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

Catalog Number 466P306AU

Device Problem Material Perforation (2205)

Patient Problem Perforation of Vessels (2135)

Event Date 05/02/2018

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 perforation that causes injury and damage to the patient.Per the implant records, the patient was status post a massive pulmonary embolus, intubated and on ventilatory support.The inferior vena cava (ivc) filter placement was indicated as the patient would not tolerate anticoagulation due to a significant recent bleed.The right femoral vein was accessed, and using fluoroscopy guidance, the filter was deployed below the renal veins at the level of the vertebral lumbar body, l2 and l3.The patient tolerated the procedure well and was transported in stable condition to the recovery room.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years post implant.The patient reports perforation of filter strut(s) outside the inferior vena cava (ivc).The patient further experienced anxiety related to the filter.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.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.Anxiety does 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.

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, perforation that causes injury and damage to the patient.Per the implant records, the patient was status post a massive pulmonary embolus, intubated and on ventilatory support.The inferior vena cava (ivc) filter placement was indicated as the patient would not tolerate anticoagulation due to a significant recent bleed.The right femoral vein was accessed, and using fluoroscopy guidance, the filter was deployed below the renal veins at the level of the vertebral lumbar body, l2 and l3.The patient tolerated the procedure well and was transported in stable condition to the recovery room.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years post implantation.The patient reports perforation of filter strut(s) outside the inferior vena cava (ivc).The patient further experienced anxiety related to the filter.

• 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
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9382719
• MDR Text Key: 168575033
• Report Number: 1016427-2019-03603
• 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
• Type of Report: Initial
• Report Date: 11/27/2019

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: 08/31/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15246128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2011
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 81 YR