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

Lot Number R0903589

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Stenosis (2263); Ulcer (2274); Vascular System (Circulation), Impaired (2572)

Event Date 10/21/2009

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.Per the medical records, the patient had recurrence of or extension of a prior deep venous thrombosis while therapeutic on coumadin.The filter was implanted in the l3 lumbar vertebral body due risk of pulmonary embolus and failure in the face of adequate coumadin therapy.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, having a second filter implanted.Per the medical records, the patient was implanted with a second non-cordis filter approximately five years and six months post implantation due to left lower extremity recurrent venous stasis ulcers.The patient has evidence of greater saphenous reflux, as well as some deep vein reflux, per venous insufficiency studies.During implant of the non-cordis filter, initial venogram showed occlusion of the common iliac vein and narrowing within the external iliac vein.The physician was able to advance through the trapease filter with a 12x40mm balloon.Angioplasty was performed and the non-cordis filter was placed just above the level of the trapease filter and below the level of the renal veins.Post venoplasty revealed residual stenosis greater than 60%, so a 14x60 smart stent was placed through the trapease filter down into the common iliac vein and then extended down into the external iliac vein.There was only mild residual stenosis with the trapease filter of approximately 20-30%.The non-cordis filter was successfully explanted approximately sixteen days post implantation.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, stenosis of ivc requiring angioplasty and stent to correct.The patient also reports suffering from anxiety.The filter remains implanted; thus, unavailable for analysis.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Circulatory insufficiency and venous stasis ulcers do not represent a device malfunction and may be related to underlying patient related issues.Anxiety does 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.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 trapease vena cava filter.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, having a second filter implanted.As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records: the patient was noted to have either recurrence of or extension of a prior deep venous thrombosis while therapeutic on coumadin.The filter was implanted in the l3 lumbar vertebral body due risk of pulmonary embolus and failure in the face of adequate coumadin therapy.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately five years and six months post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc, stenosis of ivc requiring angioplasty and stent to correct.The patient also reports suffering from anxiety.Per the patient¿s medical records, the patient was implanted with a second non-cordis filter approximately five years and six months post implantation due to left lower extremity recurrent venous stasis ulcers.The patient has evidence of greater saphenous reflux, as well as some deep vein reflux, per reported venous insufficiency studies.During implant of the non-cordis filter, initial venogram showed occlusion of the common iliac vein and narrowing within the external iliac vein.The physician was able to advance through the trapease filter with a 12x40mm balloon.Angioplasty was performed and the non-cordis filter was placed just above the level of the trapease filter and below the level of the renal veins.Post venoplasty revealed residual stenosis greater than 60%, so a 14x60 smart stent was placed within the trapease filter down into the common iliac vein and then extended down into the external iliac vein.There was only mild residual stenosis with the trapease filter of approximately 20-30%.The non-cordis filter was successfully explanted approximately sixteen days post implantation.

• 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 7793917
• MDR Text Key: 117566479
• Report Number: 1016427-2018-01730
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: R0903589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2003
• 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
• Patient Age: 54 YR