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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 466P306AU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 08/24/2016
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal brief, the patient underwent placement of a trapease permanent vena cava filter.The following additional information received per the patient profile from (ppf) indicates that the device was unable to be retrieved although there have been no documented attempts made to retrieve the filter.The patient also reports to have coughed up blood, shortness of breath and severe anxiety.According to the medical records, the patient had a history of esophagectomy with complicated post-operative course, pulmonary embolism (pe) and gastrointestinal (gi) bleeding due to anticoagulation.The filter was therefore placed for pe prophylaxis.The filter was deployed in the infrarenal inferior vena cava (ivc) during the index procedure and the patient tolerated the procedure well with no reported complications.
 
Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly.As reported, the patient underwent placement of a trapease permanent inferior vena cava (ivc) filter.Per the medical records, the patient had a history of esophagectomy with complicated post-operative course, pulmonary embolism (pe) and gastrointestinal (gi) bleeding due to anticoagulation.The filter was therefore placed for pe prophylaxis.The filter was deployed in the infrarenal inferior vena cava (ivc) during the index procedure and the patient tolerated the procedure well with no reported complications.The following additional information received per the patient profile from (ppf) indicates that the device was unable to be retrieved although there have been no documented attempts made to retrieve the filter.The patient also reports to have coughed up blood, shortness of breath and severe anxiety.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15037530 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Anxiety does 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.
 
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Brand Name
TRAPEASE PVCF FEM/JUG 55CM CSI
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI  
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7156088
MDR Text Key96111571
Report Number9616099-2017-01747
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/23/2018
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 Expiration Date09/30/2012
Device Catalogue Number466P306AU
Device Lot Number15037530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/24/2017
Initial Date FDA Received12/29/2017
Supplement Dates Manufacturer Received01/04/2018
Supplement Dates FDA Received01/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age72 YR
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