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

Model Number N/A

Device Problems Difficult to Remove (1528); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Pain (1994); Renal Failure (2041); Swelling (2091); Thrombosis (2100); No Consequences Or Impact To Patient (2199); Numbness (2415)

Event Date 06/14/2014

Event Type  Injury  

Manufacturer Narrative

Telephone and fax numbers of cordis cashel are respectively, 353-62-70062 and 353-62-70001 please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt  as reported, the patient underwent placement of an optease vena cava filter.After an unspecified period of time, the filter reportedly malfunctioned causing injury and damages to the patient including, but not limited to, tilt, embedded to wall of the ivc, and cannot be removed.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  the optease 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.Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Additionally, the timing and mechanism of the tilt has not been reported at this time.Patient, technique or procedural factors during the attempted retrieval may have contributed to the reported tilt.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 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 in the legal brief willians vs.Cordis, the patient underwent placement of a trapease filter which subsequently malfunctioned causing injuries and damages to the patient including, but not limited to, new dvts and chronic occlusion of the ivc from the level of the filter down.As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Per the medical records, the thrombus extended from the distal end of the filter through the common and external iliac arteries.When the occlusion of the ivc was noted, the patient had been off coumadin for while at the time of hospital admission as the patient had bloody dark stools and had severe anemia.The following additional information received per the patient profile from (ppf) indicates that the patient became aware of the reported failures four months and fourteen days post implantation.The patient also reports to have blood clots, clotting, caval thrombosis, swelling, pain and numbness of the right leg, shortness of breath, chest pain, dizziness, altered kidney function, anxiety and depression.According to the medical records, the patient has a history of morbid obesity, pyuria, lower gastrointestinal (gi) bleed, polyps, anemia, sleep apnea, lower extremity edema, coronary artery disease, hypertension, extensive bilateral pulmonary emboli (pe), obesity, anxiety, depression, leukocytosis and vaginal bleeding.Due to the patient¿s chronic obstructive pulmonary disease (copd) the patient had been given bronchodilators, antibiotics empirically and aggressive pulmonary hygiene.Workup, however, revealed evidence of pe and lower extremity dvt.So, the patient was put on anticoagulation.The filter was therefore implanted as the pe was significant and was causing right heart strain.The filter was deployed at the l3 level successfully and without any reported complications.The patient tolerated the index procedure well.It was reported that a patient underwent placement of a trapease filter.The information received indicated that the filter subsequently malfunctioned causing injuries and damages to the patient including, but not limited to new deep vein thrombosis (dvt) and chronic occlusion of the inferior vena cava (ivc) from the level of the filter down.Per the medical records, the thrombus extended from the distal end of the filter through the common and external iliac arteries.When the occlusion of the ivc was noted, the patient had been off coumadin for while at the time of hospital admission as the patient had bloody dark stools and had severe anemia.The following additional information received per the patient profile from (ppf) indicates that the patient became aware of the reported failures four months and fourteen days post implantation.The patient also reports to have blood clots, clotting, caval thrombosis, swelling, pain and numbness of the right leg, shortness of breath, chest pain, dizziness, altered kidney function, anxiety and depression.The indication for the filter implant was significant pulmonary embolism (pe) with right heart strain and lower extremity dvt.The patient was put on anticoagulation and the filter was deployed at the l3 level via the right internal jugular vein.The procedure was successfully completed without any reported complications.The patient tolerated the index procedure well.According to the medical records, the patient has a history of morbid obesity, pyuria, lower gastrointestinal (gi) bleed, polyps, anemia, sleep apnea, lower extremity edema, coronary artery disease with prior open-heart surgery and subsequent stenting, hypertension, extensive bilateral pulmonary emboli (pe), obesity, anxiety, depression, leukocytosis and vaginal bleeding.Approximately four months and fourteen days post implantation the patient was admitted for anemia and general weakness.The initial admission diagnosis was recent gi bleed in the setting of anticoagulation and ivc filter.Of note, the patient has been off coumadin for approximately two weeks.Since admission, the patient has received blood transfusions and colorectal surgery was consulted during the hospital stay.Inpatient workup did not find any active source of bleeding and the patient was kept without any blood thinners throughout the hospital stay.The workup in the emergency room demonstrated severe anemia with a hemoglobin of 5, acute kidney failure with a creatinine of 2.2 and new extensive bilateral lower extremity dvt since she has stopped her coumadin.An ultrasound of the left leg just one- week prior failed to show any thrombus.The patient¿s hemoglobin was monitored throughout this hospital stay.At admission after transfusion, the hemoglobin was 8.2 and throughout the next 7-9 days, the hemoglobin stayed around 7.5 until the day prior to discharge.Due to the severe anemia needing blood transfusion and the occult gi bleed, the source of which was not identified during this hospital stay, the patient was felt to be not a candidate for full anticoagulation at this time.The patient was discharged nine days later in stable condition with instructions to follow up hemoglobin levels and also follow up with outpatient gi.There is currently no additional information available.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.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.Clotting, deep vein thrombosis, 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 patient history, the indication for the implant or procedural films and post-implant imaging available for review, the reported events and a device malfunction could be confirmed.Swelling, pain, numbness, shortness of breath, dizziness, anxiety and depression 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; however, there are patient and pharmacological factors that may contributed to the reported events.Given the limited information 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASEL; cahir road; co. tipperary; cashel ; EI
• MDR Report Key: 6682534
• MDR Text Key: 78873812
• Report Number: 1016427-2017-00428
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306AU
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/13/2017
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH; UNKNOWN WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR