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

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135)

Event Date 10/02/2009

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter caused an intramural tear in the left anterior wall of the ivc and the filter's snare broke off during a retrieval attempt and failed to fully collapse causing the filter to become irretrievable.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 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.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.It is unknown how long the filter was in situ prior to the attempt to explant it.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to 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.Without the implant or attempted explant procedural details or imaging, to review, it is not possible to draw a conclusion between the reported events and the device.However, procedural factors and/or vessel characteristics may have contributed to the events.Given the limited information available for review, a relation between the device and the event could not be determined.At this time, there is nothing to suggest 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.

Event Description

As reported by the legal team, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter caused an intramural tear in the left anterior wall of the ivc and the filter's snare broke off during retrieval attempt and failed to fully collapse causing the filter to become irretrievable.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

Complaint conclusion: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter caused an intramural tear in the left anterior wall of the inferior vena cava (ivc) and the filter's snare broke off during a retrieval attempt and failed to fully collapse causing the filter to become irretrievable.The patient also reported blood clots, clotting, and/or occlusion of the ivc, experiencing fear and mental anguish over the filter being permanently lodged in the ivc, pain in area of the filter, and a clot stuck in filter making the filter irretrievable.The indication for the filter placement was prophylactically prior to bariatric surgery for morbid obesity.The filter was placed via the right common femoral vein and deployed below the renal veins.Approximately 3 months post implant the patient underwent an unsuccessful attempt to have the filter removed.During the procedure the filter was snared.In attempting to completely collapse the filter with the sheath there was only noted to be a partial collapse of the distal 2/3 of the filter and the snare broke.The doctor switched to a competitor recovery cone 10-french system.The distal hook was snared and as the sheath was advanced over the filter it would not collapse in entirety.The cone retrieval system broke and let loose.A diagnostic venocavogram demonstrated what appeared to be thrombus in the distal cone of the ivc filter, as well as retrograde filling into the left renal vein.The recovery sheath was exchanged for a 9-french regular length sheath and was sutured in place.The patient was taken for a computed tomography (ct) scan venogram which demonstrated no evidence of dissection or extravasation of contrast.However, a 3x5 mm hyperdense area in the left anterior wall of the ivc located at the level of the mid ivc filter was noted which may represent a small area of contrast accumulation from a small tear in the left anterior wall of the ivc located at the level of the ivc filter in the mid-filter level of the ivc.A linear 9x2mm filling defect in the posterior aspect of the ivc left of midline was noted on post infusion study most consistent with small thrombus in the ivc which is located at the lower half of the ivc filter.The patient reportedly tolerated the procedure well and was taken to intensive care unit and the sheath was to be removed later.The patient was ultimately placed on coumadin for long term anticoagulation.There is currently no additional information available for review.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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.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.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological, procedural and lesion characteristics.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to 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.However, review of the information provided suggests that the snare used to retrieve the filter was what fractured, not the filter.Without the implant or attempted explant procedural details or imaging, to review, it is not possible to draw a conclusion between the reported events and the device.However, procedural factors and/or vessel characteristics may have contributed to the events.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Given the limited information available for review, a relation between the device and the event could not be determined.At this time, there is nothing to suggest 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.

Manufacturer Narrative

Additional information was provided and is available in: section a2 (age at the time of event, date of birth), section b3 (event date), section b5 (event description), section b7 (relevant history race and medical history), section d11 (concomitant medical products and therapy dates), 6 french sheath, section g4 (date received by the manufacturer ), section h6 (evaluation codes), and 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 by the legal team, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter caused an intramural tear in the left anterior wall of the ivc and the filter's snare broke off during retrieval attempt and failed to fully collapse causing the filter to become irretrievable.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 medical records: patient had a history of obesity.The filter was implanted prior to a bariatric surgery.The filter was placed below the right and left renal veins.Approximately 7 months post implantation patient underwent an unsuccessful attempt to have the filter removed.During the procedure the filter was snared.In attempting to completely collapse the filer with the sheath there was only noted to be a partial collapse of the distal 2/3 of the filter and the snare broke.The doctor switched to a competitor recovery cone 10-french system.The distal hook was snared and as the sheath was advanced over the filter it would not collapse.The cone retrieval system broke and let loose.A diagnostic venocavogram demonstrated what appeared to be thrombus in the distal cone of the ivc filter, as well as retrograde filling into the left renal vein.The recovery sheath was exchanged for a 9-french regular length sheath and was sutured in place.A computerized topography (ct) scan was then performed on the patient.The scan demonstrated no evidence of dissection or extravasation of contrast.A tiny 3x5 mm hyperdense area in the left anterior wall of the ivc located at the level of the mid ivc filter around lower l2 level most consistent with small contrast collection i the anterior wall of the ivc related to earlier ivc cavagram study which may represent a small area of contrast accumulation from a small tear in the left anterior wall of the ivc located at the level of the ivc filter in the midfilter level of the ivc.A linear 9x2mm filling defect in the posterior aspect of the ivc left of midline was noted on postinfusion study most consistent with small thrombus in the ivc which is located at the level of the lower half of the ivc filter.The patient was taken to intensive care unit and the sheath was to be removed later.Patient was placed on coumadin for long term anticoagulation.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 7 months post implantation.The patient reports filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc, device unable to be retrieved.The patient also reports suffering from fear and mental anguish over the filter being permanently lodged in the ivc, pain in area of the filter, clot stuck in filter making the filter irretrievable.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• MDR Report Key: 7735216
• MDR Text Key: 115555336
• Report Number: 1016427-2018-01714
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 28 YR