BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1051804 · Received May 21, 2008

    Report

    Report Number
    2953200-2008-00333
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 19, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHODS: OTHER FILMS REVIEWED. RESULTS: OTHER (LACK OF INFORMATION, UNKNOWN IF PATIENT FOLLOWED MEDICATION TREATMENT POST STENT IMPLANT). INHERENT RISK OF PROCEDURE (SUBACUTE THROMBOSIS). CONCLUSION: OTHER (LACK OF INFORMATION, UNKNOWN IF PATIENT FOLLOWED MEDICATION TREATMENT POST STENT IMPLANT).

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT SYSTEM WAS IMPLANTED INTO A PATIENT FOR TREATMENT OF A CIRCUMFLEX ARTERY LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED 10 DAYS POST STENT IMPLANT, THE PATIENT WAS OUT AND WAS EXPERIENCING CHEST PAIN; A DEFIBRILLATOR WAS USED ON THE PATIENT AND THEN TAKEN TO THE HOSPITAL VIA AMBULANCE. WHILE IN THE EMERGENCY ROOM THE PATIENT REQUIRED A SECOND SHOCK FROM A DEFIBRILLATOR. IT IS UNKNOWN IF THE PATIENT WAS COMPLIANT TO THE MEDICATION TREATMENT PRESCRIBED BY THE PHYSICIAN. THE PATIENT WAS UNABLE TO COMMUNICATE DUE TO LANGUAGE BARRIER AND IT IS UNKNOWN IF THE PATIENT HAD TAKEN THE PRESCRIBED MEDICATION(S). THE PATIENT HAD EXPERIENCED A THROMBOSIS WHICH WAS TREATED WITH BALLOON ANGIOPLASTY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS ALIVE. MEDTRONIC RECEIVED CD IMAGES FOR THIS CASE AND THE ANALYSIS HAS BEEN COMPLETED. THE CD IMAGES OF THE ORIGINAL PROCEDURE AND THE INTERVENTION 10 DAYS POST STENT IMPLANTATION, WHEN THE OCCLUSION OCCURRED. THE IMAGES TAKEN AT THE IMPLANT PROCEDURE SHOW THAT THE LESION IN MID-CX DID NOT APPEAR TO HAVE BEEN PREDILATED PRIOR TO THE SUCCESSFULLY DEPLOYMENT OF THE ENDEAVOR STENT. POST TREATMENT IMAGES SHOW THAT DEPLOYMENT OF THE STENT WAS SUCCESSFUL IN RESTORING PATENCY TO THE MID CX VESSEL. THE IMAGES TAKEN 10 DAYS LATER SHOW THAT THE LCX WAS FULLY OCCLUDED AT THE SITE WHERE THE PROXIMAL END OF THE STENT WAS LOCATED. THE WIRE APPEARED TO BE EASILY PLACED ACROSS THE THROMBUS TO THE DISTAL LESION. "THE PROXIMAL TO MID VESSEL REGION WAS TREATED WITH A BALLOON WHICH RESTORED FLOW IN THE VESSEL. ANGIOPLASTY WAS PERFORMED THROUGH THE VESSEL IN ORDER TO ENSURE PATENCY. THE FINAL ANGIOGRAPHIC IMAGES SHOW A HEART EJECTION FRACTION OF 44% ON THE LAST IMAGE. TREATMENT WAS SUCCESSFUL BY RE-OPENING OF THE VESSEL BY ANGIOPLASTY. THE DEVICE HAS NOT BEEN IDENTIFIED AS THE ROOT CAUSE OF THE THROMBOSIS AND OCCLUSION. THERE WERE NO DIFFICULTIES REPORTED DURING DEPLOYMENT OF THE STENT AND THE CD IMAGES DID NOT SHOW ANY MECHANICAL REASON FOR THE OCCURRENCE OF IN STENT THROMBOSIS OF THE ENDEAVOR STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000611418

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention