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 Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact date of device implantation is unknown.Complaint conclusion: as reported by the legal department, the plaintiff underwent placement of a trapease filter on or about (b)(6) 2006 in (b)(6).The filter subsequently malfunctioned and caused injury and damages to the plaintiff.  including, but not limited to, ivc filter penetration of the vein wall and failure to prevent pulmonary embolism.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.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 trapease ivc 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. vessel injury is a well-known potential complication for all ivc filter implants and is listed in the instructions for use (ifu) as such.At this time, it is factors contributing to the vessel perforation could not be determined.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 by the legal department, the plaintiff underwent placement of a trapease filter on or about (b)(6) 2006 in (b)(6).The filter subsequently malfunctioned and caused injury and damages to the plaintiff.  including, but not limited to, ivc filter penetration of the vein wall and failure to prevent pulmonary embolism.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.

Manufacturer Narrative

The following additional information received per the patient profile from (ppf) indicates that the patient had blood clots, clotting and occlusion of the ivc.The patient also reports to be having issues with breathing and pain.According to the medical records, the patient¿s pre-operative diagnosis was deep vein thrombosis (dvt) and had a history of pe.The filter was successfully deployed below the renal veins.The patient tolerated the index procedure well and was transferred to recovery in stable condition.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¿s pre-operative diagnosis was deep vein thrombosis (dvt) and had a history of pe.The filter was successfully deployed below the renal veins.The patient tolerated the index procedure well and was transferred to recovery in stable condition.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, inferior vena cava (ivc) filter penetration of the vein wall and failure to prevent pulmonary embolism (pe).As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages.Per the patient profile from (ppf), the patient had blood clots, clotting and occlusion of the ivc.The patient also reports to be having issues with breathing and pain.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.A review of the device history record (dhr) associated with lot r1105206 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.It was also reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Pe (pulmonary embolus), blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Breathing difficulty and pain do not represent device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient comorbidities, specifically coagulopathy, 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6379937
• MDR Text Key: 69147724
• Report Number: 1016427-2017-00205
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1105206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2017
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR