MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

Device Problem Fracture (1260)

Patient Problems Embolus (1830); Perforation (2001); Renal Failure (2041); Thrombosis (2100); Stenosis (2263); Injury (2348)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

This report is a follow up report to mfr number 9616099-2016-00232 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, fractured, perforated his vena cava, and caused thrombosis of the vena cava and filter.As a result of these malfunctions, the patient suffered life-threatening injuries, damages and required extensive medical care and treatment, including multiple medical procedures.Plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.Successful placement of infrarenal inferior venacaval filter.The patient tolerated the procedure well with no immediate complications.According to the plaintiff profile form and medical records received on 03/20/2018 approximately 10 years, 8 months post index procedure patient presented to the emergency department with severe back pain radiating to his legs and was found to have clot within the ivc filter.Patient then developed bilateral lower extremity swelling and discoloration secondary to dvt in the bilateral iliofemoral venous system and underwent catheter directed thrombolysis 4 days later.After thrombolysis he had residual thrombus within the filter which was stable on follow up ct.Patient was switched to arixtra or concern of hit and was eventually transitioned back to coumadin.Initially following his discharge the patient noticed significant improvement in his swelling and has not experienced additional issues with anti-coagulation.Patient noted some re occurrence of his bilateral lower extremity edema over the last several weeks.No shortness of breath or exercise intolerance.According to the medical records the patient claims to be suffering of severe pain, distress and anxiety.This includes vena cava occlusion, high grade vena cava stenosis, acute kidney injury, chronic back pain, periodic debilitating pain in abdomen and back, lower extremity edema.The patient is unable to work and is in fear of fasciotomy, leg amputation and death.The patient claims to be currently suffering from decreased ability to enjoy life and weakness/numbness in legs.Patient was placed on long term disability approximately 13 years, 7 months post index procedure.Approximately 10 years, 11 months spot fluoroscopic images of the abdomen demonstrate a trapease infrarenal inferior vena cava (ivc) filter in place centered at the level of l3.Fracture of one of the six vertical struts was noted inferiorly.Capture of the filter was achieved.The majority of the filter was removed however a single fragment consisting of a medial filter strut with two cranial shoulder components remained embedded in the caval wall.Forceps were inserted and used to grasp the cranial end of the retained fragment.The fragment was removed using a combination of blunt dissection with the rigid and semi rigid forceps as well as further laser ablation while grasping the caudal end of the fragment with the rigid forceps.Inferior vena cavagram demonstrates a patent ivc with moderate stenosis through the filter.There is a filling defect within the left aspect of the filter consistent with chronic thrombus/scarring, resulting in moderate ivc stenosis.Ivc stenosis was treated with successful wall stent placement.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease permanent inferior vena cava (ivc) filter.Per the medical record, there was successful placement of infrarenal inferior vena cava filter.The patient tolerated the procedure well with no immediate complications.The device subsequently fractured, perforated his vena cava, and caused thrombosis of the vena cava and filter.Per the patient profile form and medical records received, approximately 10 years, 8 months post implant, the patient presented to the emergency department with severe back pain radiating to his legs and was found to have clot within the ivc filter.Patient then developed bilateral lower extremity swelling and discoloration secondary to dvt in the bilateral iliofemoral venous system and underwent catheter directed thrombolysis 4 days later.After thrombolysis he had residual thrombus within the filter which was stable on follow up ct.Patient was switched to arixtra or concern of hit and was eventually transitioned back to coumadin.Initially following his discharge, the patient noticed significant improvement in his swelling and has not experienced additional issues with anti-coagulation.Patient noted some re occurrence of his bilateral lower extremity edema over the last several weeks.No shortness of breath or exercise intolerance.According to the medical records the patient claims to be suffering of severe pain, distress and anxiety.This includes vena cava occlusion, high grade vena cava stenosis, acute kidney injury, chronic back pain, periodic debilitating pain in abdomen and back, lower extremity edema and blood clots.The patient is unable to work and is afraid, decreased ability to enjoy life and weakness/numbness in legs.Patient was placed on long term disability approximately 13 years, 7 months post index procedure.Approximately 10 years, 11 months spot