BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 6024640 · Received October 12, 2016

    Report

    Report Number
    2024168-2016-06896
    Event Type
    Death
    Date Received
    October 12, 2016
    Date of Event
    September 2, 2016
    Report Date
    November 16, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF DEATH AND PERFORATION, AS LISTED IN THE ABSORB GT1 INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 1

    NEW INFORMATION: IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT A LESION IN THE DISTAL DIAGONAL ARTERY. THE PATIENT PRESENTED WITH ST-ELEVATED MYOCARDIAL INFARCTION. THE PATIENT DIED A SUDDEN DEATH AT HOME ON (B)(6) 2016. NO AUTOPSY WAS PERFORMED. THE PHYSICIAN COMMENTED HE DID NOT THINK THE DEATH WAS RELATED TO THE ABSORB GT1 SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.5 X 23 MM ABSORB SCAFFOLD WAS IMPLANTED IN THE DISTAL DIAGONAL ARTERY. POST-DILATATION WAS PERFORMED AT HIGH PRESSURE AT WHICH TIME CORONARY PERFORATION OCCURRED. A NON-ABBOTT COVERED STENT WAS USED TO TREAT THE PERFORATION. TWO NON-ABBOTT DRUG ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL DIAGONAL. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT) OF TICAGRELOR AND ASPIRIN. THE PATIENT DIED AT HOME A FEW DAYS LATER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675981 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT 5041561

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death STENT: SYNERGY (X2)