MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

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

Patient Problems Occlusion (1984); Swelling (2091); Thrombosis (2100); No Code Available (3191)

Event Date 05/05/2011

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned, including, but not limited to, caval thrombosis, and caused injury and damages to the patient.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, and pain and suffering, and other damages.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.Blood clots and thrombosis within the filter and vasculature do not represent a device malfunction.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 by the legal brief, the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned, including, but not limited to, caval thrombosis, and caused injury and damages to the patient.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, and pain and suffering, and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of deep vein thrombosis (dvt), pulmonary thromboendarterectomy (pte) and cardiomyopathy.During the filter placement procedure via the right common femoral vein, the filter was deployed without any immediate complication in the ivc caudal to the renal veins.The filter subsequently malfunctioned, including, but not limited to, caval thrombosis, and caused injury and damages to the patient.Per the patient profile form (ppf), the patient became aware of the alleged events forty-one days post implantation.The patient reports blood clots, clotting, occlusion of the inferior vena cava (ivc) and that the filter is unable to be retrieved.However, there have been no known attempts made to remove the filter.The patient also reports to be suffering from mental anguish, anxiety, stress, swelling, engorging of veins, altered gait, and venous cramping.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Varicose veins, swelling and abnormal gait do not represent a device malfunction and may be related to underlying patient related issues.Anxiety does 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.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events forty-one days post implantation.The patient reports to be suffering from blood clots, clotting, occlusion of the inferior vena cava (ivc) and that the filter is unable to be retrieved.However, there have been no known attempts made to remove the filter.The patient also reports to be suffering from mental anguish, anxiety, stress, swelling, engorging of veins, altered gait, and venous cramping.According to the information received in the medical records, the patient has a history of deep vein thrombosis (dvt), pulmonary thromboendarterectomy (pte) and cardiomyopathy.During the filter placement procedure via the right common femoral vein, the filter was deployed without any immediate complication in the ivc caudal to the renal veins.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7383013
• MDR Text Key: 103875431
• Report Number: 1016427-2018-01322
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 05/04/2018; 06/07/2018
• Supplement Dates FDA Received: 06/02/2018; 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR