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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKSAVVY435 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL UNKSAVVY435 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK-PTA CATHETERS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969)
Event Date 05/01/2001
Event Type  Injury  
Manufacturer Narrative
This article was found during a recent literature search of this device. Please note that patient specific details (demographics, medical history) are not available. The device is an unknown savvy and the catalog and lot numbers are not available. Qureshi a. , i. (2001). Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement. Neurosurgery, vol. 48, no. 5. As reported in the literature by qureshi a. , i. (2001). Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement. Neurosurgery, vol. 48, no. 5. ; an angioplasty was performed with a 4. 5 savvy poststent balloon and a postoperative minor stroke occurred and within 24 hours a postoperative non-q wave myocardial infarction that was asymptomatic occurred in patient 4. The patient developed ischemic deficits 4 hours after the procedure was completed. His nihss score of 21 at 24 hours improved to a score of 1 at 7 days after the procedure was performed. A non-cordis stent was placed. The patients maximum activated coagulation time was 244. An unknown sheath was removed after nine hours, then mechanical compression was used. The patient remained in the hospital for seven days. The device was not returned for analysis. A review of the manufacturing documentation associated with precise lot number presented no issues during the manufacturing process that can be related to the reported complaint. The sterile lot number of the savvy device was not provided; therefore, no review of manufacturing documentation could be performed. Given the limited information provided, the reported event ¿stroke and non-q wave myocardial infarction¿ could not be confirmed and the exact root cause could not be determined. With the limited amount of information available and without return of the product for analysis or films of the event it is not possible to draw a clinical conclusion between the device and the reported event. Stroke 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 a stroke. The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death. Early medical intervention can halt this process and reduce the risk for irreversible complications. Myocardial infarction is a known potential adverse event associated with any invasive procedure in which medical devices/products are inserted into the patient¿s vasculature and manipulated to varying degrees and is listed in the ifu as such. Myocardial infarction (mi) or acute myocardial infarction (ami), commonly known as a heart attack is the interruption of blood supply to part of the heart, causing some heart cells to die. This is most commonly due to occlusion (blockage) of a coronary artery following the rupture of a vulnerable atherosclerotic plaque, which is an unstable collection of lipids (fatty acids) and white blood cells (especially macrophages) in the wall of an artery. There is no medical evidence to suggest a causal relationship between the stent implanted in the carotid artery and the reported mi. The inherent risk of the procedure combined with the patient¿s complex medical status, vessel characteristics and procedural factors may have contributed to the event. There is no evidence that manufacturing issues contributed to the event. Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events. This report is related to the following reports: 9616099-2019-02732. 9616099-2019-02734.
 
Event Description
As reported in the literature by qureshi a. , i. (2001). Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement. Neurosurgery, vol. 48, no. 5. ; an angioplasty was performed with a 4. 5 savvy poststent balloon and a postoperative minor stroke occurred and within 24 hours a postoperative non-q wave myocardial infarction that was asymptomatic occurred in patient 4. The patient developed ischemic deficits 4 hours after the procedure was completed. His nihss score of 21 at 24 hours improved to a score of 1 at 7 days after the procedure was performed. A non-cordis stent was placed. The patients maximum activated coagulation time was 244. An unknown sheath was removed after nine hours, then mechanical compression was used. The patient remained in the hospital for seven days.
 
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Brand NameUNKSAVVY435
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 Key8351776
MDR Text Key136591975
Report Number9616099-2019-02736
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK-PTA CATHETERS
Device Catalogue NumberUNK-PTA CATHETERS
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 Received01/25/2019
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

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