MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

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

Patient Problems Hematoma (1884); Thrombosis (2100)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown; said to be implanted in 2004.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of a trapease vena inferior cava filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: thrombus within the ivc filter.Approximately 15 years post implant, the patient underwent a limited thrombolysis and thrombectomy for thrombus within the ivc filter.The intemal aspect of the ivc filter was completely thrombosed, with a small component of thrombus that extended superiorly from the ivc filter.Approximately 24 days later, a ct scan indicated complete or near complete ivc thrombosis extending from the infrarenal filter through the bilateral common iliac veins with extension of thrombus into the right intemal iliac vein, as well as complete or near complete thrombosis of the entire iliac system and left femoral vein.Approximately 8 days later, the patient underwent an ultrasound that found he suffered from an extensive bilateral lower extremity dvt.Approximately 1 day later, the patient underwent a mechanical thrombectomy, thrombolysis, and ivc stenting during which procedure a stent had to be placed through the trapease filter, crushing it against the ivc wall.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 occlusive thrombosis within the filter and vasculature, with intervention, 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 a trapease vena cava filter and was discharged in good health.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: thrombus within the ivc filter.Approximately 15 years post implantation, the patient underwent a limited thrombolysis and thrombectomy after it was found that he suffered from a thrombus within the ivc filter.The intemal aspect of the ivc filter was completely thrombosed, with a small component of thrombus that extended superiorly from the ivc filter.Approximately 24 days later, the patient underwent a computerized tomography scan that indicated complete or near complete ivc thrombosis extending from the infrarenal filter through the bilateral common iliac veins with extension of thrombus into the right intemal iliac vein, as well as complete or near complete thrombosis of the entire iliac system and left femoral vein.Approximately 8 days later, the patient underwent an ultrasound that found he suffered from an extensive bilateral lower extremity dvt.Approximately 1 day later, the patient underwent a mechanical thrombectomy, thrombolysis, and ivc stenting during which procedure a stent had to be placed through the trapease filter, crushing it against the ivc wall.As a direct and proximate result of the failure of the trapease ivc filter, the patient suffered bodily injury and resulting in pain and suffering, disability, mental anguish, loss of capacity for enjoyment of life, expense of hospitalization, medical and nursing care and treatment, and will require ongoing medical care and monitoring for the rest of his life.The patients injuries are permanent and continuing and he will suffer such losses in the future.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a4, b3, b4, b5, b6, b7, g2, g3, g6, h1, h2 and h6.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter and was discharged in good health.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: thrombus within the inferior vena cava (ivc) filter.Approximately 15 years post implantation, the patient underwent a limited thrombolysis and thrombectomy after it was found that he suffered from a thrombus within the ivc filter.The internal aspect of the ivc filter was completely thrombosed, with a small component of thrombus that extended superiorly from the ivc filter.Approximately 24 days later, the patient underwent a computerized tomography scan that indicated complete or near complete ivc thrombosis extending from the infrarenal filter through the bilateral common iliac veins with extension of thrombus into the right internal iliac vein, as well as complete or near complete thrombosis of the entire iliac system and left femoral vein.Approximately 8 days later, the patient underwent an ultrasound that found they suffered from an extensive bilateral lower extremity deep vein thrombosis (dvt).Approximately 1 day later, the patient underwent a mechanical thrombectomy, thrombolysis, and ivc stenting during which procedure a stent had to be placed through the trapease filter, crushing it against the ivc wall.As a direct and proximate result of the failure of the trapease ivc filter, the patient suffered bodily injury and resulting in pain and suffering, disability, mental anguish, loss of capacity for enjoyment of life, expense of hospitalization, medical and nursing care and treatment, and will require ongoing medical care and monitoring for the rest of his life.The patients injuries are permanent and continuing and he will suffer such losses in the future.Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt), pulmonary embolism (pe), hyperlipidemia and hypertension.Approximately 11 years post implantation, the patient was diagnosed with years coronary artery disease (cad) for which a drug eluting stent was placed in the left anterior descending artery (lad).Approximately 13 years post implantation, the patient was diagnosed with basal cell carcinoma.Approximately 15 years post implantation, the patient was diagnosed with the following: paroxysmal atrial fibrillation, tricuspid valve regurgitation, tinnitus, benign prostatic hypertrophy (bph) and the patient had a seizure due to spontaneous subdural hematoma, while on coumadin.Approximately 17 years post implantation, the patient was diagnosed with shingles on the nose with a secondary infection.

Manufacturer Narrative

As reported a patient underwent placement of a trapease vena cava filter and was discharged in good health.The filter subsequently malfunctioned and caused thrombus within the ivc filter.The information further indicated that approximately 15 years post implant, the patient underwent a limited thrombolysis and thrombectomy after thrombus was found within the ivc filter.The internal aspect of the ivc filter was completely thrombosed, with a small component of thrombus that extended superiorly from the ivc filter.Approximately 24 days later, the patient underwent a computerized tomography (ct) scan that indicated complete or near complete ivc thrombosis extending from the infrarenal filter through the bilateral common iliac veins with extension of thrombus into the right internal iliac vein, as well as complete or near complete thrombosis of the entire iliac system and left femoral vein.Approximately 8 days later, the patient underwent an ultrasound that showed extensive bilateral lower extremity dvt.Approximately 1 day later, the patient underwent a mechanical thrombectomy, thrombolysis, and ivc stenting during which procedure a stent had to be placed through the trapease filter, crushing it against the ivc wall.According to the medical records the patient had a history of deep vein thrombosis (dvt), pulmonary embolism (pe), hyperlipidemia and hypertension.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.Blood clots, clotting, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature does not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.There is nothing in the information provided 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.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9488386
• MDR Text Key: 174663742
• Report Number: 1016427-2019-03693
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 84 KG