MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Perforation (2001)

Event Date 09/16/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.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, filter was significantly tilted and least six struts were significantly perforating the inferior vena cava (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 expensive, pain 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 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 reported filter tilt and perforation 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 by the legal brief, the patient underwent placement of defendants trapease vena cava filter.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, filter was significantly tilted and least six struts were significantly perforating the inferior vena cava (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 expensive, pain and suffering, and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the patient underwent an updated computed tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, filter was significantly tilted and least six struts were significantly perforating the inferior vena cava (ivc).The patient is also reported to have experienced blood clots, clotting, and/or occlusion of the ivc and anxiety.The medical records indicated that the filter was placed prophylactically prior to ankle repair surgery.The patient sustained an ankle injury a few months prior to the filter placement and had a deep vein thrombosis (dvt) followed by a pulmonary embolism (pe).The filter was placed via the right common femoral vein and at the level of l2 vertebrae.The filter was deployed well and remained in good position, the patient tolerated the procedure well and the left ankle surgery followed the filter placement.Approximately nine years and ten months post implant a ct scan was performed and revealed that six prongs had perforated the ivc and there was a six degree, left to right tilt of the filter.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 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.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.The timing and mechanism of the tilt 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.Without the procedural films 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues and/or patient pre-existing conditions.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

According to the information received in the patient profile from (ppf), the patient underwent placement of a trapease vena cava filter eleven years and ten months ago.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of filter struts outside of the ivc, tilt, blood clots, clotting, and/or occlusion of the ivc.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 patient became aware of the alleged failures nine years and seven months post implantation.The patient suffers daily fear that the ivc filter may create more sever bodily injuries.The following additional information received per the medical records state that during the implant procedure, the right common femoral vein was accessed by a guidewire.A vena cavagram was performed showing the renal vein at the level of l1.The trapease filter was then deployed through the introducer at the level of l2.It deployed well and remained in good position.The introducer was removed and pressure was held for two minutes.The patient tolerated the procedure well.A ct scan of the patient¿s abdomen and pelvis was performed nine years and ten months post implantation.The ct scan confirmed that six filter prongs have perforated the ivc and a six degree tilt left to right.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7145580
• MDR Text Key: 95738390
• Report Number: 1016427-2017-00907
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 08/01/2018; 08/01/2018
• Supplement Dates FDA Received: 08/31/2018; 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 61 YR