MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problems Fracture (1260); Difficult to Remove (1528)

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

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient¿s pre-operative diagnosis was deep vein thrombosis (dvt) and history of pulmonary embolism.The filter was positioned below the renal veins and was deployed successfully.There were no report complications.The filter subsequently malfunctioned and caused injury and damage, including, but not limited to malfunction including fracture that required a complex removal under general anesthesia that causes injuries and damage to the patient.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and a stroke after the filter was placed.The filter was removed percutaneously.The patient also reports to be suffering from leg and groin pain.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.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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stroke is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may have contributed to this 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 an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage, including, but not limited to malfunction including fracture that required a complex removal under general anesthesia that causes injuries and damage to the patient.The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events, 119 months, 22 days post implantation.The ppf notes that patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and a stroke after his filter was placed.The filter was removed percutaneously.The patient also reports to be suffering from leg and groin pain.The patient mentioned that he cannot bend without feeling pain and discomfort which makes it difficult to sit down.According to the information received in the medical records, the patient¿s pre-operative diagnosis was for deep vein thrombosis (dvt) and history of pulmonary embolism.The filter was positioned below the renal veins and was deployed successfully.The delivery system was removed and pressure was applied to the femoral vein until hemostasis was achieved.There were no complications.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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: 8551755
• MDR Text Key: 143116874
• Report Number: 1016427-2019-02753
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Disability
• Patient Age: 51 YR