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

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, 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.

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

Event: as reported, a patient underwent placement of a trapease vena cava filter.The information provided indicated that the patient is experiencing mood swings, difficulty concentrating, loss of focus, depression and anxiety.The information also alleged 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.The indication for the filter implant was partially occlusive venous thrombosis in the right greater saphenous vein and proximal superficial femoral vein.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.Prior to the filter placement the patient was admitted to the hospital after falling and injuring the hip.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 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.Two years, eight months and two weeks after the index procedure, the patient was checked into the hospital for abdominal pains.There is currently no additional information available for review.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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.With the limited information provided it is not possible to determine what factors may have contributed to the reported abdominal pain.Anxiety and abdominal pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6882369
• MDR Text Key: 87199385
• Report Number: 1016427-2017-00597
• 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
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 16103312
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN SHEATH.; UNKNOWN GUIDE WIRE.
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 76 YR