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U.S. Department of Health and Human Services

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

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Blood Loss (2597); No Code Available (3191)
Event Date 07/07/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient had an optease inferior vena cava (ivc) filter implanted. Approximately six months later, the patient began experiencing problems with the filter, requiring the patient¿s treating physician to surgically remove the filter. The filter was successfully removed percutaneously. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. The following additional information received per the patient profile form (ppf) indicates that the patient suffered from gastrointestinal (gi) bleed and blood in the stool. It also states that the filter was removed through the groin after an unspecified time. The patient also reports to have mental anguish, worry and concern. According to the medical records, the patient has a history of morbid obesity and was considered high risk for deep vein thrombosis (dvt) and pulmonary embolism (pe) during perioperative gastric bypass surgery. The patient also has a history of multiple myocardial infarctions (mi) in the past. The filter was successfully deployed and the patient tolerated the index procedure well, with minimal blood loss. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor a device history record (dhr) review could be performed. 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. The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation. Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts. 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. Without images or procedural films for review, no device malfunction could be confirmed. Clinical factors that may influenced any potential events include underlying patient co-morbidities, pharmacological and lesion characteristics. The information provided does not mention any specific malfunction of the device. Anxiety, mental anguish and gastro-intestinal bleed do not represent a device malfunction and may be related to underlying patient specific issues. Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken. This report is a follow up report to mfr number 9616099-2016-00463 that was submitted under the previous complaint handling software system. The information has been duplicated from the first report with additional information added.
 
Event Description
As reported by the legal brief, the patient was implanted with an optease inferior vena cava (ivc) filter. Approximately six months later, the patient began experiencing problems with the filter, requiring the patient¿s treating physician doctor to surgically remove the filter. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. The following additional information received per the patient profile form (ppf) indicates that the patient suffered from gastrointestinal (gi) bleed and blood in stool. It also states that the filter was removed through the groin after an unspecified time. The patient also reports to have mental anguish, worry and concern. According to the medical records, the patient has a history of morbid obesity and was high risk for deep vein thrombosis (dvt) and pulmonary embolism (pe) in perioperative for gastric bypass. The patient had also suffered multiple myocardial infarctions (mi) in the past. The patient tolerated the filter was successfully deployed and the patient tolerated the index procedure well. There was minimal blood loss.
 
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Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
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 Key7058042
MDR Text Key92900689
Report Number1016427-2017-00823
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2019
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/25/2017 Patient Sequence Number: 1
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