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

Model Number 466P306AU

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Perforation (2205); Unintended Movement (3026)

Patient Problems Emotional Changes (1831); Pain (1994); Perforation of Vessels (2135); Anxiety (2328)

Event Date 11/22/2019

Event Type  Injury  

Event Description

As reported in the legal brief, a patient was implanted with two trapease filters vena cava filters.The filters subsequently malfunctioned and caused injury and damage to the patient, including but not limited to symptoms including but not limited to one filter is lodged in the extravascular right paravertebral and is compressed and fractured.The second filter has a grade one perforation and slight tilt.Both filters possess a progressive risk of perforation of the vena cava and surrounding vital organs, vessels, and structures, which can result in severe pain and life-threatening complications.They also pose an increased and progressive risk of migration and fracture, causing serious injury and death.The patient is forced to live with the possibility that these complications can happen at any moment which has led the patient to severe fear, stress, anxiety, and loss of enjoyment of life.As a direct and proximate result of these malfunctions, the patient suffered life threatening injuries and damages required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information ins pending and will be submitted within 30 days upon receipt.

Event Description

Per the implant records the patient was reported to be status post motorcycle crash and sustained a t6-t7 fracture with resultant complete paraplegia.The inferior vena cava (ivc) filter was indicated due to increased risk for deep vein thrombosis (dvt) secondary to decreased mobility and trauma, as it was felt the patient was not a good candidate for anticoagulation.The patient was prepped and draped in a standard surgical fashion and the common femoral venipuncture was then performed using a needle.Under visualization utilizing fluoroscopy, a wire was then placed up into the inferior vena cava (ivc).Next, a sheath and introducer catheter were then placed over the wire up in the ivc and a venogram was completed which initially demonstrated the lumbar veins bilaterally, the ivc in the bifurcation and identified the renal veins.Next, a trapease ivc filter (filter #1) was unsheathed within what was thought to be the ivc; however, it did not open upon being unsheathed.A venogram was completed to demonstrate its placement.It was felt that it was placed within one of the right lumbar veins without any evidence of migration, and it was left in place since there was no concern for migration given its position.Next, attention was turned to the left groin.The left common femoral vein was accessed, utilizing a needle, followed by a wire inserted into the ivc.A sheath and catheter were then placed over the wire into the ivc; another venogram was obtained demonstrated the renal veins and the bifurcation.The left renal vein appeared to be at approximately t12-l1 and the right appeared to be up much higher approximately t11.Another trapease ivc filter (filter #2) was then unsheathed at approximately l1-l2 interspace.It opened without complication.The patient was transferred out of the operating room in stable condition.The following day the patient underwent open reduction internal fixation (orif) of a fractured right index finger, in addition to orif of t5-t6 and posterior fusion t2-t8.

Manufacturer Narrative

As reported a patient was implanted with two trapease vena cava filters.The information provided indicated that the filters subsequently malfunctioned and caused one filter to be lodged in the extravascular right paravertebral and is compressed and fractured.The second filter has a grade one perforation and slight tilt.The patient reported becoming aware of reports perforation of filter struts outside the inferior vena cava (ivc), migration, tilting, and fractured filter struts retained compressed and broken in the right psoas muscle, approximately thirteen years and three months post implant.The patient also reported anxiety related to the filter.According to the implant record the patient was status post motorcycle crash and sustained a t6-t7 fracture with resultant complete paraplegia.The inferior vena cava (ivc) filter was indicated due to increased risk for deep vein thrombosis (dvt) secondary to decreased mobility and trauma, as it was felt the patient was not a good candidate for anticoagulation.After performing a common femoral puncture, a venogram was shot which initially demonstrated the lumbar veins bilaterally.Another venogram was performed after removing and replacing the catheter and showed good demonstration of the ivc in the bifurcation and identified the renal veins.A trapeze ivc filter was then unsheathed within what was thought to be the ivc.However, it did not open up upon being unsheathed.A venogram was then done to try to demonstrate its placement.It was felt that it was placed within one of the right lumbar veins without any evidence of migration.It was then left in place since there was no concern for migration given its position.The catheter and sheath were removed, and hemostasis achieved.The left groin was accessed, a venogram demonstrated the renal veins and the bifurcation.The filter was then deployed at approximately l1-l2 interspace and opened without complication.The following day the patient underwent open reduction internal fixation (orif) of a fractured right index finger, in addition to orif of t5-t6 and posterior fusion t2-t8.The products remain implant and therefore not available for analysis.A review of the device history records, for both devices, revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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 practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such, given the information provided procedural factors may have contributed to the reported event.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 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.It was reported that the filter is compresses, with the information provided the event could not be further clarified.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported filter tilt, fracture, compressed and perforation could not be confirmed or further clarified.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 13573553
• MDR Text Key: 289766388
• Report Number: 9616099-2022-05362
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0406252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BENTSON WIRE, COOK NEEDLE.; UNK SHEATH, UNK CATHETER.; UNK.
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Race: White