MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Partial Blockage (1065)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had become embedded and was associated with occlusion.In addition, the patient indicated that the filter could not be retrieved; though attempts to retrieve it were not documented.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 inferior vena cava (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.Without procedural films for review, the reported filter embedment could not be confirmed and the exact cause could not be determined.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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 in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, filter embedment and occlusion causing the filter to be irretrievable which causes injury and damage to the patient.

Manufacturer Narrative

As reported, a patient had placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, filter embedment and occlusion.Per patient profile form (ppf), the patient reports filter embedment, blood clots, clotting and or occlusion of the ivc, in addition to device unable to be retrieved; however, there have been no documented attempts to remove the filter.The patient further reports anxiety related to the filter.Per the medical records, approximately sixteen years post implant, consultation for filter removal revealed that removal of the filter was a very high-risk procedure with little to no benefit.Per ct images, the filter is well embedded in the ivc with thrombus and occlusion of the filter and ivc below the filter.The filter is not penetrating through the wall of ivc.The surgeon noted that removing the ivc filter will not improve the varicosities seen on the patient¿s abdominal wall.The patient reported being truly concerned with the look of the abdominal wall varicosities and feeling ashamed of the look of own body.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Varicose veins are a known potential side effect of ivc filter use when flow through the ivc has been diminished.In this case, the ivc has become occluded, leading to development of collateral circulation.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 in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, filter embedment and occlusion causing the filter to be irretrievable which causes injury and damage to the patient.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fifteen years and eleven months post implantation.The patient reports filter embedment, blood clots, clotting and or occlusion of the ivc, in addition to device unable to be retrieved; however, there have been no documented attempts to remove the filter.The patient further experienced anxiety related to the filter.Per the medical records provided, approximately sixteen years after the filter was implanted, the patient underwent a consultation for filter removal, in which the surgeon explained to the patient that removal of the permanent inferior vena cava (ivc) filter was a very high-risk procedure with little to no benefit.The surgeon noted that based on computer tomography (ct) scan, a cordis permanent ivc filter was placed.The filter is well embedded in the inferior vena cava with thrombus in the filter and occlusion of the ivc below the filter.It would be technically almost impossible to remove the filter endovascularly.Open surgery to remove the ivc filter will be a major surgery with very high risk, with almost no benefit since the patient has had occlusion of the ivc for a long time with hypercoagulable state.It is also not indicated since the filter is not penetrating through the wall of ivc nor irritating the surrounding organs.The surgeon additionally noted that removing the ivc filter will not improve the varicosities seen on the patient¿s abdominal wall.The patient reported being truly concerned with the look of the abdominal wall varicosities and feeling ashamed of the look of own body.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9449654
• MDR Text Key: 173649876
• Report Number: 1016427-2019-03644
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening