BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1130924 · Received August 21, 2008

    Report

    Report Number
    3003742446-2008-00163
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 15, 2008
    Report Date
    August 4, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS COULD BE RETURNED FOR EVALUATION; THEY REMAINED IMPLANTED. A REVIEW OF THE MFG RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. VESSEL SPASM AND OCCLUSION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE AVAILABLE INFO SUGGEST THAT VESSEL/LESION CHARACTERISTIC OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN EARLY 2006. THE MAIN INDICATION FOR INTERVENTION WAS A MYOCARDIAL INFARCTION. DURING THIS PROCEDURE, THE PT HAD FIVE CYPHER STENT IMPLANTED. A 3.5X23MM CYPHER STENT WAS IMPLANTED IN THE OBTUSE MARGINAL BRANCH AT 12ATM. POST STENT DEPLOYMENT, THERE WAS SOME SHIFT OF PLAQUE INTO THE PROXIMAL PORTION OF THE OBTUSE MARGINAL INVOLVING THE BIFURCATION OF THE OBTUSE MARGINAL AND THE MEDIAL CIRCUMFLEX. THEN, A 3.5X8MM CYPHER STENT WAS PLACED, AT 14ATM, TANDEM AND PROXIMAL TO THE FIRST STENT; THIS ONE EXTENDED INTO THE MEDIAL CIRCUMFLEX. NEXT, A 3.0X18MM CYPHER STENT WAS IMPLANTED, AT 12ATM, IN THE DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING (LAD). THEN A 3.5X23MM CYPHER STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING BRANCH AT 12ATM. FINALLY, A 3.5X28MM CYPHER STENT WAS IMPLANTED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA) AT 16ATM. IT WAS NOTED THAT THERE WAS SOME MILD SPASM AT THE DISTAL END OF THE STENT IN THE LAD BRANCH, BUT FOLLOWING INTRACORONARY NITROGLYCERIN THERE WAS NO SIGNIFICANT RESIDUAL STENOSIS. APPROX FOUR MONTHS POST INDEX PROCEDURE, THE PT EXPERIENCED CHEST PAIN. AS TREATMENT, HE WENT TO THE HOSP AND HAD ANOTHER CORONARY INTERVENTION DONE. CORONARY ANGIOGRAPHY REVEALED A CRITICAL OSTIAL NARROWING OF THE LAD. THE STENTS THAT WERE INITIALLY PLACED IN THE LAD WERE NOTED TO BE WIDELY PATENT WITH ONLY MILD IN-STENT RESTENOSIS. IT WAS ALSO NOTED THAT THERE WAS MILD IN-STENT RESTENOSIS IN THE PREVIOUS STENTED PORTION OF THE MAIN CIRCUMFLEX AND OBTUSE MARGINAL VESSEL. THE STENT THAT WAS PLACED IN THE RCA WAS NOTED TO BE WIDELY PATENT WITHOUT SIGNIFICANT IN-STENT RESTENOSIS. THE NEW LESION FOUND IN THE LAD WAS TREATED WITH A 3.5X18MM CYPHER STENT AT 14ATM. HOWEVER, BECAUSE OF PLAQUE SHIFT THERE WAS A MODERATE TO SEVERE LESION AT THE OSTIUM OF THE CIRCUMFLEX. A 3.5X8MM CYPHER STENT WAS THEN IMPLANTED AT 14ATM. ONCE AGAIN, THERE WAS MILD PLAQUE SHIFTING INTO THE OSTIUM OF THE LAD. THEREFORE, KISSING BALLOON TECHNIQUE WAS USED TO COMPLETE THE PROCEDURE. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBERS ARE 3003742446-2008-00161, -00162, -00163 AND -00164. THIS MALE EXPERIENCED PLAQUE SHIFT AND VESSEL SPASM DURING THE IMPLANTATION OF MULTIPLE CYPHER STENTS. MEDICAL HISTORY INCLUDED CORONARY ARTERY DISEASE, HYPERTENSION, SPINAL STENOSIS AND "SEVERE BULGING DISKS" IN HIS BACK. DURING THIS INITIAL PROCEDURE, FIVE CYPHER STENTS WERE IMPLANTED, AS FOLLOWS: 3.5/23MM IN THE 1ST OBTUSE MARGINAL BRANCH LEADING TO "SOME SHIFT OF PLAQUE" INTO THE MEDIAL CIRCUMFLEX. A 3.5/8MM CYPHER WAS THEN IMPLANTED, TANDEM AND PROXIMAL TO THE 1ST STENT, WHICH EXTENDED INTO THE MEDIAL CIRCUMFLEX. A 3.0/18MM CYPHER WAS THEN IMPLANTED IN THE DIAGONAL BRANCH FOLLOWED BY A 3.5/23MM CYPHER IN THE MID LAD. THIS RESULTED IN SOME MILD SPASM THAT RESOLVED WITH IC NTG. FINALLY, A 3.5/28MM CYPHER WAS IMPLANTED IN THE PROXIMAL-TO-MID RCA. APPROX 4 MONTHS LATER, THE PT HAD A RECURRENCE OF CHEST PAIN. ANGIOGRAPHY REVEALED A CRITICAL NARROWING AT THE OSTIUM OF THE LAD. THE PREVIOUSLY IMPLANTED STENTS WERE FOUND WIDELY PATENT WITH MILD LUMINAL NARROWING. A 3.5/18MM CYPHER WAS IMPLANTED AT THE LAD OSTIUM, WHICH RESULTED IN PLAQUE SHIFT INTO THE OSTIUM OF THE CIRCUMFLEX. THIS WAS TREATED WITH A 3.5/8MM CYPHER AND FOLLOWED WITH FINAL KISSING BALLOONS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 2.5X12MM VOYAGER BALLOON CATHETER| 3.0X20MM BALLOON CATHETER| 7F HEMOSTATIC SHEATH| BMW GUIDEWIRE| 7F EBU GUIDING CATHETER| 6F DIAGNOSTIC CATHETER| ASAHI PROWATER GUIDE WIRE