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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306X
Device Problems Fracture (1260); Material Twisted/Bent (2981); Unintended Movement (3026)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); Stenosis (2263)
Event Date 06/07/2019
Event Type  Injury  
Manufacturer Narrative

Reporter 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. Please note that this is the initial report for this product. 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 filter tilt, filter strut perforation, stenosis and mild filter strut bending. 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. Information received per the patient profile form (ppf) states that the patient experienced filter fracture, perforation of filter struts outside the inferior vena cava (ivc), filter tilt, filter embedded in wall of the ivc, blood clots, clotting and or occlusion of the ivc. The patient became aware of the reported events fifteen years after the index procedure. Additionally the patient has experienced physiological issues, worry, anxiety and depression for which she is being treated with medication. The patient continues to experience nausea, intermittent abdominal pain, chest pain and discomfort. The patient noted that she takes two medications for her constant severe nausea. The results of computed tomography (ct) scans done approximately fifteen years after the index procedure indicate that the spleen is enlarged, cholecystectomy, previous gastric bypass noted, some fatty infiltration of the pancreas without focal lesion, the filter is tilted and there is filter perforation. The superior filter tip is tilted to the left by about 7 degrees and anteriorly by 21 degrees. The inferior tip of the filter contacts the ivc wall posteriorly and the superior tip of the filter is also contacting the ivc wall anteriorly. The scan also revealed there is filter strut perforation at the 6:00 and 12:00 positions. The filter strut at the 12:00 position does appear to show some slight bending, but no strut fracture. There is some mild ivc stenosis along the superior edge of the filter.

 
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Brand NameUNKNOWN TRAPEASE
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 Key10347607
MDR Text Key201438783
Report Number1016427-2020-04234
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466P306X
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 Received07/23/2020
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: 07/30/2020 Patient Sequence Number: 1
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