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

Catalog Number 466F220A

Device Problems Fracture (1260); Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Occlusion (1984); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135); No Code Available (3191)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of defendants' optease vena cava filter on or about (b)(6) 2012.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the ivc.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 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.Blood clots and occlusion within the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).The instructions for use (ifu) note vessel injuries and recurrent pulmonary embolism as possible long-term complications associated with filter implantation.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.  implant date: on or about (b)(6) 2012.

Event Description

As reported by the legal brief, the patient underwent placement of defendants' optease vena cava filter on or about (b)(6) 2012.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the ivc.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

The following additional information received per the patient profile from (ppf) indicates that the filter was fractured, the filter perforated the ivc and the fractured filter struts migrated.The form indicates that the filter was removed via an open abdominal procedure four years and five months post implantation.The patient also reports to have suffered abdominal and back pain, swelling of the lower extremities, excessive blood loss which required more than one blood transfusion, coughing up blood, bloody stool and urine, unceasing menstrual cycle (lasting for six months at a time) and inability to perform sexually.According to the medical records, on the day of the filter removal procedure, the patient had been on lovenox twice a day for an unknown period of time.During the initial finding, the filter was noted to be occluded and two of the filter prongs were noted to have eroded through the vena cava just above the bifurcation of the common iliac veins.The patient was also noted to have a lot of scar formation, a lot of venous collateral circulation and significant fibroids.The patient required two units of blood during the procedure.After its completion, there was good flow noted.The patient tolerated the removal procedure well and was transferred to the recovery room in stable condition.Although the ppf reported the filter was fractured and migrated, there is no mention of this in the medical records available.Originally, the indication of the index procedure was documented deep vein thrombosis (dvt) with recent pulmonary embolism (pe) and contraindication to anticoagulation due to gastrointestinal (gi) bleed.The filter was deployed in the infrarenal portion of the ivc without any reported complications.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication of the index procedure was documented deep vein thrombosis (dvt) with recent pulmonary embolism (pe) and contraindication to anticoagulation due to gastrointestinal (gi) bleed.The filter was deployed in the infrarenal portion of the ivc without any reported complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc).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.Per the patient profile from (ppf), the filter was fractured, the filter perforated the ivc and the fractured filter struts migrated.The form indicates that the filter was removed via an open abdominal procedure four years and five months post implantation.The patient also reports to have suffered abdominal and back pain, swelling of the lower extremities, excessive blood loss which required more than one blood transfusion, coughing up blood, bloody stool and urine, unceasing menstrual cycle (lasting for six months at a time) and inability to perform sexually.Per the medical records, on the day of the filter removal procedure the patient had been on lovenox twice a day for an unknown period of time.During the initial finding, the filter was noted to be occluded and two of the filter prongs were noted to have eroded through the vena cava just above the bifurcation of the common iliac veins.The patient was also noted to have a lot of scar formation, a lot of venous collateral circulation and significant fibroids.The patient required two units of blood during the procedure.After its completion, there was good flow noted.The patient tolerated the removal procedure well and was transferred to the recovery room in stable condition.Although the ppf reported the filter was fractured and migrated, there is no mention of this in the medical records available.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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 instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 includes 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.It was also 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.Blood clots, bleeding and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pain, swelling, collateral circulation and scar tissue do not represent device malfunctions.Clinical factors that may have influenced the event include patient comorbidities, 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.(b)(4).

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road cashel, co.; tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6657041
• MDR Text Key: 78068643
• Report Number: 1016427-2017-00379
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 41 YR