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

Model Number 466P306X

Device Problems Fracture (1260); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted when received.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, dvt, caval thrombosis, and thrombis within filter.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, pain and suffering, and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, dvt (deep vein thrombosis), caval thrombosis, and thrombosis within filter.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 optease 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, dvt and occlusive thrombosis within the filter and vasculature 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.

Manufacturer Narrative

As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, a trapease inferior vena cava (ivc) filter was deployed below the level of the renal veins via the right common femoral vein approach.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, dvt, caval thrombosis, and thrombus within filter.Per the patient profile from (ppf), the patient reports perforation of filter struts outside the ivc, perforation of filter struts into organs, filter embedded other than in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc.Approximately four years post implantation, the patient was had deep vein thrombosis (dvt).Approximately eleven years and seven months post implantation, the patient underwent percutaneous removal of the ivc filter.The patient states that there are fractured filter struts retained in their body and that the ivc filter was crushed.The patient reports that because the filter was clogged, they could not receive an ablation for their atrial fibrillation (a-fib) and instead needed major surgery ¿a mini-maze¿ to connect their a-fib.The patient states that to suffer from a-fib, dvt, varicosities legs, peripheral venous insufficiency, and collateral circulation.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.Kink/bent shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was reported that there was perforation of the ivc and surrounding structures; 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Varicose veins, venous peripheral insufficiency, and collateral circulation do not represent device malfunctions and may be related to underlying patient specific 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.

Manufacturer Narrative

The following additional information received per the medical records indicate a trapease inferior vena cava (ivc) filter was deployed below the level of the renal veins via the right common femoral vein approach.According to the information received in the patient profile from (ppf), approximately on or about eleven years and four months post implantation of the ivc filter the patient became aware of the alleged events and reports to have perforation of filter struts outside the ivc, perforation of filter struts into organs, filter embedded other than in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc.Approximately on or about four years post implantation, the patient was diagnosed with a deep vein thrombosis (dvt).Approximately on or about eleven years and seven months post implantation, the patient underwent percutaneous removal of the ivc filter.The patient states that there are fractured filter struts retained in their body and that the ivc filter was crushed.The patient reports that because the filter was clogged, they could not receive an ablation for their atrial fibrillation (a-fib) and instead needed major surgery ¿a mini-maze¿ to connect their a-fib.The patient states that to suffer from a-fib, dvt, varicosities legs, peripheral venous insufficiency, and collateral circulation.Device code '3191' was used since no code is available for 'kinked/bent - strut - in patient' patient code (b)(6) was used since no code is available for 'varicose veins,' 'venous peripheral insufficiency,' 'collateral circulation.' additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8374228
• MDR Text Key: 137300093
• Report Number: 1016427-2019-02565
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR