BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161270 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02240
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET SITE IN THE MALE PT OF UNKNOWN AGE WAS A DE NOVO, HEAVILY CALCIFIED, SLIGHTLY TORTUOUS 99% STENOSED PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION. A GUIDE WIRE (XTREME) WAS INSERTED INTO THE MID LAD, BUT THE GUIDE WIRE (GW) WAS INSERTED TO SECOND DIAGONAL. THEN A BALLOON (LEGEND 1.25MM) WAS DELIVERED, BUT THE BALLOON WOULD NOT ADVANCE THE BIFURCATED AREA OF THE MID LAD AND FIRST DIAGONAL. THEREFORE, THE BALLOON WAS INFLATED AT THE PROXIMAL END OF THE BIFURCATED AREA AND THEN THE GW (XTREME) WAS INSERTED INTO LAD AGAIN. PRE-DILATION WITH A BALLOON (LACROSSE 1.3MM) WAS CONDUCTED AT THE TARGET LESION, AND A MICRO CATHETER WAS USED AND THE GUIDE WIRE (XTREME) WAS EXCHANGED TO A DIFFERENT GUIDE WIRE (RINATO 2.0 MM). PRE-DILATION WITH A NEW BALLOON (LEGEND 2.0MM) WAS CONDUCTED AT THE TARGET LESION AGAIN. BUT DUE TO THE CALCIFICATION INDENTATION COULD NOT BE ACHIEVED SUFFICIENTLY SO POBA WAS CONDUCTED WITH A BALLOON (BP22 2.5MM) AT 24 ATM. ALTHOUGH THERE REMAINED SECTIONS WITH INSUFFICIENT INDENTATION, THE PHYSICIAN MANAGED TO IMPLANT THE FIRST TWO CYPHERS AT PROXIMAL TO MID LAD WITH OVERLAP. BECAUSE PLAQUE SHIFTED TO THE DISTAL END, THE PHYSICIAN TRIED TO IMPLANT A THIRD CYPHER DISTAL TO THE SECOND CYPHER IMPLANTED AT THE MID-LAD, BUT THE CYPHER DID NOT REACH THE TARGET LESION ALTHOUGH IT WAS UNKNOWN IF THE THIRD CYPHER BECAME CAUGHT ON THE 1ST AND 2ND CYPHER IMPLANTED. AFTER THE THIRD STENT WAS NOT ABLE TO BE INSERTED PAST THE FIRST TWO STENTS TO COVER THE PLAQUE SHIFT, EVENTUALLY, POBA WAS CONDUCTED WITH A BALLOON (LEGEND 2.0MM) AT THE DISTAL END OF THE 2ND CYPHER IMPLANTED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. IN ATTEMPT TO TREAT THE PLAQUE SHIFT WITH A THIRD CYPHER STENT, THE STENT COULD NOT BE INSERTED PAST THE TWO PREVIOUSLY PLACED CYPHER STENTS. DIFFICULTY CROSSING A LESION OR THROUGH OTHER DEVICES IS A KNOWN PROCEDURAL OCCURRENCE. VESSEL CHARACTERISTICS AND DEVICE INTERACTION APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ANALYSIS OF THE RETURNED PRODUCT IS PENDING. THE FIRST TWO STENTS REMAIN IMPLANTED AND THE LOT NUMBER IS NOT POSSIBLE. IT WAS REPORTED THAT DURING TREATMENT OF THE TARGET LESION, DUE TO THE CALCIFICATION, INDENTATION OF THE LESION COULD NOT BE ACHIEVED DURING PREDILATION PRIOR TO THE PLACEMENT OF TWO CYPHER STENTS. THE USE OF THE JAPAN CYPHER BX IS CONTRAINDICATED IN PATIENTS JUDGED TO HAVE A LESION THAT PREVENTS COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. AFTER TWO CYPHER STENTS WERE IMPLANTED AT THE TARGET SITE, DISTAL PLAQUE SHIFT WAS NOTED. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF OR MOVEMENT OF ATHEROMATOUS MATERIAL (LESION CONTENTS) DISTALLY. COMMON TECHNIQUES TO PREVENT PLAQUE SHIFTING DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. INFLATION OF BALLOONS OVER THE RECOMMENDED RATED BURST PRESSURE MAY ALSO LEAD TO EXCESSIVE INTIMAL DAMAGE AND HIGHER POTENTIAL FOR PLAQUE SHIFTING. BASED ON THE INFO PROVIDED, THERE ARE POSSIBLE PT, VESSEL AND INHERENT RISK OF PROCEDURE FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT NUMBER 9616099-2008-00241

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF TWO OVERLAPPING CYPHER STENTS TO THE TARGET LESION, BECAUSE PLAQUE SHIFTED TO THE DISTAL END, AN ATTEMPT WAS MADE TO IMPLANT A THIRD CYPHER DISTAL TO THE SECOND IMPLANTED CYPHER. HOWEVER, TRACKING DIFFICULTY THROUGH THE PREVIOUSLY IMPLANTED STENTS WAS ENCOUNTERED. EVENTUALLY, BALLOON ANGIOPLASTY WAS CONDUCTED AT THE DISTAL END OF THE SECOND IMPLANTED CYPHER STENT AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PT INJURY 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GC: LAUNCHER SL3.5 7F| LEGEND BALLOON/METRONIC| GUIDEWIRE RINATO| MICRO CATHETER/UNK MFR| LACROSSE BALLOON/ (1.3MM)| GUIDEWIRE X-TREME| KANEKA BALLOON (2.5MM