fluoroscopic images of the abdomen demonstrate a trapease infrarenal inferior vena cava (ivc) filter in place centered at the level of l3.Fracture of one of the six vertical struts was noted inferiorly.Capture of the filter was achieved.The majority of the filter was removed however a single fragment consisting of a medial filter strut with two cranial shoulder components remained embedded in the caval wall.Forceps were inserted and used to grasp the cranial end of the retained fragment.The fragment was removed using a combination of blunt dissection with the rigid and semi rigid forceps as well as further laser ablation while grasping the caudal end of the fragment with the rigid forceps.Inferior vena cavagram demonstrates a patent ivc with moderate stenosis through the filter.There is a filling defect within the left aspect of the filter consistent with chronic thrombus/scarring, resulting in moderate ivc stenosis.Ivc stenosis was treated with successful wall stent placement.The filter is unavailable for analysis.The product was not returned for analysis.The dhr could not be completed.The trapease vena cava filter is 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.The instructions for use (ifu) states filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Acute kidney injury is a known adverse event associated with the use of the vena cava filters.Anxiety, swelling of the legs, vena cava injury and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 brief, the patient underwent placement of a trapease permanent vena cava filter.The device subsequently malfunctioned and caused, inter alia, fractured, perforated his vena cava, and caused thrombosis of the vena cava and filter.As a result of these malfunctions, the patient suffered life-threatening injuries, damages and required extensive medical care and treatment, including multiple medical procedures.Plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.Successful placement of infrarenal inferior venacaval filter.The patient tolerated the procedure well with no immediate complications.According to the plaintiff profile form and medical records received on 03/20/2018 approximately 10 years, 8 months post index procedure patient presented to the emergency department with severe back pain radiating to his legs and was found to have clot within the ivc filter.Patient then developed bilateral lower extremity swelling and discoloration secondary to dvt in the bilateral iliofemoral venous system and underwent catheter directed thrombolysis 4 days later.After thrombolysis he had residual thrombus within the filter which was stable on follow up ct.Patient was switched to arixtra or concern of hit and was eventually transitioned back to coumadin.Initially following his discharge the patient noticed significant improvement in his swelling and has not experienced additional issues with anti-coagulation.Patient noted some re occurrence of his bilateral lower extremity edema over the last several weeks.No shortness of breath or exercise intolerance.According to the medical records the patient claims to be suffering of severe pain, distress and anxiety.This includes vena cava occlusion, high grade vena cava stenosis, acute kidney injury, chronic back pain, periodic debilitating pain in abdomen and back, lower extremity edema.The patient is unable to work and is in fear of fasciotomy, leg amputation and death.The patient claims to be currently suffering from decreased ability to enjoy life and weakness/numbness in legs.Patient was placed on long term disability approximately 13 years, 7 months post index procedure.Approximately 10 years, 11 months spot fluoroscopic images of the abdomen demonstrate a trapease infrarenal inferior vena cava (ivc) filter in place centered at the level of l3.Fracture of one of the six vertical struts was noted inferiorly.Capture of the filter was achieved.The majority of the filter was removed however a single fragment consisting of a medial filter strut with two cranial shoulder components remained embedded in the caval wall.Forceps were inserted and used to grasp the cranial end of the retained fragment.The fragment was removed using a combination of blunt dissection with the rigid and semi rigid forceps as well as further laser ablation while grasping the caudal end of the fragment with the rigid forceps.Inferior vena cavagram demonstrates a patent ivc with moderate stenosis through the filter.There is a filling defect within the left aspect of the filter consistent with chronic thrombus/scarring, resulting in moderate ivc stenosis.Ivc stenosis was treated with successful wall stent placement.According to the additional information received the patient claims to be suffering of blood clots.

Manufacturer Narrative

The following sections were updated accordingly.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7444577
• MDR Text Key: 105968262
• Report Number: 9616099-2018-02071
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2006
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1203014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTI COAGULATION MEDS, LIDOCAINE 1%, FENTANYL, VER; ANTI COAGULATION MEDS, LIDOCAINE 1%, FENTANYL, VER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR