BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3110879 · Received May 14, 2013

    Report

    Report Number
    3003742446-2013-00065
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN PUBLISHED IN FOERST ET AL IN CIRCUMFERENTIAL STRUT FRACTURE AS A MECHANISM OF "CRUSH" BIFURCATION RESTENOSIS; AM J CARDIOL. 2013 MAR 1;111(5):770-3. COMPLAINT CONCLUSION: INFORMATION CONTAINED IN AN ARTICLE INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS, STENT FRACTURE, THROMBOSIS AND CARDIOGENIC SHOCK SECONDARY TO AN ANTERIOR MYOCARDIAL INFARCTION RESULTING IN DEATH. THE MEDICAL HISTORY OF THE PATIENT IS UNKNOWN. THE INDICATION FOR THE PROCEDURE WAS CRESCENDO ANGINA AND A POSITIVE STRESS TEST FOR LATERAL ISCHEMIA. THE TARGET LESION WAS THE BIFURCATION OF THE CIRCUMFLEX (CFX) ARTERY AND THE FIRST OBTUSE MARGINAL (OM). THE OM WAS TREATED WITH THE IMPLANT OF A 2.5MM X 18MM CYPHER STENT, FOLLOWED BY THE PLACEMENT OF A 3.5MM X 18MM CYPHER STENT IN THE MAIN BRANCH OF THE CFX, ACROSS THE OSTIUM OF THE OM, USING CRUSH TECHNIQUE. THREE YEARS LATER, THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK SECONDARY TO AN ANTERIOR WALL MYOCARDIAL INFARCTION. AUTOPSY REVEALED THAT THE PROXIMAL PORTION OF THE 2.5-MM STENT DEPLOYED IN THE OM1 SB WAS CRUSHED AGAINST THE VESSEL WALL BY THE 3.5-MM LEFT CIRCUMFLEX MB STENT. MULTIPLE STENT FRACTURES WERE NOTED ON BOTH STENTS. A RESTENOSIS WAS NOTED NEAR THE REGION OF FLEX SEGMENT FRACTURE. HISTOLOGIC EXAMINATION CONFIRMED SUBTOTAL OCCLUSION AT THE OSTIUM OF THE OM1 BRANCH. HIGHER MAGNIFICATION IMAGE OF BIFURCATION REPRESENTED SEVERAL DISLOCATED STENT STRUTS AT THE ENTRANCE OF OM1 BRANCH, WITH THE LUMEN OCCLUDED BY ORGANIZED THROMBUS. ALSO IT WAS NOTED THAT THE VESSEL WAS SEVERELY INJURED AND DISRUPTED BY STENT STRUTS. THE STERILE LOT NUMBERS FOR THE DEVICES ARE UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED FOR EITHER STENT. RESTENOSIS, THROMBOSIS, MYOCARDIAL INFARCTION, STENT FRACTURE AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. STENT FRACTURE HAS BEEN RECOGNIZED AS A POTENTIAL MECHANISM OF THROMBOSIS AND RESTENOSIS AND MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. WITH THE VERY LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED EVENTS, HOWEVER; PROCEDURAL FACTORS SUCH AS CRUSH STENTING (AS SUGGESTED BY THE ARTICLE) MAY HAVE CONTRIBUTED TO THE STENT FRACTURES. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00065 AND 3003742446-2013-00066.

    Description of Event or Problem · 1

    AS REPORTED FROM THE LITERATURE ARTICLE, (B)(6) MAN WITH KNOWN CORONARY ARTERY DISEASE DIED OF CARDIOGENIC SHOCK SECONDARY TO AN ANTERIOR MYOCARDIAL INFARCTION. THREE YEARS BEFORE DEATH, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO TREAT CRESCENDO ANGINA AND LATERAL ISCHEMIA FOUND ON STRESS TESTING. CARDIAC CATHETERIZATION AT THAT TIME REVEALED LEFT CIRCUMFLEX/FIRST OBTUSE MARGINAL (OM1) BIFURCATION LESION THAT WAS TREATED BY DEPLOYING A 2.5 X 18-MM SIROLIMUS- ELUTING STENT (CYPHER, CORDIS, (B)(4)) IN THE OM1 AND THEN A 3.5 X 18-MM SIROLIMUSELUTING STENT IN THE LEFT CIRCUMFLEX ARTERY ACROSS THE OM1 BRANCH USING THE CRUSH TECHNIQUE. CORONARY ANGIOGRAPHY 3 YEARS LATER DEMONSTRATED SUBTOTAL OCCLUSION OF THE OM1 SB. AS PER AUTOPSY, THE PROXIMAL PORTION OF THE 2.5-MM STENT DEPLOYED IN THE OM1 SB WAS CRUSHED AGAINST THE VESSEL WALL BY THE 3.5-MM LEFT CIRCUMFLEX MB STENT. MULTIPLE STENTS FRACTURE WERE NOTED. A RESTENOSIS WAS NOTED NEAR THE REGION OF FLEX SEGMENT FRACTURE. HISTOLOGIC EXAMINATION CONFIRMED SUBTOTAL OCCLUSION AT THE OSTIUM OF THE OM1 BRANCH. HIGHER MAGNIFICATION IMAGE OF BIFURCATION REPRESENTED SEVERAL DISLOCATED STENT STRUTS AT THE ENTRANCE OF OM1 BRANCH, WITH THE LUMEN OCCLUDED BY ORGANIZED THROMBUS. ALSO IT WAS NOTED THAT THE VESSEL WAS SEVERELY INJURED AND DISRUPTED BY STENT STRUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212762 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R