MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; VENA CAVA FILTER

Model Number N/A

Device Problems Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a trapease 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.  as reported, an unspecified period of time after placement of a trapease, the filter subsequently malfunctioned and caused injury and damages to including, but not limited to, tilt, blood clots, clotting and occlusion of the ivc, with subsequent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages requiring extensive medical care and treatment.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  the trapease 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.Dvt, blood clots and thrombosis/occlusion within the ivc does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.The brief also reported filter tilt.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.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 in wright vs.Cordis, an unspecified period of time after placement of a  trapease, the filter subsequently malfunctioned and caused injury and damages to including, but not limited to, tilt, blood clots, clotting and occlusion of the ivc, with subsequent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages requiring extensive medical care and treatment.

Manufacturer Narrative

The medical records indicate that the patient has a history of pulmonary embolism, deep vein thrombosis (dvt), and gastrointestinal bleeding.The vena cava filter was deployed below the renal vein.The filter was successfully deployed and no complications were reported.According to the patient profile form (ppf) the patient experienced perforation by the filter struts outside the inferior vena cava.It also stated that the device was unable to be retrieved; however, there were no document attempts to remove the device.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of pulmonary embolism, deep vein thrombosis (dvt), and gastrointestinal bleeding.The vena cava filter was deployed below the renal vein.The filter was successfully deployed and no complications were reported.The filter subsequently malfunctioned and caused injury and damages to including, but not limited to, tilting, blood clots, clotting and occlusion of the ivc, with subsequent deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient reportedly suffered life-threatening injuries and damages requiring extensive medical care and treatment.Per the patient profile form (ppf), the patient experienced perforation by the filter struts outside the inferior vena cava.It also stated that the device was unable to be retrieved, although there were no documented attempts to remove the device.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot (15607873) revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.The trapease 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is 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.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 also reported that there was 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.Blood clots 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel 33152 ; EI 33152
• MDR Report Key: 6667239
• MDR Text Key: 78398957
• Report Number: 1016427-2017-00398
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15607873
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2017
• Date Manufacturer Received: 01/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN WIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR