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

Model Number 466P306X

Device Problems Fracture (1260); Defective Component (2292)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Swelling (2091); Thrombosis (2100); No Consequences Or Impact To Patient (2199); Ulcer (2274)

Event Date 08/29/2014

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fracture and occlusion of the ivc.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, 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, pain, suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record 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.Occlusion within the ivc does not represent a device malfunction.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or a malfunction of the filter.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, 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 team, the patient underwent placement of the trapease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement was lupus related coagulopathy.During the placement of the filter via the right internal jugular vein, the filter was placed in the infrarenal ivc.Inferior vena cavogram performed with no evidence of filling defect to suggest thrombosis.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter fractures and occlusion of the ivc.Per the patient profile form (ppf), approximately six years post implantation the patient reports that the ivc filter has fractured with struts retained in the patient¿s retroperitoneum, the filter is mangled and unable to be retrieved, and the ivc to be completely occluded.The ivc and left iliac veins were treated with balloon angioplasty and multiple stent placements.The patient also reports to have severe venous disease and have developed a left medial venous stasis ulcer that never properly healed.The leg ulcer causes the patient to have swelling and severe pain.The patient now suffers from anxiety and depression.The filter remains implanted; thus, unavailable for analysis.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.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.Along with the reported fracture, there was a noted change to the shape of the device.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Stasis ulcer with pain and swelling do not represent device malfunctions and may be related to the underlying coagulopathy issues.Anxiety does 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.

Manufacturer Narrative

The following additional information received per the medical records indicate that patient underwent placement of the inferior vena cava (ivc) filter because of their history of lupus coagulopathy.During the placement of the filter via the right internal jugular vein, the filter was placed in the infrarenal ivc.Inferior vena cavogram performed with no evidence of filling defect to suggest thrombosis.According to the information received in the patient profile form (ppf), approximately on or about six years post implantation the patient reports that the ivc filter fractured with fractured struts retained in the patient¿s retroperitoneum, the filter is mangled and unable to be retrieved, and the ivc to be completely occluded.There are no reports of removal attempts.The ivc and left iliac veins had to be reconstructed, followed by balloon angioplasty and multiple stent placement.The patient also reports to have severe venous disease and have developed a left medial venous stasis ulcer that never properly healed.The leg ulcer causes the patient to have swelling and severe pain.There was a thrombus which inhibited the ability to exit through the struts of the filter system.Additional surgeries were performed, however information on that is not currently available.The patient now suffers from anxiety and depression as well.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7104160
• MDR Text Key: 94379102
• Report Number: 1016427-2017-00869
• 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: 04/23/2018

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 Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0208441
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2017
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 03/07/2018; 04/14/2018
• Supplement Dates FDA Received: 04/05/2018; 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN .018 WIRE; UNKNOWN 4-FRENCH TRANSITION SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 34 YR