BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1062920 · Received June 19, 2008

    Report

    Report Number
    9616099-2008-01555
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 23, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION INDICATED THAT, TO FIND THE STENT, THE CATHETER WAS FLUSHED REPEATEDLY AS IT WAS POSSIBLE THE STENT REMAINED INSIDE THE CATHETER; HOWEVER, THE STENT COULD NOT BE FOUND. FURTHERMORE, IT WAS INDICATED THAT DURING THE PROCEDURE, THE GUIDEWIRE WAS INSERTED DISTALLY AND SO THE PHYSICIAN PRESUMED THAT THERE WAS LITTLE POSSIBILITY THE DISLODGED STENT WAS LEFT INSIDE THE PATIENT. THE TARGET LESIONS WERE HEAVILY CALCIFIED, HIGHLY TORTUOUS AND PRESENTING 90% STENOSIS. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE THE EVALUATION HAS NOT BEEN COMPLETED. THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES; HOWEVER IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBERS: 9616099-2008-01555 AND 9616099-2008-01557. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT THE INTENDED PROCEDURE INCLUDED TREATMENT OF LESION IN THE PROXIMAL AND THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PROCEDURE BEGAN WITH TREATMENT OF THE DISTAL LESION, THE PHYSICIAN-ENCOUNTERED DIFFICULTIES ADVANCING DILATATION CATHETERS ACROSS THE LESION; HOWEVER, THE LESION WAS PRE-DILATED. THEN THE 3.0X13MM CYPHER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WHEN THE SDS REACHED THE PROXIMAL SECTION OF THE RCA, THE DEVICE GOT STUCK AND WOULD NOT ADVANCE. THEREFORE, TO OBTAIN SUFFICIENT BACK UP, DEEP SEATING AND POWER POSITION WERE CONDUCTED USING A 7F BRITE TIP GUIDE CATHETER; HOWEVER, THE CYPHER STILL COULD NOT CROSS THE TARGET LESION. THEREFORE, THE PHYSICIAN DECIDED TO RETRIEVE THE SDS AND CONDUCT ADDITIONAL PRE-DILATION. HOWEVER, WHEN THE SDS WAS REMOVED AND THE PHYSICIAN FOUND THAT THE STENT HAD DISLODGED FROM THE SDS. APPROXIMATELY FOR AN HOUR, THE PHYSICIAN SEARCHED FOR THE STENT. THE GUIDEWIRE REMAINED POSITIONED DISTALLY IN THE RCA, BUT THE STENT WAS NOT FOUND ON THE WIRE. A CORONARY ANGIOGRAM AND INTRAVASCULAR ULTRASOUND (IVUS) WERE CONDUCTED BUT THE DISLODGED STENT COULD NOT BE FOUND INSIDE THE PATIENT. ADDITIONALLY A DISSECTION WAS IDENTIFIED AT THE PROXIMAL END OF THE PROXIMAL LESION; THEREFORE, TO TREAT THE DISSECTION ANOTHER CYPHER WAS IMPLANTED. THE DISSECTION OCCURRED DUE TO THE DIFFICULTY ENCOUNTERED WITH THE DEVICES WHILE TRACKING THE VESSEL. THE PROCEDURE WAS FINISHED; THE PATIENT RECOVERED AND NO FURTHER COMPLICATIONS WERE REPORTED.

    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 13360859

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BRITE TIP (7F JR4) GUIDE CATHETER| HIRYU (2.5/10MM) BALLOON CATHETERS| FIELDER| AND PRESTIGE (1.3MM)| FIELDER GUIDEWIRE