MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306BU

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

Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, pulmonary embolism, clotting and occlusion of the inferior vena cava (ivc) filter, and recurrent deep vein thrombosis (dvt).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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.  the trapease 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.Neither blood clots, clotting nor thrombus within the vessel (or in the filter) represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The patient¿s pulmonary embolism could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.The product¿s instructions for use (ifu) indicate that filter obstruction and thrombus formation are potential complications of filter implantation.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 vena cava filter on or about (b)(6) 2006.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, pulmonary embolism, clotting and occlusion of the inferior vena cava (ivc) filter, and recurrent deep vein thrombosis (dvt).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

Additional information was received from the patient profile form which indicates there was a clot bypassed filter to lungs.The filter is in place for more than 90 days, too risky to attempt retrieval.Future perforation and fracture are likely.There was no retrieval attempt made.The patient has fears of possible failure in the future.The extent of any device failure has not been fully documented by the patient¿s treating medical provider.Medical records received indicate at the reason for filter placement sudden onset of shortness of breath, chest pain, weakness and elevated d-dimer.The inferior vena cava filter was deployed between the level of the bifurcation and the renal veins.Venography showed successful filter placement.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The lot number previously provided is invalid.

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 and caused injury and damages to the patient, including, but not limited to, blood clots, pulmonary embolism, clotting and occlusion of the inferior vena cava (ivc) filter, and recurrent deep vein thrombosis (dvt).Additional information contained in the patient profile form indicated that a clot bypassed the filter to the lungs and that the filter was unable to be retrieved because the filter was in place more than 90 days.An attempt to remove the filter has not made.The indication for the device implant was two days status post cholecystectomy, the patient was experiencing chest pain, shortness of breath and had an elevated d-dimer.The filter was placed via the right brachial vein and deployed between the level of the bifurcation and the renal veins.Venography showed successful filter placement.The patient tolerated the procedure well with no complications.There is currently no additional information available.The product was not returned for analysis and the sterile lot number provided is invalid; therefore, no device analysis nor device history record review could be performed.The trapease 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.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.Pulmonary embolism and filter occlusion are known long term complications associated with filter implant and are listed as such in the instructions for use (ifu).Clotting, deep vein thrombosis, pulmonary emboli and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and a device malfunction could be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

Additional information was received: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a recent history of cholecystectomy and a questionable history of transient ischemic attack (tia).The indication for the filter placement was reported to be the sudden onset of shortness of breath (sob), chest pain, weakness and an elevated d-dimer level associated with pulmonary embolism (pe).The filter was implanted via the right brachial vein and successfully deployed between the level of the bifurcation and the renal veins.The patient is reported to have tolerated the procedure well.The filter subsequently malfunctioned including blood clots, pe, clotting and occlusion of the filter and recurrent deep vein thrombosis (dvt).Approximately four years after implantation, the patient presented to the emergency room with sob, palpitations, gastroesophageal reflux disease (gerd), anemia, proteinuria and anxiety/panic attacks.A computerized tomography (ct) scan was positive for pulmonary embolism of a sub-segmental branch of the right lower lobe.A doppler ultrasound study revealed no evidence of dvt.During the course of this hospitalization, the patient developed lower substernal chest pain that was treated with a gastrointestinal (gi) cocktail.An echocardiogram revealed an ejection fraction of 68%.A repeated ct scan revealed mild basilar atelectasis that was treated with amoxicillin.Laboratory findings included hypomagnesemia that was treated with magnesium sulfate.Approximately ten years and one month after the implantation, the patient became aware that the filter was associated with blood clots, clotting and/or occlusion of the inferior vena cava (ivc) that had bypassed the filter to the lungs.The filter was noted to have been in place for more than 90 days at that time and was deemed too risky to attempt retrieval.No attempts to retrieve the filter were documented.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 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 that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.Blood clots and thrombosis and/or occlusion within device or within the ivc and/or the development of a dvt do not represent a device malfunction.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6683740
• MDR Text Key: 78899500
• Report Number: 1016427-2017-00431
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306BU
• Device Lot Number: R9108393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR