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

Catalog Number UNKFILTER

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an unknown vena cava filter.The filter subsequently malfunctioned and caused injury and damage, including, but not limited to thrombosis in the inferior vena cava (ivc), tilt and perforation of the ivc filter struts through the ivc wall.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.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.The presence of a thrombosis in a vessel does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.The timing and mechanism of the tilt has not been reported at this time.The brief also reported perforation of the inferior vena cava; 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 an unknown vena cava filter.The filter subsequently malfunctioned and caused injury and damage, including, but not limited to thrombosis in the inferior vena cava (ivc), tilt and perforation of the ivc filter struts through the ivc wall.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

After further review of additional information received the following have been updated accordingly.Event: additional information received per the patient profile form (ppf), the patient reports fracture with retained struts in the ivc, perforation of the struts outside of the ivc, tilt, embedded in the ivc, blood clots, clotting and/or occlusion of the ivc.The patient discovered that his ivc filter fractured, tilted, embedded and suffered from blood clots, clotting and/or occlusion of the ivc on or around (b)(6) 2016.It is further reported that the filter was removed percutaneously and there was an unsuccessful percutaneous removal attempt of the fractured strut.The patient sought removal of his optease ivc filter where thrombus, tilt, perforation, embedment and fracture were reported.There is a remaining strut which was unable to be removed.The patient further reports lifetime anticoagulation.Thrombosis in the ivc, tilt, perforation of the ivc filter struts through the ivc, embedment, fracture and lifetime anticoagulation.These events have caused emotional distress, mental anguish, anxiety and stress.Per the medical records, (b)(6) 2016, there was a successful complex retrieval of an embedded and fractured optease ivc filter along with multiple filter fragments.Successful venoplasty for treatment of high grade ivc and common iliac stenosis.There was a small residual ivc pseudoaneurysm noted with no extravasation.As reported, the patient had placement of an optease ivc inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage, including, but not limited to thrombosis in the inferior vena cava (ivc), tilt and perforation of the ivc filter struts through the ivc wall.Per the patient profile form (ppf), the patient reports fracture with retained struts in the ivc, perforation of the struts outside of the ivc, tilt, embedded in the ivc, blood clots, clotting and/or occlusion of the ivc.It is further reported that the filter was removed percutaneously and there was an unsuccessful percutaneous removal attempt of the fractured strut.The filter was removed; however, there is a strut which was unable to be removed.The patient further reports lifetime anticoagulation.These events have caused emotional distress, mental anguish, anxiety and stress.Per the medical records, there was a successful complex retrieval of an embedded and fractured optease ivc filter along with multiple filter fragments.Successful venoplasty for treatment of high grade ivc and common iliac stenosis.There was a small residual ivc pseudoaneurysm noted with no extravasation.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.The instructions for use (ifu) states filter fracture with separation 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; 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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does 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 device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 8343128
• MDR Text Key: 136254163
• Report Number: 9616099-2019-02713
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 33 YR