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

Model Number 466P306X

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, 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, deep vein thrombosis, stenosis, caval thrombosis, and perforation.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 (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.Deep vein thrombosis (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.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Without images or procedural films for review, the reported vena cava stenosis and 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.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.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.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis, stenosis, caval thrombosis, and perforation.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 provided on the patient profile form (ppf) indicated that there was perforation of the filter struts outside the wall of the inferior vena cava (ivc) and that there were blood clots, clotting and/or occlusion of the ivc.The patient was diagnosed with blood clots approximately three years post implant.The patient claims to be suffering physical injuries because is not able to get proper medical treatment due to the filter and doctors don¿t want to perform any treatment due to the risks.The patient also claims to suffer emotionally because of the filter.Information contained in the medical records indicated that the filter was placed due to a history of bilateral pulmonary embolism (pe) and gastro-intestinal bleed and not a candidate for long term anticoagulation.The filter was placed via the right internal jugular vein and deployed such that the tip of the filter corresponds to the l 1-l2 interspace.The day prior to the implant, a left lower extremity ultrasound was performed for complaints of left calf pain, the exam was negative for deep vein thrombosis (dvt).A ventilation perfusion scan was also performed the day prior to the filter implant that was indeterminate for the presence of pe.The day after the filter implant, a right hip x-ray was performed for sever right hip and sacral pain, the exam was negative.Four days after the filter implant a computed tomography scan (ct) of the abdomen and pelvis was performed to rule out ischemic bowel or bowel obstruction.There was no acute abnormality noted in the abdomen or pelvis, a nonobstructive bowel gas pattern, no ischemic or inflammatory bowel changes and no abnormal fluid collections or free air.Six days post filter implant the patient underwent an upper and lower gastrointestinal exam due to anemia, abdominal pain and severe nausea.No active bleeding was identified.The patient¿s medical history is significant for chest pain, copd, epistaxis, bilateral pe, hypertension, dyslipidemia, back pain, sleep apnea, gerd, congestive heart failure and transient ischemic attack.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of bilateral pulmonary emboli (pe), gastrointestinal (gi) bleeding, chest pain, chronic obstructive pulmonary disease (copd), epistaxis, hypertension, dyslipidemia, back pain, sleep apnea, gastroesophageal reflux disease (gerd), congestive heart failure (chf) and transient ischemic attack (tia).The indication for the filter implant was reported to have for the prevention of pe and recurrent gi bleeding.The patient is reported to have not been a candidate for long term anticoagulation.The day before the implant, the patient underwent a left lower extremity ultrasound for left calf pain.This study was negative for deep vein thrombosis (dvt).The patient also underwent a ventilation perfusion scan that was indeterminate for the presence of pe.The filter was implanted via the right internal jugular vein and deployed with its tip at the level of the l1-l2 level.The next day, the patient experienced severe right hip and sacral pain and underwent a right hip x-ray that was negative.Four days after the implant, an abdominal/pelvis computerized tomography (ct) scan revealed to rule out ischemic bowel or bowel obstruction.This study revealed no acute abnormality with non-obstructive bowel gas pattern, no ischemic or inflammatory bowel changes and no abnormal fluid collections or free air.Six days after the implant, the patient experienced anemia, abdominal pain and severe nausea.An upper and lower gi exam revealed no active bleeding.The patient is subsequently reported to have experienced a dvt and leg pain, perforation of the filter outside the inferior vena cava (ivc), caval thrombosis, stenosis, complete occlusion of the device, heparin therapy and chest and abdominal pain.The patient further reported emotional distress and loss of enjoyment of life.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.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.These events do not represent a malfunction of the device.Blood clots, thrombosis, stenosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.The reported ivc perforation could not be confirmed without procedural films for review.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced these events include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Due to the nature of the complaint, the reported abdominal, hip and chest pain experienced by the patient could not be confirmed and the exact cause could not be determined.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, 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 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, deep vein thrombosis, stenosis, caval thrombosis, and perforation.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.Additional information provided on the patient profile form (ppf)indicated that there was perforation of the filter struts outside the wall of the inferior vena cava (ivc) and that there were blood clots, clotting and/or occlusion of the ivc.The patient was diagnosed with blood clots approximately three years post implant.The patient claims to be suffering physical injuries because is not able to get proper medical treatment due to the filter and doctors don¿t want to perform any treatment due to the risks.The patient also claims to suffer emotionally because of the filter.Information contained in the medical records indicated that the filter was placed due to a history of bilateral pulmonary embolism (pe) and gastro-intestinal bleed and not a candidate for long term anticoagulation.The filter was placed via the right internal jugular vein and deployed such that the tip of the filter corresponds to the l 1-l2 interspace.The day prior to the implant, a left lower extremity ultrasound was performed for complaints of left calf pain, the exam was negative for deep vein thrombosis (dvt).A ventilation perfusion scan was also performed the day prior to the filter implant that was indeterminate for the presence of pe.The day after the filter implant, a right hip x-ray was performed for sever right hip and sacral pain, the exam was negative.Four days after the filter implant a computed tomography scan (ct) of the abdomen and pelvis was performed to rule out ischemic bowel or bowel obstruction.There was no acute abnormality noted in the abdomen or pelvis, a nonobstructive bowel gas pattern, no ischemic or inflammatory bowel changes and no abnormal fluid collections or free air.Six days post filter implant the patient underwent an upper and lower gastrointestinal exam due to anemia, abdominal pain and severe nausea.No active bleeding was identified.The patient¿s medical history is significant for chest pain, copd, epistaxis, bilateral pe, hypertension, dyslipidemia, back pain, sleep apnea, gerd, congestive heart failure and transient ischemic attack.According to the discovery form, the patient received the ivc filter for prevention of pulmonary embolism with recurrent gastrointestinal bleeds; not able to take long term anticoagulation.Medical conditions and treatments alleged to be attributable to the implanted ivc filter include dvt and leg pain, perforation of the ivc filter outside the ivc lumen, caval thrombosis, stenosis, filter completed occluded; prescribed heparin, chest pain and abdominal pain.The patient further reports emotional distress, loss of enjoyment of life and other consequential damages as allowed by law.

