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

Model Number 466P306X

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

Patient Problems Internal Organ Perforation (1987); Swelling (2091); Perforation of Vessels (2135); Claudication (2550)

Event Date 05/27/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported by the legal department, 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, perforation of several struts through the vena cava making contact with the duodenum.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 following additional information was received per the patient¿s implant records: the patient had the filter placed due to upper gi bleed.Under sterile conditions and local anesthesia, the right common femoral vein was accessed using seldinger technique, and a guide wire was passed up the ivc.After skin tract dilatation, a 7-french sheath was placed and venacavogram was performed, which showed a patent ivc and identified the level of the renal veins.Following further skin tract dilatation, over a super-stiff wire, the delivery system was advanced and a trapease filter was deployed in the infrarenal ivc location, which was confirmed with follow-up venacavogram.The patient tolerated the procedure well.Technically successful ivc filter placement.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fifteen years post implantation.The patient also reports perforation of filter strut(s) outside of the ivc, perforation of filter strut(s) into organs, and suffers from anxiety and depression.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.An inferior vena cava (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.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.The reported anxiety that the patient is suffering does not represent a device malfunction.The legal briefing mentioned a perforation of the filter struts outside ivc wall and into organs.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Also, with the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or 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 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, perforation of several struts through the vena cava making contact with the duodenum.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 following additional information was received per the patient¿s implant records: the patient had the filter placed due to upper gi bleed.Under sterile conditions and local anesthesia, the right common femoral vein was accessed using seldinger technique, and a guide wire was passed up the ivc.After skin tract dilatation, a 7-french sheath was placed and venacavogram was performed, which showed a patent ivc and identified the level of the renal veins.Following further skin tract dilatation, over a super-stiff wire, the delivery system was advanced and a trapease filter was deployed in the infrarenal ivc location, which was confirmed with follow-up venacavogram.The patient tolerated the procedure well.Technically successful ivc filter placement.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fifteen years post implantation.The patient also reports perforation of filter strut(s) outside of the ivc, perforation of filter strut(s) into organs, and suffers from anxiety and depression.

Event Description

As reported by the legal department, 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, perforation of several struts through the vena cava making contact with the duodenum.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 following additional information was received per the patient¿s implant records: the patient had the filter placed due to upper gi bleed.Under sterile conditions and local anesthesia, the right common femoral vein was accessed using seldinger technique, and a guide wire was passed up the ivc.After skin tract dilatation, a 7-french sheath was placed and venacavogram was performed, which showed a patent ivc and identified the level of the renal veins.Following further skin tract dilatation, over a super-stiff wire, the delivery system was advanced and a trapease filter was deployed in the infrarenal ivc location, which was confirmed with follow-up venacavogram.The patient tolerated the procedure well.Technically successful ivc filter placement.According to the information received in the patient profile from (ppf), the patient became aware of the reported events approximately fifteen years post implantation.The patient also reports perforation of filter strut(s) outside of the ivc, perforation of filter strut(s) into organs, and suffers from leg pain, swelling.Anxiety and depression.Per the patient¿s ct scan performed fifteen years after implantation, several of the metallic legs exceed the outer wall of the opacified ivc lumen by 5mm and protrude beyond the wall.Also, some of the leg portions displace the horizontal portion of the duodenum.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of several struts through the vena cava making contact with the duodenum.According to the information received in the patient profile from (ppf), the patient became aware of the reported events approximately fifteen years post implantation.Results of a computerized tomography (ct) scan, performed fifteen years post implant, revealed several of the metallic legs exceed the outer wall of the opacified ivc lumen by 5mm and protrude beyond the wall.Also, some of the leg portions displace the horizontal portion of the duodenum.The patient is also reported to have experienced leg pain, swelling, anxiety and depression.The indication for the device implant was an upper gastro-intestinal bleed while on anticoagulants.The device was placed via the right common femoral vein and deployed in the infrarenal ivc.The patient is reported to have tolerated the procedure well.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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.With the limited information available and without the procedural films or post implant images to review the reported device perforation of the inferior vena cava could not be confirmed.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Anxiety, swelling and leg pain 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 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: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• MDR Report Key: 7344860
• MDR Text Key: 102599548
• Report Number: 1016427-2018-01252
• 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: 05/07/2018

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: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 03/19/2018; 04/23/2018
• Supplement Dates FDA Received: 04/18/2018; 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR