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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN CYPHER JAPAN; CORONARY DRUG-ELUTING STENT

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CORDIS CASHEL UNKNOWN CYPHER JAPAN; CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number CJSXXXX
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The devices are cypher stents but the catalog and lot numbers are not available.Usui e, yonetsu t, kanaji y, hoshino m, yamaguchi m, hada m, hamaya r, kanno y, murai t, lee t, hirao k, kakuta t.Prevalence of neoatherosclerosis in sirolimus-eluting stents in a very late phase after implantation.Eurointervention 2018; jaa-443 2018, doi: 10.4244/eij-d-18-00486.As reported in the publication by usui, e.Et al., (2018).Prevalence of neoatherosclerosis in sirolimus-eluting stents in a very late phase after implantation.Eurointervention 2018; jaa-443; there were seventeen cases of stent malapposition at the 5 to 10 year follow-up.The products were not returned for analysis.No lot numbers were provided therefore product history record (phr) reviews could not be generated.The reported ¿stent underexpanded¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event, as calcified lesions may be resistant to stenting.According to the safety information in the instructions for use, ¿contraindications coronary artery stenting is generally contraindicated in the following patient types: patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.¿ according to the directions for use, which is not intended as a mitigation of risk, ¿under fluoroscopic visualization, inflate the balloon to deploy the stent but do not exceed the labeled rated burst pressure (16 atm).Optimal expansion requires the stent to be in full contact with the artery wall, with the stent internal diameter matching the size of the reference vessel diameter.Stent wall contact should be verified through routine angiography or intravascular ultrasound.¿ neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Event Description
As reported in the publication by usui, e.Et al., (2018).Prevalence of neoatherosclerosis in sirolimus-eluting stents in a very late phase after implantation.Eurointervention 2018; jaa-443; there were seventeen cases of stent malapposition post cypher stent implantation at the 5 to 10 year follow-up.
 
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Brand Name
UNKNOWN CYPHER JAPAN
Type of Device
CORONARY DRUG-ELUTING STENT
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
7863134823
MDR Report Key8042140
MDR Text Key128255601
Report Number9616099-2018-02498
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCJSXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2018
Initial Date FDA Received11/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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