MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hemorrhage, Cerebral (1889); Thrombosis (2100)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Implant date was on or about (b)(6) 2007.As reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt¿s), severe and persistent chest pain, shortness of breath, and stroke.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The inferior 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Without medical records available for review, the cause of the chest pain, shortness of breath and stroke is unknown.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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, the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt¿s), sever and persistent chest pain, shortness of breath, and stroke.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and require extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient had a massive pulmonary emboli, was contraindicated for anticoagulation therapy and was at risk for recurrent pulmonary embolism.The filter was deployed via the femoral vein into the l3 position.There was no tilt and there were no complications during the index procedure.Additional information received per the patient profile form (ppf) states that four years and eight months after implantation, the device was removed percutaneously.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 injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt¿s), severe and persistent chest pain, shortness of breath, and stroke.The indication for the filter implant was massive pulmonary embolism (pe), a contraindication for anticoagulation and risk for recurrent pe.At the time of the implant the patient was in the intensive care unit on full support.The filter was placed via the femoral vein and deployed at the l3 level, the renal veins were identified at the l1-l2 level.There was no tilt and there were no complications during the index procedure.Following this compression was held to the right groin in preparation for a hemodialysis catheter.Approximately four years and eight months after implantation, the device was removed percutaneously.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 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.With the limited information provided it is not possible to determine what factors may have contributed to the reported events of stroke, deep vein thrombosis, chest pain and shortness of breath.It is unknown if the stroke was embolic or hemorrhagic in nature.These events do not represent a device malfunction.The trapease filter is not indicated for use in the prevention of dvt.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Review of the information provided does not suggest that there is 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g4, g7, h1 and h2.Section b5: additional information received per an amended patient profile form (ppf) states that the patient experienced fear of future failure.As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was massive pe (pulmonary embolism) with contraindication for anticoagulation.The filter was deployed at the l3 position.There was no tilt and no reported complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt¿s), severe and persistent chest pain, shortness of breath, and stroke.Per the patient profile form (ppf), the filter was successfully removed approximately 4.5 years after implant.Further the patient reports fear.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.Stroke is a known potential adverse event associated to the use of the ivc filters, in this case, the stroke is probably related to the underlying coagulation issues that predate the filter implant.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Chest pain and shortness of breath 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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7448105
• MDR Text Key: 106136628
• Report Number: 1016427-2018-01413
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 07/18/2018; 11/07/2019
• Supplement Dates FDA Received: 08/01/2018; 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 71 YR