BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 2193154 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05548
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE HUB AND BALLOON, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. 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. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO ADVANCING THE SDS WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THE ZETA INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER. THE HYPOTUBE AND JACKET WERE SEPARATED 16 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACES WERE OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THE JACKET WAS STRETCHED AND JAGGED AT THE SEPARATION. THERE WAS A KINK IN THE HYPOTUBE 2.1 CM PROXIMAL TO THE SEPARATION. THERE WERE MULTIPLE BENDS IN THE FULL LENGTH OF THE HYPOTUBE. 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. THE PATIENT ANATOMY WAS MODERATELY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES AS THERE WAS NO DAMAGE NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AS RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE SDS, THE HYPOTUBE WAS MANIPULATED SUCH THAT IT KINKED AND AS FORCE WAS APPLIED, THE HYPOTUBE ULTIMATELY SEPARATED. IT SHOULD BE NOTED THE IFU STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE SDS CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR HYPOTUBE SEPARATIONS FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING ARTERY, WAS 98% STENOSED, WITH MODERATE CALCIFICATION. THIS WAS A PLANNED DIRECT STENTING WITH A MULTI LINK ZETA. AS THE LESION WAS CALCIFIC, THE BALLOON DELIVERY SYSTEM SHAFT BECAME BENT AND WITH FURTHER ATTEMPTS TO CROSS THE LESION WITH ADDITIONAL FORCE, THE SHAFT SEPARATED IN TWO PIECES. THE 3.0 X 38 MULTI LINK ZETA STENT IMPLANT WAS STILL INTACT, IN THE CRIMPED STATE ON THE DELIVERY SYSTEM. AFTER PREDILATATION WAS PERFORMED, A SHORTER 3.0 X 28 MULTI LINK ZETA WAS DEPLOYED. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX ZETA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0062141

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT