MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE PERMANENT VENA CAVA FILTER; THROMBECTOMY SYSTEMS

Model Number N/A

Device Problems Fracture (1260); Failure to Align (2522); Migration (4003)

Patient Problem Perforation of Vessels (2135)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

The details provided do not indicate a specific date in (b)(6) when the patient had the follow up visit that identified the reported events and therefore the event date chosen was the 1st.(b)(4).Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.Patient demographics including medical history were not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported, a patient underwent placement of a trapease vena cava filter.Approximately 10 ¾ years later, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the ivc.As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, paint and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The trapease 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 reported filter tilt could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.The brief also reported perforation of the ivc; however, 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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.However, 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.

Event Description

As reported in a legal brief, a patient underwent placement of a trapease vena cava filter.Approximately 10 ¾ years later, the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the ivc.As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, paint and suffering, and other damages.

Manufacturer Narrative

Additional information was received from the patient profile form that the patient fears that the filter is going to break or injur a major organ.She has difficulty walking and does not know if it has any bearing on her legs.She constantly wonders what injuries it is causing her body.The filter has perforated the ivc.At filter placement, pre-operative diagnoses was recurrent dvt despite anticoagulation with coumadin.The trapease filter was successfully deployed.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that approximately ten and three quarters years later, the patient underwent an updated computerized tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).The patient is also reported to experience difficulty walking and does not know if it has any bearing on the legs.The patient also fears that the filter is going to break or injure a major organ.The indication for the filter implant was a history of recurrent deep vein thrombosis (dvt) despite anticoagulation with coumadin.The filter was placed via the right groin and deployed below the renal veins at the level of the mid body of the l3 vertebrae.Final angiogram showed good position and complete coverage of the ivc.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.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 complications related to ivc filters.It is unknown if the tilt contributed to the reported perforation.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 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 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.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and perforation of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.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.Anxiety and difficult ambulation do not represent a device malfunction and may be related to underlying patient specific issues.The patient¿s medical history has not been provided.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.

Manufacturer Narrative

After further review of additional information received.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that approximately ten years and nine months later, the patient underwent an updated computerized tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).The patient is also reported difficulty walking and does not know if it has any bearing on the legs.The patient also has fear related to the filter.The indication for the filter implant was a history of recurrent deep vein thrombosis (dvt) despite anticoagulation with coumadin.The filter was placed via the right groin and deployed below the renal veins at the level of the mid body of the l3 vertebrae.Final angiogram showed good position and complete coverage of the ivc.The patient has subsequently reported filter fracture within the ivc, perforation of filter struts outside the ivc, migration of entire filter within vena cava and perforation abutting organ.The product remains implant and unavailable for analysis, 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 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 practitioner 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) and notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also 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.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Anxiety and difficult ambulation do not represent a device malfunction and may be related to underlying patient specific issues.The patient¿s medical history has not been provided.Without post implant image reports the reported events could not be confirmed or further clarified.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 an amended patient profile form (ppf) states that the patient experienced filter fracture within the ivc, perforation of filter struts outside the ivc, migration of entire filter within vena cava and perforation abutting organ.The patient became aware of the reported events approximately fifteen years and four months after the index procedure.

• Brand Name: UNKNOWN TRAPEASE PERMANENT VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7157041
• MDR Text Key: 96148096
• Report Number: 1016427-2018-00934
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/07/2017
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female