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

Model Number 466P306X

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

Patient Problems Occlusion (1984); Thrombosis (2100); Stenosis (2263)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

As reported, 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, stenosis.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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The inferior vena cava (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 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.A stenosis is an abnormal narrowing in a blood vessel.Without medical records available, it is not possible to determine the location/cause of the stenosis.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 b the legal team, 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, stenosis.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

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported failures ten years and a month post implantation after undergoing a computerized tomography (ct) scan.The scan noted the stenosis appeared in the lumen of the filter.The patient reports to have blood clots, clotting and occlusion of the inferior vena cava (ivc) and to be suffering from pain, mental anguish, anxiety and stress.According to the information received in the medical records, the patient has a history of pulmonary embolus and intracranial hemorrhage.During the filter placement procedure, the filter was deployed from the l1-2 inferiorly.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

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 stenosis, identified in a computerized tomography (ct) scan performed ten years and one-month post filter implant.The scan noted the stenosis appeared in the lumen of the filter.The patient is also reported to have experienced blood clots, clotting and occlusion of the inferior vena cava (ivc) and pain, mental anguish, anxiety and stress.The indication for the filter implant was a history of pulmonary embolus and intracranial hemorrhage.The filter was placed and deployed via the right common femoral vein.Procedural findings note the ivc is of normal caliber with no filling defect and the renal veins entered l1 bilaterally and the filter extends from l1-2 inferiorly.There is currently no additional information available.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 inferior vena cava (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 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.A stenosis is a narrowing in a blood vessel.Without the procedural films or post-placement imaging and the limited information provided, the report of stenosis, blood clots, clotting and occlusion of the ivc could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Without medical records available it is not possible to determine the location/cause of the stenosis.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7213111
• MDR Text Key: 98004612
• Report Number: 1016427-2018-01078
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• 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
• Distributor Facility Aware Date: 12/26/2017
• Date Manufacturer Received: 05/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR