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

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted and that filter struts were associated with perforation with multiple struts extending beyond the wall of the inferior vena cava (ivc) and into surrounding tissue and organ.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Without images or procedural films for review, the reported filter tilt, ivc perforation and organ perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information 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.

Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: tilt and perforation of filter struts with multiple struts extending beyond the wall of the ivc and into surrounding tissue and organs.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b6, b7, g3, g4, g7, h1, h2 and h6.Section b5: additional information received per the medical records indicate that the patient has a history of surgical repair of herniated discs (c4 and c5) eight years prior to the index procedure, bulging disc at c6, hysterectomy, right knee surgery, bladder repair, appendectomy, cholecystectomy, hypothyroidism and arthritis.Two months before the index procedure the patient was admitted to the hospital due to bilateral upper extremity radicular pain and numbness from cervical spine ddd (degenerative disc disease).Testing revealed bilateral neuropathy of the upper extremities.One months before the index procedure the patient was admitted to the hospital due to cervical ddd, spondylosis and radicular pain.Testing of cervical spine showed severe changes at the c5-c6 level and moderate changes at c6-c7.One week before the index procedure the patient was admitted to the hospital for surgical revision of hardware and extensive surgical intervention with hardware for cervical ddd.Two days before the index procedure the patient was admitted to the hospital for deep vein thrombosis (dvt) of the left leg.The optease filter was successfully deployed below the level of the renal veins.There were no reported complications.Imaging confirmed the filter placement.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, perforation of ivc, perforation of organs and a blood clot in their left leg.The patient became aware of the reported events nine years after the index procedure.The patient reported that that they continue to experience pain in the area of the filter, worry and depression related to the filter.Computed tomography (ct) scans done approximately six years after the index procedure were re-evaluated nine years after the index procedure.It revealed that the superior end of the filter was at the l2-l3 interspace and tilted laterally.All of the struts perforate the ivc up to 6 mm.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g4, g7, h1 and h2.As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of surgical repair of herniated discs (c4 and c5), bulging discs at c6, hysterectomy, right knee surgery, bladder repair, appendectomy, cholecystectomy, hypothyroidism and arthritis.In addition, two months prior to the filter implantation, the patient had been admitted to hospital with bilateral upper extremity pain and numbness that was attributed to cervical spine degenerative disease.Diagnostic testing revealed bilateral neuropathy of the upper extremities.One month prior to the filter implantation, the patient was admitted with cervical spine degenerative disc disease, spondylosis and radicular pain.Diagnostic testing revealed severe changes at the c5-c6 level and moderated changes at the level of c6-c7.One week prior to the filter implantation, the patient was admitted for surgical revision of hardware and extensive surgical intervention with placement of hardware in the patient¿s cervical spine.The patient subsequently developed deep vein thrombosis (dvt) of the left leg.The filter was implanted in an infrarenal position without complications.Approximately six years after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that the superior aspect of the filter was located at the l2-l3 interspace and was tilted laterally.All of the filter struts had perforated the inferior vena cava (ivc) by up to 6mm.Approximately nine years after the filter implantation, the patient also reported that the filter had perforated into surrounding tissues and/or organs and had developed a blood clots of the left leg.The patient further reported having experienced pain, worry, mental anguish and depression associated with the filter.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Without images or procedural films for review, the reported filter tilt and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported ivc and tissue and/or organ perforations.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.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.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety and depression experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information 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.

