MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Pain (1994); Perforation of Vessels (2135); Injury (2348)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted in a follow up report when received.

Event Description

As reported by an updated legal brief, 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, tilt of the ivc filter.As a result of the malfunction, 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, pain and suffering, and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the ivc filter.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 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.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 an updated legal brief, 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, tilt of the ivc filter.As a result of the malfunction, 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, pain and suffering, and other damages.

Event Description

As reported by an updated legal brief, 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, tilt of the inferior vena cava (ivc filter).As a result of the malfunction, 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, pain and suffering, and other damages.Per the medical records provided, four days before the index procedure, the patient was involved in a motor vehicle crash.The patient was an unrestrained passenger in a motor vehicle and was thrown from the vehicle.The patient was taken to the hospital and upon evaluation, presented a right femoral neck fracture and a right open mid shaft femur "fracture".It was then decided to proceed with an urgent reduction of the patient's femoral neck and fixation in order to minimize the patient's risk for osteonecrosis of the femoral head.A schanz pin was placed into the proximal femur in order to gain control of that fragment.The patient was extubated and transferred to the post anesthesia care unit without incident.Approximately twelve years after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan indicated for an unspecified injury of the inferior vena cava.The ct images obtained were used for filter evaluation.The ct scan findings noted a ¿trapease¿ type ivc filter in place with the tip approximately 3.2cm below the right renal vein.The ivc filter was seen tilted (5 degrees) towards the left with approximately 9 degrees anterior tilting of the cranial aspect.The cranial tip may contact the anterior wall of the ivc.The inferior tip is away from the wall.No definite strut fracture or bending was seen; no ivc stenosis and no definite perforation beyond the ivc wall.No acute findings on ct of the abdomen.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and five months post implantation.The patient reports filter tilting and fracture; however, the ppf also noted no claim of ivc filter fracture; no fractured filter struts retained in the patient¿s body and that no fractured filter struts have been removed from the patient.The patient also experienced anxiety related to the filter and further asserts to coughing up and urinating blood, right leg pain and limping from the right leg post implant.

Manufacturer Narrative

As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, the indication for filter was a motor vehicle crash with extended immobility.Femoral orif was also conducted during this hospitalization.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the ivc filter.Approximately twelve years after implant, a ct scan noted a ¿trapease¿ type ivc filter in place with the tip approximately 3.2cm below the right renal vein.The ivc filter was seen tilted (5 degrees) towards the left with approximately 9 degrees anterior tilting of the cranial aspect.The cranial tip may contact the anterior wall of the ivc.The inferior tip is away from the wall.No definite strut fracture or bending was seen; no ivc stenosis and no definite perforation beyond the ivc wall.No acute findings on ct of the abdomen.Per the patient profile form (ppf), the patient reports filter tilting and fracture; however, the ppf also noted no claim of ivc filter fracture; no fractured filter struts retained in the patient¿s body and that no fractured filter struts have been removed from the patient.The patient also reports anxiety, coughing up and urinating blood, right leg pain and limping from the right leg post implant.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.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.Hemoptysis and hematuria, while not specifically mentioned in the filter ifu, are known events that occur in patients who received ivc filters.These events are usually associated to the concurrent use of anticoagulation regimens.In this case, there is no definite perforation beyond the ivc walls.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 an updated legal brief, 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, tilt of the inferior vena cava (ivc) filter.As a result of the malfunction, 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, pain and suffering, and other damages.Per the medical records provided, four days before the index procedure, the patient was involved in a motor vehicle crash.The patient was an unrestrained passenger in a motor vehicle and was thrown from the vehicle.The patient was taken to the hospital and upon evaluation, presented a right femoral neck fracture and a right open mid shaft femur facture.It was then decided to proceed with an urgent reduction of the patient's femoral neck and fixation in order to minimize the patient's risk for osteonecrosis of the femoral head.A schanz pin was placed into the proximal femur in order to gain control of that fragment.The patient was extubated and transferred to the post anesthesia care unit without incident.Per the implant records, the patient had suffered fractures in an accident and the postoperative course was complicated by deep vein thrombosis (dvt).The filter was indicated as the patient was not a good candidate for anticoagulation and was reported to have had a pulmonary embolus.Under fluoroscopic guidance, the right common femoral vein was accessed.A guidewire was advanced into the vena cava and a sheath was placed and advanced to the level of l2 -l3.The vena cavogram through the sheath demonstrated a patent vena cava with no evidence of thrombus.The renal veins were located at the lower border of l1.The sheath was then positioned at the l2 -l3 junction.An optease ivc filter was then fully deployed through the sheath using standard techniques.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.Approximately twelve years after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan indicated for an unspecified injury of the inferior vena cava.The ct images obtained were used for filter evaluation.The ct scan findings noted a ¿trapease¿ type ivc filter in place with the tip approximately 3.2cm below the right renal vein.The ivc filter was seen tilted (5 degrees) towards the left with approximately 9 degrees anterior tilting of the cranial aspect.The cranial tip may contact the anterior wall of the ivc.The inferior tip is away from the wall.No definite strut fracture or bending was seen; no ivc stenosis and no definite perforation beyond the ivc wall.No acute findings on ct of the abdomen.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and five months post implantation.The patient reports filter tilting and fracture; however, the ppf also noted no claim of ivc filter fracture; no fractured filter struts retained in the patient¿s body and that no fractured filter struts have been removed from the patient.The patient also experienced anxiety related to the filter and further asserts to coughing up and urinating blood, right leg pain and limping from the right leg post implant.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt of the inferior vena cava (ivc) filter.The patient reported becoming aware of filter tilt and fracture; however, the patient also indicated that the was no ivc filter fracture, approximately ten years and five months post implant.The patient also reported anxiety related to the filter, coughing up and urinating blood, right leg pain and limping from the right leg post implant.The indication for the filter implant was deep vein thrombosis and pulmonary embolus in a patient that sustained a right femoral neck fracture and a right open mid shaft femur facture and therefore anticoagulation was contraindicated.Four days prior to the filter implant the patient underwent open reduction and internal fixation of the right femoral neck fracture, intramedullary nailing of the open right femur fracture and debridement of a right thigh wound associated with the open fracture, including skin, subcutaneous tissue, muscle and bone.The filter was placed via the right common femoral vein and deployed at the level of l2-l3 after identifying the renal veins at the lower border of l1.The patient tolerated the procedure well and was transferred to the recovery room in stable condition.Approximately twelve years post implant the patient underwent an abdominal computed tomography (ct) scan indicated for an unspecified injury of the inferior vena cava.The ct scan findings noted a ¿trapease¿ type ivc filter in place with the tip approximately 3.2cm below the right renal vein.The ivc filter was seen tilted (5 degrees) towards the left with approximately 9 degrees anterior tilting of the cranial aspect.The cranial tip may contact the anterior wall of the ivc.The inferior tip is away from the wall.No definite strut fracture or bending was seen; no ivc stenosis and no definite perforation beyond the ivc wall.No acute findings on ct of the abdomen.There is currently no additional information available for review.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 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 filter tilt reported could not be confirmed.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or images for review the reported event(s) could not be confirmed.While the patient did check the box on the form indicating that filter fracture occurred, the results of the ct scan saw no definite filter fracture.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.Hemoptysis and hematuria, while not specifically mentioned in the filter ifu, are known events that occur in patients who received ivc filters.These events are usually associated to the concurrent use of anticoagulation regimens.In this case, there is no definite perforation beyond the ivc walls.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.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: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9815112
• MDR Text Key: 188506683
• Report Number: 1016427-2020-03917
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R0306635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 0.035 GLIDEWIRE; UNK 6F SHEATH
• Patient Age: 40 YR