Manufacturer Narrative

It was reported that a patient underwent placement of the 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, deep vein thrombosis, stenosis, caval thrombosis, and perforation of the filter struts outside the wall of the inferior vena cava (ivc).It was also reported that there were blood clots, clotting and/or occlusion of the ivc.The patient was diagnosed with blood clots approximately three years post implant.The patient claims to be suffering physical injuries because is not able to get proper medical treatment due to the filter and doctors don¿t want to perform any treatment due to the risks.The patient also claims to suffer emotionally because of the filter.The indication for the filter implant was a history of bilateral pulmonary embolism (pe) and gastro-intestinal bleed and not a candidate for long term anticoagulation.The filter was placed via the right internal jugular vein and deployed such that the tip of the filter corresponds to the l 1-l2 interspace.The day prior to the implant, a left lower extremity ultrasound was performed for complaints of left calf pain, the exam was negative for deep vein thrombosis (dvt).A ventilation perfusion scan was also performed the day prior to the filter implant that was indeterminate for the presence of pe.The day after the filter implant, a right hip x-ray was performed for sever right hip and sacral pain, the exam was negative.Four days after the filter implant a computed tomography scan (ct) of the abdomen and pelvis was performed to rule out ischemic bowel or bowel obstruction.There was no acute abnormality noted in the abdomen or pelvis, a nonobstructive bowel gas pattern, no ischemic or inflammatory bowel changes and no abnormal fluid collections or free air.Six days post filter implant the patient underwent an upper and lower gastrointestinal exam due to anemia, abdominal pain and severe nausea.No active bleeding was identified.The patient¿s medical history is significant for chest pain, copd, epistaxis, bilateral pe, hypertension, dyslipidemia, back pain, sleep apnea, gerd, congestive heart failure and transient ischemic attack.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Without the procedural films or post-placement imaging and the limited information provided, the reported perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.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.Stenosis is an abnormal narrowing in a blood vessel.With the limited information provided and the location of the stenosis not revealed it is not possible to determine a relationship between the filter and the stenosis.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, clotting, and device occlusion related to clotting do not indicate a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.This event does not represent a malfunction of the device.Additionally, without post implant films for review the report of clotting, occlusion, and blood clots could not confirmed of a cause be determined.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.After further review of additional information received the following sections pma/510k, if follow-up, what type have been 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: 7481070
• MDR Text Key: 107157504
• Report Number: 1016427-2018-01442
• 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,Followup
• Report Date: 07/10/2019

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 Expiration Date: 10/31/2014
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15512523
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 07/15/2018; 06/24/2019
• Supplement Dates FDA Received: 06/29/2018; 07/18/2018; 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR