vena cava was opened longitudinally, and the hook of the filter that was embedded in the posterior wall of the vena cava was freed up from fibrous tissue with metzenbaum scissors.Once this was freed, an 11-french sheath without the dilator was brought onto the field and a snare was introduced through the sheath, and the snare was used to grab the filter hook and the sheath was pushed down onto the filter to collapse the filter and retrieve it.This was successfully done.The filter was then examined on the back table and one of the long legs was incomplete with about 15 mm of the distal end of the leg missing.The vena cava was then carefully examined and then closed with running 5-0 prolene suture.The duodenum was palpated and dissected free of the cava, and there was no palpable prong in the duodenum." "second cavotomy was made distally to assess for the embedded leg of the filter in the distal part of the cava and there was no evidence of any retained filter leg." "flow was reestablished to the vena cava.The vena cava did not appear to be significantly narrowed for patch repair.C-arm was brought into the field and oblique projections of the cava were obtained and compared with the previous ct scan.This confirmed that the retained 15 mm distal leg of the filter was embedded in an osteophyte in the vertebral body.I palpated the vertebral body and palpated the osteophyte, but there was no evidence of any filter outward that could be grafted.At this point, i decided that there was no need to remove the retained filter in the vertebral body." per ct report, "vessels: there are postsurgical changes from open removal of an inferior vena cava filter.There is a redemonstrated retained strut within an anterior lumbar osteophyte.There are multiple additional surgical clips in this region.There appears to be occlusion of the infrarenal ivc at this level given poor contrast opacification with distal reconstitution." "compared to the prior exam there is markedly increased retroperitoneal fat stranding which begins just posterior to the pancreas and extends inferiorly posterior to the duodenum and to the pelvis.The duodenal wall is poorly defined posteriorly with areas of adjacent fat stranding.There is a rounded, well formed collection in the right retroperitoneum with layering hyperdense material, suggesting a hematoma, see series 603 image 122 where it measures 5.5 x 4.2 cm.There is a less well organized region of fluid in the right retroperitoneum, suggesting a phlegmonous collection measuring approximately 5.1 x 3.7 cm on series 6 and 3 image 89." "the inferior vena cava appears nonopacified, likely occluded, at the level of ivc filter extraction and is distally reconstituted.".

• Brand Name: UNKNOWN
• Type of Device: 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 ; 56868686
• MDR Report Key: 12277716
• MDR Text Key: 265571837
• Report Number: 3002808486-2021-01668
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 12/02/2021
• 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): Life Threatening; Hospitalization
• Patient Sex: Male
• Patient Weight: 127 KG