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

Model Number G48373

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Sepsis (2067); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440); Unspecified Vascular Problem (4441)

Event Type  Injury  

Event Description

The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2012.Approximately five years and four months later, the patient underwent a computed tomography scan which revealed that the ivc filter had moved and several struts perforated the ivc wall, right iliac artery, right psoas muscle, and vertebra.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: organ/(right psoas muscle, vertebra)/venacava/iliac artery perforation.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, vena cava perforation, vena cava penetration.Catalog number and lot number are unknown; however, the alleged celect 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.

Event Description

Patient allegedly received the filter via the right common femoral vein for preventions of deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging device tilt, vena cava perforation, device is unable to be retrieved, dvt, caval thrombosis, embedment, and "getting varicose veins in abnormal areas (groin) from ivc".Patient notes and further alleges experiencing "getting bulging veins from the collapsed artery that the ivc filter was.I have/getting a varicose artery removed from my groin, which has caused sepsis, constant bleeding.Surgery is due on (b)(6) for removal".Per a ct abdomen and pelvis: "impression: 1.Deep venous thrombosis of the right lower extremity with involvement of the right common femoral and visualized portions of the femoral vein as documented on recent ultrasound.Likely intrapelvic extension to involve the right external and common iliac arteries"."2.There is an inferior vena cava filter".Per a ct neck, chest, abdomen, pelvis: "an infrarenal ivc filter is noted with chronic appearing thrombosis of the ivc and right iliac veins including stable appearing distention of the right external iliac vein.There are postoperative changes of the right groin and along the iliac vessel ls.There venous collateralization secondary to ivc thrombosis".Per a ct neck, chest, abdomen, pelvis: "filter type: cook celect".Filter position: below the renal veins.Filter migrations: none.Filter fracture: none, ivc stenosis: none." "impressions: the filter is tilted to the left with the cone of the filter lying on the wall of the ivc possibly embedded within it.All of the arms and legs of the filter penetrated through the wall of the ivc into the pericaval/mesenteric fat.There is been penetration into the right common iliac artery.There is been penetration into the right psoas muscle.There is contact with the anterior periosteum of a vertebra".Per a ct neck, thorax, abdomen, pelvis: "ivc filter with chronic thrombosis of the ivc again noted.There is venous collateralization secondary to ivg thrombosis.Thrombosis extending to the iliac vein is again noted, with distention of the right external iliac vein".Per a ct: "stable appearance and position of the ivc filter"."stable expansile thrombus or lesion along the distal right external iliac vein measures 3.5 cm, series 2 image 255, was 3.5 cm"."other: multiple collateral vessels are seen along the pelvic and abdominal wall due to prior dvt".Per a successful ivc filter retrieval: "findings: patent juxtarenal and suprarenal ivc with complete occlusion of the infrarenal ivc and occluded cook select ivc filter with single extravascular fracture fragment"."the right common femoral vein is chronically occluded along with the right external and common iliac veins.The infrarenal ivc is also completely occluded"."follow up venogram demonstrates persistent long segment high-grade stenosis and bilateral iliac veins and infrarenal ivc along with the right common femoral vein"."impression: 1.Fractured infrarenal cook select ivc filter status post successful forceps retrieval with single 1-2 cm retained extravascular fragment.2.Chronic iliocaval and right common femoral occlusion status post successful complex recanalization, angioplasty, and metallic stenting".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b2, b5, b6, b7, d6b, d1, d4, g4, h4, h6 (patient and device codes).Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, organ/(right psoas muscle, vertebra)/venacava/iliac artery perforation, embedment, deep vein thrombosis (dvt), caval thrombosis/occlusion/collapse, stenosis, difficult to remove, tilt, varicose veins, sepsis, bleeding.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.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.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.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 varicose veins, sepsis, and bleeding are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, no 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.

• Brand Name: COOK CELECT FEMORAL VENA CAVA FILTER SET
• 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
• MDR Report Key: 12835886
• MDR Text Key: 280954294
• Report Number: 3002808486-2021-01963
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002483736
• UDI-Public: (01)00827002483736(17)121122(10)E2673200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• 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: 04/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2012
• Device Model Number: G48373
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2673200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 04/05/2022
• 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; Life Threatening
• Patient Sex: Female
• Patient Weight: 107 KG