BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3140351 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03409
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE DID RETURN FOR EVALUATION. EVALUATION SUMMARY: THIS IS A DUPLICATE REPORT. DEVICE EVALUATION HAS BEEN REPORTED TO THE FDA UNDER MFR REPORT# 2024168-2013-03393: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATHS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE PROTECTIVE SHEATHS WERE NOT RETURNED. THE REPORTED MATERIAL RUPTURE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED; HOWEVER, A PROXIMAL SEAL SEPARATION WAS NOTED. BASED ON THE VISUAL AND DIMENSIONAL ANALYSIS OF THE 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 THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THOUGH THE DEVICE IS NOT APPROVED FOR SALE IN THE U.S., IT USES A DELIVERY SYSTEM WHICH IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE PRODUCT CODE AND THE PMA# LISTED ARE BASED ON THE PREDICATE DEVICE (XIENCE V STENT SYSTEM) THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS DEVICE.

    Description of Event or Problem · 1

    THIS IS A DUPLICATE REPORT PREVIOUSLY REPORTED TO THE FDA UNDER MFR REPORT# 2024168-2013-03393: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 12 MM NON-ABBOTT BALLOON. THE 3.0 X 18 MM IMPLANT WAS PLACED AND INFLATED TO 4-6 ATMOSPHERES, AT WHICH TIME THE PRESSURE STARTED TO DROP, EVEN WHEN ATTEMPTING TO INCREASE THE PRESSURE. AS AN ATTEMPT WAS MADE TO CHANGE THE INDEFLATOR, BLOOD CAME OUT AT THE CONNECTION POINT. THE ENTIRE SYSTEM WAS REMOVED AND THE IMPLANT REMAINED INTACT ON THE BALLOON. IT WAS FURTHER REPORTED THAT THERE HAD BEEN SOME DIFFICULTY REMOVING THE PROTECTIVE SHEATH DURING PREP OF THE DEVICE. A 3.5 X 18 IMPLANT WAS SUCCESSFULLY DEPLOYED AT NOMINAL PRESSURE AND POST-DILATED WITH A 3.5 X 12 NON-ABBOTT BALLOON. THE PATIENT OUTCOME WAS GOOD. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (PLAD) PROCEDURE, THE DEVICE WAS TAKEN TO THE MILDLY CALCIFIED LESION, BUT THE BALLOON RUPTURED AT 4 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241521 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3012561

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR GUIDE WIRE: RUNTHROUGH, GUIDE CATH: LAUNCHER