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

Catalog Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2021

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 filter tilting.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 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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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 filter tilting.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 and suffering and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of hypertension, non-insulin diabetes mellitus, anxiety, depression and anemia.The indication for the filter placement was reported to be for extensive bilateral lower extremity deep vein thrombosis (dvt).The filter was implanted via the right femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well and without complications.More than ten years after the filter implantation, the patient became aware that the filter had tilted.The patient further reported having experienced anxiety associated with 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 inferior vena cava (ivc) 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 filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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

Additional information received per the medical records indicate that the patient has a history of hypertension, diabetes (oral treatment), anxiety, depression and anemia.The indication for filter placement was extensive bilateral deep vein thrombosis.The filter was deployed via the patient's right femoral vein.A guide wire was inserted into the needle hole and advanced to area of inferior vena cava without any difficulty.The needle was pulled out.A cordis trapease guiding catheter was threaded in over the guide wire.The tip of the guiding catheter was located at the upper margin of the first lumbar vertebra.The guide wire was pulled out.The filter was deployed at the level of third and fourth lumbar vertebra without any difficulty.The patient tolerated the procedure well without any complications.  additional information received per the patient profile form (ppf) states that the patient experienced filter tilt.The patient became aware of the reported event approximately ten years and nine months after the index procedure.The patient also experienced anxiety.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 12233359
• MDR Text Key: 263820375
• Report Number: 1016427-2021-05134
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15152563
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR