MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

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

Patient Problems Occlusion (1984); Swelling (2091); Thrombosis (2100); No Code Available (3191)

Event Date 03/18/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of trapease vena cava filter.The information provided indicated that the patient is reported to have blood clots, clotting, and/or occlusion of the ivc, and states that the has been filter in place more than ninety days making it too risky to attempt retrieval.The patient also reports to suffer from anxiety and fear of possible device failure in the future and to have major lower extremity swelling after insertion.The patient states that the swelling in lower extremities makes walking difficult.The patient also states that standing or walking for long periods makes their legs and feet unrecognizable.The indication for the filter implant was morbid obesity and scheduled for bariatric surgery with a history of deep vein thrombosis (dvt) and pulmonary embolism (pe).The filter was place via the right femoral vein and deployed at the level of the top of the third lumber vertebra to the bottom of the third lumbar vertebra.The patient was brought to the recovery room in satisfactory condition.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 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.Collateral circulation is established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Blood clots, clotting, and device occlusion related to clotting 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 or a device malfunction could not be confirmed.Lower leg edema and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently available for review, there is nothing to suggest that 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.

Event Description

As reported by the legal brief, the patient underwent placement of trapease vena cava filter.The filter is still in place.The extent of the device failure has not been fully documented by patient¿s treating medical provider(s).As a result of the malfunction, the patient has or may suffer life-threatening injuries and damages and require extensive medical care and treatment the patient has or may suffer and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots, and may need a risky surgery to attempt to remove the filter.The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter because of their history of morbid obesity for bariatric surgery and a high risk for postoperative deep venous thrombosis (dvt) and pulmonary embolism (pe).The patient has a history of dvt and pe.During implantation of the ivc filter via right femoral vein, the filter was open at the level of the top of the third lumber vertebra to the bottom of the third lumbar vertebra.The patient was brought to the recovery room in satisfactory condition.According to the information received in the patient profile form (ppf), the patient became aware of the alleged events approximately on or about eleven years and nine months post implantation of the filer.The patient reports to have blood clots, clotting, and/or occlusion of the ivc, and states that the has been filter in place more than ninety days making it too risky to attempt retrieval.However, no known attempts to retrieve the ivc filter have been made.The patient also reports to suffer from anxiety and fear of possible device failure in the future and to have major lower extremity swelling after insertion.The patient states that the swelling in lower extremities makes walking difficult.The patient also states that standing or walking for long periods makes their legs and feet unrecognizable.

Manufacturer Narrative

Section h6: patient code '3191' was used as there are no codes available for 'venous insufficiency' additional information is pending and will be submitted when received.

Manufacturer Narrative

It was reported that a patient underwent placement of trapease vena cava filter.The information provided indicated that the patient is reported to have blood clots, clotting, and/or occlusion of the ivc, and states that the has been filter in place more than ninety days making it too risky to attempt retrieval.The patient also reports to suffer from anxiety and fear of possible device failure in the future and to have major lower extremity swelling after insertion.The patient states that the swelling in lower extremities makes walking difficult.The patient also states that standing or walking for long periods makes their legs and feet unrecognizable.The patient has additionally reported chronic non-occlusive thrombus, and venous insufficiency.The indication for the filter implant was morbid obesity and scheduled for bariatric surgery with a history of deep vein thrombosis (dvt) and pulmonary embolism (pe).The filter was place via the right femoral vein and deployed at the level of the top of the third lumber vertebra to the bottom of the third lumbar vertebra.The patient was brought to the recovery room in satisfactory condition.Approximately thirteen years post implant a venous duplex study noted that the patient had varicose veins.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 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.Collateral circulation is established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling and discomfort of the affected extremity.The risk of varicose veins increases with age, obesity, pregnancy and standing for long periods.Varicose veins are the result of weak valves in the veins that allows blood to flow back into the veins rather than up to the heart.Blood clots, clotting, and device occlusion related to clotting 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 or a device malfunction could not be confirmed.Lower leg edema and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently available for review, there is nothing to suggest that 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.

• Brand Name: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7776478
• MDR Text Key: 116879961
• Report Number: 1016427-2018-01725
• 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,Followup
• Report Date: 08/20/2019

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 Expiration Date: 01/31/2007
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0204582
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 07/10/2019; 08/13/2019
• Supplement Dates FDA Received: 08/09/2019; 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR