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

Catalog Number 466P306AU

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Coagulation Disorder (1779); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 11/13/2020

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 deep vein thrombosis (dvt) the indication for the filter implant, full procedural details and medical history have not been provided.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 ivc 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.This event does not represent a malfunction of the device.With the limited information provided the report of dvt could not be confirmed or further clarified, nor a relationship between the event and the device established.Ivc filters are not indicated for use in the prevention of dvt¿s.There is nothing to suggest that the reported event is related to the design and/or 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 deep vein thrombosis (dvt).As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain, suffering and other damages.

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 deep vein thrombosis (dvt).The patient subsequently reported becoming aware of perforation of filter struts outside the ivc, blood clots, clotting and occlusion of the ivc approximately sixteen years and eight months post implant.The patient also reported left leg lymphedema, blood clots inside the filter and anxiety related to the filter.According to the implant record the indication for the filter implant was dvt.The filter was placed via the right common femoral vein and deployed in the infrarenal ivc after localizing the renal veins.There were no immediate complications.The product was not returned for analysis.The device history record review could not be completed.The trapease ivc 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, clotting and occlusion of the device or the vasculature do not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.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.Without procedural films or post implant imaging available for review, the reported filter perforation could not be confirmed or further clarified.Lymphedema and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or 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

Per the implant records, the filter was indicated for deep vein thrombosis (dvt).The right groin was evaluated with ultrasound, showing a widely patent common femoral vein.The right groin was prepped and draped in a sterile manner and the common femoral vein was then punctured using a micropuncture system, followed by placement of a guidewire and a dilator.An inferior vena cavagram revealed a normal caliber inferior vena cava (ivc) and localized the renal veins.The trapease filter was deployed within the inferior vena cava in the infrarenal area.There were no immediate complications.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, blood clots, clotting and occlusion of the ivc, becoming aware of these events approximately sixteen years and eight months after the filter implantation.The patient further asserts to have suffered from constant left leg lymphedema, blood clots inside the trapease filter and experienced anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12324366
• MDR Text Key: 266680780
• Report Number: 1016427-2021-05289
• Device Sequence Number: 1
• Product Code: DTK
• 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,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1103159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNK GUIDEWIRE, UNK 6F DILATOR.; UNK MICROPUNCTURE SYSTEM.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male