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

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Defective Component (2292); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Hematoma (1884); Perforation of Vessels (2135); No Code Available (3191)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is embedded and cannot be retrieved.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 optease 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 implantation date of the filter and the attempted retrieval date is unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 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, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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 team, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is embedded and cannot be retrieved.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

On 8dec2018 complaint conclusion being updated with new information received: new codes of tilt, retrieval difficulty, shape altered, ivc perforation, bleeding, hematoma, non-reportable code of anxiety, non-complaint of hysterectomy as reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.Per the medical records, the patient developed deep venous thrombosis after fracture of the foot with casting.The dvt led to left calf hematoma with compartment syndrome.During the implant procedure, the filter was deployed at the level of l2-l3 and the sheath was removed.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is embedded and cannot be retrieved.Per the patient profile from (ppf), there is perforation of filter strut(s) outside the ivc, tilt, and the filter embedded in wall of the ivc.The patient reports stress.Further, the patient is reports suffering from hysterectomy, severe internal bleeding, and hematoma.The patient had three filter removal attempts.The first unsuccessful removal attempt was made three months post implant, the second unsuccessful removal attempt was made six years and two months post implant, and the third successful removal occurred six years and four months post implant.During the first implant removal attempt, the barbs on the filter were noted to be embedded in the venous endothelium.The retrieval was aborted.A venogram suggested that the filter is essentially somewhat deformed and partially blocking the flow.The initial venogram revealed the filter was fully deployed and appropriately positioned.The subsequent views revealed appropriate capture of the filter and then a mild staining which later seemed to be resolved, and then occlusive physiology was noted which then improved after the filter was redeployed.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 optease 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.Altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Bleeding and hematoma do not represent a device malfunction and are related to the retrieval attempts.Anxiety 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.

Manufacturer Narrative

As reported, the patient had placement of the optease inferior vena cava (ivc) filter.Per the medical records, the indication was deep venous thrombosis (dvt) after fracture of the foot, complicated by left calf hematoma leading to compartment syndrome.During the implant procedure, the filter was deployed at the level of l2-l3.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter is embedded and cannot be retrieved.Per the patient profile from (ppf), the patient reports perforation of filter strut(s) outside the ivc, tilt, and filter embedded in wall of the ivc.The patient reports stress, hysterectomy, severe internal bleeding, and hematoma.The patient has been on blood thinners for six years to prevent blood clots.The patient experienced an abdominal hematoma infection from the blood thinners.The patient had three filter removal attempts.The first unsuccessful removal attempt was made three months post implant, the second unsuccessful removal attempt was made six years and two months post implant, and the third successful removal occurred six years and four months post implant.During the first implant removal attempt, the barbs on the filter were noticed to have been embedded into the venous endothelium.A venogram suggested that the filter is essentially somewhat deformed and partially blocking the flow.Per the medical records, a ct scan, thirteen years and ten months post implant, revealed two anterior struts contact but do not penetrate the posterior border of the pancreatic head and duodenum while a single posterior strut contacts but does not penetrate the lumbar spine.The remaining struts only contact the retroperitoneal fat.The suprarenal ivc is patent and normal in caliber.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 optease 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.Altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Bleeding and hematoma do not represent a device malfunction and are related to the retrieval attempts.Anxiety 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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• MDR Report Key: 7733359
• MDR Text Key: 115523076
• Report Number: 1016427-2018-01708
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2019

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 Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 11/12/2018; 06/24/2019
• Supplement Dates FDA Received: 12/15/2018; 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR