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

Catalog Number 466F220A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)

Event Date 07/18/2013

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (15848940) presented no issues during the manufacturing process that can be related to the reported event.This report is a follow up report to mfr number 9616099-2016-00565 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter and then later on an optease filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, blood clots, clotting and occlusion of inferior vena cava (ivc) filter, deep vein thrombosis (dvt) and caval thrombosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, requiring extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.The following additional information received per the patient profile from (ppf) indicates that the patient underwent an unsuccessful attempt to remove one of the filters percutaneously.Although the ppf reports that the patient underwent a removal attempt, the procedure described on the medical record for that date described a thrombectomy procedure and does not show an attempt to remove the filter.The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.According to the medical records, the patient had a history of recurrent deep vein thrombosis (dvt) and pulmonary embolism (pe).During the first implantation procedure, the trapease filter was successfully deployed.During the second implantation procedure for the optease, the second filter was implanted as the patient has extensive thrombosis including a large clot above the filter already in place.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly.It was reported that a patient underwent placement of a trapease vena cava filter and then later an optease filter.The indication for the trapease filter was recurrent deep vein thrombosis (dvt) with a history of pulmonary embolism (pe).The device was deployed without incident in the mid inferior vena cava (ivc) well below the orifices of the renal veins and noted to be completely engaged and firmly attached to the vena cava wall.According to the information received the filter subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, blood clots, clotting and occlusion of inferior vena cava (ivc) filter, (dvt) and caval thrombosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, requiring extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.The following information contained in the patient profile form indicated that the patient underwent an unsuccessful attempt to remove one of the filters percutaneously.Although the form reports that the patient underwent a removal attempt, the procedure described on the medical record for that date described to be a thrombectomy procedure and no attempt to remove the filter.The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.According to the records received approximately six and a half years later an optease filter was implanted above the trapease filter due to clot formation within and above the trapease filter.The patient presented for re- evaluation after being administered tissue plasminogen activator (tpa) through an ekos catheter for thrombus that was previously identified in the filter and extensive clotting in both the iliac veins and the superficial femoral vein.Imaging then revealed no real resolution to the thrombus that was previously identified.At that time angiojet and angiojet solvent with a silent proxy device was used to jet and thrombus removal of the ivc, the ivc filter, the iliac veins, the superficial femoral vein and the common femoral vein.Several passes were made, repeat venography revealed no resolution of the clot.There was extensive clot involving the distal ivc proximal to the ivc filter, there appeared to be stenosis involving the right common iliac, the superficial femoral vein was not visualized.The physician opted to place an optease filter to address the primary concern of thrombus above the previously implanted filter.The plan was to put the patient on anticoagulant therapy and bring the patient back in approximately three weeks to have the temporary filter removed, in addition to continued therapy directed at the right lower extremity.The patient was brought back for follow up approximately one month later.Imaging at that time revealed extensive clot still between the supra-renal filter and the infra-renal filter, despite aggressive management with tpa and heparin.Mechanical thrombectomy was then performed to the ivc, the left common and external iliac, the left common and a portion of the left superficial femoral veins.Due to the inability to visualize flow beyond the common femoral vein, angioplasty was performed with two different cordis powerflex pro balloons to the entire iliac and common femoral veins.That was followed by angioplasty with a maxi balloon and finally deployment of three smart stents in the left common iliac vein and a fourth stent was placed in the distal left external iliac vein.The stents were then post dilated with a powerflex balloon at high pressures.The patient was to be placed on coumadin and lovenox with a follow up visit in two weeks.There is no other information currently available.Neither of the two filters were returned for analysis.A review of the device history records (dhr) for the trapease and optease filters revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.The trapease and optease filters are 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 reported ¿filter embedded in wall of the ivc¿, clotting, occlusion, dvt and retrieval difficulty, could not be confirmed and could not be further clarified at this time.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the patient¿s entire medical history available for review it is not possible to determine what factors may have contributed to the clotting issues that were reported.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently available for review, there is nothing to suggest that a malfunction in 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.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1016427-2017-00855.

Manufacturer Narrative

Per the new information received from the short form complaint (sfc), the patient states to have experienced filter fracture, tilt, embedment, and migration of the device.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Approximately six years later, the patient also had an optease filter placed.Per the medical records received, the patient has history of recurrent dvt and a pulmonary embolism (pe).The trapease inferior vena cava (ivc) filter was placed well below the orifices of the renal veins.The device was deployed without incident and was noted to be completely engaged and firmly attached to the wall of the inferior vena cava.The filter(s) subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, blood clots, clotting and occlusion of inferior vena cava (ivc) filter, deep vein thrombosis (dvt) and caval thrombosis.Per the medical records, around five and half years post implant, it was noted that the patient has an ivc filter thrombus with extensive clot involving the iliac veins and superficial femoral vein (sfv).Tissue plasminogen activator (tpa) was administered through and ekos catheter.Upon a re-evaluation procedure, angiojet (mechanical thrombectomy) was also performed during this procedure.There was an extensive clot that remained involving the distal ivc proximal to the ivc filter.At this time, an optease ivc filter was placed proximal to the trapease ivc filter.The plan of treatment was to anticoagulated and the remove the temporary filter (optease) not before 3 weeks.Upon follow up, 44 days later, tpa with ekos catheter treatment was administered for a clot between the supra and infrarenal filter in addition to extensive clot involving the entire iliofemoral region.Upon evaluation of the treatment it was noted that clot remained between the supra and infrarenal filter.Thrombectomy was performed and three smart stents were placed in the left iliac vein.Due to the presence of the clot noted between the filters, the planned removal of the optease filter was not performed, as stated per the ppf.Per the patient profile form, the patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress.Per the information received from the short form complaint (sfc), the patient states to have experienced filter fracture, tilt, embedment, migration, but it does not specify as to which filter experienced these events.The filters remain implanted; thus, unavailable for analysis.The products were not returned for analysis.A review of the device history records revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease and optease vena cava filters are 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.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.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.After further review of additional information received the following sections have been updated accordingly.

Manufacturer Narrative

(b)(6)2019 complaint conclusion being updated with new information received: new codes of pain and previous codes of embedded, tilt, fracture, migration, clotting, occlusion, thrombosis, and anxiety as reported, the patient had placement of a trapease inferior vena cava (ivc) filter, and approximately six years later, the patient had an optease filter placed.Per the medical records, history includes recurrent dvt and pulmonary embolism (pe).The trapease inferior vena cava (ivc) filter was placed well below the orifices of the renal veins.The device was deployed without incident and was noted to be completely engaged and firmly attached to the wall of the inferior vena cava.Approximately 6 years post implant, it was noted that the patient has an ivc filter thrombus with extensive clot involving the iliac veins and superficial femoral vein (sfv).Tissue plasminogen activator (tpa) was administered through and ekos catheter.Upon a re-evaluation procedure, angio-jet was also performed during this procedure.There was an extensive clot that remained involving the distal ivc proximal to the ivc filter.At this time, an optease ivc filter was placed proximal to the trapease ivc filter.The plan of treatment was to anticoagulated and the remove the temporary filter (optease) not before 3 weeks.Upon follow up 44 days later, tpa with ekos catheter treatment was administered for a clot between the supra and infrarenal filter in addition to extensive clot involving the entire iliofemoral region.Post treatment, clot remained between the supra and infrarenal filter.Thrombectomy was performed and three smart stents were placed in the left iliac vein.Due to the presence of the clot noted between the filters, the planned removal of the optease filter was not performed.The filters subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, blood clots, clotting and occlusion of inferior vena cava (ivc) filter, deep vein thrombosis (dvt) and caval thrombosis.Per the patient profile form (ppf), the patient reports emotional distress, mental anguish, anxiety, pain and stress, filter fracture, tilt, embedment, migration, but it does not specify as to which filter experienced these.Case(b)(4) : 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.Case(b)(4) : 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.(b)(6)2019 the trapease and optease vena cava filters are 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and pain 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: 7077666
• MDR Text Key: 93566563
• Report Number: 1016427-2017-00856
• 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,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 466F220A
• Device Lot Number: 15848940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 55 YR