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

Catalog Number 466P306AU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Embolus (1830); Occlusion (1984); Pain (1994); Perforation (2001); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: 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 pain and a grade 1 perforation.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 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 images or procedural films for review, the reported perforation could not be confirmed, and the exact causes could not be determined.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.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed or further clarified.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: pain and a grade 1 perforation.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, 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: a3, b3, b4, b6, b7, d1, d4, g3, g4, g7, h1, h2, h4 and h6.Section b5: 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 pain and a grade 1 perforation.Additional information provided by the patient indicated that there were blood clots, clotting, and/or occlusion of the ivc.The patient became aware of the reported events approximately two years after the index procedure.The patient has also experienced pain at the site of the implant and difficulty walking.According to the medical records, the patient's history includes recurrent colon cancer, undergoing chemotherapy, pulmonary emboli, deep vein thrombosis (dvt) after hematemesis with mallory-weiss tear of the esophagus, chronic neck and back pain.The indication for filter placement was dvt with a contraindication for anticoagulation therapy.A venocavagram was done to locate the renal veins, then the trapease was deployed at the l2-3 vertebral space.No complications were reported during the index procedure.Four months after the index procedure the patient reported experienced abdominal pain and leg cramps for three weeks.The patient was evaluated in the emergency room and discharged the same day.Eight months after the index procedure the patient experienced cervical and upper extremity pain, was seen in the emergency department and discharged the same day.The results of computed tomography (ct) scans done approximately one year and seven months after the index procedure indicate that the filter was located at the mid l2 to mid l4 level.There was a grade 1 perforation and probable nonocclusive thrombus right lateral ivc at the level of the filter.The scans indicate that the filter was negative for tilt and migration was unlikely.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 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.Blood clots and occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without images or procedural films for review, the reported perforation could not be confirmed, and the exact causes could not be determined.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.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Anxiety, pain, leg cramps and difficulty walking do not represent a device malfunction and may be related to underlying patient specific issues.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8855462
• MDR Text Key: 153105489
• Report Number: 1016427-2019-03107
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17376367
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening