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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 Problems Stent; Appropriate Term/Code Not Available
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 device is a cypher stent and 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 five cases of stent malapposition post cypher stent implantation at the greater than 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 atmospheres). 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 five cases of stent malapposition post cypher stent implantation at the greater than 10 year follow-up.

 
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Brand NameUNKNOWN CYPHER JAPAN
Type of DeviceCORONARY 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
7863138372
MDR Report Key8042026
Report Number9616099-2018-02495
Device Sequence Number1
Product CodeNIQ
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
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
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

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