MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

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

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused fracture and tilting.The indication for the filter implant has not been provided and 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.The trapease ivc 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 the anatomy of the vessel, specifically asymmetry and tortuosity.Without procedural films or post implant imaging available for review, the reported filter fracture and tilt could not be confirmed or further clarified.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.There is nothing to suggest that the reported event is related to the design and/or 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 the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, fracture and tilting.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused fracture and tilting.The patient reported becoming aware of filter tilt and fracture with fractured struts retained within the inferior vena cava (ivc) approximately eight years and eleven months post implant.The patient also reports anxiety related to the filter.According to the implant record the indication for the filter implant was left lower extremity deep vein thrombosis and a contraindication to anticoagulation.The patient was also noted to have a history of alcoholism.The filter was placed via the right common femoral vein and deployed with the tip at the mid l1 vertebral body, below the renal inflow.The filter appeared in good position without tilting.The patient tolerated the procedure well.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.The trapease ivc 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 the anatomy of the vessel, specifically asymmetry and tortuosity.Without procedural films or post implant imaging available for review, the reported filter fracture and tilt could not be confirmed or further clarified.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.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or 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 the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, fracture and tilting.Per the implant records, the patient was reported to have a history of left lower extremity deep vein thrombosis (dvt), contraindications to anticoagulation and alcoholism.The trapease inferior vena cava (ivc) filter was deployed in an infrarenal location.The right common femoral vein was identified, and patency established with ultrasound.Under ultrasound guidance, the right common femoral vein was accessed with micro puncture technique using a needle, a guidewire and a coaxial catheter.Under fluoroscopic guidance, a guidewire was advanced into the ivc.The coaxial catheter was exchanged for the trapease introducer sheath over the wire.Injection of contrast material demonstrated a normal caliber ivc without evidence of thrombus.Renal inflow was demonstrated at approximately t12-l1 level.Under fluoroscopic guidance, the guidewire was reintroduced and the sheath advanced so that its tip was at the mid l1 vertebral body level.The trapease ivc filter was then advanced through the sheath and deployed with its dome at the mid l1 vertebral body level.The filter appeared in good position without tilting.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately eight years and eleven months post implantation.The patient reports filter tilting and fracture, with the fractured filter struts retained within the ivc.The patient further experienced anxiety related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9861125
• MDR Text Key: 188515727
• Report Number: 1016427-2020-03946
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 0.018 GUIDEWIRE; UNK 21G NEEDLE; UNK 4F COAXIAL CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR