MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE PERMANENT FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Bowel Perforation (2668)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown.If received it will be provided.Complaint conclusion: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter perforated the wall of the inferior vena cava (ivc) by the struts of the ivc filter, the anterior struts of the ivc filter abut the posterior margin of the duodenum.These complications have led to severe fear, stress anxiety and loss of enjoyment of life.There is currently no additional information available for review.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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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 and long-term complications associated with ivc filters.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 department, 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, emotional and physical damages from perforation of the wall of the inferior vena cava (ivc) by the struts of the ivc filter and the resultant symptoms.Additionally, the anterior struts of the ivc filter abut the posterior margin of the duodenum.The implanted filter noses a progressive risk of additional perforation of the vena cava and surrounding vital organs, vessels and structures which can result in severe pain and life-threatening complications.It also noses an increase, and progressive risk of migration fractures, embolization of a fracture, and thrombosis/clotting causing serious injury and death.The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear, stress anxiety and loss of enjoyment of life.As a direct and proximate result, 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

The implant date was confirmed to be accurate.Complaint conclusion: as reported, the patient had placement of the optease inferior vena cava (ivc) filter.Per the medical records, the pre-implant diagnosis was scoliosis.An optease vena cava filter was implanted during the spinal fusion.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from perforation of the wall of the inferior vena cava (ivc) by the struts of the ivc filter and the resultant symptoms.Additionally, the anterior struts of the ivc filter abut the posterior margin of the duodenum.Approximately fourteen years and nine months post implant, a ct scan noted a small cyst in the upper pole of the left kidney, in addition to moderate to advance scoliosis of the lower thoracic and upper lumbar spine with metallic fixation noted throughout much of the lumbar spine.An inferior vena cava filter is in place, the superior tip is at the level of the renal veins, the peripheral struts lie within of adjacent to the inferior vena cava walls, the anterior struts abut the posterior margin of the duodenum.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc.The patient further reports anxiety and loss of enjoyment of life.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.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 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.

Event Description

As reported by the legal department, 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, emotional and physical damages from perforation of the wall of the inferior vena cava (ivc) by the struts of the ivc filter and the resultant symptoms.Additionally, the anterior struts of the ivc filter abut the posterior margin of the duodenum.The implanted filter noses a progressive risk of additional perforation of the vena cava and surrounding vital organs, vessels and structures which can result in severe pain and life-threatening complications.It also poses an increase, and progressive risk of migration fractures, embolization of a fracture, and thrombosis/clotting causing serious injury and death.The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear, stress anxiety and loss of enjoyment of life.As a direct and proximate result, 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.Information contained in the medical records indicated the pre-implant diagnosis was scoliosis.An optease vena cava filter was implanted during the spinal fusion.Approximately fourteen years and nine months post implant the patient underwent a computed tomography scan for evaluation of the inferior vena cava (ivc) filter.The findings noted a small cyst in the upper pole of the left kidney, in addition to moderate to advance scoliosis of the lower thoracic and upper lumbar spine with metallic fixation noted throughout much of the lumbar spine.An inferior vena cava filter is in place, the superior tip is at the level of the renal veins, the peripheral struts lie within of adjacent to the inferior vena cava walls, the anterior struts abut the posterior margin of the duodenum.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately fifteen years and two months post implantation.The patient reports perforation of filter strut(s) outside the ivc.The filter subjects the patient to the risk of future and progressive filter failure including migration, fracture, embolization of a fracture, perforation, clotting, thrombosis and even death.The patient also reports that the filter poses a progressive risk of additional perforation of the vena cava and surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications.It also poses an ongoing risk of deep vein thrombosis (dvt) and thrombosis, an increased and progressive risk of migration and fracture causing serious injury and death.The patient further reports living with the possibility that these complications can happen at any moment which has led to severe fear, stress, anxiety and loss of enjoyment of life.

Event Description

As reported by the legal department, 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, emotional and physical damages from perforation of the wall of the inferior vena cava (ivc) by the struts of the ivc filter and the resultant symptoms.Additionally, the anterior struts of the ivc filter abut the posterior margin of the duodenum.The implanted filter noses a progressive risk of additional perforation of the vena cava and surrounding vital organs, vessels and structures which can result in severe pain and life-threatening complications.It also poses an increase, and progressive risk of migration fractures, embolization of a fracture, and thrombosis/clotting causing serious injury and death.The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear, stress anxiety and loss of enjoyment of life.As a direct and proximate result, 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.Information contained in the medical records indicated the pre-implant diagnosis was scoliosis.An optease vena cava filter was implanted during the spinal fusion.Approximately fourteen years and nine months post implant the patient underwent a computed tomography scan for evaluation of the inferior vena cava (ivc) filter.The findings noted a small cyst in the upper pole of the left kidney, in addition to moderate to advance scoliosis of the lower thoracic and upper lumbar spine with metallic fixation noted throughout much of the lumbar spine.An inferior vena cava filter is in place, the superior tip is at the level of the renal veins, the peripheral struts lie within of adjacent to the inferior vena cava walls, the anterior struts abut the posterior margin of the duodenum.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately fifteen years and two months post implantation.The patient reports perforation of filter strut(s) outside the ivc.The filter subjects the patient to the risk of future and progressive filter failure including migration, fracture, embolization of a fracture, perforation, clotting, thrombosis and even death.The patient also reports that the filter poses a progressive risk of additional perforation of the vena cava and surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications.It also poses an ongoing risk of deep vein thrombosis (dvt) and thrombosis, an increased and progressive risk of migration and fracture causing serious injury and death.The patient further reports living with the possibility that these complications can happen at any moment which has led to severe fear, stress, anxiety and loss of enjoyment of life.Per the medical records, approximately fifteen years and five months post implantation, the patient was seen for an annual physical.Medical history includes chronic back pain, diabetes, lumbar degenerative disc disease with multiple surgeries, ivc filter placement prior to spinal tumor resection, back debridement for infections, hypertension, obesity and scoliosis with fixation and fall.Approximately fifteen years and seven months post implantation, a computerized tomography (ct) scan of the abdomen and pelvis without contrast demonstrated an ivc filter in place; the struts seem to perforate the ivc wall contiguous with the duodenum.According to the information received in the redacted amended patient profile form (ppf), the patient further reports perforation of filter strut(s) outside the ivc and perforation of filter strut(s) into organs.

Manufacturer Narrative

As reported, the patient had placement of the optease inferior vena cava (ivc) filter.Medical history includes chronic back pain, diabetes, lumbar degenerative disc disease with multiple surgeries, ivc filter placement prior to spinal tumor resection, back debridement for infections, hypertension, obesity and scoliosis with fixation and fall.The filter was implanted during spinal surgery.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of the wall of the inferior vena cava (ivc) by the struts of the ivc filter and the anterior struts of the ivc filter abut the posterior margin of the duodenum.Approximately 15 years post implant, a ct scan revealed a small cyst in the upper pole of the left kidney, moderate to advance scoliosis of the lower thoracic and upper lumbar spine with metallic fixation noted throughout much of the lumbar spine.The ivc filter is in place, the superior tip is at the level of the renal veins, the peripheral struts lie within of adjacent to the inferior vena cava walls, the anterior struts abut the posterior margin of the duodenum.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc and into the organs.The patient further reports anxiety and fear.Approximately fifteen years and seven months post implantation, a ct scan of the abdomen and pelvis revealed an ivc filter in place; the struts seem to perforate the ivc wall contiguous with the duodenum.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.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 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: OPTEASE PERMANENT FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8429430
• MDR Text Key: 139096943
• Report Number: 1016427-2019-02624
• 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: 08/29/2019

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 Expiration Date: 10/01/2005
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F200A
• Device Lot Number: R1102378
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 08/16/2019
• Supplement Dates FDA Received: 05/14/2019; 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR
• Patient Weight: 90