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

Catalog Number 466P306X

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); No Code Available (3191)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation and extension of the filter struts through the wall of the inferior vena cava.The form states that the patient underwent a removal procedure; however, the filter was too embedded and could not be removed.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 filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.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 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 perforation and extension of the filter struts through the wall of the inferior vena cava.The form states that the patient underwent a removal procedure; however, the filter was too embedded and could not be removed.

Manufacturer Narrative

Section h6: patient code '3191' was used for " collateral vessels".Section b5: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication for filter was pulmonary embolism and left lower extremity deep vein thrombosis (dvt) the patient also experienced mental status changes and abdominal pain at the time of implantation.X-rays showed severe fatty liver.The ivc-gram shows no evidence of inferior vena cava (ivc) thrombus.A trapease filter was deployed into the infrarenal area of the ivc.A final hand-injected ivc-gram was performed through the delivery sheath showing satisfactory position.The patient tolerated the procedure well with no evidence of complication.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation and extension of the filter struts through the wall of the inferior vena cava.The form states that the patient underwent an unsuccessful removal procedure; however, the filter was embedded.Approximately eleven years after implant, the patient presented with gross hematuria.A ct revealed bilateral renal calculi and collateral vessels in the abdominal cavity.The patient also experienced lower extremity swelling, pain and chronic fatigue.The ivc filter was visualized, some of the limbs slightly extended beyond the ivc wall.Approximately eleven years and one month after implant, medical history includes bleeding tendency, coagulation problem, dvt (deep vein thrombosis), pulmonary embolus (pe), ivc filter, sleep apnea, renal stone removal, umbilical hernia repair, ivc filter removal with ivc reconstruction for ivc occlusion and significant collateral venous drainage with abdominal pain.Inferior venacavogram followed by balloon venoplasty of the ivc and bilateral common iliac and external iliac veins.Ivc filter removal attempt unsuccessful.A self-expanding covered stent placement in the ivc across the filter with balloon venoplasty of the ivc stent and repeat balloon venoplasty of the bilateral common iliac and external iliac veins.Next, self-expanding stent placement within the bilateral common iliac veins and right external iliac vein.Followed by balloon venoplasty of the stented ivc and bilateral iliac veins.Impression: unsuccessful filter removal with successful ivc reconstruction.Per the patient profile form (ppf), the patient reports perforation of filter struts outside of the ivc, filter embedded, blood clots, clotting and/or occlusion of the ivc and the device is unable to be retrieved.The patient became aware of the reported events approximately eleven years after the index procedure.There was an attempted percutaneous retrieval made that was unsuccessful.The patient also reports fear, sadness, chronic pain, fatigue and swelling of the legs.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.It was reported that there was perforation of the ivc; 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation and swelling of the legs do not represent a device malfunction and may be related to underlying patient related issues.Anxiety, fatigue 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

Additional information received per the medical records indicate that the filter was implanted secondary to pulmonary embolism and left lower extremity deep vein thrombosis (dvt) the patient also experienced mental status changes and abdominal pain at the time of implantation.X-rays showed severe fatty liver.The ivc-gram shows no evidence of inferior vena cava (ivc) thrombus.A trapease filter was deployed into the infrarenal area of the ivc.A final hand-injected ivc-gram was performed through the delivery sheath showing satisfactory position.The patient tolerated the procedure well with no evidence of complication.Approximately eleven years after the index procedure, the patient presented with gross hematuria.A computed tomography (ct) revealed bilateral renal calculi and collateral vessels in the abdominal cavity.The patient also experienced lower extremity swelling, pain and chronic fatigue.The ivc filter was visualized, some of the limbs slightly extended beyond the ivc wall.  medical records from approximately eleven years and one month after the index procedure, state that the patient's medical history includes bleeding tendency, coagulation problem, dvt (deep vein thrombosis), pulmonary embolus (pe), ivc filter, sleep apnea, renal stone removal, umbilical hernia repair, ivc filter removal with ivc reconstruction for ivc occlusion and significant collateral venous drainage with abdominal pain.Inferior venacavogram followed by balloon venoplasty of the ivc and bilateral common iliac and external iliac veins.Ivc filter removal attempt unsuccessful.A self-expanding covered stent placement in the ivc across the filter with balloon venoplasty of the ivc stent and repeat balloon venoplasty of the bilateral common iliac and external iliac veins.Next, self-expanding stent placement within the bilateral common iliac veins and right external iliac vein.Followed by balloon venoplasty of the stented ivc and bilateral iliac veins.Impression: unsuccessful filter removal with successful ivc reconstruction.Per the patient profile form (ppf), the patient reports perforation of filter struts outside of the ivc, filter embedded, blood clots, clotting and/or occlusion of the ivc and the device is unable to be retrieved.The patient became aware of the reported events approximately eleven years after the index procedure.There was an attempted percutaneous retrieval made that was unsuccessful.The patient also reports fear, sadness, chronic pain, fatigue and swelling of the legs.

• 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: 9007587
• MDR Text Key: 162292370
• Report Number: 1016427-2019-03304
• 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
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2008
• Device Catalogue Number: 466P306X
• Device Lot Number: R0303001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR