BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 1935788 · Received December 22, 2010

    Report

    Report Number
    2024168-2010-02853
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 27, 2010
    Manufacturer
    AV-CLONMEL
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: JOCATH MERCURY; STENT: 4.0 X 38 MM ML ZETA. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MULTI-LINK ZETA STENT DELIVERY SYSTEM (SDS) NOTED THAT THE STENT IMPLANT WAS UNDAMAGED AND STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE SDS WOULD NOT INFLATE TO DEPLOY THE STENT; HOWEVER, FUNCTIONAL TESTING WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTY AS A NEW INDEFLATOR WAS USED TO INFLATE THE SDS TO THE RATED BURST PRESSURE (RBP), 16 ATMOSPHERES, AND THE BALLOON SUCCESSFULLY INFLATED AND HELD PRESSURE WITHOUT ANY ANOMALIES NOTED. THE INFLATION DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED, WHICH MAY HAVE AIDED IN THE INVESTIGATION. THE INABILITY TO INFLATE THE SDS MAY BE RELATED TO NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, CONTRAST CONCENTRATION, LEAKS, TEARS IN THE BALLOON OR INFLATION LUMEN, MANUFACTURING, KINKS, BENDS, INFLATION LUMEN OBSTRUCTIONS, INTERACTION WITH ACCESSORIES (INDEFLATOR, RHV, OR GC), PLACEMENT OF THE BALLOON/STENT WITHIN LESION, OR INFLATION TECHNIQUE. THE LESION WAS REPORTED AS MILDLY CALCIFIED AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. SINCE THE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTY INFLATING THE BALLOON AND DID NOT IDENTIFY ANY MALFUNCTION WITH THE RETURNED SDS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THE DEVICE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, INCLUDING FUNCTIONAL TESTING FOR BALLOON INFLATION/DEFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE PROXIMAL TO DISTAL, MILDLY CALCIFIED, ECCENTRIC LESION WITH 90% STENOSIS OF THE MID RIGHT CORONARY ARTERY, THE 4.0 X 38 MM MULTILINK ZETA STENT DELIVERY SYSTEM WAS PLACED BUT THE STENT BALLOON DID NOT INFLATE AT ALL. THE DEVICE WAS REMOVED AND A SECOND 4.0 X 38 MM MULTILINK ZETA WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT EFFECT. 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-CLONMEL 9111041

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR