MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

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

Patient Problems Pulmonary Embolism (1498); Cardiopulmonary Arrest (1765); Coagulation Disorder (1779); Occlusion (1984)

Event Date 06/09/2016

Event Type  Death  

Manufacturer Narrative

The exact implant date is unknown.The date of death is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion.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, pulmonary embolism resulting in untimely death.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.A device malfunction has not been reported at this time.Without the cause of death being provided and the limited information regarding the patient¿s medical history it is not possible to determine what factors may have contributed to the reported events.Given the limited information currently available for review, there is nothing to suggest that 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.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, pulmonary embolism resulting in untimely death.The patient suffered fatal injuries, damages, and untimely death.

Manufacturer Narrative

Concomitant medical products and therapy dates: unknown 6 french sheath, boston scientific guidewire, cordis 8 french trapease sheath.The implant date was confirmed to be accurate.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, pulmonary embolism resulting in untimely death.The patient suffered fatal injuries, damages, and untimely death.The following additional information was received per the patient¿s medical records: patient had a history of hypertension and left sided weakness, left lower extremity deep vein thrombosis.Pre-operative diagnosis was patient had a left lower extremity deep vein thrombosis, acute right-sided hemisphere cerebrovascular accident with left-side deficit.Patient was felt not to be a candidate for anticoagulation therapy with heparin and coumadin.The filter was deployed by unwrapped sheath at the level l3 and l4 and follow-up ivc venocavogram documented good filter placement.According to certificate of death, patient passed away 3 years 5 months post implantation due to cardiopulmonary arrest, and pulmonary embolism.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.

Manufacturer Narrative

After further review of additional information received the following sections and have been updated accordingly.Describe event or problem: the following additional information was received per the patient¿s medical records: patient had a history of hypertension and left sided weakness, left lower extremity deep vein thrombosis.Pre-operative diagnosis was patient had a left lower extremity deep vein thrombosis, acute right-sided hemisphere cerebrovascular accident with left-side deficit.Patient was felt not to be a candidate for anticoagulation therapy with heparin and coumadin.The filter was deployed by unwrapped sheath at the level l3 and l4 and follow-up ivc venocavogram documented good filter placement.According to certificate of death, patient passed away 3 years 5 months post implantation due to cardiopulmonary arrest, and pulmonary embolism.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.In addition, the patient reports discomfort, neck pain, chest pain, and leg pain.Corrected data: brand name, if implanted, give date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava and a post implant pulmonary embolism resulting in death.The patient also reportedly experienced discomfort, neck, chest and leg pain.The patient had a history of hypertension and experienced an acute right-sided hemisphere cerebrovascular accident with left-side deficit prior to the filter implant.The indication for the filter implant was a left lower extremity deep vein thrombosis and the patient was felt to not be a candidate for anticoagulants.The filter was placed via the right femoral vein and deployed at the level of l3-l4, below the level of the renal veins.A death certificate that was provided indicated that the patient expired 3 years and 5 months post implant due to cardiopulmonary arrest due to pulmonary embolism.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.There are possible patient and pharmacological factors that may have contributed to the reported events.A device malfunction has not been reported at this time.Neck, chest and leg discomfort was also reported, with the limited information provided it is not possible to determine what factors might have contributed to the reported discomfort, however, they may be related to underlying patient specific issues.Given the limited information currently available for review, there is nothing to suggest that 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 7845729
• MDR Text Key: 119206118
• Report Number: 1016427-2018-01772
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15753480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2019
• 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): Death
• Patient Age: 84 YR
• Patient Weight: 55