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U.S. Department of Health and Human Services

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

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abdominal Pain (1685)
Event Date 09/01/2017
Event Type  Injury  
Manufacturer Narrative
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter for the treatment of deep venous thrombosis. The device in the patient was positively identified by medical records. Two years, eight months and two weeks after the index procedure, the patient was checked into the hospital for abdominal pains. As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects. As a result of the trapease filter 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 her body. Additional information received per the medical records indicate that the patient was admitted to the hospital after falling and injuring their hip. The indication for the filter implant was partially occlusive venous thrombosis in the right greater saphenous vein and proximal superficial femoral vein. The patient has a history of deep vein thrombosis (dvt) in the right lower extremity, a hematoma, bone fractures, dizziness, shortness of breath, cardiomegaly, depressive disorder, venous embolism and thrombosis of superficial vessels. A computerized tomography (ct) scan of the patient¿s hip revealed non-displaced fractures involving the right superior and inferior pubic rami, a large hematoma in the right pelvis adjacent to the superior pubic ramus measuring about 9 cm in diameter. The patient also had a ct scan of the head for dizziness while on anticoagulants. The scan showed no evidence of acute intracranial pathology. A chest x-ray was performed for a complaint of shortness of breath and showed cardiomegaly. The filter was placed via the left common femoral vein and deployed uneventfully near the l3-l4 level. A 10 mm x 40 mm balloon was then used adjacent to the filter for repositioning of the filter. Procedural notes indicated satisfactory placement of the vena caval filter. Additional information contained in the patient profile form (ppf) states that the patient is suffering from mood swings, difficulty concentrating, loss of focus, depression and anxiety. The form also states that there is a device defect, not listed that results in more follow up care, monitoring, and treatment than normal because it is not functioning properly. Additional information is pending and will be submitted within 30 days of receipt.
 
Manufacturer Narrative
As reported, the patient underwent a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep venous thrombosis. The device that was implanted into the patient¿s right groin at the l4 level. The device in the patient was positively identified by medical records. Sometime after the placement of the device, the patient was admitted to the hospital for abdominal pains. 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 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 her body. The product was not returned for analysis. Additionally, as the sterile lot number was not available, the device history record (dhr) 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. Abdominal pain also does not represent a malfunction of the device. Clinical factors that may have influenced the event include patient, pharmacological, or other comorbidities and are not necessarily related to the implantation of the filter. Without available films or medical records for review we are unable to confirm correlation of the related complaints with the device. 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/or 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 a surgical procedure to implant a trapease permanent vena cava filter for the treatment of deep venous thrombosis. The device that was implanted into the patient¿s right groin at the l4 level. The device in the patient was positively identified by medical records. On or about (b)(6) 2017, the patient was checked into the hospital for abdominal pains. 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 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 her body.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
MDR Report Key6882369
MDR Text Key291614065
Report Number1016427-2017-00597
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2017
Device Model Number466P306X
Device Catalogue Number466P306AU
Device Lot Number16103312
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/21/2017 Patient Sequence Number: 1
Treatment
UNKNOWN SHEATH; UNKNOWN GUIDE WIRE
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