Manufacturer Narrative

As reported a patient underwent placement of a optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and perforation of filter struts with multiple struts extending beyond the wall of the inferior vena cava (ivc) and into surrounding tissue and organs.The patient reported becoming aware of filter tilt, perforation of ivc, perforation of organs and a blood clot in their left leg, approximately nine years post implant.The patient also reported experiencing pain in the area of the filter, worry and depression related to the filter.According to the medical records had a history of surgical repair of herniated discs (c4 and c5) eight years prior to the index procedure, bulging disc at c6, hysterectomy, right knee surgery, bladder repair, appendectomy, cholecystectomy, hypothyroidism and arthritis.Two months before the index procedure the patient was admitted to the hospital due to bilateral upper extremity radicular pain and numbness from cervical spine ddd (degenerative disc disease).Testing revealed bilateral neuropathy of the upper extremities.One month prior to the filter implant the patient was admitted to the hospital due to cervical ddd, spondylosis and radicular pain.Testing of cervical spine showed severe changes at the c5-c6 level and moderate changes at c6-c7.One week before the index procedure the patient was admitted to the hospital for surgical revision of hardware and extensive surgical intervention with hardware for cervical ddd.Two days before the index procedure the patient was admitted to the hospital for deep vein thrombosis (dvt) of the left leg.The optease filter was successfully deployed below the level of the renal veins.There were no reported complications.Imaging confirmed the filter placement.A computed tomography (ct) scan was performed approximately six years and again at eleven years and six months post implant.The original scan results were not provided.Reformatted coronal images were submitted for independent review.The reviewer notes from the last scan indicated that the filter is tilted anteriorly and laterally at the inferior end and contacts the ivc wall.All struts if the filter perforate the ivc up to 9mm.One anterior and one medial strut perforate 5mm and reside in the soft tissue and contacts the lumbar artery, respectively.A medial and a lateral strut perforate 6mm and contacts the aorta, and resides in the soft tissues, respectively.One posterior strut perforates 7mm and contacts the l3 vertebral body and on lateral strut perforates 9mm and contacts the right psoas muscle.There were no hemorrhage, thrombus or fracture fragments seen.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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.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.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.The anxiety and depression experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information 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.

Event Description

Computed tomography (ct) scans done approximately six years after the index procedure were re-evaluated nine years after the index procedure.It revealed that the superior end of the filter was at the l2-l3 interspace and tilted laterally at the superior end but does not contact the ivc wall.The ivc filter is tilted anteriorly at the inferior end and it contacts the ivc wall.All of the struts perforate the ivc up to 6 mm.Two (2) lateral struts perforate the ivc wall and contact the aorta.Two (2) posterior struts perforate the ivc wall and contact the l3 vertebral body.Computed tomography (ct) scans done approximately eleven years and six months after the index procedure were evaluated.It revealed that the superior end of the filter is at the l2-l3 interspace.The inferior vena cava (ivc) filter is not tilted at the superior end.The ivc filter is tilted anteriorly and laterally at the inferior end.The filter does contact the ivc wall.All of the struts of the ivc filter perforate the ivc up to 9mm.One (1) anterior strut perforates the ivc wall 5mm and resides within the soft tissues.One (1) medial strut perforates the ivc wall 6mm and contacts the aorta.One (1) medial strut perforates the ivc wall 5mm and contacts a lumbar artery.One (1) posterior strut perforates the ivc wall 7mm and contacts the l3 vertebral body.One (1) lateral strut perforates the ivc wall 9mm and contacts the right psoas muscle.One (1) lateral strut perforates the ivc wall 6mm and resides within the soft tissues.No hemorrhage was seen.No thrombus was seen within the ivc.No fracture fragments were identified.This later study was compared to ct scans done approximately six years after the index procedure.The superior end of the filter is at the l2-l3 interspace.The ivc filter is not tilted at the superior end.The ivc filter is tilted anteriorly and laterally at the inferior end and it does contact the ivc wall.All the struts of the ivc filter perforate the ivc up to 6mm.One (1) anterior strut perforates the ivc wall 3mm and resides within the soft tissues.One (1) medial strut perforates the ivc wall 5mm and contacts the aorta.One (1) medial strut perforates the ivc wall 4mm and contacts a lumbar artery.One (1) posterior strut perforates the ivc wall 6mm and contacts the l3 vertebral body.Two (2) lateral struts perforate the ivc wall 4mm and 5mm and reside within the soft tissues.Thrombus within the ivc or filter could not be evaluated on this non contrast study.No fracture fragments were identified.

• Brand Name: 466FXXXX
• 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 ; 7863138372
• MDR Report Key: 9305230
• MDR Text Key: 173331850
• Report Number: 1016427-2019-03542
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2021
• 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
• Treatment: UNK.
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female