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

Model Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problem Perforation (2001)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from perforation of the vena cava by six (6) filter struts.Information contained in the patient profile form indicated that the filter had perforated outside of the inferior vena cava and tilted.The patient became aware of the events approximately nine years and ten months post implant.The patient also reports having a fear that the filter might cause further damage as it has not yet been safely removed.Information contained in the medical records indicated that filter was implanted due to extensive deep vein thrombosis of the left leg from the mid to distal superficial femoral vein extending down into the popliteal vein.The patient had a history of cellulitis, dysmenorrhea, menorrhagia, a large fibroid uterus and was scheduled for a hysterectomy in the next few weeks.Prior surgery of cholecystectomy.The filter was placed via the right femoral vein and deployed below the level of the renal veins.The patient tolerated the procedure well.The patient also has a history of hypertension and tobacco use and a strong family history of hypercoagulability.Twenty-two days later the patient underwent a laparoscopic supracervical hysterectomy cystoscopy.Approximately nine years and ten months post implant the patient underwent a computed tomography scan to evaluate the ivc filter.The findings noted the filter was within the axis angled by 16 on the sagittal plane with the head abutting the left anterior wall of the ivc.There were 6 struts coursing through the wall of the ivc, most pronounced posteriorly and posterior lateral.No filter fragment fracture or migration was detected.An incidental finding of a left renal parapelvic cyst or possible cystic mass was noted.A correlation with ultrasound was recommended.

Manufacturer Narrative

Complaint conclusion: as reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, the filter was implanted due to extensive deep vein thrombosis of the left leg from the mid to distal superficial femoral vein extending down into the popliteal vein.The filter was deployed below the level of the renal veins.The patient tolerated the procedure well.Medical history includes cellulitis, dysmenorrhea, menorrhagia, cholecystectomy, hypertension, + family history of hypercoagulability, a large fibroid uterus and had a hysterectomy 22 days post filter implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from perforation of the vena cava by six (6) filter struts.Per the patient profile form (ppf), the filter perforated outside of the inferior vena cava and tilted.The patient also reports having a fear.Approximately nine years and ten months post implant the patient had a ct scan to evaluate the ivc filter.The findings noted the filter was within the axis angled by sixteen (16) on the sagittal plane with the head abutting the left anterior wall of the ivc.There were six (6) struts coursing through the wall of the ivc, most pronounced posteriorly and posterior lateral.No filter fragment fracture or migration was detected.An incidental finding of a left renal parapelvic cyst or possible cystic mass was noted.A correlation with ultrasound was recommended.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.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 tortuousness.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.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8437047
• MDR Text Key: 139344167
• Report Number: 1016427-2019-02633
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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: 04/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306X
• Device Lot Number: R0908402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR
• Patient Weight: 107