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

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Perforation of Vessels (2135); Bowel Perforation (2668)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava filter.Per the medical records, the indication was left leg deep venous thrombosis (dvt).The trapease filter was successfully deployed within the ivc at l2-l3 disc space level.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation, tilting of the inferior vena cava (ivc) filter and perforation abutting an organ.Per the patient profile form (ppf), the patient became reports perforation of filter strut(s) outside the ivc in addition to a grade iii perforation against the duodenum.The patient further reports anxiety.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 and duodenum; 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 ivc 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.

Event Description

As reported by 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, tilting of the inferior vena cava (ivc) filter and perforation abutting an organ.The following additional information was received per the patient¿s implant records, the indication for filter placement was left leg deep venous thrombosis (dvt).Using ultrasound and fluoroscopy guidance, a trapease type filter was successfully deployed within the ivc at l2-l3 disc space level.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately nine years and six months post implantation.The patient reports perforation of filter strut(s) outside the ivc in addition to a grade iii perforation against the duodenum.The patient further reports living with the anxiety of having a filter that could fail at any time, but that may not be retrievable without serious surgery, and living with the fear that the filter has perforated the vena cava and it is abutting another organ.

• 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: 9244104
• MDR Text Key: 164822963
• Report Number: 1016427-2019-03458
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15015585
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2009
• 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: 72 YR