BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2770732 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05988
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    April 16, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, STENT FRACTURE OCCURRED. A 4.0X20MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT CORONARY TRUNK. TWELVE DAYS POST IMPLANT, THE PATIENT RETURNED FOR A PLANNED STAGED PROCEDURE. TWO UNSPECIFIED GUIDE CATHETERS CANNOT ACHIEVE CANNULATION OF LEFT CORONARY TRUCK. A NON-BSC GUIDE CATHETER COULD NOT CANNULATE THE MOUTH OF THE STENT, BEING THE DEFORMATION GREATER. DUE TO THIS REASON THE GUIDE CATHETER IS CHANGED TO ANOTHER NON-BSC GUIDE CATHETER. ALTHOUGH MULTIPLE ATTEMPTS ARE DONE, THE CANNULATION OF THE PROXIMAL MOUTH OF THE STENT IN THE LEFT CORONARY TRUNK COULD NOT BE ACHIEVED. IN CONSEQUENCE, IT IS DECIDED TO PASS NON-BSC GUIDES TO THE DISTAL DESCENDING ARTERY (DA) THROUGH THE AREA OF THE OSTIAL FRACTURE, PREDILATATION WITH A NON-BSC BALLOON 3.5/12 AT 20 ATM , POSTERIOR IMPLANTATION OF A NON-BSC STENT 4/12 MM AT 20 ATM COVERING THE OSTIUM OF THE LEFT CORONARY TRUCK AND THE AREA OF THE FRACTURE. IT REMAINS EXCLUDED THE PROXIMAL SEGMENT OF THE STENT PROMUS PREVIOUSLY IMPLANTED THAT PROTRUDES IN THE AORTA AND REMAINS JOINED TO THE REST OF THE STENT. IT IS CONSIDERED AN ACCEPTABLE ANGIOGRAPHIC RESULT AND THE PROCEDURE IS FINISHED WITH FLOW TIMI 3 IN LEFT CORONARY TRUCK-DA AND CIRCUMFLEX ARTERY (CX). NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, STENT FRACTURE OCCURRED. A 4.0X20MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE LEFT CORONARY TRUNK. TWELVE DAYS POST IMPLANT, THE PATIENT RETURNED FOR A PLANNED STAGED PROCEDURE. TWO UNSPECIFIED GUIDE CATHETERS CANNOT ACHIEVE CANNULATION OF LEFT CORONARY TRUCK. A NON-BSC GUIDE CATHETER COULD NOT CANNULATE THE MOUTH OF THE STENT, BEING THE DEFORMATION GREATER. DUE TO THIS REASON THE GUIDE CATHETER IS CHANGED TO ANOTHER NON-BSC GUIDE CATHETER. ALTHOUGH MULTIPLE ATTEMPTS ARE DONE, THE CANNULATION OF THE PROXIMAL MOUTH OF THE STENT IN THE LEFT CORONARY TRUNK COULD NOT BE ACHIEVED. IN CONSEQUENCE, IT IS DECIDED TO PASS NON-BSC GUIDES TO THE DISTAL DESCENDING ARTERY (DA) THROUGH THE AREA OF THE OSTIAL FRACTURE, PREDILATATION WITH A NON-BSC BALLOON 3.5/12 AT 20 ATM , POSTERIOR IMPLANTATION OF A NON-BSC STENT 4/12 MM AT 20 ATM COVERING THE OSTIUM OF THE LEFT CORONARY TRUCK AND THE AREA OF THE FRACTURE. IT REMAINS EXCLUDED THE PROXIMAL SEGMENT OF THE STENT PROMUS PREVIOUSLY IMPLANTED THAT PROTRUDES IN THE AORTA AND REMAINS JOINED TO THE REST OF THE STENT. IT IS CONSIDERED AN ACCEPTABLE ANGIOGRAPHIC RESULT AND THE PROCEDURE IS FINISHED WITH FLOW TIMI 3 IN LEFT CORONARY TRUCK-DA AND CIRCUMFLEX ARTERY (CX). NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320400 14866255

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER EBU 3.5 (NON-BSC DEVICE)| GUIDE CATHETER JL5 (NON-BSC DEVICE)| GUIDE CATHETER JL4 (NON-BSC DEVICE)