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

Catalog Number 466P306AU

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

Patient Problems Embolus (1830); Hemorrhage, Cerebral (1889); Occlusion (1984)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, a stroke.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.Stroke is a known potential adverse event associated with the ivc filter devices, with the available information it is not possible to assess other contributing factors to the reported event.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 trapease vena cava filter.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, a stroke.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

After further review of additional information received, the following sections have been updated accordingly.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 and pulmonary embolisms while on anticoagulant therapy.Because he had a recent history of falls, the patient was deemed to not be a good candidate to continue anticoagulation therapy.A venacavogram was done and the trapease filter was placed below the renal veins without any reported complications.The filter subsequently malfunctioned and case injury and damages to the patient, including, but not limited to, a stroke.Per the patient profile form (ppf), the patient reports fear, blood clots, clotting, and/or occlusion of the inferior vena cava.The filter has been in place more than ninety days, too risky to attempt retrieval and future perforation and fracture are likely.There were no documented attempts to remove the device.The filter remains implanted; thus, unavailable for analysis.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 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 with the use of the ivc filter products and is listed as such in the ifu, the underlying coagulopathy issues may have contributed to the reported event.Does not represent a device malfunction and may be related to underlying patient related issues.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis and pulmonary embolisms while on anticoagulant therapy.Because he had a recent history of falls, the patient was deemed to not be a good candidate to continue anticoagulation therapy.A venacavogram was done and the trapease filter was placed below the renal veins without any reported complications.Additional information received per the patient profile form (ppf) states that the patient experienced fear, blood clots, clotting, and/or occlusion of the inferior vena cava.The patient became aware of these events approximately seven years and three weeks after the index procedure.The filter has been in place more than ninety days, too risky to attempt retrieval and future perforation and fracture are likely.There were no documented attempts to remove the device additional information is pending and will be submitted within 30 days of receipt.

• 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
• MDR Report Key: 7430437
• MDR Text Key: 105454777
• Report Number: 1016427-2018-01375
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15069926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6-FRENCH SHEATH.
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 73 YR