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

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problem Not Applicable (3189)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.The device remains implanted and is not available for evaluation.Please note that the contact is not a medical professional but a more accurate choice is not available.As reported, a patient was treated with a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury, damage, including, but not limited to tilt.The filter remains implanted; thus, unavailable for analysis.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 in the legal brief, a patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury, damage, including, but not limited to tilt.As a direct and proximate result of these malfunctions, the patient suffered life- threatening 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

As reported, a patient was treated with a trapease inferior vena cava (ivc) filter which subsequently malfunctioned including, but not limited to tilt.Per the implant records, the indication was need for exploratory laparotomy surgery with history of deep vein thrombosis (dvt) and required an exploratory laparotomy.A veno cavogram evaluated the diameter and patency of the ivc and located the renal veins.The trapease filter was deployed into the infra-renal ivc.A follow up imaging demonstrated good positioning of the filter with no appreciable tilting or other abnormality.Per the patient profile form (ppf), the patient reports tilting of the filter, pain and anxiety.A ct scan confirms the reported tilt.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 in the legal brief, a patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury and damage, 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.Per the implant records the patient was reported to have a clinical history of deep vein thrombosis (dvt) and required an exploratory laparotomy, for which the filter was requested.The right brachial vein was accessed, and a wire was advanced through the heart into the inferior vena cava (ivc), where a catheter was placed, and a diagnostic venography was performed to evaluate patency of the ivc and renal veins.The trapease filter was then deployed without difficulty into the ivc in the juxtarenal position of the ivc.A follow up venography demonstrated good positioning of the filter with no appreciable tilting or other abnormality.According to the information received in the patient profile form (ppf), the patient reports tilting of the filter which was also reported by a computed tomography (ct) scan of the trapease filter, and further experienced pain and anxiety post implant, becoming aware of these events approximately fifteen years and four months after the filter implantation.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10520415
• MDR Text Key: 206507984
• Report Number: 1016427-2020-04373
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK WIRE, UNK PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 42 YR