MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466FXXXX

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

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Perforation of Vessels (2135)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Description of problem or event: as reported, the patient had placement of an unknown inferior vena cava (ivc) filter.The indication for filter was recurrent deep vein thrombosis and pulmonary embolus with an inability to tolerate coumadin.The patient has a history of blood clots and unspecified cancer.The patient is allergic to intravenous (iv) dye.The filter was deployed under direct fluoroscopic visualization.After placement of the filter, marcaine and kenalog were injected into the patient's mcburney incision.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation of filter struts outside the inferior vena cava wall.A ct scan, done approximately twelve years and eight months after the index procedure, indicates that the filter is in place with the superior tip position approximately 1.3 cm below the renal veins and the device appears to be an optease filter.The ct scan revealed that the orientation appears to be normal without significant tilt.Strut penetration is below 2 mm.Diffuse hepatic steatosis and mild atelectasis at the lung bases were observed.Per the patient profile form (ppf), the patient reports blood clots, abdominal pain, back pain, chest pain, rapid heart pain, pelvis pain, leg pain, lightheadedness and can't perform sexual intercourse.The form also states that the patient has had two lung scopes and has a blood clot in one lung.The operative notes and the ppf state that the implanted device is a trapease vena cava filter.The legal brief states that the device is an optease vena cava filter.The ct scan states that the implanted device appears to be an optease vena cava filter.Neither a catalog number nor lot number were provided.As such, the implanted device is currently unknown.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 cordis vena cava filters are 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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Sexual dysfunction, lightheadedness and pain do 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.Should additional information become available, the file will be updated accordingly.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an unknown vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to: perforation of filter struts outside the inferior vena cava wall.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 operative report medical records indicate that the device was implanted for the indication of recurrent deep vein thrombosis and pulmonary embolus with an inability to tolerate coumadin.The patient has a history of blood clots and unspecified cancer.The patient is allergic to intravenous (iv) dye.  the filter was deployed via the right femoral vein under direct fluoroscopic visualization.As the patient is allergic to iv dye, a venogram was not performed.After placement of the filter, marcaine and kenalog were injected into the patient's mcburney incision.The results of computed tomography (ct) scans done approximately twelve years and eight months after the index procedure indicate that the filter is in place with the superior tip position approximately 1.3 cm below the renal veins and the device appears to be an optease filter.The ct scan revealed that the orientation appears to be normal without significant tilt.Strut penetration is below 2 mm.Diffuse hepatic steatosis and mild atelectasis at the lung bases were observed.The patient profile form (ppf) states that the patient experienced blood clots, abdominal pain, back pain, chest pain, rapid heart pain, pelvis pain, leg pain, lightheadedness and can't perform sexual intercourse.The form sates that the patient has had two lung scopes and has a blood clot in one lung.The operative notes and the ppf state that the implanted device is a trapease vena cava filter.The legal brief states that the device is an optease vena cava filter.The ct scan states that the implanted device appears to be an optease vena cava filter.Neither a catalog number nor lot number were provided.As such, the implanted device is currently unknown.

• Brand Name: UNKNOWN VENA CAVA FILTER
• 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: 8607460
• MDR Text Key: 144962265
• Report Number: 1016427-2019-02822
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR