MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); No Code Available (3191)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Please note: weight is unknown.Please note expiration date is unknown.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep vein thrombosis (dvt).The device was placed in the renal vein.The device in the patient was positively identified by medical records.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside his body.According to the information provided on the patient profile form (ppf), the filter has tilted and is unable to be retrieved, however there are no documented attempts to retrieve the filter.The ppf indicated that the patient was hospitalized due to a clogged filter and that the patient is suffering from mental anguish related to the device.The medical records indicate that the device was implanted due to recurrent deep vein thrombosis (dvt) while on anticoagulation.The device was implanted via the left femoral vein and deployed approximately 3-4 cm below the level of the renal veins.The patient was taken to the recovery room in stable condition at the conclusion of the procedure.Approximately nine years later a computerized tomography (ct) scan of the abdomen was performed due to a history of cholecystectomy and hiatal hernia repair and to evaluate the filter.The scan results noted that the filter lies just below the left and right renal veins, there is a twenty-four-degree tilt towards the patients left and the apex appears to touch the left side wall.There is no evidence of perforation and the ivc struts are intact without fracture.The inferior vena cava appears normal in size.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of recurrent deep vein thrombophlebitis (dvt) while on anticoagulant therapy and the patient also has a right ureteral stent.The patient was implanted due to an extended dvt in his right leg.The filter was deployed nicely and was in a good position.According to the patient profile form (ppf) the patient was hospitalized for eighteen days due to clogging of the filter.The ppf states that the device is surrounded by scar tissue and it would be too risky to remove the filter.The device has affected the patients lungs, caused the patient to feel weak and the patient has suffered physically and mentally.

Manufacturer Narrative

It was reported that a patient underwent implant of a trapease permanent inferior vena cava (ivc) filter.According to the information provided on the patient profile form (ppf), the filter has tilted and is unable to be retrieved, however there are no documented attempts to retrieve the filter.The ppf indicated that the patient was hospitalized due to a clogged filter and that the patient is suffering from mental anguish related to the device.The indication for the filter implant was recurrent deep vein thrombosis (dvt) while on anticoagulation.The device was implanted via the left femoral vein and deployed approximately 3-4cm below the level of the renal veins.The patient was taken to the recovery room in stable condition at the conclusion of the procedure.Approximately nine years later a computerized tomography (ct) scan of the abdomen was performed due to a history of cholecystectomy and hiatal hernia repair and to evaluate the filter.The scan results noted that the filter lies just below the left and right renal veins, there is a twenty-four-degree tilt towards the patients left and the apex appears to touch the left side wall.There is no evidence of perforation and the ivc struts are intact without fracture.The inferior vena cava appears normal in size.There is currently no additional information available.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 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 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 procedural films and post-implant imaging available for review, the reported events and a device malfunction could be confirmed.Additionally, anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: date of report, pma/510k, type of reportable event and if follow-up, what type.Event: as reported, the patient underwent implantation of a trapease permanent inferior vena cava filter for the treatment of deep vein thrombosis (dvt).Additional information received per the medical records indicate that the patient has a history of recurrent deep vein thrombophlebitis while on anticoagulant therapy and the patient also has a right ureteral stent.The patient was implanted due to an extended dvt in his right leg.The filter was deployed nicely and was in a good position.The medical records indicate that the device was implanted due to recurrent deep vein thrombosis (dvt) while on anticoagulation.The device was implanted via the left femoral vein and deployed approximately 3-4cm below the level of the renal veins.The patient was taken to the recovery room in stable condition at the conclusion of the procedure.Per the patient profile form (ppf), the filter has tilted and is unable to be retrieved, however there are no documented attempts to retrieve the filter.Per the medical records, approximately nine years later a computerized tomography (ct) scan of the abdomen was performed due to a history of cholecystectomy and hiatal hernia repair and to evaluate the filter.The scan results noted that the filter lies just below the left and right renal veins, there is a twenty-four-degree tilt towards the patients left and the apex appears to touch the left side wall.There is no evidence of perforation and the ivc struts are intact without fracture.The inferior vena cava appears normal in size.According to the patient profile form (ppf) the patient was hospitalized for eighteen days due to clogging of the filter.The ppf indicated that the patient was hospitalized due to a clogged filter and that the patient is suffering from mental anguish related to the device.The device has affected the patient¿s lungs, caused the patient to feel weak.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 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Lung disorder, weakness and anxiety 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.

Manufacturer Narrative

Patient code '3191' was used as there are no codes available for the reported unspecified 'lung disorder'.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; cahir road ; EI
• MDR Report Key: 7385645
• MDR Text Key: 103966701
• Report Number: 9616099-2018-02035
• 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,Followup
• Report Date: 07/03/2018

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 Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0708299
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/05/2018
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 02/05/2018; 05/01/2018; 05/01/2018; 06/12/2018
• Supplement Dates FDA Received: 04/03/2018; 05/30/2018; 05/30/2018; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MICROPUNTURE SETUNKNOWN INJECTEDUNKNOW; UNKNOWN MICROPUNTURE SETUNKNOWN INJECTEDUNKNOW
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 72 YR