MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Perforation (2001); Perforation of Vessels (2135)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused filter perforation and tilt.The indication for the filter implant has not been provided and 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.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.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.Please note that this is the initial 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 filter perforation and tilt.As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, pain and suffering, and other damages.

Event Description

Additional information received per the medical records indicate that the patient has a history of blood clots, deep vein thrombosis, thrombophlebitis and morbid obesity.The filter was placed prior to bariatric surgery to prevent pulmonary embolism.The filter was implanted via the patient's right femoral vein.A diagnostic venogram showed the cava was patent, but visualization was poor.The caval bifurcation and renal veins were clearly seen and the filter was placed between them.Post procedure inferior vena cavogram was not clear; however, there was good flow through the cava.Imaging was done in the recovery room and they could visualize the filter right under the level of the renal vein.The patient tolerated the procedure well.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava and filter tilt.The patient became aware of the reported events approximately sixteen years and nine months after the index procedure.The patient has experienced back pain and continues to experience mental anguish related to the filter.The patient has also been hospitalized for clots related to the filter.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused filter perforation and tilt.The patient reported becoming aware of the events approximately sixteen years and nine months post implant.The patient also reported back pain, hospitalizations for blood clots and anxiety related to the filter.According to the medical records the indication for the filter placement was a history of blood clots, deep vein thrombosis, thrombophlebitis and morbid obesity.The filter was placed prior to bariatric surgery to prevent pulmonary embolism.The filter was implanted via the right femoral vein and deployed between the caval bifurcation and renal veins.Post procedure inferior vena cavogram was not clear; however, there was good flow through the cava.Imaging was done in the recovery room, and they could visualize the filter right under the level of the renal vein.The patient tolerated the procedure well.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 do not indicate a device malfunction and may be related to patient history, vessel characteristics and pharmacological factors.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Anxiety does 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.

• Brand Name: UNKNOWN TRAPEASE
• 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 32574
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 32574 ; 7863138372
• MDR Report Key: 15407802
• MDR Text Key: 299767945
• Report Number: 9616099-2022-05972
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GLIDE WIRE; UNKNOWN INTRODUCER; UNKNOWN STRAIGHT FLUSH CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female