MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problem Failure to Align (2522)

Patient Problems Cellulitis (1768); Embolus (1830); Occlusion (1984); Perforation (2001); Phlebitis (2004)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of optease vena cava filter.Approximately 7 years, 9 months the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient, suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require 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.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 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.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt has not been reported at this time.The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.However, 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 by the legal brief, the patient underwent placement of defendants¿ optease vena cava filter.Approximately 7 years, 9 months the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient, suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require 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

Additional information received per the medical records indicate that the patient has a history of multiple lower extremity pulmonary embolism with failure to anticoagulate, a history of nausea and a history of vomiting.The filter was deployed via the common femoral vein.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava, thrombophlebitis in both legs with chronic swelling and ulcerations.The patient was hospitalized several times for infection, abscess formation at the site of the thrombi and cellulitis.The patient fears the filter may cause more injuries.The ppf also states that there was an unsuccessful removal procedure approximately seven years after implantation.The results of computed tomography (ct) scans done approximately 7 years, 9 months after the index procedure indicate that the filter extends from the inferior l3 vertebral body to the l4-l5 disc space.A total of six prongs perforated the inferior vena cava.The ct scan revealed that the maximum distance of prong perforation is 4 mm.The scan images also show a 3-degree tilt right to left.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of multiple pulmonary embolism with failure of anticoagulation, a history of nausea and vomiting.The filter was deployed via the common femoral vein and there are no reports of complications.Approximately 7 years, 9 months the patient had a ct scan, revealing that the filter had subsequently malfunctioned and caused injury and damages to the patient, including but not limited to, the filter was significantly tilted and at least six struts were significantly perforating the inferior vena cava (ivc).Per the patient profile form (ppf), the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava, thrombophlebitis in both legs with chronic swelling and ulcerations.The patient was hospitalized for infections, with abscess formation at the site of the thrombi and cellulitis.The ppf also states that there was an unsuccessful removal procedure approximately seven years after implantation.The results of the ct scan indicate that the filter extends from the inferior l3 vertebral body to the l4-l5 disc space.A total of six prongs perforated the inferior vena cava.The ct scan revealed that the maximum distance of prong perforation is 4 mm.The scan images also show a 3-degree tilt right to left.The patient reports fear.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 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, thrombophlebitis, and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.Anxiety and cellulitis 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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7145560
• MDR Text Key: 95736218
• Report Number: 1016427-2017-00905
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 466F220A
• Device Lot Number: 14146195
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 5-FRENCH SHEATH; UNKNOWN CATHETER; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 52 YR