BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1931630 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02791
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DILATATION CATHETER: 3.0X12 SPRINTER; STENT 4.0X12 DRIVER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX VISION SDS FOUND BLOOD VISIBLE ON THE SHAFT AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT. THIS IS CONSISTENT WITH PREPARATION AND THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE HYPOTUBE HAD SEPARATED 20.7 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THE HYPOTUBE JACKET WAS STRETCHED AT THE LOCATION BUT WAS STILL IN ONE PIECE. THERE WERE BENDS AND KINKS NOTED TO THE HYPOTUBE NEAR THE SEPARATION. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. FURTHER INFORMATION RECEIVED CONFIRMED THE SEPARATION DID NOT OCCUR DURING THE PROCEDURE AND LIKELY OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. ANALYSIS NOTED BALLOON PEELING ON THE DISTAL TAPER OF THE BALLOON, WHICH WAS NOT INITIALLY REPORTED WITH THE INCIDENT INFORMATION. THE BALLOON PEELING APPEARS TO BE THE RESULT OF THE PROCEDURE CIRCUMSTANCES, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MANUFACTURING PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING THE FAILED ATTEMPT TO CROSS THE LESION. TO HELP ENSURE THAT THE BALLOON SHREDDING IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR BALLOON SHREDDING. IT IS POSSIBLE THAT THE BALLOON MAY HAVE SCRAPED AGAINST THE LESION, WHICH MAY HAVE CONTRIBUTED TO THE SHREDDING OF THE BALLOON MATERIAL. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, IT WAS NOTED THAT ANOTHER SDS WAS ALSO UNABLE TO CROSS THE LESION, WHICH SUGGESTS THE ANATOMY WAS DIFFICULT. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. 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 REPORT. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE AND NOTED HYPOTUBE SEPARATION AND BALLOON PEELING APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON CATHETER, THE RX VISION STENT DELIVERY SYSTEM WOULD NOT CROSS. A NON-ABBOTT DEVICE WAS ALSO TRIED WHICH COULD NOT CROSS EITHER. ENDED UP WITH POBA. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING RETURNED DEVICE ANALYSIS, BALLOON PEELING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-CLONMEL 0052341

    Patients

    Seq Age Sex Outcome Treatment
    1