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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Difficult to Remove (1528)
Patient Problem Injury (2348)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
Additional details were received from the patient profile that the filter had perforation of the filter strut outside of the ivc, tilt, embedded, blood clot, clotting and occlusion of the ivc, unable to be removed. Patient developed shortness of breath, chest discomfort, dizziness, and groin/abdominal pain the day of implant. She presented for planned retrieval two months later, but there had been pseudointimal ingrowth into the side track of the filter. The filter was snared, but there was some resistance as it was starting to collapse, as the last part of the filter was still embedded; the patient began to develop pain in her back and flank at this point, so it was decided that the filter was too well embedded into the ivc to safely remove it. A follow up venogram showed the proximal struts being embedded. Medical records received indicate the reason for filter removal was deep vein thrombosis and pulmonary embolus. The filter was unable to be removed and the procedure was aborted. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter. Per the medical records, the reason for filter implant was deep vein thrombosis and pulmonary embolus. The filter subsequently malfunctioned and caused injury and damages, including, but not limited to, filter embedded in wall of the ivc and filter unable to be retrieved. Per the patient profile form (ppf), the filter had perforation of the filter strut outside of the ivc, tilt, embedded, blood clot, clotting and occlusion of the ivc, unable to be removed. On the day of the implant, the patient developed shortness of breath, chest discomfort, dizziness, and groin/abdominal pain. The patient presented for planned retrieval two months later. During the removal attempt, it was noted there had been pseudointimal ingrowth into the side track of the filter. The filter was snared, but there was some resistance as it was starting to collapse, as the last part of the filter was still embedded; the patient began to develop pain in her back and flank at this point, so it was decided that the filter was too well embedded into the ivc to safely remove it. A follow up venogram showed the proximal struts being embedded. The filter was unable to be removed and the procedure was aborted. 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 optease 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. Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined. Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. The predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization and intimal thickening has been shown to lead to explantation problems after as short a period as 12 days. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Pain, shortness of breath and dizziness 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.
 
Event Description
As reported by the legal department, plaintiff underwent placement of defendant's optease vena cava filter on or about (b)(6) 2011. The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, filter embedded in wall of the ivc and filter unable to be retrieved. As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
 
Manufacturer Narrative
As reported by the legal department, a patient underwent placement of an optease vena cava filter on or about (b)(6) 2011. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded in wall of the ivc and filter unable to be retrieved. As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and 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. Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined. The reported event notes implantation of the filter on or about (b)(6) 2011; however, the attempted retrieval date is unknown at this time. Retrieval of the optease vena cava filter is indicated up to 23 days post implantation. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. The predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization has been shown to lead to explantation problems after as short a period as 12 days. 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.
 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
p.o. box 025700
miami FL 33152
MDR Report Key6216081
MDR Text Key280708131
Report Number1016427-2016-00141
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot Number16444314
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/05/2016
Event Location No Information
Date Manufacturer Received03/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

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