BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 7015430 · Received November 9, 2017

    Report

    Report Number
    2024168-2017-08854
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    September 25, 2017
    Report Date
    November 9, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS STUDY ALSO SHOWS A 1.9 PERCENT RATE OF DEVELOPING BLOOD CLOTS (THROMBOSIS) WITHIN THE BVS VERSUS 0.8 PERCENT WITHIN THE XIENCE STENT AT 2 YEARS. THESE OBSERVED HIGHER ADVERSE CARDIAC EVENT RATES IN BVS PTS WERE MORE LIKELY WHEN THE DEVICE WAS PLACED IN SMALL HEART VESSELS. THE FDA IS WORKING WITH ABBOTT VASCULAR, INC., TO CONDUCT ADDL ANALYSES TO BETTER UNDERSTAND THE CAUSE(S) OF THE HIGHER CARDIAC EVENT AND DEVICE THROMBOSIS RATES IN PTS TREATED WITH BVS COMPARED TO THE XIENCE STENT. THE FDA WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE BVS IN ONGOING CLINICAL STUDIES AND IN REPORTS SUBMITTED TO FDA THROUGH MEDWATCH. WE WILL UPDATE THIS COMMUNICATION WHEN ADD'L INFO OR ANALYSES BECOME AVAILABLE. BACKGROUND: THE BVS IS USED TO OPEN HEART BLOOD VESSELS (CORONARY ARTERIES) BLOCKED BY SCAR TISSUE (PLAQUE) IN ORDER TO INCREASE BLOOD FLOW INTO THE HEART MUSCLE. UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST AND RESTENOSIS AS LISTED IN THE ABSORB GT1 INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, 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 ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH (REPORT #: MW5072617) REPORT RECEIVED THAT STATES: I HAD A SEVERE CARDIAC ARREST ON (B)(6) 2015 AND DONE ANGIOPLASTY FROM (B)(6). THEY HAVE DONE THE ANGIOPLASTY WITH THE STENT NAMED ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) BY ABBOTT VASCULAR: LAST 2 YEARS, I HAD ATTENDED MANY F/U SESSIONS AND CONTINUING THE MEDICINE FOR LAST 2 YEARS. BUT RECENTLY I HAD A SEVERE CARDIAC ARREST ON (B)(6) 2017 MORNING AND ADMITTED IN HOSPITAL FOR 4 DAYS. DONE THE ANGIOGRAM AND ANGIOPLASTY, IT HAS COME TO KNOW THAT THE STENT WHICH WE USED 2 YEARS BACK IS ALREADY DISSOLVED FROM MY BODY. THE SAME PLACE AGAIN GOT BLOCKED DUE TO THE ABSENCE OF THE STENT. ACCORDING TO THE DOCTOR, THE STENT WAS DISSOLVED LONG BACK. THE REPORTS CAME THE ABSORB GT1 HAS BEEN CALL BACK BY THE FDA. (B)(4) ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) BY ABBOTT VASCULAR. LETTER TO HEALTH CARE PROVIDERS - FDA INVESTIGATING INCREASED RATE OF MAJOR ADVERSE CARDIAC EVENTS [POSTED (B)(6) 2017] AUDIENCE: CARDIOLOGY, SURGERY, RISK MANAGER, ISSUE: THE FDA IS INFORMING HEALTH CARE PROVIDERS TREATING PTS WITH ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT THERE IS AN INCREASED RATE OF MAJOR ADVERSE CARDIAC EVENTS OBSERVED IN PTS RECEIVING THE BVS, WHEN COMPARED TO PTS TREATED WITH THE APPROVED METALLIC XIENCE DRUG-ELUTING STENT. THE FDAS INITIAL REVIEW OF TWO-YEAR DATA FROM THE BVS PIVOTAL CLINICAL STUDY (THE ABSORB ILL TRIAL) SHOWS AN 11 PERCENT RATE OF MAJOR ADVERSE CARDIAC EVENTS (E. G., CARDIAC DEATH, HEART ATTACK, OR THE NEED FOR AN ADD'L PROCEDURE TO RE-OPEN THE TREATED HEART VESSEL) IN PTS TREATED WITH THE BVS AT TWO YEARS, COMPARED WITH 7.9 PERCENT IN PTS TREATED WITH THE ALREADY-APPROVED ABBOTT VASCULARS METALLIC XIENCE DRUG-ELUTING STENT (P = 0.03).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795815 ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R