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

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congestive Heart Failure (1783); Hemorrhage/Bleeding (1888); Swelling (2091); Respiratory Failure (2484)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

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 and prevention of extensive deep venous thrombosis (dvt).The device was implanted below the patient¿s renal veins.The device in the patient was positively identified by medical records.As of the present, the patient is still implanted with the device.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.Per the patient profile form (ppf), the patient received a trapease filter.It was reported that the patient requires medical monitoring and is at risk for future health complications.There has been no attempt to remove the filter.The patient reports mood swings, difficulty concentrating, loss of focus, depression, anxiety, pain, suffering and fear that the implant has moved or will move and cause injury or death.Per the medical records, the patient was brought to the cardiac catheterization lab for venacavogram, right venous angiogram of the right popliteal vein, thrombectomy of the right common femoral vein, superficial femoral vein, external iliac and common iliac veins using a mechanical thrombectomy catheter and followed by infusion of t-pa.It was reported that the patient had extensive dvt in the right lower extremity from iliac venous system to the superficial femoral vein as well as a pulmonary embolism (pe).The patient also has a history of appendectomy, cholecystectomy, diabetes, hypertension, and hypercholesterolemia.The trapease filter was deployed below the renal veins and above the bifurcation.Good deployment of the filter was seen.Then pta was done to the right common femoral and superficial veins, external ad common iliac veins using cordis balloon catheters.The patient tolerated the procedure well.Two days after the intervention with t-pa and post implantation of the ivc filter, a computerized tomography (ct) of the abdomen was done because of abdominal pain and swollen right lower extremity.The ct noted a 10 cm retroperitoneal hematoma with venous blush and active arterial bleeding, that was displacing the right kidney anteriorly.The ivc filter was in the expected site and a filling defect with in the right common femoral vein consistent with deep vein thrombosis was noted.The patient was taken to the interventional radiology suite that same day for treatment of the retroperitoneal bleed.The right renal artery was located and visualized, microcatheter was placed and embolic coils were delivered to the selected site.Approximately on or about four days post implantation of the ivc filter, the patient underwent a chest x-ray for respiratory failure and it was noted that the patient had new densities at the bases that may represent pleural effusion on the right and atelectasis on the left but underlying infiltrates cannot be excluded.The next two days after the patient continued to have chest x-rays with few other changes noted.Approximately seven days post implantation of the ivc filter, the patient underwent another chest x-ray that reported cardiomegaly with congestive heart failure and effusions.The patient continued to undergo chest x-rays for the next two days that noted some improvement but similar findings to previous studies.

Manufacturer Narrative

As reported, the patient underwent implantation of a trapease permanent vena cava filter for the treatment and prevention of extensive deep venous thrombosis (dvt).Per the medical records, the patient was brought to the cardiac catheterization lab for venacavogram, right venous angiogram of the right popliteal vein, thrombectomy of the right common femoral vein, superficial femoral vein, external iliac and common iliac veins using a mechanical thrombectomy catheter and followed by infusion of t-pa.It was reported that the patient had extensive dvt in the right lower extremity from iliac venous system to the superficial femoral vein as well as a pulmonary embolism (pe).The patient also has a history of appendectomy, cholecystectomy, diabetes, hypertension, and hypercholesterolemia.The trapease filter was deployed below the renal veins and above the bifurcation.Good deployment of the filter was seen.Then pta was done to the right common femoral and superficial veins, external ad common iliac veins using cordis balloon catheters.The patient tolerated the procedure well.Per the patient profile form (ppf), the patient received a trapease filter.It was reported that the patient requires medical monitoring and is at risk for future health complications.Per the medical records, two days after the intervention with t-pa and post implantation of the ivc filter, a computerized tomography (ct) of the abdomen was done because of abdominal pain and swollen right lower extremity.The ct noted a 10cm retroperitoneal hematoma with venous blush and active arterial bleeding, that was displacing the right kidney anteriorly.The ivc filter was in the expected site and a filling defect with in the right common femoral vein consistent with deep vein thrombosis was noted.The patient was taken to the interventional radiology suite that same day for treatment of the retroperitoneal bleed.The right renal artery was located and visualized, microcatheter was placed and embolic coils were delivered to the selected site.Approximately on or about four days post implantation of the ivc filter, the patient underwent a chest x-ray for respiratory failure and it was noted that the patient had new densities at the bases that may represent pleural effusion on the right and atelectasis on the left but underlying infiltrates cannot be excluded.The next two days after the patient continued to have chest x-rays with few other changes noted.Approximately seven days post implantation of the ivc filter, the patient underwent another chest x-ray that reported cardiomegaly with congestive heart failure and effusions.The patient continued to undergo chest x-rays for the next two days that noted some improvement but similar findings to previous studies.There has been no attempt to remove the filter.The patient reports mood swings, difficulty concentrating, loss of focus, depression, anxiety, pain, suffering and fear.The filter remains implanted; thus, 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.Retroperitoneal bleed, respiratory failure and congestive heart failure maybe related to the implant procedure; however, do not represent a device malfunction.Anxiety, pain and swelling 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7597690
• MDR Text Key: 110963174
• Report Number: 1016427-2018-01528
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/16/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 8-FRENCH SHEATH; UNKNOWN 8-FRENCH SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 70 YR
• Patient Weight: 102