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

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Perforation of Vessels (2135)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and perforation.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

Section b5: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of recurrent deep vein thrombosis (right leg).The filter was deployed between the l1 and l2 vertebrae.The patient tolerated the procedure well.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and perforation.A ct scan indicates that the filter was tilted and there was perforation of filter strut(s).Per the patient profile form (ppf), the patient experienced filter tilting, perforation of filter strut(s) outside the inferior vena cava, blood clots, clotting and or occlusion of the inferior vena cava.The patient also experienced pain, emotional distress, mental anguish, anxiety and stress.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.The dhr could not be completed.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and pain do 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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of recurrent deep vein thrombosis (right leg).The filter was deployed via the left femoral vein.It was placed between the l1 and l2 vertebrae.The patient tolerated the procedure well.The results of computed tomography (ct) scans indicate that the filter was tilted and there was perforation of filter strut(s).Additional information received per the patient profile form (ppf) states that the patient experienced filter tilting, perforation of filter strut(s) outside the inferior vena cava, blood clots, clotting and or occlusion of the inferior vena cava.The patient became aware of the reported events approximately thirteen years after the index procedure.The patient also experienced pain, emotional distress, mental anguish, anxiety and stress.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilting of the filter and perforation.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was 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.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.The lot number was received after the conclusion was written.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8161558
• MDR Text Key: 130262719
• Report Number: 1016427-2018-02358
• 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
• Report Date: 02/07/2019
• 2 Devices were Involved in the Event: 1 2

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: 10/31/2006
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1103319
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/19/2018; 02/06/2019
• Supplement Dates FDA Received: 01/17/2019; 02/07/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 16 GAUGE NEEDLE; UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 62 YR