MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 4XXXX

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

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

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

Se please note that the exact event date is unknown and that the event date is the complaint awareness date.Implant date is "sometimes in 2008." occupation: other, litigation paralegal.It was reported that a patient underwent placement of an unspecified vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to the filter had projected beyond the lumen of the inferior vena cava and one strut abuts the lateral wall of the aorta.An unspecified scan noted a cordis filter and the reported event.The patient is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the patient's body.There is currently no additional information available for review.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 notes vessel damage such as intimal tears and perforation as a long-term complication and procedural complication related to ivc filters.An inferior 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.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.Please note that this is the initial/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an unspecified vena cava filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to the filter had projected beyond the lumen of the inferior vena cava and one strut abuts the lateral wall of the aorta.Per the patient, a scan performed noted a cordis filter.The patient is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the patient's body.

Manufacturer Narrative

After further review of additional information received, sections have been updated accordingly:.Event: additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc and requires medical monitoring.The patient became aware of the events approximately nine years after the index procedure.The patient also experienced pain in lower left stomach, groin pain, emotional distress, pain, suffering, and fear that the implant will have further complications and cause injury or death.The results of computed tomography (ct) scans done approximately nine years after the index procedure indicate that the filter is positioned just proximal to the convergence of the common iliac veins.The filter is located at the l3-l4 level.The filter is positioned just below the retroaortic left renal vein which is low-lying.All of the struts of the ivc filter at the mid portion of the filter project beyond the lumen of the ivc.There is an anterior strut which abuts the lateral wall of the aorta on the right.There is no penetration of the aorta.There is no abnormal tilt of the filter.There is no evidence of fracture involving the struts of the filter.Incidental findings include fatty infiltration of the liver, bilateral nephrolithiasis, aortoiliac atherosclerosis, colonic diverticulosis, lumbar degenerative joint disease (djd) and chronic l4 compression fracture.It was reported that a patient underwent placement of an unspecified vena cava filter.The information provided indicated that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc.The patient also reports experiencing pain in the lower left stomach, groin and emotional distress, suffering, and fear.Approximately nine years post implant the patient underwent a computed tomography scan for evaluation of the filter.The results of the scan noted that the filter is positioned just proximal to the convergence of the common iliac veins.The filter is located at the l3-l4 level.The filter is positioned just below the retroaortic left renal vein which is low-lying.All of the struts of the ivc filter at the mid portion of the filter project beyond the lumen of the ivc.There is an anterior strut which abuts the lateral wall of the aorta on the right.There is no penetration of the aorta.There is no abnormal tilt of the filter.There is no evidence of fracture involving the struts of the filter.The patient¿s medical records and indication for the filter implant have not been provided.There is currently no additional information available for review.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 notes vessel damage such as intimal tears and perforation as a long-term complication and procedural complication related to ivc filters.An inferior 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, clotting and/or occlusion of the inferior vena cava or the filter do not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without the procedural films or post-placement imaging and the limited information provided, the report of occlusion and perforation could not be confirmed or further clarified, nor a relationship between the device and the event be drawn.Anxiety and pain 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 draw a clinical conclusion between the events and the device.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: UNKNOWN VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7878779
• MDR Text Key: 120381030
• Report Number: 9616099-2018-02386
• 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
• Report Date: 05/16/2019

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 Catalogue Number: 4XXXX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 65 YR