BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904263 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02427
    Event Type
    Death
    Date Received
    November 11, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY OR COMPLICATIONS DURING THE INDEX PROCEDURE, AND AN AUTOPSY WAS NOT PERFORMED. HOSPITALIZATION, CARDIAC ARREST, RESPIRATORY DISTRESS AND DEATH ARE LISTED AS POTENTIAL ADVERSE EVENTS OF CORONARY STENTING IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    *PLEASE NOTE THAT THIS REPORT INCLUDES INFORMATION REGARDING THREE PROBLEMATIC DEVICES. MANUFACTURER REPORT # 3005099803-2010-05222 ADDRESSES THE REPORTED ISSUE WITH THE MAXFORCE DILATATION CATHETER, WHILE MANUFACTURER REPORT #S 3005099803-2010-05237 AND 3005099803-2010-05238 ADDRESS THE WALLFLEX STENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED TO TRY AND TREAT TWO OCCLUDED WALLFLEX BILIARY STENTS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD TWO WALLFLEX BILIARY STENTS IMPLANTED WITHIN THE PANCREAS AN UNKNOWN DATE (THESE DEVICES THE SUBJECT OF MANUFACTURER REPORT #S 3005099803-2010-05237 AND 3005099803-2010-05238). ALTHOUGH THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS AND/OR COMPLICATIONS, THEY WERE CHECKED BACK INTO THE HOSPITAL BECAUSE THE TWO WALLFLEX BILIARY STENTS WERE "CLOGGED UP." IN AN EFFORT TO TRY AND CLEAR THE BLOCKAGES, THE PHYSICIAN PLANNED TO USE THE MAXFORCE DILATATION CATHETER (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-05222). HOWEVER, PRIOR TO INFLATING THE BALLOON, THE CATHETER OF THE DEVICE GOT STUCK ON THE STRUTS OF THE STENTS; WHEN THE PHYSICIAN TRIED TO REMOVE THE BALLOON, THE CATHETER BROKE 5CM PROXIMALLY FROM THE BALLOON. THE PHYSICIAN NEEDED TO USE A PAIR OF FORCEPS TO REMOVE THE DEVICE FROM THE PATIENT; NO PORTION OF THE DEVICE WAS LEFT WITHIN THE BODY. AT THIS TIME, THE PROCEDURE WAS ABORTED, AND THE PHYSICIAN PLANS TO CONDUCT A TRANSHEPATIC EXAM AT A LATER DATE. THE PATIENT WAS LISTED AS BEING IN STABLE CONDITION. THE PHYSICIAN ADDED THAT THE STENTS WERE NOT DISLOCATED AS A RESULT OF THIS EVENT, AND THAT THEY DID NOT NEED TO BE RE-POSITIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT WAS DEPLOYED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT FELL OFF A MOTOR BIKE AND SUFFERED CARDIOPULMONARY ARREST, RESULTING IN DEATH. THERE DID NOT SEEM TO BE ANY SUBSTANTIAL EXTERNAL INJURIES OBSERVED ON THE DECEASED. IT APPEARED MORE LIKELY THE PATIENT HAS BEEN RIDING THE MOTOR BIKE AND STOPPED, THEN FELL OFF THE MOTOR BIKE. IT IS LESS LIKELY THE PATIENT HAD A ROAD ACCIDENT AND DIED AS A RESULT. THE CAUSE OF DEATH IS UNK AT THIS TIME. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0011241

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H DIL CATH: APEX,| HIRYU| GUIDE CATH: MACH1 AL1 SH,| MACH1 AL2 SH