BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4141279 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06445
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS ABLE TO BE CONFIRMED; HOWEVER, THE INFLATION ISSUE WAS UNABLE TO BE CONFIRMED. THE PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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 THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: THE XIENCE V EVEROLIMUS-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE OTHER XIENCE V REFERENCED, IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY CALCIFIED, NON-TORTUOUS, RESTENOSED 3.5 X 28 MM XIENCE V STENT IN THE UNSPECIFIED CORONARY SAPHENOUS VEIN GRAFT (SVG) AFTER PREDILATATION THE 3.0 X 15 MM XIENCE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED WITH RESISTANCE TO ADVANCE SEVERAL TIMES TO THE TARGET LESION AND WAS DELIVERED, HOWEVER, DURING THE INFLATION ATTEMPT AT 6 ATMOSPHERE (ATM) THE INDEFLATOR LOST PRESSURE. THE SDS WAS REMOVED FROM THE ANATOMY AND IT WAS NOTED THE STENT IMPLANT HAD DISLODGED OFF THE BALLOON AND REMAINED IN THE PROXIMAL PORTION OF THE SVG. THE STENT WAS DEPLOYED IN THE VESSEL AT THIS LOCATION BUT NOT IN THE TARGET LESION. OUTSIDE THE ANATOMY THE SDS DID NOT REVEAL ANY BALLOON RUPTURE OR VISIBLE HOLES IN THE BALLOON OR SHAFT. USING THE SAME INDEFLATOR, A 3.0 X 15 MM XIENCE V STENT WAS ADVANCED AND DEPLOYED IN THE DISTAL TARGET LOCATION WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620397 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4062541

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention STENT: 3.5 X 28 MM XIENCE V