MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Reocclusion (1985); Swelling (2091); Thrombosis (2100); Stenosis (2263)

Event Date 08/01/2016

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, post-thrombotic syndrome, and occlusion of the ivc.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 device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.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).Post thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt without images or procedural films for review, the reported vena cava stenosis could not be confirmed and the exact cause could not be determined.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.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 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, post-thrombotic syndrome, and occlusion of the ivc.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.

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, post-thrombotic syndrome, and occlusion of the ivc.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 were blood clots, clotting and/or occlusion of the inferior vena cava (ivc), ivc filter clogged not allowing proper blood flow to the lower extremity, and that the device cannot be retrieved.There was an unsuccessful percutaneous removal attempt performed approximately eight years post implant.The patient is also reported to have experienced acute deep vein thrombosis (dvt) of both lower extremities with swelling and burning pain and is not able to walk long distances.The patient is also reported to have experienced depression.Information contained in the medical records indicated that the patient¿s medical history is noted for morbid obesity, history of hepatitis c, hypertension, chronic venous stasis, arthralgia, arthritis and non-insulin dependent diabetes.The patient has also had bilateral hip replacements.The filter was placed via the right femoral vein and deployed below the level of the renal veins at the level of the l2-l3intervertebral disc and l2 vertebral body.The filter was placed during the same procedure for a roux-en-y gastric bypass and liver biopsy.The patient¿s post-operative course was uneventful except for elevated liver enzymes noted on post-op day 4.The enzymes started to trend down, but there was concern for cholelithiasis, a hida scan was performed and the gall bladder was not visualized.The patient was discharged five days postoperatively in stable condition.

Manufacturer Narrative

The implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Per in the medical records, the patient¿s medical history is noted for morbid obesity, history of hepatitis c, hypertension, chronic venous stasis, arthralgia, arthritis and non-insulin dependent diabetes.The patient has also had bilateral hip replacements.The filter was placed via the right femoral vein and deployed below the level of the renal veins at the level of the l2-l3intervertebral disc and l2 vertebral body.The filter was placed during the same procedure for a roux-en-y gastric bypass and liver biopsy.The patient¿s post-operative course was uneventful except for elevated liver enzymes noted on post-op day 4.The enzymes started to trend down, but there was concern for cholelithiasis, a hida scan was performed and the gall bladder was not visualized.The patient was discharged five days postoperatively in stable condition.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis, stenosis, caval thrombosis, post-thrombotic syndrome, and occlusion of the ivc.Per on the patient profile form (ppf), there was blood clots, clotting and/or occlusion of the inferior vena cava (ivc), ivc filter clogged and that the device cannot be retrieved.There was an unsuccessful percutaneous removal attempt performed approximately eight years post implant.The patient also reported acute deep vein thrombosis (dvt) of both lower extremities with swelling and burning pain and is not able to walk long distances.The patient also reported depression.The filter remains implanted; thus, unavailable for analysis.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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Blood clots, post thrombotic syndrome, and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Swelling of the legs, pain and depression 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.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: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7472317
• MDR Text Key: 106868342
• Report Number: 1016427-2018-01436
• 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: 07/24/2018

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 Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0907342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 07/15/2018
• Supplement Dates FDA Received: 06/22/2018; 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 213