BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 4210655 · Received October 29, 2014

    Report

    Report Number
    2024168-2014-07086
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEFLATION ISSUE WAS NOT CONFIRMED. THE REPORTED DIFFICULTY TO DEPLOY THE SCAFFOLD COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO DEPLOY THE SCAFFOLD AND DEFLATION ISSUE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.5X18MM DEVICE WAS SUCCESSFULLY ADVANCED AND THE IMPLANT WAS SUCCESSFULLY DEPLOYED. THE 3.0X18MM DEVICE WAS SUCCESSFULLY ADVANCED AND THE IMPLANT WAS DEPLOYED; HOWEVER, THE IMPLANT WAS NOT FULLY APPOSED TO THE VESSEL WALL. ADDITIONALLY, THE DELIVERY SYSTEM BALLOON COULD NOT BE DEFLATED. SEVERAL ATTEMPTS WERE MADE TO INFLATE AND DEFLATE THE DELIVERY SYSTEM; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. THE DELIVERY SYSTEM WAS REMOVED AS A SINGLE UNIT WITH THE GUIDING CATHETER. A NON-ABBOTT NON-COMPLAINT (NC) BALLOON DILATATION CATHETER (BDC) WAS USED TO FULLY APPOSE THE IMPLANT TO THE VESSEL WALL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692811 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD NIQ AV-TEMECULA-CT 404146P

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: 2.5X18MM ABSORB