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

Model Number 466P306AU~TPMECC

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

Patient Problems Calcium Deposits/Calcification (1758); Embolus (1830); Thrombosis (2100); Ascites (2596)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

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 (dvt) of left lower extremity.The device that was implanted into the patient¿s right groin at the 12-13 level.The device in the patient was positively identified by medical records.On or about nine years and five months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient has extensive calcification that was seen within the inferior vena cava (ivc) filter, along with superior mesenteric thrombosis with a thrombus seen present in the main portal vein and right portal vein.Additionally, the patient has small ascites in the area.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care 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 and will have this faulty device permanently implanted along with other injuries 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 inferior 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.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.A thrombus within the vena cava or its branches may impede perfusion and cause venous insufficiency.A thrombus does not represent a device malfunction.The briefing also mentioned a diagnosis of ascites.Ascites is a gastroenterological term for accumulation of fluid in the peritoneal cavity that exceeds twenty five ml.Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation of the filter.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore no corrective action will be taken.

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 (dvt) of left lower extremity.The device that was implanted into the patient¿s right groin at the 12-13 level.The device in the patient was positively identified by medical records.On or about nine years and five months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient has extensive calcification that was seen within the inferior vena cava (ivc) filter, along with superior mesenteric thrombosis with a thrombus seen present in the main portal vein and right portal vein.Additionally, the patient has small ascites in the area.As a result of the malfunction of the trapease filter, the patient has suffered permanent and life-threatening injuries, requiring extensive medical care 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 and will have this faulty device permanently implanted along with other injuries.

Manufacturer Narrative

According to the patient profile form (ppf), there is calcification and mesenteric thrombosis noted and the patient is reported to be experiencing mental anguish related to the filter.The medical records provided with the ppf indicated that the device was implanted due to subacute to chronic dvt of the right popliteal and gastrocnemius vein as well as the entire left deep venous system.The left great saphenous vein was noted to be patent.The device was implanted via the right femoral vein and deployed at the level of l2-l3.The patient tolerated the procedure well and was transported to the recovery room in stable condition.Approximately a year later a magnetic resonance angiograph (mra) scan of the abdomen was performed for shortness of breath and abdominal pain.The scan showed thrombosis of the iliac veins extending into the inferior vena cava bilaterally.The following day a magnetic resonance imaging (mri) scan was performed to correlate the findings of the mra and showed a large clot within the common iliac veins extending into the ivc, just to the level of the filter.No filling defects were noted above the ivc to suggest a clot.A computerized tomography scan performed at the same time was inconclusive other than mild infiltrative seen within peri-pancreatic fat which could represent pancreatitis.The recommendation was to correlate with pancreatic enzymes.Product: trapease pvcf fem/jug 55cm csi, lot number: r0706382, catalog number: 466p306au~tpmecc.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.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient had a trapease permanent vena cava filter implanted.According to the patient profile form (ppf), there is calcification and mesenteric thrombosis noted and the patient is reported to be experiencing mental anguish related to the filter.The medical records provided with the ppf indicated that the device was implanted due to subacute to chronic dvt of the right popliteal and gastrocnemius vein as well as the entire left deep venous system.The left great saphenous vein was noted to be patent.The device was implanted via the right femoral vein and deployed at the level of l2-l3.The patient tolerated the procedure well and was transported to the recovery room in stable condition.On or about nine years and five months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient has extensive calcification that was seen within the inferior vena cava (ivc) filter, along with superior mesenteric thrombosis with a thrombus seen present in the main portal vein and right portal vein.Additionally, the patient has small ascites in the area.Approximately a year later a magnetic resonance angiograph (mra) scan of the abdomen was performed for shortness of breath and intractable abdominal pain.The scan showed thrombosis of the iliac veins extending into the inferior vena cava bilaterally.The following day a magnetic resonance imaging (mri) scan was performed to correlate the findings of the mra and showed a large clot within the common iliac veins extending into the ivc, just to the level of the filter.No filling defects were noted above the ivc to suggest a clot.A computerized tomography scan performed at the same time was inconclusive other than mild infiltrative seen within peri-pancreatic fat which could represent pancreatitis.The recommendation was to correlate with pancreatic enzymes.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.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 a device malfunction could be confirmed, nor is it possible to establish a relationship between the reported events and the device.Mesenteric thrombosis, ascites, portal vein thrombosis, anxiety, abdominal pain, shortness of breath, clotting and device site calcification 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 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

An additional patient profile form was received which indicates the patient has mood swings, difficulty concentrating, loss of focus, depression, anxiety, pain, suffering, fear that the implant has moved or will move and cause injury or death.No additional information is available.

Manufacturer Narrative

It was reported that a patient had a trapease permanent vena cava filter implanted.According to the patient profile form (ppf), there is calcification and mesenteric thrombosis noted and the patient is reported to be experiencing mental anguish and mood swings related to the filter.The medical records provided with the ppf indicated that the device was implanted due to subacute to chronic dvt of the right popliteal and gastrocnemius vein as well as the entire left deep venous system.The left great saphenous vein was noted to be patent.The device was implanted via the right femoral vein and deployed at the level of l2-l3.The patient tolerated the procedure well and was transported to the recovery room in stable condition.On or about nine years and five months after the procedure, the patient received a scan on the abdomen and pelvis.The scan showed that the patient has extensive calcification that was seen within the inferior vena cava (ivc) filter, along with superior mesenteric thrombosis with a thrombus seen present in the main portal vein and right portal vein.Additionally, the patient has small ascites in the area.Approximately a year later a magnetic resonance angiograph (mra) scan of the abdomen was performed for shortness of breath and intractable abdominal pain.The scan showed thrombosis of the iliac veins extending into the inferior vena cava bilaterally.The following day a magnetic resonance imaging (mri) scan was performed to correlate the findings of the mra and showed a large clot within the common iliac veins extending into the ivc, just to the level of the filter.No filling defects were noted above the ivc to suggest a clot.A computerized tomography scan performed at the same time was inconclusive other than mild infiltrative seen within peri-pancreatic fat which could represent pancreatitis.The recommendation was to correlate with pancreatic enzymes.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.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 a device malfunction could be confirmed, nor is it possible to establish a relationship between the reported events and the device.Mesenteric thrombosis, ascites, portal vein thrombosis, anxiety, mood swings, abdominal pain, shortness of breath, clotting and device site calcification 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 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6893476
• MDR Text Key: 87353753
• Report Number: 1016427-2017-00615
• 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: 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 Model Number: 466P306AU~TPMECC
• Device Catalogue Number: 466P306AU~TPMECC
• Device Lot Number: R0706382
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 02/05/2018; 02/05/2018; 05/01/2018; 05/31/2018
• Supplement Dates FDA Received: 03/30/2018; 04/23/2018; 05/29/2018; 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN #5 FRENCH MICROPUNTURE UNKNOWN SHEATH UNK
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR