MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF BRACH 90CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306BU

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 02/23/2021

Event Type  Injury  

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 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.

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date in is the complaint awareness date.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 tilt.The indication for the filter placement, procedural details and medical history have not been provided and there is 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.Please note that this is the initial report for this product.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

According to the medical records, the patient was admitted to the hospital with deep venous thrombosis (dvt) and a urinary tract infection (uti).The trapease inferior vena cava (ivc) filter was placed without reported complications during the hospitalization.It was noted that the patient had a chest x-ray that showed no acute disease.Additionally, an ultrasound of the right internal jugular (ij) vein, showed a patent right internal jugular vein and the ivc filter below the level of the renal veins.The patient underwent pain management consultation the day after the filter was implanted.The patient¿s medical history was noted to be significant for chronic lumbosacral back pain with known lumbar degenerative disk disease, cervicalgia, hepatitis b, hypertension, gastroesophageal reflux disease (gerd), benign prostatic hypertrophy, and long-term opiate use, opiate tolerance, and opiate dependence.Regarding the pain, medical management was recommended at the time with no indication for invasive pain procedure.According to the information received in the patient profile form (ppf), the patient reports tilting of the filter, becoming aware of this event approximately seven years and three months after the filter implantation and further experienced anxiety related to the filter.

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 tilt.The patient reported becoming aware of tilting of the filter, approximately seven years and three months post implant.The patient also reported anxiety related to the filter.According to the medical records, the patient was admitted to the hospital with deep venous thrombosis (dvt) and a urinary tract infection (uti).The trapease inferior vena cava (ivc) filter was placed without reported complications during the hospitalization.It was noted that the patient had a chest x-ray that showed no acute disease, the patient had a recent upper respiratory infection.The patient underwent pain management consultation the day after the filter was implanted and medical management was recommended at the time with no indication for invasive pain procedure.The patient¿s medical history was notable for chronic lumbosacral back pain with known lumbar degenerative disc disease, cervicalgia, hepatitis b, hypertension, gastroesophageal reflux disease (gerd), benign prostatic hypertrophy, long-term opiate use, opiate tolerance, and opiate dependence.The product remains implant and therefore not available 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.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.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.

• Brand Name: TRAPEASE PVCF BRACH 90CM 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 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13152297
• MDR Text Key: 285698090
• Report Number: 9616099-2022-05248
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 466P306BU
• Device Lot Number: 1589771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male