BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141875 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04522
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. (B)(4) (USE IN SAPHENOUS VEIN GRAFT). CONCOMITANT MEDICAL PRODUCTS: DIL CATH: 30 X 15 MM MAVERICK BALLOON (BOSTON SCIENTIFIC), 3.5 X 20 MM QUANTUM MAVERICK BALLOON (BOSTON SCIENTIFIC). GUIDE WIRE: ATW X 2. GUIDE CATH: 6 FR JR 4, 7 FR JR4, SHEATH: 6 FR 23 CM. ATHERECTOMY: 3.0 X 10 MM FLEXTOME CUTTING BALLOON (BOSTON SCIENTIFIC). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PERFORATION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED IN A SAPHENOUS VEIN GRAFT (SVG). IT SHOULD BE NOTED THAT THE PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (PROMUS STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IMPLANTATION OF THE STENT IN A SAPHENOUS VEIN GRAFT (SVG) DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PERFORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED DURING THE PROCEDURE TO PLACE A DRUG ELUTING STENT IN THE SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING BRANCH OF RIGHT CORONARY ARTERY (RCA) INITIAL ATTEMPTS WERE MADE TO PREDILATATE THE LESION USING NON-ABBOTT BALLOONS, VIA AN UNKNOWN GUIDE CATHETER, OVER A NON-ABBOTT GUIDE WIRE. THE LESION APPEARED TO BE HEAVILY FIBROTIC AND A NON-ABBOTT CUTTING BALLOON WAS USED FOLLOWED BY ADDITIONAL BALLOON INFLATIONS TO ACHIEVE FULL BALLOON EXPANSION. A PROMUS STENT WAS IMPLANTED IN THE VEIN GRAFT TO THE RCA. STAINING WAS NOTICED, QUESTIONING A PERFORATION. A DISEASED SEGMENT IN THE MAIN BODY OF THE VEIN GRAFT WAS IDENTIFIED AND A SECOND PROMUS STENT WAS IMPLANTED PROXIMAL WITH A 2-3 MM OVERLAP. STAINING WAS STILL OBSERVED AFTER PLACEMENT OF THE SECOND STENT. A 2D ECHOCARDIOGRAM WAS PERFORMED; THERE WAS NO EVIDENCE FOR PERICARDIAL EFFUSION. THE EXTRAVASATION OF DYE CONTINUED FOR 15 MINUTES AND THE PERFORATION WAS TREATED USING A GRAFTMASTER COVERED STENT. AFTER THE COVERED STENT WAS PLACED AND FOLLOWED BY ADDITIONAL NON-ABBOTT BALLOON INFLATIONS THE STAINING RESOLVED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. THOUGH REQUESTED 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 77 YR Required Intervention