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

Model Number 466P306X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could 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.Blood clots and pulmonary embolism do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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.

Event Description

As reported by the legal team, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the medical records indicate that the patient presented to the emergency room with pain and swelling of the left lower extremity.A scan performed showed a new phlebitis in a superficial femoral vein.As a result, the patient underwent placement of the inferior vena cava (ivc) filter due to recurrent phlebitis following pulmonary embolism while on adequate anticoagulation.The patient also has a history of bariatric surgery, and morbid obesity.During the implantation of the ivc filter via the femoral vein, a venogram was done showing no evidence of clot in the ivc at the level and noting that the size of the ivc was less then three centimeters.The filter was deployed at the l-2/3 region without difficulty.It deployed and lodged appropriately.The patient tolerated the procedure well.Two films were obtained immediately post implantation which showed a filter overlying the right side of what was believed to be the l4 vertebral body.The filter was found near the junction of the right common iliac vein and ivc.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events approximately on or about twelve years and nine months post implantation of ivc filter.The patient reports to suffer from mental anguish, pulmonary embolism, blood clots, clotting, and/or occlusion of the ivc.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient presented to the emergency room with pain and swelling of the left lower extremity.A scan performed showed a new phlebitis in a superficial femoral vein.As a result, the patient underwent placement of the inferior vena cava (ivc) filter due to recurrent phlebitis following pulmonary embolism while on adequate anticoagulation.The patient also has a history of bariatric surgery, and morbid obesity.During the implantation of the ivc filter via the femoral vein, a venogram was done showing no evidence of clot in the ivc at the level and noting that the size of the ivc was less than three centimeters.The filter was deployed at the l-2/3 region without difficulty.It deployed and lodged appropriately.Two films were obtained immediately post implantation which showed a filter overlying the right side of what was believed to be the l4 vertebral body.The filter was found near the junction of the right common iliac vein and ivc.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism.Per the patient profile from (ppf), the patient reports to suffer from mental anguish, pulmonary embolism, blood clots, clotting, and/or occlusion of the ivc.The filter remains implanted; thus, unavailable for analysis.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.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Blood clots, pulmonary emboli and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, 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, tipperary 0000 ; EI 0000
• MDR Report Key: 7444072
• MDR Text Key: 106004167
• Report Number: 1016427-2018-01404
• 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,Followup
• Report Date: 07/02/2018

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 Expiration Date: 08/31/2006
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0903183
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/21/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 05/21/2018; 06/26/2018
• Supplement Dates FDA Received: 06/19/2018; 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR