BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 8358101 · Received February 21, 2019

    Report

    Report Number
    2024168-2019-01275
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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 PATIENT DEATHS REFERENCED IN THE ARTICLE ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S.

    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 MALAPPOSED SCAFFOLD STRUTS. 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
    152560 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR