BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 726432 · Received May 17, 2006

    Report

    Report Number
    3003742446-2006-00352
    Event Type
    Injury
    Date Received
    May 17, 2006
    Date of Event
    April 7, 2006
    Report Date
    May 17, 2006
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: UPON INSPECTION OF THE RETURNED DEVICE, THE DISLODGED COMPLAINT WAS CONFIRMED. A CYPHER RX SDS WAS RECEIVED WITH THE STENT DEPLOYED. A COMPETITOR'S 6 FRENCH GUIDING CATHETER WITH A SNARE DEVICE WAS ALSO ENCLOSED IN THE BAG STAINED WITH DRIED BLOOD. MICROSCOPIC EXAMINATION REVEALED AMPLE EVIDENCE OF STENT IMPRESSIONS IN THE OUTER SURFACE OF THE PARTIALLY INFLATED BALLOON, INDICATIVE OF PROPER STENT CRIMPING DURING MANUFACTURE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND THE BALLOON FUNCTIONAL TESTING RESULTS CONFIRMED THAT THE LOT FULFILLED PRODUCT FUNCTIONAL SPECIFICATIONS. THE EXACT CAUSE FOR THE REPORTED DISLODGED STENT COULD NOT CONCLUSIVELY BE DETERMINED; ALTHOUGH IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. AN INVESTIGATION HAS BEEN OPENED TO ADDRESS DISLODGMENT ISSUES WITH CYPHER STENTS.

    Description of Event or Problem · 1

    A CYPHER STENT DISLODGED DURING A CORONARY INTERVENTION. THE PT REQUIRED SURGICAL REMOVAL OF THE DEVICE. THIS PT WAS ADMITTED FOR ANGIOGRAPHIC EVALUATION FOLLOWING A POSITIVE STRESS TEST. PRE-PROCEDURE, THE PT RECEIVED LOPRESSOR, LASIX, ASPIRIN, SIMVASTATIN, AND EFFEXOR. ANGIOGRAPHY REVEALED A 99% CALCIFIED, TORTUOUS, DISCREET, B-TYPE STENOSIS IN THE DISTAL LAD. A LOADING DOSE OF 300 MG PLAVIX WAS ADMINISTERED PO. A BOLUS OF 67.5MG ANGIOMAX WAS ADMINISTERED IV, FOLLOWED BY A DRIP @31.5CC/HR. A CORDIS JL4 GUIDING CATHETER AND A BMX GUIDEWIRE WERE USED TO ACCESS THE VESSEL VIA THE RIGHT FEMORAL ARTERY WITHOUT DIFFICULTY. THE LESION WAS PRE-DILATED WITH A 2.5 X 9MM MAVERICK BALLOON INFLATED TO 12 ATMS FOR 24 SECONDS. A 2.5 X 23MM CYPHER STENT WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION SITE. THE CYPHER WAS WITHDRAWN BACK THROUGH THE GUIDING CATHETER. THE LESION WAS AGAIN PREDILATED WITH A 1.5 X 10MM RAPTORRAIL BALLOON INFLATED TO 8ATMS FOR 48 SECONDS. THE JLA GUIDING CATHETER WAS EXCHANGED OVER THE WIRE FOR A NEW )IDENTICAL) CATHETER. A NEW BMW GUIDEWIRE WAS PLACED ACROSS THE LESION LINE. AN EXTRA S'PORT GUIDWIRE WAS ALSO ADVANCED ACROSS THE LESION (BUDDY WIRE). A 3.0 X 6MM STORMER BALLOON WAS ADVANCED TO THE LESION, BUT WAS UNABLE TO CROSS. IT WAS REMOVED FROM THE PT. A 2.5 X 20MM MAVERICK BALLOON WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION SITE. A 1.5 X 15MM MAVERICK WAS ULTIMATELY ABLE TO CROSS AND WAS INFLATED TO 12 ATMS (TIMES FOUR). THEN , THE 2.0 X 20MM MAVERICK WAS AGAIN ADVANCED TO THE LESION AND WAS INFLATED TO 10ATMS (TIMES TWO). THE 2.5 X 23MM CYPHER STENT WAS THEN ADVANCED TO THE LESION, BUT WAS UNABLE TO CROSS. THE CYPHER STENT WAS WITHDRAWN BACK THROUGH THE GUIDER, DURING WHICH TIME, IT APPARENTLY DISLODGED FROM THE BALLOON. A 1.5 X 6MM STRIKER BALLOON WAS INSERTED TO THE LESION AND WAS INFLATED TO 6 ATMS FOR 50 SECONDS. AT THIS TIME, THE GUIDING CATHETER AND GUIDEWIRE WERE AGAIN EXCHANGED. A 2.5 X 24MM TAXUS STENT WAS ADVANCED TO THE LESION SITE AND AS DEPLOYED TO 14 ATMS FOR 22 SECONDS. A 2.5 X 12MM TAXUS WAS ALSO ADVANCED TO THE LESION AND WAS DEPLOYED TO 14 ATMS FOR 24 SECONDS. THE DEPLOYED STENTS WERE ALL OVERLAPPING. THE LEFT GROIN WAS PREPPED AND ARTERIAL ACCESS WAS OBTAINED WITH A 6 FR SHEATH. A CORDIS IMA CATHETER WAS INSERTED INTO THE VASCULATURE. A SNARE DEVICE WAS ADVANCED THROUGH THE GUIDER AND AN ATTEMPT TO SNARE THE DISLODGED STENT WAS MADE. THE SNARE WAS REMOVED; HOWEVER, THERE WAS NO STENT WITHIN THE BASKET. UNDER FLUORO, THE STENT WAS LOCATED AT THE TIP OF THE SHEATH, IN THE FEMORAL ARTERY. AFTER ATTEMPTS TO SNARE THE STENT, IT EMBOLIZED DOWN THE LEG. A GUIDWIRE, BALLOON AND SNARE DEVICE WERE INSERTED THROUGH THE STENT. THE BALLOON WAS EXPANDED TO 4 ATMS AND THE STENT WAS DRAGGED BACK UP THE LEG TO THE SHEATH IN THE RFA. THE SHEATH WAS SUTURED IN PLACE WITH THE BALLOON STILL INSERTED THROUGH THE SHEATH AND STENT. THE SHEATH IN THE LFA WAS PULLED AND AN ANGIOSEAL WAS DEPLOYED. THE PT WAS SENT TO THE OR FOR SURGICAL REMOVAL OF THE DEVICE (FEMORAL CUT DOWN), WHICH WAS SUCCESSFUL. THE PT IS REPORTED TO BE IN STABLE CONDITION FOLLOWING SURGERY. THIS IS AN INITIAL/FINAL REPORT. PLEASE NOTE THE FOLLOWING FINAL ASPECTS OF THE FILE: IN SUMMARY, THIS FEMALE PT WITH A HISTORY OF CAD, HTN, HIGH CHOLESTEROL, MITRAL VALVE STENOSIS, SMOKING, AND A FAMILY HISTORY OF CAD HAD CYPHER STENT IMPLANTATION. THE LESION LOCATED IN THE DISTAL LAD WAS CALCIFIED AND TORTUOUS. THE SAFETY AND EFFECTIVENESS OF THE CYPHER STENT HAS NOT BEEN ESTABLISHED IN LESIONS THAT PREVENT COMPLETE INFLATION OF THE BALLOON AND IN LESIONS THAT ARE TORTUOUS. WHEN RESISTANCE IS MET, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A ASINGLE UNIT. AT THIS TIME, 2 OTHER BRAND STENTS WERE ADVANCED TO THE LESION SITE AND DEPLOYED OVERLAPPING. SNARING OF THE DISLODGED STENT WAS UNSUCCESSFUL. THE STENT EMBOLIZED DOWN THE LEG BUT WAS DRAGGED TO THE SHEATH AND REMOVED BY CUT DOWN. IN CONCLUSION, THERE ARE LESION AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA A0306446

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R ANGIOMAX| ASPIRIN| 1.5 X 15MM MAVERICK BALLOON| 2.0 X 20MM MAVERICK ABLLOON| 2.5 X 28MM CYPHER STENT| IMA GUIDE CATHETER| 25MM GOOSE NECK SNARE| 2.5 X 23 MM CYPHER STENT| 2.5 X 12 MM TAXUS STENT| 2.5 X 24MM TAXUS STENT| 1.5 X 6MM SPRINTER BALLOON| 3.0 X 6MM STORMER BALLOON| 2.5 A 20MM MAVERICK BALLOON| 1.5 A 10MM RAPTORRAIL BALLOON| EXTRA SPORT GUIDEWIRE, 2.5 X 9MM MAVERICK BALLOON| JL4GUIDE CATHETER (CORDIS), BMW GUIDEWIRE| SIMVASTATIN| EFFEXOR| LASIX| LOPRESSOR| PLAVIX| 3.0 A 9MM MAVERICK BALLOON