BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1582795 · Received January 18, 2010

    Report

    Report Number
    9616099-2010-00061
    Event Type
    Injury
    Date Received
    January 18, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO REMOVE THE REMAINING PART OF THE SDS, A GC (BRITE TIP 7F XB3.0) WAS RE-ENGAGED AND THE SNARE CATHETER WAS DELIVERED TO THE LAD. THEN AN ANGIOGRAPHIC CATHETER (4F PIG TAIL) APPROACHED FROM THE FEMORAL ARTERY, WAS ALSO DELIVERED TO THE LAD. THE REMAINING PART OF THE SDS WAS PICKED UP WITH THE DISTAL CIRCLE OF THE ANGIOGRAPHIC CATHETER (4F PIG TAIL) AND THEN THE HUB OF THE ANGIOGRAPHIC CATHETER WAS SEVERED AND THE REMAINING PART OF THE SDS AND THE GC WERE SAFELY REMOVED FROM THE PT USING A SNARE FROM RADIAL ARTERY. TO FINISH THE PROCEDURE, A GW (X-TREME) RE-CROSSED THE LESION AND POST-DILATION WAS CONDUCTED TO FURTHER DILATE THE CYPHER STENT. AFTERWARDS, A SECOND CYPHER (3.5/13MM) WAS IMPLANTED PROXIMAL TO THE CYPHER, OVERLAPPING IT. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PT INJURY REPORTED. THE PHYSICIAN COMMENTED THAT WHEN THE PROXIMAL PORTION OF THE STENT WAS INFLATED OUTSIDE THE PT, AN UNEXPECTED PORTION OF THE STENT WAS ALSO INFLATED, AND SO THE PORTION WAS SWAGED AND TWISTED TO MOUNT THE BALLOON. THE POSSIBLE CAUSE OF THE INFLATION DIFFICULTY WAS THAT THE STENT STRUTS MIGHT BECOME STUCK EACH OTHER OR THE BALLOON MIGHT BECOME STUCK WITH THE STENT STRUT WHEN THE STENT WAS SWAGED AND TWISTED. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A CORONARY STENT PLACEMENT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PLACING THE STENT IN THE INTENDED TARGET LESION DUE TO INFLATION DIFFICULTIES WITH THE BALLOON. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT DELIVERY SYSTEM (SDS) FROM THE VESSEL, THE SDS SEPARATED AND NEEDED TO BE REMOVED WITH A SNARE. THE PT'S AGE WAS UNK, BUT WAS A FEMALE. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS A DE NOVO, BIFURCATED, NOT CALCIFIED AND NOT TORTUOUS LESION. THERE WAS 90% STENOSIS. A RIGHT RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. A BRITE TIP 6F XB3.0 GUIDE CATHETER WAS ENGAGED AND THEN A GUIDEWIRE (GW)(FIELDER) CROSSED THE TARGET LESION, AND ANOTHER GW (RINATO) WAS DELIVERED TO THE LEFT CIRCUMFLEX (LCX). PRE-DILATION WAS PERFORMED WITH A MAVERICK 2.5/15MM BALLOON CATHETER AND IVUS WAS CONDUCTED. THEN, A CYPHER (3.5/23MM: COMPLAINT PRODUCT) STENT, IN WHICH THE PROXIMAL PORTION OF THE STENT WAS INFLATED AT 5ATM OUTSIDE THE PT, AND A STRUT OF THE PROXIMAL PORTION OF THE STENT WAS CROSSED WITH GW BEFORE THE DELIVERY WAS DELIVERED TO THE TARGET LESION. WHEN THE CYPHER WAS INFLATED UP TO 25ATM, THE PROXIMAL AND DISTAL PORTION OF THE BALLOON WERE INFLATED BUT THE MID-PORTION OF THE BALLOON WOULD NOT BE INFLATED AT ALL. THEREFORE, THE PHYSICIAN TRIED TO DISPLACE THE BALLOON, BUT THE SDS OF THE CYPHER BECAME STUCK. WHEN THE PHYSICIAN PULLED STRONGLY THE SDS OF THE CYPHER, THE GUIDE WIRE EXIT-PORT AREA OF THE SHAFT WAS SEPARATED. THE TWO GWS (FIELDER AND RINATO) CAME OFF OF THE LEFT ANTERIOR DESCENDING (LAD) AND LCX AT THE TIME, SO THE DISTAL PART OF THE SDS REMAINED IN THE LAD.

    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 15041810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R APEX 1.5/12MM| QUANTUM 3.0/8MM| STENT: CYPHER 3.5/13MM| X-TREME| BC: QUANTUM 3.5/15MM| MAVERICK 2.5/15MM| FIELDER FC| FIELDER| GW: RINATO| INFLATION DEVICE: NEICH'S| GC: BRITE TIP 6F XB3.0| BRITE TIP 7F XB3.0| SHEATH: TERUMO'S