MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE W/CSI INTRO KIT 55CM; TRAPEASE PERMANENT VENA CAVA FILTER

Model Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100); Thrombus (2101); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2013

Event Type  Death  

Manufacturer Narrative

As reported in a legal brief, the patient was implanted with one of the defendants' inferior vena cava filter products ("cordis ivc filter product(s)") on or about (b)(6) 2006, specifically a cordis trapease permanent vena cava filter ("trapease filter") to treat chronic deep vein thrombosis ("dvt"). in or about the spring of 2013, the patient suffered a major dvt which became intertwined with the trapease filter. since that time, the patient has suffered chronic pain.He has found it increasingly harder to work and has mostly stopped exercising. in or about early 2016, after receiving a ct scan and/or ultrasound showing the trapease filter had become stuck.It was determined that surgery to remove the trapease filter would be both next to impossible and life threatening and as such, the trapease filter was not removed. the trapease filter is now blocking the proper blood flow in the patient¿s body and he was been advised by his physicians that he may eventually lose the ability to walk. the physical and mental trauma that (b)(6) has suffered due to having been implanted with a cordis ivc filter product contributes to the patient suffering from severe depression, a condition he continues to live with. prior to and at the time which he was implanted with the trapease filter, he received no or inadequate warnings about the magnitude of risks of developing injuries and complications (as defined herein) from using a cordis ivc filter product. had the patient been aware of the magnitude of risks of developing injuries and complications, he would not have agreed to being implanted with a cordis ivc filter product and would have requested use of an alternative and/or safer filter or treatment.    the product remains implanted and is not available for analysis.A review of the manufacturing records could not be conducted without a lot number   the cordis trapease permanent vena cava filter with the angiographic vessel dilator and introduction kit is designed for percutaneous delivery of a permanent vena cava filter to the inferior vena cava (ivc).Dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of your lower leg (calf), and can spread up to the veins in your thigh.Dvt can also first develop in the deep veins in your thigh and, more rarely, in other deep veins, such as the ones in your arm.Deep vein thrombosis is the result of three principal factors : reduced or stagnant blood flow in deep veins (venous stasis).Injury to the blood vessel wall.An increase in the activity of those substances in the blood that are part of the normal clotting mechanism, a condition called hypercoagulability (which means a more active clotting state).Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt.  factors that may have influenced the event include patient, pharmacological and lesion.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt.  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

The plaintiff, (b)(6), is an individual residing in (b)(6).(b)(6) is the mother of (b)(6) and is pursuing her claim in that capacity.The plaintiffs' experiences (b)(6) was implanted with one of the defendants' inferior vena cava filter products ("cordis ivc filter product(s)") on or about (b)(6) 2006, specifically a cordis trapease permanent vena cava filter ("trapease filter") to treat chronic deep vein thrombosis ("dvt").In or about the spring of 2013, (b)(6) suffered a major dvt which became intertwined with the trapease filter.Since that time, (b)(6) has suffered chronic pain.He has found it increasingly harder to work and has mostly stopped exercising.In or about early 2016, (b)(6) received a ct scan and/or ultrasound showing the trapease filter had become stuck.It was determined that surgery to remove the trapease filter would be both next to impossible and life threatening and as such, the trapease filter was not removed.The trapease filter is now blocking the proper blood flow in (b)(6) body and (b)(6) has been advised by his physicians that he may eventually lose the ability to walk.The physical and mental trauma that (b)(6) has suffered due to having been implanted with a cordis ivc filter product contributes to (b)(6) suffering from severe depression, a condition he continues to live with.Prior to and at the time which (b)(6) was implanted with the trapease filter, he received no or inadequate warnings about the magnitude of risks of developing injuries and complications (as defined herein) from using a cordis ivc filter product.Had (b)(6) been aware of the magnitude of risks of developing injuries and complications, he would not have agreed to being implanted with a cordis ivc filter product and would have requested use of an alternative and/or safer filter or treatment.But for the defendants' wrongful conduct, (b)(6) would not have incurred his damages.(b)(6) and other class members have suffered and continue to suffer damages including loss of care, guidance, companionship, and consortium, as well as financial expenses and special damages due to the wrongful conduct of the defendants.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The indication for filter placement was to treat chronic deep vein thrombosis (dvt). the filter was deployed via the patient's right groin.The filter was placed distal to the renal veins.There were no problems during the implantation procedure.Approximately seven years after the index procedure the patient experienced a major dvt which became intertwined with the trapease filter. since that time, the patient has suffered chronic pain.He has found it increasingly harder to work and has mostly stopped exercising. approximately ten years after the index procedure the patient had a computed tomography (ct) scan and/or ultrasound showing the trapease filter had become stuck.It was determined that surgery to remove the trapease filter would be both next to impossible and life threatening and as such, the trapease filter was not removed. the trapease filter is now blocking the proper blood flow.The patient was advised by his physicians that he may eventually lose the ability to walk. the patient continues to experience physical and mental trauma including severe depression related to the filter.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication was chronic deep vein thrombosis (dvt).A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.Approximately seven years after implant, the patient had recurrence of dvt, involving the ivc and filter resulting in chronic pain.Approximately ten years after implant, a ct scan revealed the filter is occluded, stuck and not removable.The patient also reports physical pain and mental trauma.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.Depression 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.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.

