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

Catalog Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/21/2021

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 information provided indicated that the filter subsequently malfunctioned and caused clot in filter, stenosis, caval thrombosis, filter embedment and complex removal.The indication for the filter implant, procedural details and medical history of the patient 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is 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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Trapease ivc filters are indicated for permanent placement.Stenosis, blood clots, clotting, and occlusion of the device or vasculature do not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.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 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

After further review of additional information received, the following sections have been updated accordingly: a1, b3, b4, b5, b7, d10, g2, g3, g6, h1, h2 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.The patient reported becoming aware of filter tilt approximately ten years and one month post implant.The patient also reported vasovagal syncope, random weakness in legs that causes falling, limited ability to walk, shortness of breath, back pain and anxiety.According to the medical record the indication for the filter implant was a history of pulmonary embolism, lower extremity deep vein thrombosis (dvt), gastrointestinal bleeding and inability to take oral anticoagulation treatment.The filter was placed via the right femoral vein and deployed below the level of the renal veins.A post-procedural angiograph revealed adequate placement of the filter.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.Due to the nature of the complaint the reported vasovagal syncope, leg weakness, shortness of breath, back pain and anxiety could not be further clarified.These events 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of pulmonary embolism, lower extremity deep vein thrombosis (dvt), gastrointestinal bleeding and inability to take oral anticoagulation treatment.The filter was deployed via the patient's right femoral vein.It was placed below the level of the renal veins.A post-procedural angiograph revealed adequate placement of the filter.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt.The patient became aware of the reported events approximately ten years and one months after the index procedure.The patient also experienced vasovagal syncope, random weakness in legs that cause falling, limited ability to walk, shortness of breath, back pain and anxiety.

• 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 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12387724
• MDR Text Key: 280456315
• Report Number: 1016427-2021-05356
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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: 12/06/2021
• 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 6 FRENCH ANGLE PIGTAIL CATHETER; UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male