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

Catalog Number 466P306X

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Occlusion (1984); Thrombosis (2100)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an trapease vena cava filter and for which the catalog and lot numbers are not currently available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease permanent vena cava filter.The following additional information received per the patient profile form (ppf) indicates that on or about five years post implantation the filter was tilted, the patient had blood clots, clotting, occlusion of the inferior vena cava (ivc) and the filter was unable to be retrieved, although there have been no documented attempts made.The patient reported to have lost use of the legs, amputation of the toes and part of the foot due to loss of circulation from extreme filter occlusion.The patient also reported to have kidney damage due to deep vein thrombosis (dvt) of the renal vein, extreme anxiety up until death.The cause of death is unknown.According to the medical records, the patient had a history of recurrent pulmonary emboli and was contraindicated for coumadin as the patient had suffered gastrointestinal (gi) hemorrhage.The filter was successfully deployed below the renal veins during the index procedure and the patient was returned to the intensive care unit in stable condition.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease permanent vena cava filter.The indication for the filter implant was recurrent pulmonary embolus (pe) with a contraindication to anti-coagulant therapy as a result of a gastrointestinal hemorrhage.The following information received in the patient profile form (ppf) indicates that on or about five years post implantation the filter was tilted, the patient had blood clots, clotting, occlusion of the inferior vena cava (ivc) and the filter was unable to be retrieved, although there have been no documented attempts made.The patient reported to have lost use of the legs, amputation of the toes and part of the foot due to loss of circulation from extreme filter occlusion.The patient also reported to have kidney damage due to deep vein thrombosis (dvt) of the renal vein, extreme anxiety up until death.The cause of death is unknown.According to the medical records, the patient had a history of recurrent pulmonary emboli and was contraindicated for coumadin as the patient had suffered gastrointestinal (gi) hemorrhage.The filter was successfully deployed below the renal veins during the index procedure and the patient was returned to the intensive care unit in stable condition.The product was not returned for analysis and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.The trapease 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 and retrieval difficulty could not be confirmed.Additionally, the timing and mechanism of the filter tilt and retrieval difficulty is unknown.Clotting, deep vein thrombosis, and device occlusion related to clotting, and embedded in the wall do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the patient history, procedural films and post-implant imaging available for review, the reported events and a device malfunction could be confirmed.The reported information indicates that the patient had lost use of the legs, amputation of the toes and part of the foot due to loss of circulation from extreme filter occlusion.The patient also reported to have kidney damage due to deep vein thrombosis (dvt) of the renal vein, extreme anxiety up until death.With the limited information provided it is not possible to draw a conclusion between the reported event and the device.Additionally, anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Without the cause of death being provided and the limited information regarding the patient¿s medical history it is not possible to determine what factors may have contributed to the patient expiring.Given the limited information available for review, there is nothing to suggest that there is a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease permanent inferior vena cava (ivc) filter.According to the medical records, the patient had a history of recurrent pulmonary emboli and was contraindicated for coumadin as the patient had suffered gastrointestinal (gi) hemorrhage.The filter was successfully deployed below the renal veins during the index procedure and the patient was returned to the intensive care unit in stable condition.Per the patient profile form (ppf), approximately five years post implantation the filter was tilted, the patient had blood clots, clotting, occlusion of the inferior vena cava (ivc) and the filter was unable to be retrieved, although there have been no documented attempts made.The patient reported loss of use of the legs, amputation of the toes/foot from extreme filter occlusion.The patient also reported to have kidney damage due to deep vein thrombosis (dvt) of the renal vein, extreme anxiety up until death.The cause of death is unknown.According to the information received in the patient profile short form, the patient reported migration of the device.The filter is 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 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.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Death is a known adverse outcome associated with the use of the trapease filter; however, in this unfortunate case, the cause of death is unknown therefore contributing factors cannot be adequately assessed.Blood clots, deep vein thrombosis 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.After further review of additional information received the following sections have been updated accordingly.

Manufacturer Narrative

According to the information received in the patient profile short form, the patient reported migration of the device.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: 7058067
• MDR Text Key: 92898079
• Report Number: 1016427-2017-00830
• 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,Followup,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/25/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 05/31/2018; 07/06/2018
• Supplement Dates FDA Received: 12/28/2017; 06/28/2018; 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR