BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 8358029 · Received February 21, 2019

    Report

    Report Number
    2024168-2019-01273
    Event Type
    Death
    Date Received
    February 21, 2019
    Date of Event
    June 13, 2018
    Report Date
    March 25, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT HAS BEEN ESTIMATED BASED ON DATE OF ARTICLE PUBLICATION. DATE OF IMPLANT HAS BEEN ESTIMATED BASED ON DATE OF FIRST PATIENT ENROLLMENT. ALERT DATE HAS BEEN ESTIMATED BASED ON DATE THE ARTICLE WAS READ. THE SCAFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE: ANGIOGRAPHIC AND MIDTERM OUTCOMES OF BIORESORBABLE VASCULAR SCAFFOLD FOR CORONARY BIFURCATION LESIONS. AUTHOR- PIETER SMITS, AMERICAN JOURNAL OF CARDIOLOGY 122. 12: 2035-2042. ELSEVIER INC. (DEC 15, 2018). THE ADDITIONAL ADVERSE PATIENT EFFECTS AND MALAPPOSED SCAFFOLD STRUTS REFERENCED IN THE ARTICLE ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE VESSEL; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, 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

    IT WAS REPORTED THROUGH A DATA REVIEW OF 107 PATIENTS BETWEEN JULY 2009 AND DECEMBER 2015 IDENTIFYING ABSORB BIORESORBABLE VASCULAR SCAFFOLDS (BVS) THAT MAY BE RELATED TO DEATH/CARDIAC DEATH. ARTICLE TITLED "ANGIOGRAPHIC AND MIDTERM OUTCOMES OF BIORESORBABLE VASCULAR SCAFFOLD FOR CORONARY BIFURCATION LESIONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150003 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death