MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 08/21/2019

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 a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: tilt, perforation of filter strut(s) beyond the wall of the ivc, thrombus, fracture, caval thrombosis, device unable to be retrieved.The filter remains implanted; thus, unavailable for analysis.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 trapease 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.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.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 complications related it ivc filters.Ivc 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.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 procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: tilt, perforation of filter strut(s) beyond the wall of the ivc, thrombus, fracture, caval thrombosis, device unable to be retrieved.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: b4, g4, g7, h1, h2 and h6.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of leg swelling, acute and chronic deep vein thrombosis (dvt) involving the left femoral and popliteal veins.The patient developed acute and chronic echogenic material in the left femoral vein.A computerized tomography (ct) scan revealed mild cardiac enlargement and infiltrates in both lower lobes of the lungs.The filter was implanted via the right transfemoral vein and placed at the level of the superior endplate of the l2 vertebral body.The patient is reported to have tolerated the procedure well and without complications.Approximately six years and three months after the filter implantation, the patient underwent a ct scan that revealed that the superior aspect of the filter was located at the level of the mid l2 interspace.The superior aspect of the filter was tilted anteriorly and was in contact with the ivc wall.The inferior aspect of the filter was tilted anteriorly and did not contact the ivc wall.The anterior and medial struts had perforated the ivc wall by 4mm and were in contact with the bowel.The medial strut had perforated the ivc wall.Another medial strut perforated the ivc wall by 4mm and was within the soft tissues.The posterior strut had perforated the ivc wall by 5mm and was within the soft tissues.The lateral strut perforated the ivc wall by 6mm and was in contact with the bowel.Another lateral strut had perforated the ivc wall by 6mm and was within the soft tissues.In addition, the ct scan revealed a filling defect that was seen within the filter that was compatible with thrombus.Two months later, the patient underwent an attempt to retrieve the filter.The details of this procedure were not provided.The patient further reported having experienced depression, leg pain and swelling and blood clots throughout the legs associated with the filter.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 trapease 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, fracture, retrieval difficulty 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.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that 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.The reported details indicate that retrieval was attempted more than six years after implantation.The trapease vena cava filter is designed for permanent 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 twelve days.It is unknown if the tilt contributed to the reported ivc and tissue/organ perforations.A review of the 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 and 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 and swelling 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 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

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d1, d4, d11, g3, g4, g7, h1, h2, h4 and h6.Continuation of section b5: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes left leg swelling, acute and chronic deep venous thrombosis (dvt) of femoral and popliteal vein.A ct scan prior to implant revealed mild cardiac enlargement and ground-glass interstitial -type infiltrate in both lower lobes.The filter was deployed with the tip at the level of the superior endplate of the l2 vertebral body.There were no apparent immediate complications.The filter subsequently malfunctioned and caused injury and damages including, but not limited to tilt, perforation of the ivc, thrombus, fracture, caval thrombosis, device unable to be retrieved.Per the patient profile form (ppf), the patient reports tilt, perforation of filter strut(s) beyond the wall of the ivc and into organs, blood clots, clotting and or occlusion of the ivc the patient also has a linear density along the anterior aspect of the central thrombus, this may represent a fractured strut versus calcification of a central clot.The patient further reports depression, legs pain, leg swelling.A ct scan, approximately six years after implant, reveals the superior end of the filter is at the mid l2 interspace.The ivc filter is tilted anteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted anteriorly at the inferior end and it does not 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 4mm and contacts the bowel.One (1) medial strut perforates the ivc wall 4mm and contacts the bowel.One (1) medial strut perforates the ivc wall 4mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 5mm and resides within the soft tissues.One (1) lateral strut perforates the ivc wall 6mm and contacts bowel.One (1) lateral strut perforates the ivc wall 6mm and resides within the soft tissues.There was a filling defect seen centrally within the ivc filter compatible with thrombus.Approximately two months later there was an attempt to remove the device.The product was not returned for analysis.The trapease 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.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.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 complications related it ivc filters.Ivc and organ perforation from 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.Blood clots, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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 procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.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.Depression and leg pain with swelling 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of left leg swelling, acute deep and chronic venous thrombosis involving the left femoral vein and popliteal vein.Immediately prior to the index procedure chronic and acute echogenic material was noted in the left femoral vein.Chronic and acute echogenic material was noted in the popliteal vein.Reflux was noted in the femoral vein.All other vessels seen appeared patent and compressible.A computed tomography (ct) scan done immediately before the index procedure revealed mild cardiac enlargement and groundglass interstitial -type infiltrate in both lower lobes.The filter was deployed via the right transfemoral vein.It was placed with the tip of the filter at the level of the superior endplate of the l2 vertebral body.The patient tolerated the procedure well and there were no apparent immediate complications.  additional information received per the patient profile form (ppf) states that the patient experienced tilt, perforation of filter strut(s) beyond the wall of the inferior vena cava (ivc), perforation of filter strut(s) into organs, blood clots, clotting and or occlusion of the ivc the patient also has a linear density along the anterior aspect of the central thrombus, this may represent a fractured strut versus calcification of a central clot.The patient continues to experience depression, legs pain, leg swelling and blood clots throughout legs.The results of computed tomography (ct) scans done approximately six years after the index procedure indicate that the superior end of the filter is at the mid l2 interspace.The ivc filter is tilted anteriorly at the superior end and it contacts the ivc wall.The ivc filter is tilted anteriorly at the inferior end and it does not 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 4mm and contacts the bowel.One (1) medial strut perforates the ivc wall 4mm and contacts the bowel.One (1) medial strut perforates the ivc wall 4mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 5mm and resides within the soft tissues.One (1) lateral strut perforates the ivc wall 6mm and contacts bowel.One (1) lateral strut perforates the ivc wall 6mm and resides within the soft tissues.There was a filling defect seen centrally within the ivc filter compatible with thrombus.Approximately two months later there was an attempt to remove the device.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9459836
• MDR Text Key: 184891813
• Report Number: 1016427-2019-03656
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15871044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH ANGIOGRAPHIC CATHETER; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR