BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053434 · Received May 27, 2008

    Report

    Report Number
    9616099-2008-01394
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    May 5, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT REC'D INDICATED THAT A PT EXPERIENCED IN-STENT AND PERI STENT RESTENOSIS AFTER HAVING A CORONARY STENT IMPLANTED. THE PT'S HISTORY IS SIGNIFICANT FOR HYPERLIPIDEMIA, PERIPHERAL VASCULAR DISEASE, REMOTE HISTORY OF TOBACCO ABUSE AND DIABETES ALL OF WHICH PUT THE PT AT INCREASED RISK FOR MACE. THE INDICATION FOR THE PROCEDURE WAS A PRIOR MI AND POSITIVE STRESS TEST. ANGIOGRAPHY SHOWED THREE VESSEL DISEASE WITH ONE TO BE TREATED DURING THE INDEX PROCEDURE BUT NO STAGED PROCEDURE PLANNED. THE TARGET VESSEL WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS DESCRIBED AS 80% STENOSED AND DE NOVO. THE LESION WAS PRE-DILATED FOLLOWED BY THE DEPLOYMENT OF A 2.75 MM X 13 MM CYPHER SELECT PLUS AT 12 ATMS. POST-DILATATION WAS NOT REQUIRED, THE PROCEDURE WAS FINISHED SUCCESSFULLY AND THE PT WAS DISCHARGED THE FOLLOWING DAY. APPROX SIX MOS LATER THE PT HAD A CLINICALLY DRIVEN ANGIOGRAM REVEALING AN 80% STENOSED PROXIMAL CIRCUMFLEX ARTERY (CFX), A 90% STENOSED LEFT POSTERIOR DESCENDING ARTERY (PDA) AND 90% RESTENOSIS IN AND PROXIMAL TO THE LAD. THE LAD WAS TREATED WITH POBA ONLY, NO INFO WAS PROVIDED ON THE CFX AND THE PDA REC'D A DES FROM ANOTHER MFR. THE PROD REMAINS IMPLANTED IN THE PT THUS IS NOT AVAILABLE FOR EVAL. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED, AS THE LOT NUMBER FOR THE INVOLVED DEVICE WAS NOT PROVIDED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING A CORONARY STENT. CO-MORBIDITIES SUCH AS HISTORY OF SMOKING, DIABETES AND PERIPHERAL VASCULAR DISEASE PUT A PT AT INCREASED RISK OF ADVERSE EVENTS OCCURRING. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT PT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT: NOTIFICATION WAS REC'D FROM THE REGISTRY INDICATING THAT APPROX FOUR MOS POST INDEX PROCEDURE (2008), THE PT EXPERIENCED ANGINA PECTORIS, WHICH REQUIRED A CORONARY ANGIOGRAM. ANGIOGRAM RESULTS CONFIRMED 90% RESTENOSIS AT THE TARGET LESION. SIX DAYS LATER, THE PT UNDERWENT RE-PCI. THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION. AT THE TARGET LESION TIMI FLOW WAS II. DIAMETER STENOSIS WAS 90% AND FOCAL IN-STENT RESTENOSIS PATTERN WAS <10MM LENGTH; CONFIRMED ON CORONARY ANGIOGRAM. THERE WAS PROXIMAL PERI-STENT RESTENOSIS. THE RESTENOSIS WAS TREATED WITH BALLOON DILATATION ONLY. THERE WAS NO ANEURYSM FORMATION. TWO ADD'L LESIONS WERE ALSO TREATED AT THE PROXIMAL CIRCUMFLEX AND AT THE POSTERIOR DESCENDING ARTERY. THE EVENT WAS REPORTED AS PROBABLY RELATED TO THE CYPHER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R CHOICE INTERMEDIATE WIRE| GUIDING CATHETER SIZE (FR) 6