MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 01/07/2017

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and is not available for evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department, the plaintiff underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, required extensive medical care and treatment as the filter was removed and replaced.As a further proximate result.The patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.Additional information was received from the patient profile form that there were blood clots, clotting and/or occlusion of the ivc.The filter was removed percutaneously.Additional medical records received indicate that 11 months after filter placement, the patient was anticoagulated on lovenox and it was felt to be a candidate for filter removal.A venacavogram showed no significant thrombus in the ivc or in the filter prior to proceeding.During removal of the filter, it was noted that one of the struts had broken off but it appeared to be imbedded in the wall of the ivc.It was left behind.The patient tolerated the procedure well.Approximately one month later, a non cordis filter was implanted.At filter placement, the patient presented with extensive thrombosis down the left leg and needed thrombolysis.The patient had extensive pulmonary embolus in the right lower lobe.The tip of the optease filter was in the l2 mid vertebral body with the more proximal hook of the filter located in the l3-4 disc space area.The patient tolerated the procedure well and there were no complications.

Manufacturer Narrative

The product remains implanted and is thus not available for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

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 was removed and replaced.It was also reported that there were blood clots, clotting and/or occlusion of the inferior vena cava and that the patient has extreme pain and swelling in the leg with activity and protruding collateral veins in the left leg and abdomen.The indication for the filter placement extensive deep vein thrombosis (dvt down the left leg and extensive pulmonary embolus (pe) in the right lower lung lobe.The notes indicate that the patient needed thrombolysis for the left leg dvt.The filter was placed via the right femoral vein and deployed with the tip of the filter in the midportion of the l2 vertebral body with the more proximal hook portion located in the l3-l4 disc space.The patient tolerated the procedure well there were no complications.Approximately one month later it was decided to exchange the cordis filter out for a filter that can remain in place for a longer period of time due to the patient¿s persistent left leg dvt.During the removal procedure a venogram was performed and noted a patient ivc.The filter hook was snared, and a sheath was advanced over the filter and removed.Post procedure imaging did not show any extravasation.Under fluoroscopic guidance a bard meridian filter was placed in the exact location of the previous filter.The patient tolerated the procedure well and there were no reported complications.Approximately eleven months later it was felt that the patient was a candidate to remove the non-cordis filter as the patient was now anticoagulated on lovenox.During the removal procedure access was made via the right common femoral vein and a venogram confirmed that there was no significant thrombus in the ivc or the filter.Access was then gained through the right internal jugular vein.The filter was eventually snared with a gooseneck snare and pulled into the sheath.While pulling the filter out it was noticed that one of the struts had become broken off, but it appeared to be embedded in the wall of the ivc and was left behind.The patient reportedly tolerated the procedure well.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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling/edema/bulging of the effected extremity(s).Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Blood clots and thrombosis within the filter do not represent a device malfunction.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter.Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, clotting and occlusion of the inferior vena cava (ivc) filter could not be confirmed or clarified, nor can a conclusion about a relationship between the reported events and the filter be drawn.Leg pain and swelling do not represent a device malfunction and is most likely related to the patient¿s history of persistent dvt.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

Correction to section h4 (device manufacture date).

Event Description

As reported by the legal department, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, required extensive medical care and treatment as the filter was removed and replaced.As a further proximate result.The patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.Additional information was received from the patient profile form that there were blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The filter was removed percutaneously.Additional medical records received indicate that eleven months after filter placement, the patient was anticoagulated on lovenox and it was felt to be a candidate for filter removal.A venacavogram showed no significant thrombus in the ivc or in the filter prior to proceeding.During removal of the filter, it was noted that one of the struts had broken off but it appeared to be imbedded in the wall of the ivc.It was left behind.The patient tolerated the procedure well.Approximately one month later, a non cordis filter was implanted.At filter placement, the patient presented with extensive thrombosis down the left leg and needed thrombolysis.The patient had extensive pulmonary embolus in the right lower lobe.The tip of the optease filter was in the l2 mid vertebral body with the more proximal hook of the filter located in the l3-4 disc space area.The patient tolerated the procedure well and there were no complications.According to the discovery form, the patient received the ivc filter for deep vein thrombosis (dvt), pulmonary embolism, factor v leiden and thrombophilia.Medical conditions and treatments alleged to be attributable to the implanted ivc filter include having to have filter removed and replaced.The patient further reports having to have the filter retrieved because the doctors determined that the filter was not capable of long-term placement, and it was replaced with one that can remain in place for longer period due to persistent left leg thrombosis.

Manufacturer Narrative

As reported, the patient had placement of an optease inferior vena cava (ivc) filter.The indication for filter placement was extensive deep vein thrombosis (dvt) of the left leg, and pulmonary embolism in the right lower lobe.History includes factor v leiden and thrombophilia.The filter was deployed with the tip at the midportion of the l2 vertebral body after location of the renal veins at the l1-2 disc space.The filter subsequently malfunctioned and caused injury and damages to the patient including fracture, filter embedded, blood clots, clotting and/or occlusion of the ivc, the filter had to be retrieved because the physician determined the filter was not capable of long-term placement and wanted to replace it with one that would remain in place for longer period due to persistent left leg thrombosis.Approximately one month later, a non-cordis filter was implanted.At the time of second filter placement, the patient presented with extensive thrombosis down the left leg and needed thrombolysis.The patient also had extensive pulmonary embolus in the right lower lobe.The tip of the optease filter was noted to be at the l2 mid vertebral body with the more proximal hook of the filter located in the l3-4 disc space area.The patient tolerated the procedure well and there were no complications.Approximately eleven months after optease filter placement, the patient was on lovenox and felt to be a candidate for filter removal.A venacavogram showed no significant thrombus in the ivc or in the filter prior to proceeding.During removal of the filter, it was noted that one of the struts had broken off and appeared to be imbedded in the wall of the ivc.The strut was left behind.The patient tolerated the procedure well.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient further reports extreme pain and swelling in the leg, collateral veins in the legs and abdomen.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Leg pain, swelling of the legs and collateral circulation are all known potential adverse events associated to the use of ivc filters, and in this case may be related to the underlying clotting disorder.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: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel 33152 ; EI 33152
• MDR Report Key: 7562466
• MDR Text Key: 109884896
• Report Number: 1016427-2018-01515
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15581926
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2018
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 32 YR