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

Model Number 466P306BU

Device Problem Unintended Movement (3026)

Patient Problems Perforation of Vessels (2135); Stenosis (2263); Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Reporter 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 information provided indicated that the filter subsequently malfunctioned and caused filter tilt and the inferior vena cava (ivc) is stenosed.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.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.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.

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 is tilted and the inferior vena cava (ivc) is stenosed.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

After further review of additional information received.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 tilt and the inferior vena cava (ivc) is stenosed.The patient reported becoming aware of perforation of filter strut(s) outside the ivc and filter embedded in wall of the ivc, approximately twelve years and two months post implant.The patient also reported experiencing leg and stomach swelling and leg pain.According to the medical records, the patient had a history of depression, migraine, peripheral neuropathy, calculus kidney, cellulitis in left foot, degenerative joint disease in left knee, degenerative disc disease in lumbosacral spine with radiculopathy, insomnia, edema in leg, closed metatarsal fracture, back pain, saddle embolus, hypertension, gastroesophageal reflux disease, deep vein thrombosis, obesity and in remission for opioid abuse.The indication for hospital admission was saddle pulmonary embolism with shortness of breath while at rest and chest pain.Diagnostics studies revealed extensive bilateral pe with a saddle embolus extending along the main pulmonary artery.The right lower extremity was positive for dvt in the popliteal vein to the distal superficial femoral vein.The patient was treated with tissue plasminogen activator, heparin, lovenox and coumadin.The ivc filter was implanted the day after the patient was admitted.The patient was discharged to home six days post implant.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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Trapease ivc filters are indicated for permanent placement.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Stomach swelling does not represent a device malfunction and may be related to underlying patient specific issues and /or comorbidities.Without imaging available for review the events 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, d6a.Date changed from (b)(6) 2009 to (b)(6) 2009.

Event Description

Additional information received per the medical records state that the patient has a history of depression, migraine, peripheral neuropathy, calculus kidney, cellulitis in left foot, degenerative joint disease in left knee, degenerative disc disease in lumbosacral spine with radiculopathy, insomnia, edema in leg, closed metatarsal fracture, back pain, saddle embolus, hypertension, gastroesophageal reflux disease, deep vein thrombosis, obesity and in remission for opioid abuse.The indication for hospital admission was saddle pulmonary embolism with shortness of breath while at rest and chest pain.The patient was treated with heparin infusion, lovenox and coumadin.The trapease inferior vena cava (ivc) filter was implanted the day after the patient was admitted.The patient was discharged to home six days after the filter implantation.As reported by another legal brief, the patient experienced filter perforation.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the ivc and filter embedded in wall of the ivc.The patient became aware of the reported events approximately twelve years and two months after the index procedure.The patient also experienced leg swelling, swollen stomach and leg pain.

Event Description

Additional information received per the medical records indicate that the patient has a history of chronic back pain (six back surgeries), residual left lower extremity weakness, toxic overdose and chronically immobile.The patient presented to the emergency room (er) with shortness of breath, chest pain, diaphoresis, nausea and worsening left leg swelling.The indication for the filter implant was saddle pulmonary embolism with proximal clot in the popliteal vein and deep vein thrombosis of the right leg.The filter was placed via the right brachial vein and was deployed in good position with the tip at the top of the l2 level.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 eleven years and two months after the index procedure.The patient also reports mental anguish related to the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a4, b4, b5, b6, g3, g6, h1, h2, h4 and h6.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 tilt and the inferior vena cava (ivc) is stenosed.The patient reported becoming aware of perforation of filter strut(s) outside the ivc and filter embedded in wall of the ivc, approximately twelve years and two months post implant.The patient also reported experiencing leg and stomach swelling and leg pain.According to the medical records, the patient had a history of depression, migraine, peripheral neuropathy, calculus kidney, cellulitis in left foot, degenerative joint disease in left knee, degenerative disc disease in lumbosacral spine with radiculopathy, insomnia, edema in leg, closed metatarsal fracture, back pain, saddle embolus, hypertension, gastroesophageal reflux disease, deep vein thrombosis, obesity and in remission for opioid abuse.The indication for hospital admission was saddle pulmonary embolism with shortness of breath while at rest and chest pain.Diagnostics studies revealed extensive bilateral pe with a saddle embolus extending along the main pulmonary artery.The right lower extremity was positive for dvt in the popliteal vein to the distal superficial femoral vein.The patient was treated with tissue plasminogen activator, heparin, lovenox and coumadin.The ivc filter was implanted the day after the patient was admitted.The patient was discharged to home six days post implant.Additional medical history noted chronic back pain (six back surgeries), residual left lower extremity weakness, toxic overdose and chronically immobile.The patient presented to the emergency room (er) with shortness of breath, chest pain, diaphoresis, nausea and worsening left leg swelling.The indication for the filter implant was saddle pulmonary embolism with proximal clot in the popliteal vein and deep vein thrombosis of the right leg.The filter was placed via the right brachial vein and was deployed in good position with the tip at the top of the l2 level.The patient subsequently reported becoming aware of filter tilt approximately eleven years and two months post implant and anxiety related to the filter.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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Trapease ivc filters are indicated for permanent placement.Stenosis is an abnormal narrowing of a vessel; this does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Stomach swelling does not represent a device malfunction and may be related to underlying patient specific issues and /or comorbidities.Without imaging available for review the events could not be confirmed nor a cause attributed.Anxiety is an emotion characterized by an unpleasant state of inner turmoil, often accompanied by nervous behavior, somatic complaints, and rumination.The physiological symptoms of anxiety may include, but are not limited to neurological, respiratory, cardiac, muscular, and cutaneous.These symptoms of anxiety do 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12255127
• MDR Text Key: 264469102
• Report Number: 1016427-2021-05192
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009475
• UDI-Public: 20705032009475
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306BU
• Device Catalogue Number: 466P306BU
• Device Lot Number: R0308499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Race: White