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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER THROMBECTOMY SYSTEMS

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER THROMBECTOMY SYSTEMS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Occlusion Within Device (1423)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 01/07/2017
Event Type  Injury  
Manufacturer Narrative

The device remains implanted and is not available for evaluation. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported by the legal department, the plaintiff underwent placement of an optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries, damages, required extensive medical care and treatment as the filter was removed and replaced. As a further proximate result. The patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information was received from the patient profile form that there were blood clots, clotting and/or occlusion of the ivc. The filter was removed percutaneously. Additional medical records received indicate that 11 months after filter placement, the patient was anticoagulated on lovenox and it was felt to be a candidate for filter removal. A venacavogram showed no significant thrombus in the ivc or in the filter prior to proceeding. During removal of the filter, it was noted that one of the struts had broken off but it appeared to be imbedded in the wall of the ivc. It was left behind. The patient tolerated the procedure well. Approximately one month later, a non cordis filter was implanted. At filter placement, the patient presented with extensive thrombosis down the left leg and needed thrombolysis. The patient had extensive pulmonary embolus in the right lower lobe. The tip of the optease filter was in the l2 mid vertebral body with the more proximal hook of the filter located in the l3-4 disc space area. The patient tolerated the procedure well and there were no complications.

 
Manufacturer Narrative

The product remains implanted and is thus not available for analysis. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceTHROMBECTOMY SYSTEMS
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co. tipperary
cashel 33152
EI 33152
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7562466
MDR Text Key109884896
Report Number1016427-2018-01515
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2015
Device MODEL NumberN/A
Device Catalogue Number466F220A
Device LOT Number15581926
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/03/2018
Event Location No Information
Date Manufacturer Received08/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2012
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: 06/01/2018 Patient Sequence Number: 1
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