BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2461283 · Received February 17, 2012

    Report

    Report Number
    2024168-2012-01011
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 23, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE; GUIDE CATH: LAUNCHER. IT IS INDICATED THAT THE DEVICE REMAINS IN THE PATIENT. A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT QUERY CANNOT BE CONDUCTED AS THE PART AND LOT ARE UNKNOWN. A SUPPLEMENTAL MEDWATCH WILL BE FILED IF THERE IS ANY FURTHER RELEVANT INFORMATION. THE 2 X 15 MM MINI TREK IS BEING FILED UNDER A SEPARATE MEDWATCH NUMBER. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). REMOVED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF OCCLUSION, AS LISTED IN THE (B)(4) PROMUS INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERVENTIONAL PROCEDURE WAS PERFORMED TO TWO LESIONS, ONE IN THE PROXIMAL, LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH HEAVY TORTUOSITY AND ECCENTRIC, HEAVY CALCIFICATION AND 90% STENOSIS, AND THE OTHER IN THE OCCLUDED FIRST DIAGONAL. DILATION WAS PERFORMED TO THE PROXIMAL LAD WITH A 3 X 15 MM NON-ABBOTT BALLOON CATHETER TO 10 ATMOSPHERES (ATM) THREE TIMES. A 3 X 15 MM PROMUS STENT WAS DEPLOYED IN THE PROXIMAL LAD. BLOOD FLOW DECREASED TO THE FIRST DIAGONAL. THE 2 X 15 MM MINI TREK BALLOON DILATATING CATHETER (BDC) WAS PREPPED AND SOAKED OUTSIDE OF THE ANATOMY AND IT WAS ADVANCED THROUGH THE PROMUS STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO THE FIRST DIAGONAL AT 8 ATM THREE TIMES. AN ATTEMPT WAS MADE TO PERFORM BALLOON KISSING TECHNIQUE (KBT) TO THE FIRST DIAGONAL WITH THE NON-ABBOTT BALLOON AND THE SAME MINI TREK. DURING SIMULTANEOUS INFLATION WITH THE NON-ABBOTT BALLOON, THE MINI TREK BALLOON RUPTURED AT 6 ATM ON THE FIRST INFLATION FOR THE POBA (ITS SECOND INFLATION FOR THE PROCEDURE) AND THE TREK WAS WITHDRAWN. ANOTHER LIKE NON-ABBOTT BALLOON WAS USED WITH THE FIRST NON-ABBOTT BALLOON TO COMPLETE THE KBT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    REVISED EVENT: IT WAS REPORTED THAT DILATION WAS PERFORMED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A 3 X 15 MM NON-ABBOTT BALLOON CATHETER TO 10 ATMOSPHERES (ATM) THREE TIMES. A 3 X 15 MM PROMUS STENT WAS DEPLOYED IN THE PROXIMAL LAD. BLOOD FLOW DECREASED TO THE FIRST DIAGONAL, IN FACT IT OCCLUDED THE FIRST DIAGONAL. THE 2 X 15 MM MINI TREK BALLOON DILATATING CATHETER (BDC) WAS PREPPED AND SOAKED OUTSIDE OF THE ANATOMY AND IT WAS ADVANCED THROUGH THE PROMUS STENT. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO THE FIRST DIAGONAL AT 8 ATM THREE TIMES. AN ATTEMPT WAS MADE TO PERFORM BALLOON KISSING TECHNIQUE (KBT) TO THE FIRST DIAGONAL WITH THE NON-ABBOTT BALLOON AND THE SAME MINI TREK. DURING SIMULTANEOUS INFLATION WITH THE NON-ABBOTT BALLOON, THE MINI TREK BALLOON RUPTURED AT 6 ATM ON THE FIRST INFLATION FOR THE POBA (ITS SECOND INFLATION FOR THE PROCEDURE) AND THE TREK WAS WITHDRAWN. ANOTHER LIKE NON-ABBOTT BALLOON WAS USED WITH THE FIRST NON-ABBOTT BALLOON TO COMPLETE THE KBT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention