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

Catalog Number 466F220A

Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problems Unspecified Infection (1930); Perforation of Vessels (2135)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava filter at the right side of the l3-l4 vertebral body, recurrent infections (sepsis, bacteremia, urinary tract infections), recurrent/progressive deep vein thrombosis, abdominal pain and chest pain.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Infection is a known potential event associated to all device implantation procedures and maybe related to surgical technique and underlying patient related issues.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pain 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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava filter at the right side of the l3-l4 vertebral body, recurrent infections (sepsis, bacteremia, urinary tract infections), recurrent/progressive deep vein thrombosis, abdominal pain and chest pain.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

A positron emission tomography (pet) scan done nine months after the index procedureshowed no evidence of squamous cell disease.  ten months after the index procedure the patient was admitted to the hospital.  infectious disease and psych consults were done.The patient had a right nephro-urinary stent in place secondary to hydronephrosis.The stent was changed, and antibiotics initiated.It was noted that the stent was encased in a right pelvic mass in the distal portion of the ureter.That same month, the patient was admitted to the hospital for dizziness and was diagnosed with a urinary tract infection (uti).  imaging showed no evidence of pulmonary embolism.  eleven months after the index procedure the patient was admitted to the hospital for chest pain.  the cardiac work up was negative.  the patient did have a urinary tract infection with vancomycin resistant enterococci and candida.  two years and six months after the index procedure a venous doppler showed no evidence of deep vein thrombosis bilaterally.An abdominal ct scan noted an ivc filter present; no anomalies were reported.  two years and eleven months after the index procedure the patient was admitted to the hospital for an infected medi-port.The port was removed, and an antibiotic regimen was initiated.  three years after the index procedure, the patient had an unspecified allergic reaction to a pharmaceutical antibiotic drug used to treat and prevent infections.  three years and two months after the index procedure, the patient was admitted for gastritis without hemorrhage and an intestinal infection, with fever and bacteremia.  the medical records noted that the patient had been previously admitted for similar issues.  the exact source of the  infection was unclear despite all diagnostic studies.The only foreign body left was the ivc filter.It was felt that the filter may need to be retrieved.  after consultation with the infectious disease group, it was demined that the filter would remain in place.  a peripherally inserted central catheter (picc) and central venous lines were used to continue the patient¿s antibiotic treatment.  during that same month, the patient was admitted to the hospital for medical management of recurrent klebsiella bacteremia with history of clostridium difficile (cdiff) colitis.The patient had consultations for possible removal of the ivc filter as the patient had experienced ongoing abdominal discomfort, pain and recurrent gram-negative infections.Infectious disease and vascular surgery were consulted, and the decision was made to leave the ivc filter in place.  six years and five months after the index procedure the patient had a magnetic resonance imaging (mri) scan of lower extremity for right hip pain, status after radiation therapy and avascular necrosis (avn).The study revealed avascular necrosis of the right femoral head, moderate-sized effusion of the right hip joint and partial tear of the right quadratus femoris muscle.  six years and six months after the index procedure, the patient had a ct scan of their abdomen for right abdominal pain and status after a right nephrectomy.The study showed status post right nephrectomy to be unremarkable, visualized left kidney, no abnormal adenopathy or ascites and unremarkable osseous structures.  the ivc filter was noted.The scan indicated that the filter was located at the superior l3 to l4-l5 space.Migration was unable to be determined based on the imaging provided.There was no significant tilt indicated.  a grade 1 perforation was found with compressed side struts as of the date of the study.  six years and nine months after the index procedure the patient was seen by her physician for lab results and discussion of continued right hip pain.The patient also reported chronic gastritis.The medical records state that the patient has a medical history of anemia, anxiety disorder, add, back pain, thrombophilia, constipation, chronic depression, gastritis, hypertension with resultant stage iv chronic kidney disease, hypothyroidism, ibs, pneumothorax x 2, osteonecrosis of the right hip, right nephrectomy, dvt, stent in right leg, rhinitis, osteoporosis, perimenopausal disorders, dysphagia and insomnia.The patient¿s surgical history includes gall bladder removal, port placement/removal, nephrectomy (two years prior to the index procedure), and total abdominal hysterectomy (tah).  additional information was received per the patient profile form (ppf).  the patient became aware of the reported events three years and two months after the index procedure.  the form states that the patient experienced  perforation of the filter struts outside of the ivc,  compressed side struts of the inferior vena cava filter, recurrent/progressive deep vein thrombosis, recurrent  infections, abdominal pain, , irregular heart beating, leg numbness, unspecified lower extremity circulation issues, nausea/vomiting, severe depression, low quality of life and in constant fear and anxiety that this device is killing her.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.  the report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to inferior vena cava filter at the right side  of  the  l3-l4  vertebral  body,  recurrent  infections  (sepsis, bacteremia, urinary tract infections), recurrent/progressive deep vein thrombosis, abdominal pain and chest pain.  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.  additional information received per the medical records indicate that the patient has a history of bilateral upper extremity deep vein thrombosis, polymicrobial urinary tract infection, hydronephrosis, right nephrostomy stent, anemia, hypertension and diabetes.  the medical records also reveal that the patient has a history of right pelvic squamous cell carcinoma of unknown primary origin, previous history of chemotherapy and radiation treatment, persistent nausea/vomiting/diarrhea, previous history of esophagogastroduodenoscopy (egd) and enteroscope  (c-scope) without evidence of pathology, urinary tract infections and anemia.     information received per the medical records indicate that during the time of implantation of the referenced device, the patient had been hospitalized for ten days.  the discharge diagnosis were squamous cell carcinoma of the right pelvic region and thigh and right lower extremity deep vein thrombosis.  a left subclavian port was in place.Chemotherapy was done and a consult for radiation was done.A computed tomography (ct) of the abdomen showed small right kidney with mild dilation and nephrostomy catheter in place.Heterogenous enlarged uterus with multiple fibroids was noted.An amorphous soft tissue structure in the right pelvis abutting right iliopsoas muscle suspected malignancy was observed.There was also poorly visualized right external iliac vein worrisome for thrombosis, recanalized right common femoral vein with suspicion of partial thrombosis.During this admission, the optease vena cava filter was inserted.  the position of the device was verified post deployment with fluoroscopy.There were no reports of complications.Also, during this admission, a right nephrostomy tube check and replacement was done, it was noted that there was total obstruction of the distal right ureter at the level of the pelvic inlet.  a positron emission tomography (pet) scan revealed evidence of increased uptake within the right lateral pelvic mass consistent with the history of squamous cell cancer. a cta (computed tomography angiography) of the chest was done that did not confirm pulmonary embolus.A ct scan of the abdomen showed enlarged heterogenous uterus with fibroids, distended bladder and heterogenous soft tissue in the right pelvis abutting the iliopsoas muscle measuring 4.5 x 2.7 cm.The patient¿s right external mac vein was compressed and poorly visualized.The right common femoral vein was recanalized.Partial thrombosis cannot be excluded and there was no pelvic lymphadenopathy.Continued in section h10.

Manufacturer Narrative

Section b5: as reported the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, has a history of bilateral upper extremity deep vein thrombosis, polymicrobial urinary tract infection, hydronephrosis, right nephrostomy stent, anemia, hypertension and diabetes.The patient has a history of right pelvic squamous cell carcinoma of unknown primary origin, previous history of chemotherapy and radiation treatment, persistent nausea/vomiting/diarrhea, previous history of esophagogastroduodenoscopy (egd) and endoscopy (c-scope) without evidence of pathology, urinary tract infections and anemia.Information received per the medical records indicate that during the time of implantation of the referenced device, the patient had been hospitalized for ten days.The discharge diagnosis were squamous cell carcinoma of the right pelvic region and thigh and right lower extremity deep vein thrombosis.A left subclavian port was in place.Chemotherapy was done and a consult for radiation was done.A computed tomography (ct) of the abdomen showed small right kidney with mild dilation and nephrostomy catheter in place.Heterogenous enlarged uterus with multiple fibroids was noted.An amorphous soft tissue structure in the right pelvis abutting right iliopsoas muscle suspected malignancy was observed.There was also poorly visualized right external iliac vein worrisome for thrombosis, recanalized right common femoral vein with suspicion of partial thrombosis.During this admission, the optease vena cava filter was inserted.The position of the device was verified post deployment with fluoroscopy.There were no reports of complications.Also, during this admission, a right nephrostomy tube check and replacement was done, it was noted that there was total obstruction of the distal right ureter at the level of the pelvic inlet.A positron emission tomography (pet) scan revealed evidence of increased uptake within the right lateral pelvic mass consistent with the history of squamous cell cancer.A cta (computed tomography angiography) of the chest was done that did not confirm pulmonary embolus.A ct scan of the abdomen showed enlarged heterogenous uterus with fibroids, distended bladder and heterogenous soft tissue in the right pelvis abutting the iliopsoas muscle measuring 4.5 x 2.7 cm.The patient¿s right external mac vein was compressed and poorly visualized.The right common femoral vein was recanalized.Partial thrombosis cannot be excluded and there was no pelvic lymphadenopathy.The report states that the filter subsequently malfunctioned including, but not limited to inferior vena cava filter at the right side of the l3-l4 vertebral body, recurrent infections (sepsis, bacteremia, urinary tract infections), recurrent/progressive deep vein thrombosis, abdominal pain and chest pain.Ten months after the index procedure the patient was admitted to the hospital for infection.The patient had a right nephro-urinary stent in place secondary to hydronephrosis.The stent was changed, and antibiotics initiated.It was noted that the stent was encased in a right pelvic mass in the distal portion of the ureter.That same month, the patient was admitted to the hospital for dizziness and was diagnosed with a urinary tract infection (uti).Imaging showed no evidence of pulmonary embolism.Eleven months after the index procedure the patient was admitted for chest pain.The cardiac work up was negative.The patient did have a urinary tract infection with vancomycin resistant enterococci and candida.Two years and six months after the index procedure an abdominal ct scan noted an ivc filter present; no anomalies were reported.Two years and eleven months after the index procedure the patient was admitted for an infected medi-port.The port was removed, and an antibiotic regimen was initiated.Three years after the index procedure, the patient had an unspecified allergic reaction to a pharmaceutical antibiotic drug used to treat and prevent infections.Three years and two months after the index procedure, the patient was admitted for gastritis without hemorrhage and an intestinal infection, with fever and bacteremia.The exact source of the infection was unclear despite all diagnostic studies.The only foreign body left was the ivc filter.It was felt that the filter may need to be retrieved.After consultation with the infectious disease group, it was demined that the filter would remain in place.A peripherally inserted central catheter (picc) and central venous lines were used to continue the patient¿s antibiotic treatment.During that same month, the patient was admitted for medical management of recurrent klebsiella bacteremia with history of clostridium difficile (c-diff) colitis.The patient had consultations for possible removal of the ivc filter as the patient had experienced ongoing abdominal discomfort, pain and recurrent gram-negative infections.Infectious disease and vascular surgery were consulted, and the decision was made to leave the ivc filter in place.Six years and five months after the index procedure the patient had a magnetic resonance imaging (mri) scan of lower extremity for right hip pain, status after radiation therapy and was diagnosed with avascular necrosis (avn) of the right femoral head, moderate-sized effusion of the right hip joint and partial tear of the right quadratus femoris muscle.Six years and six months after the index procedure, the patient had a ct scan of their abdomen for right abdominal pain and status after a right nephrectomy.The study showed status post right nephrectomy to be unremarkable, visualized left kidney, no abnormal adenopathy or ascites and unremarkable osseous structures.The ivc filter was noted.The scan indicated that the filter was located at the superior l3 to l4-l5 space.Migration was unable to be determined based on the imaging provided.There was no significant tilt indicated.A grade 1 perforation was found with compressed side struts as of the date of the study.Six years and nine months after the index procedure the patient reported chronic gastritis.Per the patient profile form (ppf), the patient states that the patient experienced perforation of the filter struts outside of the ivc, compressed side struts of the inferior vena cava filter, recurrent/progressive deep vein thrombosis, recurrent infections, abdominal pain, , irregular heart beating, leg numbness, unspecified lower extremity circulation issues, nausea/vomiting, severe depression, low quality of life and in constant fear.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.Kink/bent strut 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.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.Pain, dizziness, irregular heart rate, and poor peripheral circulation 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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8233569
• MDR Text Key: 132624237
• Report Number: 1016427-2019-02387
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15238292
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/28/2019; 03/06/2019
• Supplement Dates FDA Received: 02/27/2019; 04/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR