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

Model Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was history of deep vein thrombosis, pulmonary embolism and acute shortness of breath.The filter was deployed above the l2 level.No complications were encountered.The patient tolerated the procedure well.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation (perforation abutting an adjacent organ) and tilt.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the inferior vena cava (ivc) (abutting an organ) and filter tilt.The patient also reports anxiety and worry.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 and organ perforation from 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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation (perforation abutting an adjacent organ) and tilt.Information received per the medical records indicate that the patient has a history of deep vein thrombosis, pulmonary embolism and acute shortness of breath.The filter was deployed via the patient's right common femoral vein.The filter was placed above the l2 level.No complications were encountered.The patient tolerated the procedure well.Information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc) (abutting an organ) and filter tilt.The patient continues to experience anxiety and worry.The patient became aware of the reported events seven years and ten months after the index procedure.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10240974
• MDR Text Key: 197844757
• Report Number: 1016427-2020-04150
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15575609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDEWIRE; UNKNOWN LONG 6 FRENCH SHEATH; UNKNOWN NEEDLE; UNKNOWN SHORT 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR
• Patient Weight: 159