MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

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

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Initial reporter, occupation: other, senior counsel, litigation.Please note that the exact event date is unknown.As reported, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava filter thrombosis, inferior vena cava occlusion, venous insufficiency, leg swelling and pain.The ivc filter poses a progressive risk of perforation of surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications.It also poses an ongoing and progressive risk of migration, fracture and embolization of a fracture causing serious injury and death.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 review could not be performed.The inferior 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.A thrombosis noted in the device does not represent a device malfunction.Occlusion within the ivc does not represent a device malfunction.An occlusion within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to possible swelling and pain of the lower extremities.However, 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.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava filter thrombosis, inferior vena cava occlusion, venous insufficiency, leg swelling and pain.The ivc filter poses a progressive risk of perforation of surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications.It also poses an ongoing and progressive risk of migration, m fracture and embolization of a fracture causing serious injury and death.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 received per the medical records indicate that the patient has a history of right leg deep vein thrombosis, rheumatoid arthritis, diabetes mellitus, anxiety, hypertension, cholecystectomy, abdominal pain, heartburn, previous smoker, anterior cervical decompression and fusion.Prior to the index procedure the patient had lower extremity paralysis and cervical myelopathy, this lead to the patient having anterior decompression and fusion procedure.The patient was also noted to have a cerebrospinal fluid (csf) leak and a lumbar drain was placed and subsequently removed.  the filter was deployed via left femoral vein.Additional information received per the medical records indicate that the patient experienced abdominal pain four days after the index procedure.The cramping was noted to have begun several months prior to the index procedure.Bowel movements and passing of flatulence provide relief of the spasms.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), venous insufficiency, ivc thrombosis, leg swelling and pain.The patient became aware of the reported events six years and five months after the index procedure.The patient also experienced fear, stress, anxiety and loss of enjoyment of life.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of right leg deep vein thrombosis, rheumatoid arthritis, diabetes mellitus, anxiety, hypertension, cholecystectomy, abdominal pain, heartburn, previous smoker, anterior cervical decompression and fusion.Prior to the index procedure the patient had lower extremity paralysis and cervical myelopathy, this was treated by an anterior decompression and fusion procedure.The patient was also noted to have a cerebrospinal fluid (csf) leak and a lumbar drain was placed and subsequently removed.The filter was deployed via left femoral vein.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava filter thrombosis, inferior vena cava occlusion, venous insufficiency, leg swelling and pain.Per the medical records, the patient experienced abdominal pain four days after the index procedure.The cramping was noted to have begun several months prior to the index procedure.Bowel movements and passing of flatulence provide relief of the spasms.Per the patient profile form (ppf), the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), venous insufficiency, ivc thrombosis, leg swelling and pain.The patient also experienced fear, stress, anxiety and loss of enjoyment of life.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, venous insufficiency, swelling of the legs, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pain 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b1, b4, g4, g7, h1, h2 and h6.The results of computed tomography (ct) scans done approximately nine years after the index procedure indicate that there is slight posterior tilting of the lower filter tip.The upper filter tip lies at the level of the renal veins, slightly elevated.The report states that there is no migration, no perforation, no fracturing or bending and no inferior vena cava stenosis (ivc) stenosis.Additional information received per an amended patient profile form (ppf) states that the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc), venous insufficiency, ivc thrombosis, leg swelling, pain and tilting of the filter.The patient became aware of the reported events six years and five months after the index procedure.The patient also experienced fear, stress, anxiety and loss of enjoyment of life.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of right leg deep vein thrombosis (dvt), abdominal pain, rheumatoid arthritis, diabetes mellitus, anxiety, hypertension, cholecystectomy, heartburn, previous smoking, lower extremity paralysis and cervical myelopathy with anterior cervical decompression and fusion.The patient was also noted to have had a recent history of cerebrospinal fluid (csf) leak with a lumbar drain that had been removed.Four days after the filter implantation, the patient experienced abdominal pain.The associated cramping was noted to have started several months prior to the index procedure.It was reported that bowel movements and flatulence provided relief of the spasms.Approximately six years and five months after the filter implantation, the patient became aware that the filter was associated with blood clots, clotting and/or occlusion of the inferior vena cava (ivc), filter and ivc thrombosis, venous insufficiency, leg swelling and pain.Approximately nine years after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that there was a slight posterior tilting of the lower aspect of the filter.The upper aspect of the filter was noted to be at the level of the renal veins; slightly elevated.There was no evidence of migration, perforation, fracture, bending or ivc stenosis.The patient further reported having experienced fear, stress, anxiety and loss of enjoyment of life associated with the filter.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 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 images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Blood clots and 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, venous insufficiency and leg swelling 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 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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8289047
• MDR Text Key: 134491495
• Report Number: 1016427-2019-02466
• Device Sequence Number: 0
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR