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

Model Number 466P306AU

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease vena cava filter.There is sufficient evidence via a ct scan of the abdomen that all six prongs of the patient¿s filter have perforated the patient¿s vena cava and evidence of a calcified thrombus in the filter.The patient suffered life-threatening injuries and damages and required extensive medical care and treatment.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.An inferior vena cava (ivc) 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.The briefing mentioned that a perforation occurred.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Thrombosis and treatment for thrombosis does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Also, with the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or 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.There is sufficient evidence via a ct scan of the abdomen that all six prongs of the patient¿s filter have perforated her vena cava and evidence of a calcified thrombus in the filter.The patient suffered life-threatening injuries and damages and required extensive medical care and treatment.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

The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due having multiple pulmonary embolisms (pe).During implantation of the filter, the trapease cava filter was selected and positioned in the inferior vena cava below the level of the renal veins.It was deployed appropriately and symmetrically.A completion vena cavogram was done, which confirmed appropriate placement and no occlusion of the filter itself.The patient was taken to the recovery room in stable condition.According to the information received in the patient profile form (ppf), approximately on or about six years and six months post implantation of the ivc filter the patient became aware of the alleged events and reports to have fracture filter, perforation of filter struts outside the ivc, blood clots, clotting, and/or occlusion of the ivc.The patient states that the fractured filter struts are retained in their body inside the filter.The patient states to have undergone a ct scan for evaluation of her trapease ivc filter.The ct scan report noted that the filters 6 limbs have a grade 1 perforation of the caval wall, the apex of the filter is a grade 2 perforation of the caval wall greater than 3mm, a calcified thrombus in the filter and wire from strut below filter.The patient also states to suffer from pain post implant including constant severe abdominal pain.These injuries have caused emotional distress, mental anguish, anxiety, and stress.As reported, the patient had placement of the trapease vena cava filter.Per the medical records, the indication for placement was pulmonary embolisms (pe).The filter was deployed in the inferior vena cava below the level of the renal veins.It was deployed appropriately and symmetrically.A completion venocavagram was done, which confirmed appropriate placement and no occlusion of the filter itself.A ct scan of the abdomen revealed that all six prongs of the patient¿s filter have perforated the vena cava with evidence of a calcified thrombus in the filter.Per the patient profile form (ppf), the patient reports fracture filter, perforation of filter struts outside the ivc, blood clots, clotting, and/or occlusion of the ivc.The patient also reports pain post implant including constant severe abdominal pain and anxiety.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.The instructions for use (ifu) states filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was reported that there was perforation of the ivc and surrounding structures; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety 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.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.There is sufficient evidence via a ct scan of the abdomen that all six prongs of the patient¿s filter have perforated her vena cava and evidence of a calcified thrombus in the filter.The patient suffered life-threatening injuries and damages and required extensive medical care and treatment.The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due having multiple pulmonary embolisms (pe).During implantation of the filter, the trapease cava filter was selected and positioned in the inferior vena cava below the level of the renal veins.It was deployed appropriately and symmetrically.A completion vena cavogram was done, which confirmed appropriate placement and no occlusion of the filter itself.The patient was taken to the recovery room in stable condition.According to the information received in the patient profile form (ppf), approximately on or about six years and six months post implantation of the ivc filter the patient became aware of the alleged events and reports to have fracture filter, perforation of filter struts outside the ivc, blood clots, clotting, and/or occlusion of the ivc.The patient states that the fractured filter struts are retained in their body inside the filter.The patient states to have undergone a ct scan for evaluation of her trapease ivc filter.The ct scan report noted that the filters 6 limbs have a grade 1 perforation of the caval wall, the apex of the filter is a grade 2 perforation of the caval wall greater than 3mm, a calcified thrombus in the filter and wire from strut below filter.The patient also states to suffer from pain post implant including constant severe abdominal pain.These injuries have caused emotional distress, mental anguish, anxiety, and stress.As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of multiple filter struts, migration and fracture of one or more of the struts.As a result of the malfunction, 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, pain and suffering, and other damages.

Manufacturer Narrative

Section b5 (event description).Section g4 (date received by the manufacturer).Section h6 (evaluation codes: addition of device code 4003 and conclusion code 4310).Complaint conclusion: it was reported that a patient underwent placement of a trapease vena cava filter.According to the information provided a computed tomography (ct) scan of the abdomen showed that all six prongs of the filter have perforated the inferior vena cava (ivc) and there was evidence of a calcified thrombus in the filter.Subsequent information indicated that the filter migrated.The patient reported becoming aware of filter fracture, perforation, blood clots, clotting, and/or occlusion of the ivc approximately six years and six months post implant.The patient also reports constant severe abdominal pain and anxiety.According to the implant record the indication for the filter placement was multiple pulmonary emboli (pe).A trapease filter was deployed appropriately and symmetrically in the ivc below the level of the renal veins.A completion vena cavogram was done, which confirmed appropriate placement and no occlusion of the filter itself.The patient was taken to the recovery room in stable condition.Approximately six years and six months post implant the patient underwent a ct scan to evaluate the ivc filter.The ct report noted that the filters 6 limbs have a grade 1 perforation of the caval wall, the apex of the filter is a grade 2 perforation of the caval wall greater than 3mm, a calcified thrombus in the filter and a wire from a strut below the filter.There is currently no additional information available for review.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 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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Ivc filter migration is a known potential adverse event associated ivc filters and is listed in the ifu as such.Possible causes for migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Perforation of the ivc and surrounding structures was reported; however, a clinical conclusion could not be determined as to the cause of the event.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction nor do anxiety and pain.These events may be related to underlying patient specific 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.

• 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
• MDR Report Key: 8267966
• MDR Text Key: 133762989
• Report Number: 1016427-2019-02445
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15191261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GLIDEWIRE; UNKNOWN INJECTION SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR