BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2123187 · Received June 14, 2011

    Report

    Report Number
    3003742446-2011-00302
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 16, 2010
    Report Date
    May 19, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT (B)(4) STUDY PATIENT SUFFERED AN ARTERIAL DISSECTION DURING THE INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, AND AN ALLERGY TO SULFA. DIAGNOSTIC ANGIOGRAPHY REVEALED TRIPLE VESSEL DISEASE; HOWEVER, THE CYPRESS TARGET LESION WAS MID RCA. THE TARGET LESION WAS DESCRIBED AS DE NOVO, 3.0MM REFERENCE DIAMETER, 12MM IN LENGTH, MODERATELY CALCIFIED AND 95% STENOTIC. ANGIOMAX WAS USED FOR THE PROCEDURE, AND AN ASA AND PLAVIX REGIMEN WAS INITIATED AND MAINTAINED POST PROCEDURE. PREPROCEDURE TIMI 0, POST STENT IMPLANTATION TIMI 3. THE LESION WAS PRE-DILATED THREE TIMES WITH A 3.0 X 15 MM BALLOON CATHETER AT 16 ATM. THE PHYSICIAN HAD DIFFICULTY ACCESSING THE TARGET LESION WITH THE CYPHER 3.0 X 18 MM STENT ON THE FIRST ATTEMPT BUT SUCCESSFULLY IMPLANTED IT AT 16 ATM. A GRADE A EDGE DISSECTION WAS NOTED. THE DISSECTION WAS TREATED BY IMPLANTATION OF AN ADDITIONAL CYPHER 3.0 X 8 MM STENT IN OVERLAPPING FASHION. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15109288 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND WAS FOUND TO HAVE THREE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE STUDY INDEX PROCEDURE. THE TARGET LESION FOR THE PROCEDURE WAS THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED THREE TIMES WITH A 3.0 X 15 MM BALLOON CATHETER AT 16 ATM. THE PHYSICIAN HAD DIFFICULTY ACCESSING THE TARGET LESION WITH THE CYPHER 3.0 X 18 MM STENT ON THE FIRST ATTEMPT BUT SUCCESSFULLY IMPLANTED IT AT 16 ATM. A GRADE A EDGE DISSECTION WAS NOTED. THE DISSECTION WAS TREATED BY IMPLANTATION OF AN ADDITIONAL CYPHER 3.0 X 8 MM STENT IN OVERLAPPING FASHION. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MID RCA TARGET LESION WAS REPORTED TO BE: DE NOVO, 3.0 MM VESSEL DIAMETER, A 95% STENOSIS, 12 MM LENGTH, MODERATELY CALCIFIED, NOT TORTUOUS, AND TYPE B1. THE RESIDUAL STENOSIS WAS 0% AND THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15109288

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 3.0 X 15 MM BALLOON CATHETER