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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Migration (4003)
Patient Problems Pulmonary Embolism (1498); Abrasion (1689); Coagulation Disorder (1779); Edema (1820); Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Ulcer (2274); Thrombosis/Thrombus (4440)
Event Date 08/12/2016
Event Type  Injury  
Manufacturer Narrative
Product name optease retrieval filter. Product catalog number 466f220a lot number 15781096. According to the additional information received in the patient profile form (ppf), additional information provided on the patient profile form (ppf) indicated that the patient became aware approximately three years and five months post filter implant that there were blood clots, clotting and/or occlusion of the inferior vena cava (ivc) filter. The ppf also indicated that the patient has suffered from mental anguish, continuing clots and swelling of the legs. According to the medical records the filter was implanted for recurrent dvt and non-compliance with coumadin, in addition, the patient incurred a fracture to the left ankle and awaits surgical repair. The filter was implanted via the right femoral vein and deployed at the location of the third lumbar vertebral body. The patient tolerated the procedure well. The product remains implanted and is thus not available for analysis. A review of the manufacturing records could not be conducted without a lot number. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
As reported by the legal team, the patient underwent placement of the optease filter on or about (b)(6) 2013 in (b)(6). The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, dvts, pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound. As a direct and proximate result of these malfunctions; the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. 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. Thrombosis, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound does not represent a device malfunction. 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/or 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 team, the patient underwent placement of the optease filter on or about (b)(6) 2013 in tennessee. The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, dvts, pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound. As a direct and proximate result of these malfunctions; the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6791582
MDR Text Key256748583
Report Number1016427-2017-00534
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 other
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2015
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot Number15781096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/31/2017
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2013
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: 08/14/2017 Patient Sequence Number: 1
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