Manufacturer Narrative

After further review of additional information received.Section h6: health effect - clinical code: code 4581 was used for 'death'.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of intravenous (iv) drug abuse, smoking, bronchial asthma, chronic deep vein thrombosis (dvt) and non-compliance with anticoagulation therapy.The patient had recently presented to the hospital with bilateral calf and chest pain.Diagnostic testing had revealed multiple acute and chronic pulmonary emboli (pe), dvt and possible right-sided cardiac failure.The indication for the filter placement was reported to be as prophylaxis against recurrent dvt and pe.The filter was implanted via the right groin and placed in an infrarenal position.Approximately six years and eight months after the filter implantation, the patient presented to hospital with increasing shortness of beath, bilateral lower extremity swelling and pain.Diagnostic testing revealed chronic obstructive pulmonary disease (copd) and a massive dvt involving the inferior vena cava (ivc), common iliac vein and the veins of the right lower extremity.A computerized tomography (ct) was negative for pe.Approximately seven years after the filter implantation, the patient underwent diagnostic testing that revealed a major dvt that had become entwined with the filter.The patient reported having experienced chronic pain since and has been finding harder to work or exercise.Approximately ten years after the filter implantation, the patient underwent further diagnostic testing that revealed that the filter had become stuck and that the filter was surgically irretrievable due to the associated risks involved.No evidence of a filter retrieval attempt was provided.The filter was noted to be blocking proper blood flow and the patient was advised that they would eventually lose mobility.The patient further reported having experienced severe depression associated with the filter.It was subsequently reported that the patient had expired.The date and cause of death were not reported.Information as to whether the patient¿s death was related to the filter has not been provided.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 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.Without procedural films for review, the reported filter embedment could not be confirmed and the exact cause could not be determined.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety and/or depression experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.Two weeks prior to the index procedure the patient presented to the emergency room for bilateral calf pain and chest pain.A computed tomography (ct) scan was performed and confirmed multiple pulmonary emboli (pe).Additional review of the ct scan noted that some of the pe¿s were chronic and some acute.The patient has a history of intravenous (iv) drug abuse and bronchial asthma.The records state that the patient was non-complaint with anticoagulant therapy.The indication for filter implantation was recurrent pe, dvt and non-compliance with anticoagulation therapy.The filter was deployed via the patient's right groin.The filter was placed distal to the renal veins.There were no problems during the implantation procedure.Approximately six years and eight months after the index procedure the patient presented to the hospital with increasing shortness of breath and leg pain, bilateral swelling.The patient was diagnosed with massive dvt involving the ivc, common iliac and right leg vein and chronic obstructive pulmonary disease (history of smoking).A ct scan was negative for pe.Approximately seven years after the index procedure the patient experienced a major dvt which became intertwined with the trapease filter. since that time, the patient has suffered chronic pain.He has found it increasingly harder to work and has mostly stopped exercising.  approximately ten years after the index procedure the patient had a computed tomography (ct) scan and/or ultrasound showing the trapease filter had become stuck.It was determined that surgery to remove the trapease filter would be both next to impossible and life threatening and as such, the trapease filter was not removed. the trapease filter is now blocking the proper blood flow.The patient was advised by his physicians that he may eventually lose the ability to walk. the patient continues to experience physical and mental trauma including severe depression related to the filter.  a document indicated the patient was deceased, but there was no indication if this was related to the device.The date and cause of death were not provided.

• Brand Name: TRAPEASE W/CSI INTRO KIT 55CM
• Type of Device: TRAPEASE PERMANENT VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• MDR Report Key: 6043690
• MDR Text Key: 57975077
• Report Number: 1016427-2016-00097
• 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
• Report Date: 08/25/2021

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 Expiration Date: 10/31/2008
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306A
• Device Lot Number: R1105652
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/30/2016
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: 05/12/2021; 08/27/2021
• Supplement Dates FDA Received: 06/21/2021; 08/25/2021
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 31 YR