MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER.; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problems Complete Blockage (1094); Difficult to Remove (1528)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100); Stenosis (2263); No Code Available (3191)

Event Date 03/12/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, litigation paralegal.Implant date: date of implant is in or about 2004.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The patient was implanted in or about 2004.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to the filter becoming occluded.Additionally, the patient suffered thrombosis and the filter was unable to be retrieved.The filter remains implanted; thus, unavailable for analysis.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Please note that this is the initial/final report for this product.

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 the filter becoming occluded.Additionally, the patient suffered thrombosis and the filter was unable to be retrieved.The patient has 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, suffering, and other damages.The patient was implanted in or about 2004.

Manufacturer Narrative

Correction to product code.

Event Description

Additional information received per the medical records indicate that the patient has a history of a previous femoral-femoral arterial bypass, acute pulmonary embolism, protein c deficiency, type 2 diabetes, hypertension, depression and bipolar disorder.Approximately five years and nine months after the index procedure, the patient had an above the knee amputation due to peripheral artery disease.  thirteen years and two months after the index procedure, the patient presented to the hospital with early phlegmanic changes to his left leg and massive bilateral scrotal swelling.The patient has experienced ileocaval occlusion from a thrombi in the filter.There were focal areas of residual thrombus in the left femoral vein, left external iliac vein, right common vein and right external iliac vein.The patient also experienced caval stenosis associated with the filter.A catheter directed thrombolysis was initiated.Immediately after the thrombolysis, there were multiple attempts to remove the filter, the filter was left in place.The records note that the cava was injured during the removal attempt.The leak was successfully treated with a covered stent graft.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting, occlusion of the inferior vena cava, post implant deep vein thrombosis, pulmonary embolism and other thrombosis.There was an unsuccessful attempt to remove the filter.

Manufacturer Narrative

Section d6: implant date: the patient profile form (ppf) states that the implant date is (b)(6) 2004.Section h6: patient code '3191' was used as there are no codes available for 'injury to inferior vena cava'.Patient code "2091" was used for the event of scrotal swelling.Section b5: as reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of a previous femoral-femoral arterial bypass, acute pulmonary embolism, protein c deficiency, type 2 diabetes, hypertension, depression and bipolar disorder.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to the filter becoming occluded.Additionally, the patient suffered thrombosis and the filter was unable to be retrieved.Approximately five years and nine months after the index procedure, the patient had an above the knee amputation due to peripheral artery disease.Thirteen years and two months after the index procedure, the patient presented to the hospital with early phlegmatic changes to his left leg and massive bilateral scrotal swelling.The patient had ileo-caval occlusion from thrombi in the filter.There were focal areas of residual thrombus in the left femoral vein, left external iliac vein, right common vein and right external iliac vein.The patient also experienced caval stenosis associated with the filter.A catheter directed thrombolysis was initiated.Immediately after the thrombolysis, there were multiple attempts to remove the filter, the filter was left in place.The records note that the cava was injured, causing leakage, during the removal attempt.The leak was successfully treated with a covered stent graft.Per the patient profile form (ppf), the patient experienced blood clots, clotting, occlusion of the inferior vena cava, post implant deep vein thrombosis, pulmonary embolism and other thrombosis.The filter remains implanted; thus, unavailable for analysis.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.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.Injury to the ivc during removal attempts does not represent a device malfunction and may be related to the length 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, dvt, post procedural thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Scrotal swelling from thrombosis 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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER.
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7823807
• MDR Text Key: 118469931
• Report Number: 1016427-2018-01753
• Device Sequence Number: 1
• 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
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 57 YR