BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 2033040 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02143
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST IN THE PROXIMAL HALF OF THE INFLATION LUMEN. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED AND THE BALLOON WAS TIGHTLY FOLDED. THIS IS CONSISTENT WITH THE BALLOON NOT BEING INFLATED AND THE STENT NOT BEING DEPLOYED. THE REPORTED BALLOON RUPTURE WAS CONFIRMED. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE SDS. THERE WAS A DIAGONAL TEAR NOTED IN THE MIDDLE OF THE PROXIMAL BALLOON TAPER. THERE WAS PEELING ON THE BALLOON ON THE PROXIMAL END OF THE TEAR. THERE WERE RADIAL SCRATCHES ON THE BALLOON, OVER THE PROXIMAL BALLOON MARKER THAT WENT ALL AROUND THE BALLOON. THERE WAS A DEEP RADIAL INDENTATION, 3 MM IN LENGTH, OVER THE PROXIMAL BALLOON MARKER 2 MM DISTAL TO THE TEAR. THE INDENTATION CONTINUED UNDER THE BALLOON FOLD. THIS INDENTATION NOTED IN THE BALLOON WAS IDENTIFIED AS AN ARTIFACT FROM THE BALLOON BLOW OPERATION DURING MANUFACTURING. IT WAS CONFIRMED THAT THERE WAS NO LEAK OR RUPTURE NOTED AS A RESULT OF THIS ARTIFACT AND THAT IT DID NOT CONTRIBUTE TO THE TEAR AT THE PROXIMAL BALLOON TAPER. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS CASE, THE LESION SITE WAS DESCRIBED AS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE SCRATCHES AND TEAR NOTED IN THE PROXIMAL TAPER. BECAUSE THERE WAS NO REPORT OF LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY SUGGEST THAT THE BALLOON WAS DAMAGED DURING USE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE BALLOON. BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED OMNILINK, IT IS LIKELY THAT THE BALLOON RUPTURE OCCURRED AS A RESULT OF INTERACTION WITH THE HIGHLY CALCIFIED LESION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIL CATH: 6.0 MM. GUIDE WIRE: GLIDE 0.035 X 260 CM. SHEATH: 6 FR. STENT: OMNILINK 7 X 28. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED RIGHT AND LEFT COMMON ILIAC ARTERIES, AFTER PRE-DILATATION, TWO 7 X 28 OMNILINK STENT SYSTEMS WERE POSITIONED USING THE KISSING STENT TECHNIQUE. BOTH BALLOONS WERE INFLATED AT THE SAME TIME WHILE INITIATING STENT DEPLOYMENT. A LACK OF BALLOON INFLATION WAS NOTED IN THE RIGHT ILIAC ARTERY AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE ANATOMY. OUTSIDE OF THE ANATOMY, THE DEVICE WAS CLEANED WITH SOLUTION IN PREPARATION OF INFLATING THE BALLOON AGAIN; HOWEVER, IT WAS NOTED THAT CONTRAST WAS LEAKING OUT OF THE PROXIMAL SEGMENT OF THE BALLOON. THE DEVICE WAS NO LONGER USED. THE RIGHT ILIAC LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY. THE STENT WAS DEPLOYED SUCCESSFULLY IN THE LEFT ILIAC ARTERY. THERE WAS NO ADVERSE PATIENT EFFECT; HOWEVER, THERE WAS A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM BILIARY STENT SYSTEM FGE AV-TEMECULA-CT 0021151

    Patients

    Seq Age Sex Outcome Treatment
    1