MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an unspecified cordis vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused inferior vena cava (ivc)thrombosis.The indication for the filter implant, procedural details and medical history of the patient have not been provided.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The cordis vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots, clotting and/or occlusion of the inferior vena cava (ivc) or the filter do not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and vessel characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal department, the patient underwent placement of the unknown vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, thrombosis vena cava inferior.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of an unspecified cordis vena cava filter.The patient is reported to have had a history of obesity.The patient had been initially admitted to hospital for spinal cord decompression surgery.The indication for the filter placement was reported to be the patient¿s high risk for pulmonary embolism (pe).The filter was implanted via the right common femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well and without complications.More than eleven years after the filter implantation, the patient was admitted to hospital with massive bilateral lower extremity edema.During this admission, the patient is reported to have been non-compliant with her home diuretic therapy.Diagnostic testing revealed no evidence of congestive heart failure or deep vein thrombosis (dvt).The patient was treated with aggressive diuresis.The patient underwent a computerized tomography (ct) scan that revealed a filter in situ with findings that were consistent with non-flow limiting thrombus within the filter.There was no evidence of central venous thrombosis or extrinsic compression.The ct scan also noted subcutaneous edematous changes in the lower pelvis and proximal thighs.And enlarged right and left external iliac and inguinal lymph nodes.More than twelve years after the filter implantation, the patient was evaluated for possible filter removal despite there being no evidence of obstruction.The consulting physician felt that filter retrieval was not indicated and that retrieval would likely make the patient¿s chronic venous insufficiency worse.More than thirteen years after the filter implantation, the patient presented for an office visit with massive bilateral lower extremity edema that was painful and made ambulating difficult.The patient was subsequently admitted to hospital for aggressive intravenous diuresis.More than sixteen years after the filter implantation, the patient reported having become aware that the filter was associated with thrombosis of the inferior vena cava (ivc).The patient also reported venous insufficiency, massive edema, blood clots, clotting and/or occlusion of the ivc.The patient further reported having experienced anxiety associated with the filter.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.Cordis vena cava filters are indicated for use in the prevention of recurrent pe via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal department, the patient underwent placement of the unknown vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, thrombosis vena cava inferior.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of thoracic compression requiring decompression laminectomy and was at high risk for pulmonary embolism (pe).The patient was prepped and draped in the appropriate manner.The right common femoral vein was cannulated using single wall technique, and an introducer sheath was then placed over a guidewire.An iliofemoral venogram with an inferior venacavogram was then performed demonstrating a thrombus free iliofemoral vein as well as the inferior vena cava and identifying the origin of the right and left renal veins at the top of l2.Under fluoroscopy control, the cordis filter was then placed without difficulty just distal to the origin of the renal veins and the inferior vena cava.The patient tolerated the procedure well; there were no complications encountered throughout the case.About eleven years and ten months after the filter was implanted, the patient was admitted due to massive edema involving both legs with no congestive heart failure (chf) or dvt.An abdominal and pelvis computerized tomography (ct) scan along with aggressive diuresis were indicated.On admission the patient was noted to use a walker and being non complaint with taking bumex.The ct was indicated to evaluate for inferior vena cava (ivc) and or iliac vein thrombosis.The scan reported the patient was status post ivc filter placement.The inferior vena cava demonstrated small irregular filling defect consistent with thrombus within the filter, not likely flow limiting.There was no evidence of central venous system thrombosis or extrinsic compression.Incidental findings included edematous changes in the lower pelvis and proximal thighs and enlarged right and left inguinal lymph nodes.About twelve years and nine months after the filter was implanted, the patient had a follow up office visit for massive edema involving both lower extremities.It was noted that the patient had a second opinion with another physician who felt that the patient might benefit from having the vena cava filter removed, although there was no evidence of obstruction.The consulting physician disagreed with the surgical option and informed the patient, who had also been sent to the lymphedema clinic with lymphedema control instructions; none of which had helped.The patient was waiting on panty hose support hose, to begin wearing them daily, and was also informed of having chronic venous insufficiency.The medical history at the time is notable for lymphedema, arthritis, obesity and cvod.The surgical history included spinal cord decompression, gastric bypass, lithotripsy and ivc filter placement.Approximately thirteen years and four months the patient had another office visit for massive edema involving the lower legs extending up to the groins, described as severely painful in nature, making it difficult to ambulate and bend the knees due to the edema.The patient also reported extreme dyspnea on exertion.The patient was admitted to the hospital, five days later, for aggressive diuresis.The patient was also noted to have cellulitis, secondary to the edema.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, and occlusion of the ivc, becoming aware of these events approximately sixteen years and six months after the filter implantation.The patient further asserts to have suffered from venous insufficiency and massive edema and experienced anxiety related to the filter.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12173440
• MDR Text Key: 261703231
• Report Number: 1016427-2021-05083
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SHEATH INTRODUCER, UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Weight: 123