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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466P306AU FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION 466P306AU FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306AU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); No Code Available (3191)
Event Date 10/21/2016
Event Type  Injury  
Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date is the complaint awareness date. (b)(4). As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter. The indication for filter placement is not available. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation of, and injury to the inferior vena cava (ivc) wall. 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. It was reported that there was perforation of, and injury to 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. 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 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 perforation of and injury to the inferior vena cava (ivc) wall. 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.

 
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Brand Name466P306AU
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10291048
MDR Text Key199704314
Report Number1016427-2020-04215
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466P306AU
Device LOT Number15766861
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2020 Patient Sequence Number: 1
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