BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK 14 PLUS STENT SYSTEM

    MDR report key: 1920328 · Received December 10, 2010

    Report

    Report Number
    3004742046-2010-00600
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE TWO RX HERCULINK STENT SYSTEMS (PART 1008021-12, LOT 0062251 AND PART 1008018-12, LOT UNK) INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. (B)(4): VASCULAR USE OF BILIARY STENT. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DIFFICULTY TO DEPLOY CAN BE A RESULT OF, BUT IS NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DAMAGE TO THE STENT DELIVERY SYSTEM (SDS), DEPLOYMENT TECHNIQUE AND/OR DEVICE SIZE SELECTION. REPORTEDLY, THE PHYSICIAN COMMENTED THAT THE VESSEL DIAMETER BECAME 8MM DUE TO THE DISSECTION. IT IS LIKELY THAT THE DIFFICULTY TO DEPLOY AND SUBSEQUENT STENT MIGRATION ARE DUE TO SIZE SELECTION AS THE STENT IMPLANT WAS 6.0MM IN DIAMETER. THE REPORTED COMPLAINT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. REPORTEDLY, THE HERCULINK PLUS SDS WAS USED TO TREAT A RENAL ARTERY LESION. IT SHOULD BE NOTED THAT THE HERCULINK PLUS INSTRUCTIONS FOR USE (IFU) STATES THAT THE RX HERCULINK PLUS BILIARY STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. IN THIS CASE, IT DOES NOT APPEAR THAT THE OFF LABEL USE OF THE DEVICE CONTRIBUTED TO THE REPORTED COMPLAINT AND APPEARS TO BE RELATED TO DEVICE SIZE SELECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE AT THE OSTIUM OF THE RENAL ARTERY, A 5.5X12 HERCULINK PLUS STENT SYSTEM WAS ADVANCED AND DEPLOYED SUCCESSFULLY AT THE TARGET LESION; HOWEVER, A DISSECTION OCCURRED AT THE DISTAL END OF THE STENT. A 6.0X12 HERCULINK PLUS STENT SYSTEM WAS ADVANCED AND AN ATTEMPT WAS MADE TO OVERLAP THE PREVIOUS STENT TO COVER THE DISSECTION. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM) AND THEN THE BALLOON WAS DEFLATED. UPON DEFLATION OF THE BALLOON THE STENT JUMPED 30MM DISTAL. THE HERCULINK PLUS BALLOON WAS ADVANCED AND WAS ABLE TO RETRIEVE THE STENT TO THE SITE OF THE DISSECTION. THE BALLOON WAS INFLATED TO 14ATM AND THE STENT AGAIN JUMPED DISTAL. A 6.0X15 HERCULINK PLUS STENT SYSTEM WAS ADVANCED TO THE SITE OF THE DISSECTION AND THE BALLOON WAS INFLATED TO 10ATM. THE BALLOON WAS DEFLATED AND THE STENT JUMPED DISTAL. A 8.0X40 NON ABBOTT STENT SYSTEM WAS ADVANCED IN AN EFFORT TO COVER THE DISSECTION, BUT THE STENT SYSTEM COULD NOT CROSS AND WAS REMOVED FROM THE ANATOMY. THE TWO STENTS THAT REMAINED DISTAL TO THE DISSECTION WERE RETRIEVED USING THE HERCULINK PLUS BALLOON AND PLACED AT THE SITE OF THE DISSECTION. THE 6.0X12 STENT REMAINED 3MM FROM THE 5.5X12 STENT AND THE 6.0X15 STENT REMAINED 3MM FROM THE 6.0X12 STENT. THE PHYSICIAN STATED THAT THE DISSECTION CAUSED THE VESSEL TO BECOME AN 8MM VESSEL AND THAT IS THE REASON WHY THE STENTS WERE NOT ADHERING TO THE VESSEL. THE PHYSICIAN ALSO STATED THAT ONCE THE DISSECTION HEALS, THE STENTS WILL ADHERE TO THE VESSEL. THERE WERE NO ADVERSE PATIENT EFFECTS THROUGHOUT OR POST PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK 14 PLUS STENT SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention