MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306AU

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

Patient Problems Occlusion (1984); Scar Tissue (2060); Swelling (2091); Thrombosis (2100)

Event Date 06/27/2003

Event Type  Injury  

Manufacturer Narrative

The exact event date is not known.The exact catalog and lot numbers are not known.As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and occlusion of the ivc and iliac veins.The filter remains implanted; thus, unavailable for analysis.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 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.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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and occlusion of the ivc and iliac veins.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.

Manufacturer Narrative

Corrected data: product code.

Manufacturer Narrative

Additional information was provided and is available in: section a2 (age at the time of event, date of birth) section b3 (event date) section b4 (event description) section b7 (relevant medical history) section d1 (brand name) section d4 (model, catalog, lot number, udi number, implant date) section d11 (concomitant medical products) unknown needle, unknown wire, unknown 5f sheath, unknown.035 wire section g4 (date received by the manufacturer) section h6 (evaluation codes) 1498 - post procedural pulmonary embolism 2100 - thrombosis 1985 - device occlusion 2061 - scarring 2091 - swelling additional information is pending and will be submitted within 30 days upon receipt.As reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the indication for filter was left popliteal deep vein thrombosis.History includes recurrent lower extremity dvt.It was reported that the patient was pre-operative for spinal surgery.A doppler of the left leg revealed chronic deep venous thrombosis of the popliteal vein and left calf distribution.The filter was implanted in the infrarenal position.The patient tolerated the procedure well.There were no complications.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and occlusion of the ivc and iliac veins.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, and post-implant pe.The patient also reports emotional and physical pain.A ct scan post implant revealed thrombus within the ivc and iliac veins, as well as in the lower extremity.The ivc, the filter, and iliac veins were completely occluded.The patient had recanalization of both right and left common iliac veins and ivc thrombosis by infusion catheter.Additionally, the patient suffered a pulmonary embolism.The filter remains implanted.The patient continues to suffer from severe leg swelling, veins that stick out from his legs and scarring.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.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.Swelling of the legs, scarring, anxiety and pain do not represent device malfunctions 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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and occlusion of the ivc and iliac veins.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¿s preoperative diagnosis was left popliteal deep vein thrombosis.The patient underwent right femoral vein canalization with sheath placement and right femoral iliac and vena cava venogram.The patient needed cervical spine surgery.He has a history of recurrent lower extremity dvt x 2, most recently with a left leg deep vein thrombosis.A doppler was performed of the patient¿s left leg and he had chronic deep venous thrombosis in the popliteal vein and left calf distribution.Because of the need for immobility and increased risk of propagation of clot, it was recommended that the patient have a filter put in prior to his surgery.The filter was implanted in the infrarenal position.The patient tolerated the procedure well.There were no complications.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately two months post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc, and post-implant pe.The patient also reports suffering from emotional and physical pain and suffering.A ct scan revealed thrombus within the ivc and iliac veins, as well as lower extremity thrombus.The ivc, the filter, and iliac veins were completely occluded.The patient subsequently underwent recanalization of both right and left common iliac veins and ivc thrombosis with a valve tip infusion catheter.Additionally, the patient suffered from a massive clot that completely closed his common iliac veins and suffered from a pulmonary embolism.The filter remains implanted.The patient will require lifelong monitoring of his ivc filter, thus, creating a life-threatening situation for the patient.The patient must now live with constant worry and anxiety about the state of his health related to the filter.The patient continues to suffer from severe leg swelling.The patient must also live with veins that stick out of his legs and scarring.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8612601
• MDR Text Key: 145133950
• Report Number: 1016427-2019-02839
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

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: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: S1002111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 04/19/2019; 08/13/2019
• Supplement Dates FDA Received: 05/23/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR