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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKSAVVY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL UNKSAVVY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Hemorrhage, Cerebral (1889); Thrombosis (2100)
Event Date 01/01/2000
Event Type  Injury  
Manufacturer Narrative
As noted in a literature publication by ¿ishi, a. Et al. , (2000). Carotid stenting with the use of wallstent. Interventional neuroradiology 6 (suppl1): 181-185;¿ one patient had a minor stroke with agnosia after the final angiography of the procedure. Heparin should have been given intravenously but was actually given subcutaneously. It was thought that the inadequate heparinization caused thrombosis and the distal embolism. The activated clotting time (act) was <200 seconds even though 5000 units of heparin was given. The procedure was a carotid artery stent case and a 3. 5-millimeters (mm) savvy balloon was used to dilate lesions one or two times for predilatation. The device was not returned for evaluation. Without a lot number available, the device history record (dhr) review for the device was unable to be conducted. Stroke/cerebrovascular accident (cva) is a known potential risk associated with implanting a stent in a carotid artery and is listed in the ifu as such. It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure. The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process). The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion. This act, inherent to the procedure may have contributed to the reported event. A blood vessel that is not blocked, but is extremely narrowed, can also cause an ischemic stroke. The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death. 80% of all strokes are ischemic. During ischemic stroke, diminished blood flow initiates a series of events (called ischemic cascade) that may result in additional, delayed damage to brain cells. Early medical intervention can halt this process and reduce the risk for irreversible complications. Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events. As it was noted, inadequate heparinization caused the thrombosis and distal embolism experienced by the patient. There is no indication that the event is related to the device design or manufacturing process. Therefore, no preventative or corrective actions will be taken at this time. Ishii, a. , mitsudo, k. , kikuta, k. , arakawa, y. , hojo, m. , goto, y. ,. Yamagata, s. (2000). Carotid stenting with the use of wallstent. Interventional neuroradiology, 6(1_suppl), 181-185. Doi:10. 1177/15910199000060s128. This article was found during a recent clinical evaluation review/literature search of this device. Please note that patient specific details (demographics, medical history and reason for intervention) are not available. The devices are savvy but the catalog and lot numbers are not available.
 
Event Description
As noted in a literature publication by ¿ishi, a. Et al. , (2000). Carotid stenting with the use of wallstent. Interventional neuroradiology 6 (suppl1): 181-185;¿ one patient had a minor stroke with agnosia after the final angiography of the procedure. Heparin should have been given intravenously but was actually given subcutaneously. It was thought that the inadequate heparinization caused thrombosis and the distal embolism. The activated clotting time (act) was <200 seconds even though 5000 units of heparin was given. The procedure was a carotid artery stent case and a 3. 5-millimeters (mm) savvy balloon was used to dilate lesions one or two times for predilatation.
 
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Brand NameUNKSAVVY
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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
7863138372
MDR Report Key8348038
MDR Text Key136489207
Report Number9616099-2019-02724
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received01/23/2019
Was Device Evaluated by Manufacturer? No
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: 02/18/2019 Patient Sequence Number: 1
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