MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Dyspnea (1816); Occlusion (1984); Perforation (2001); Skin Discoloration (2074); Swelling (2091); Ulceration (2116); Vascular System (Circulation), Impaired (2572)

Event Date 04/26/2010

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient.The information provided also indicated that as a direct and proximate result of these malfunctions, the patient suffered life- threatening injuries and damages, and required extensive medical care and treatment and as a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.There is currently no additional information available.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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 trapease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Given the limited information currently available for review, 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 defendants' trapease vena cava filter.The filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient.As a direct and proximate result of this malfunction, the patient, suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

The implant date was confirmed to be accurate.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 defendants' trapease vena cava filter.The filter subsequently malfunctioned, including, but not limited to, perforation, and caused injury and damages to the patient.As a direct and proximate result of this malfunction, the patient, suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the filter was implanted below the level of the renal hilum at the second lumbar vertebra due to multiple bilateral pulmonary emboli and deep venous thrombosis of right lower extremity.According to the information received in the patient profile form (ppf), patient had a ct scan approximately four years and three months post implantation.The patient reports experiencing tilt, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved; however, a removal attempt has not been made.The patient also reports suffering from spinal stenosis, varicose veins, shortness of breath, discoloration in legs and feet, skin ulceration, poor circulation, swelling, and pain and anxiety.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and tilted, perforated the inferior vena cava (ivc) wall, is embedded, there are blood clots, clotting and/or occlusion of the ivc and the filter cannot be retrieved; however, there are not documented attempts to retrieve the filter.The patient is also reported to have experienced spinal stenosis, varicose veins, shortness of breath, discoloration in legs and feet, skin ulceration, poor circulation, swelling, and pain and anxiety due to the complications of the filter.Approximately four years and three months post implantation, the patient had a review of a computed tomography (ct) scan performed, it is unclear when the actual scan was performed, the scan noted evidence of blood clotting.The indication for the filter implant was multiple bilateral pulmonary embolism (pe) and deep vein thrombosis (dvt) of the right lower extremity.At the time of the filter implant, it was the patient¿s second episode of bilateral pe.The filter was implanted via the right femoral vein and deployed below the level of the renal hilum at the second lumbar vertebra.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Without procedural films for review, the reported filter tilt, perforation and filter embedded could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt and perforation are unknown at this time and it is unknown if the tilt contributed to the perforation.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Without the procedural films or post implant imaging available for review the reported events could not be confirmed or further clarified.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling and discoloration of the affected extremity.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Anxiety, spinal stenosis, varicose veins, shortness of breath, discoloration in legs and feet, skin ulceration, poor circulation, swelling, and pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.

Manufacturer Narrative

Updated section (evaluation codes).No further information available.

Event Description

As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned, including, but not limited to, perforation of the ivc, and caused injury and damages to the patient.As a direct and proximate result of this malfunction, the patient, suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the filter was implanted below the level of the renal hilum at the second lumbar vertebra due to multiple bilateral pulmonary emboli and deep venous thrombosis of right lower extremity.According to the information received in the patient profile form (ppf), patient had a ct scan approximately four years and three months post implantation.The patient reports experiencing tilt, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved; however, a removal attempt has not been made.The patient also reports suffering from spinal stenosis, varicose veins, shortness of breath, discoloration in legs and feet, skin ulceration, poor circulation, swelling, and pain and anxiety.According to the information received in the discovery form, the patient was implanted due to prior combo of dvt/pe.

Manufacturer Narrative

Additional information was provided and is available in: section b4 (event description).Section g4 (date received by the manufacturer).Complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the filter was implanted below the level of the renal hilum at the second lumbar vertebra, the indication was multiple bilateral pulmonary emboli and deep venous thrombosis of right lower extremity.The filter subsequently malfunctioned, including, but not limited to, perforation of the ivc, and caused injury and damages to the patient.Per the patient profile form (ppf), a ct scan, approximately four years and three months post implant, was performed.The patient reports tilt, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved; however, a removal attempt has not been made.The patient also reports suffering from spinal stenosis, varicose veins, shortness of breath, discoloration in legs and feet, skin ulceration, poor circulation, swelling, and pain and anxiety.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Without procedural films for review, the reported filter tilt, perforation and filter embedded could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt and perforation are unknown at this time and it is unknown if the tilt contributed to the perforation.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Without the procedural films or post implant imaging available for review the reported events could not be confirmed or further clarified.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling and discoloration of the affected extremity.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.Anxiety, spinal stenosis, varicose veins, shortness of breath, discoloration in legs and feet, skin ulceration, poor circulation, swelling, and pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.

Manufacturer Narrative

Additional information was provided and is available in: section d4 (expiration date).Section g4 (date received by the manufacturer).Section h4 (manufacturing date).

• Brand Name: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary ; EI
• MDR Report Key: 7394077
• MDR Text Key: 104247596
• Report Number: 1016427-2018-01349
• 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,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2008
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0305428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR