BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1963033 · Received January 18, 2011

    Report

    Report Number
    2024168-2011-00368
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 24, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DIL CATH: VOYAGER 2.5X12. GUIDE WIRE: .014 HT FLOPPY II (X2). STENT: PROMUS ELEMENT 3.0X12, 3.0X16. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THAT THERE IS A STENT SHADOW IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING BEYOND THE DIAGONAL TAKEOFF. THERE IS ALSO A STENT SHADOW IN THE OSTIAL/PROXIMAL DIAGONAL BRANCH. THE OSTIUM OF THE DIAGONAL IS SEVERELY STENOSED. THERE IS A RADIOPAQUE MARKER VISIBLE AT THE CARINA OF THE LAD/DIAGONAL BIFURCATION. THE LAD IS THEN WIRED, PRE-DILATED AND STENTED ACROSS THE DIAGONAL TAKEOFF. AFTER THIS, THE GUIDE WIRE IS REMOVED FROM THE LAD. THE RADIOPAQUE MARKER IS STILL VISIBLE. THE MID RIGHT CORONARY ARTERY (RCA) IS THEN PRE-DILATED AND STENTED. THE REVIEWER CONCLUDED THAT THERE ARE NO IMAGES OF THE PASSAGE OF THE BALLOON TO THE SITE OF BIFURCATION. THUS, IT CANNOT BE CONFIRMED THROUGH THESE IMAGES THAT THE TINY RADIOPACITY REPRESENTS A DETACHED MARKER FROM THE VOYAGER BALLOON. HOWEVER, THE POSSIBILITY EXISTS THAT THE MARKER COULD HAVE CAUGHT ON A NON-ENDOTHELIALIZED STENT STRUT. ANALYSIS OF THE RETURNED PRODUCT NOTED THAT THE BALLOON WAS TIGHTLY FOLDED. THE SHAFT WAS NOT SEPARATED AS REPORTED. THERE WAS NO DAMAGE NOTED TO THE CATHETER. THE 2/3 COLLAPSED BALLOON PROFILE WAS MEASURED AND MET MANUFACTURING CRITERIA. BASED ON THE CINE REVIEW AND ANALYSIS OF THE RETURNED DEVICE, IT IS STILL UNCLEAR WHAT THE RADIOPAQUE MARKER IS THAT WAS VISUALIZED IN THE PATIENT ANATOMY. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. AS ANALYSIS OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORTED SEPARATION, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE POSITIONING THE VOYAGER BALLOON INSIDE A NON-ABBOTT IN-STENT RESTENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), THE BALLOON CAUGHT ON A STENT STRUT. THE BALLOON WAS NEVER INFLATED. THE VOYAGER WAS REMOVED FROM THE PATIENT, RESULTING IN A FRAGMENT OF THE CATHETER DETACHING IN THE OSTIUM OF THE FIRST DIAGONAL ARTERY. THE SEPARATED PIECE WAS SUBSEQUENTLY TRAPPED BY THE MID LAD STENT. THE CASE WAS NOT PROLONGED AND A NEW VOYAGER 2.5 WAS USED TO CONTINUE THE PROCEDURE. THE PATIENT EXPERIENCED QUITE A BIT OF PAIN, AND WAS TREATED WITH FENTANYL. THE PATIENT WAS DISCHARGED THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0051362

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R