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

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the implantation, the patient became aware that the filter had tilted and was associated with a deep vein thrombosis (dvt).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 inferior vena cava (ivc) 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.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).This event does not represent a malfunction of the device.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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: dvt, filter tilt.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

Section b5: the filter was deployed via the patient's right femoral vein.The filter was placed just inferior to the level of the renal veins.A post procedural view demonstrated good alignment.  additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava (ivc).The form specified that the patient experienced three blood clots in the lungs, shortness of breath, problems walking and pain.The patient became aware of the reported events approximately one year and eight months after the index procedure.The patient states that stints were placed in both legs to help blood flow, scar tissue has grown over the stints which limits blood flow.Due to the stints, the right kidney stopped working and a tube was placed "in the kidney where it would work." the patient has physical therapy to assist with walking.Additionally, the patient claims that they will be disabled for life.Section h6: patient code '3191' was used for "scar tissue has grown over the stints".Additional information is pending and will be submitted within 30 days of receipt.

• 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: 8884467
• MDR Text Key: 154173145
• Report Number: 1016427-2019-03162
• 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: 09/20/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17237648
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR