MAUDE Adverse Event Report: CORDIS CASHEL 466F220A; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problems Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Perforation (2001); Swelling (2091); No Code Available (3191)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: filter tilted, became embedded, occluded and is perforating the vena cava wall.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.No additional information is available.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 inferior 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 within the device or occlusion of the device does not represent a device malfunction.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation of the filter.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.The legal briefing mentioned a perforation.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.It is unknown if the tilt contributed to the reported perforation.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Endothelialization, remodeling/restructuring of the internal lumen of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: filter tilted, became embedded and occluded, and is perforating the vena cava wall.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.No additional information is available.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was provided and is available in: (age at the time of event, date of birth), (event date), (event description), (brand name), (model, catalog, lot number, and expiration date), (date received by the manufacturer), (manufacturing date), (evaluation codes): code 3191 (leg pain), the implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported through the legal department via legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: filter tilted, became embedded and occluded, and is perforating the vena cava wall.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 following additional information was received per the patient¿s implant records: the filter was implanted at the level of the l2-l3 interspace.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately one year and nine months post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from leg swelling and leg pain, and vein damage.The patient states to have undergone three procedures due to these issues and takes blood thinners to prevent clotting as well as lovenox injections.The patient also reports suffering from anxiety.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to, filter tilt, became embedded and occluded, and is perforating the vena cava wall.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately one year and nine months post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc.The patient also reports suffering from leg swelling and leg pain, and vein damage.The patient states to have undergone three procedures due to these issues and takes blood thinners to prevent clotting as well as lovenox injections.The patient also reports suffering from anxiety.The indication for the filter implant has not been provided.The filter was placed via the left femoral vein and deployed at the level of the l2-l3 interspace.The patient is reported to have tolerated the procedure well with no reported complications.There is currently no additional information available for review.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.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.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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 related to ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.The timing and mechanism of the tilt, migration and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.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.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity.The skin of the lower legs can become thick, dry, and fragile.Blood clots, clotting and/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Anxiety, leg pain and swelling and vein damage do not represent a device malfunction and may be related to underlying patient specific issues.With the very limited information provided and without the procedural films or post implant images to review the reported events could not be confirmed or further clarified.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.

• Brand Name: 466F220A
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7626943
• MDR Text Key: 111979854
• Report Number: 1016427-2018-01565
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15999199
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/25/2018
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5F NON-CORDIS CATHETER.; 6F CORDIS DELIVERY SHEATH.; 6F SHEATH.; GUIDEWIRE 0.035 J.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 36 YR