BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1887524 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02242
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PLACED INSIDE ANOTHER STENT. THE 2.5 X 23 MM XIENCE V (1009545-23, 8010861) AND 2.5 X 12 MM XIENCE V (1009545-12, 9082461) ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS. EVAL SUMMARY: STENT FRACTURE CAN BE A RESULT OF, BUT NOT LIMITED TO, STENT MATERIAL, POST DILATATION TECHNIQUE, ANATOMICAL MOTION RESULTING IN STRESS/FATIGUE OF THE STENT MATERIAL AND/OR INTERACTION WITH OTHER DEVICE POST DEPLOYMENT. THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. TWO OTHER STENTS WERE IMPLANTED TO TREAT THE IN STENT RESTENOSIS OF THE 2.50 X 23 MM XIENCE V AND AT A LATER DATE, A STENT FRACTURE WAS NOTED HOWEVER IT IS UNK WHICH STENT HAD FRACTURED. THE PT UNDERWENT CORONARY ARTERY BYPASS GRAFT AND WAS HOSPITALIZED. REPORTEDLY, THE PT EXPERIENCED ANGINA AND IN STENT RESTENOSIS WAS NOTED. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) LISTS ANGINA AND STENOSIS AS KNOWN RISKS ASSOCIATED WITH CORONARY STENTING PROCEDURES. IT IS POSSIBLE THAT THE RESTENOSIS CONTRIBUTED TO THE ANGINA. ADDITIONALLY, IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED IN A BIFURCATION LESION. IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN UNPROTECTED LEFT MAIN CORONARY ARTERY, OSTIAL LESIONS, CHRONIC TOTAL OCCLUSIONS OR LESIONS LOCATED AT A BIFURCATION. IT IS POSSIBLE THAT TREATMENT IN THIS LESION CONTRIBUTED TO THE REPORTED STENT FRACTURE; HOWEVER, THIS CANNOT BE CONFIRMED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT SEPARATION COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CINE AND IMAGES OF THE PROCEDURE WERE RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THAT THERE ARE BASELINE ANGIOS SHOWING A FIRST DIAGONAL WITH DISEASE AT THE OSTIUM THAT EXTENDS DOWN THE VESSEL INTO A 90 DEGREE BEND. THIS AREA HAS A GREAT DEAL OF VESSEL MOVEMENT THROUGHOUT THIS SECTION. IT IS TREATED WITH PRE-DILATATION, STENT PLACEMENT AND POST DILATATION OF THE STENT. THE PROXIMAL STENT APPEARS TO EXTEND INTO THE LEFT ANTERIOR DESCENDING (LAD) AND THEY FINISH WITH KISSING BALLOONS IN THE LAD AND DIAGONAL. AFTER TREATMENT THE VESSEL HAS BEEN STRAIGHTENED SO THAT THE ORIGINAL ANGULATION AND VESSEL MOVEMENT ARE DECREASED. ON (B)(6) 2009 THE PATIENT RETURNS. THE PROXIMAL AND DISTAL STENT LOOKS GOOD WITH SOME RESTENOSIS AT THE ANGULATED SECTION AND IN THE DIAGONAL OSTIUM. THE PREVIOUS ANGULATION HAS RETURNED TO THE VESSEL AND A KINK IN THE STENT CAN BE SEEN AT THE ANGLE. THE STENT APPEARS TO BE INTACT. A STENT IS DEPLOYED THAT EXTENDS PAST THE DISTAL EDGE OF THE ORIGINAL STENT. A LONG STENT IS POSITIONED TO OVERLAP PROXIMAL AND COVER THE PREVIOUS STENT INTO THE LAD. THESE TWO STENTS OVERLAP APPROXIMATELY AT THE LOCATION OF THE PREVIOUS ANGULATED SECTION. THE ANGULATED AREA IS NOW STRAIGHTENED AGAIN AND VESSEL MOVEMENT IS DECREASED. ON (B)(6) 2009, THE PATIENT RETURNS AGAIN. THE REVIEWER COULD NOT RESOLVE IF THE STENT IS FRACTURED BUT VESSEL/STENT MOTION MAKE IT APPEAR THAT IT MIGHT BE. THE ANGULATION HAS RETURNED. THE REVIEWER CONCLUDED THAT THE IMAGES OF (B)(6) 2009 CONFIRM A CIRCUMFERENTIAL STENT FRACTURE IN THE PREVIOUSLY IMPLANTED STENT, WHICH WAS TREATED WITH A SECONDARY STENT. THE SECOND CD OF (B)(6) 2010 CONFIRMS THAT THERE IS AGAIN A CIRCUMFERENTIAL STENT FRACTURE (MOST LIKELY THE STENT IMPLANTED ON (B)(6) 2009). THE AREA OF STENT(S) FRACTURE OCCURS AT A SIGNIFICANTLY ACUTE ANGLE IN THE DIAGONAL. THIS ANGLE IS SUBJECT TO CONTINUAL BENDING WITH SYSTOLIC MOVEMENT. A LIKELY CAUSE FOR THE STENT(S) FRACTURE COULD BE METAL FATIGUE SECONDARY TO THE CONTINUAL BENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETIME IN 2009, SEVERAL MONTHS POST XIENCE V (2.5 X 23 MM) STENT IMPLANTATION IN A BIFURCATION LESION IN THE PROXIMAL FIRST DIAGONAL ARTERY, THE PT EXPERIENCED INCREASING CHEST PAIN UPON EXERTION. ON (B)(6) 2009, ANGIOGRAM SHOWED IN-STENT RESTENOSIS (ISR) AND TWO NON-ABBOTT STENTS WERE PLACED AS TREATMENT, FULLY COVERING THE XIENCE STENT AS WELL AS COVERING PROXIMAL AND DISTAL TO THE STENTED AREA. ON (B)(6) 2009, ISR WAS FOUND WITHIN THE TWO NON-ABBOTT STENTS. A STENT FRACTURE WAS FOUND AS WELL; HOWEVER, IT IS UNCLEAR WHICH STENT WAS FRACTURED. REPORTEDLY, THE STENT FRACTURE WAS NOT CIRCUMFERENTIAL. TWO XIENCE V STENTS (2.5 X 23 MM & 2.5 X 12 MM - PLACED (B)(6) 2009) WERE PLACED WITHIN THE TWO NON-ABBOTT STENTS. ON (B)(6) 2010, THE PT EXPERIENCED RECURRENT CHEST PAIN. ON (B)(6) 2010, TOTAL OCCLUSION OF THE STENT AND A STENT FRACTURE WAS OBSERVED, AGAIN, UNSURE WHICH STENT WAS FRACTURED. ADDITIONALLY, THE STENT FRACTURE MAY HAVE BEEN CIRCUMFERENTIAL. CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ON (B)(6) 2010, THE PT WAS DISCHARGED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTING THAT DURING A STENTING TREATMENT PROCEDURE, THE MARKERBAND WAS UNABLE TO BE SEEN. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. THE LESION WAS TREATED WITH DEPLOYMENT OF A 190CM FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM AND PLACEMENT OF A CAROTID WALLSTENT. AFTER THE STENT WAS SUCCESSFULLY DEPLOYED, THE PHYSICIAN ADVANCED THE FILTERWIRE EZ FILTER RETRIEVAL SHEATH. IT WAS NOTED THAT THE PHYSICIAN WAS UNABLE TO VIEW THE RADIOPAQUE MARKER BAND ON THE DISTAL PART OF THE SHEATH UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9061861

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R