BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 1790282 · Received August 6, 2010

    Report

    Report Number
    2024168-2010-01617
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD ON THE SHAFT, BALLOON, STENT IMPLANT, AND IN THE GUIDE WIRE LUMEN. THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THE HYPOTUBE HAD SEPARATED 17.2 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED AS IF KINKED PRIOR TO SEPARATING. THE JACKET WAS STRETCHED AND SEPARATED AT THE SAME LOCATION. THERE WERE KINKS IN THE HYPOTUBE 1.5 CM PROXIMAL TO THE SEPARATION AND 1.1 CM AND 2.3 CM DISTAL TO THE SEPARATION. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THERE WERE NO KINKS NOTED TO THE TIP OR TO THE INNER MEMBER. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A SNAP GAUGE WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THEY 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. THE HYPOTUBE AND JACKET MATERIAL HAD SEPARATED 18.3 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THE MATERIAL AT THE SEPARATION WAS STRETCHED. 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 SDS MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. THERE WERE MULTIPLE KINKS NOTED TO THE SDS. REPORTEDLY, THE PATIENT ANATOMY WAS MODERATELY TORTUOUS AND HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THE SHAFT MOST LIKELY KINKED DURING ADVANCEMENT OF THE CATHETER IN THE CALCIFIED ANATOMY AND FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. IT WAS REPORTED THE SDS FAILED TO ADVANCE AND WAS REMOVED FROM THE LESION, AND THEN ADVANCED AGAIN. IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE (IFU) STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED, AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. IT WAS ALSO REPORTED THE PHYSICIAN USED EXCESSIVE FORCE WHEN ATTEMPTING TO CROSS THE LESION, WHICH LIKELY CONTRIBUTED TO THE SHAFT KINKING AND SEPARATING. THE IFU STATES: APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. THE REPORTED FAILURE TO ADVANCE, STENT DAMAGE, AND HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: PROXIMAL SHAFT SEPARATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT WHILE TRYING TO NEGOTIATE A CHRONIC TOTALLY OCCLUDED LESION IN THE MID RIGHT CORONARY ARTERY, THE MULTI-LINK 8 2.75 X 28 STENT COULD NOT BE NEGOTIATED TO THE LESION EVEN AFTER MULTIPLE PREDILATATIONS WITH AN RX VOYAGER 2.00 X 15. A 2.00 X 10 CUTTING BALLOON WAS THEN USED TO TRY AND OPEN THE LESION. AFTER USING THE CUTTING BALLOON, THE MULTI-LINK 8 2.75 X 28 WAS ADVANCED TO THE LESION SITE, BUT THE STENT WAS NOT ABLE TO GET THROUGH THE LESION. THE HUB WAS PUSHED A LITTLE HARDER AND THE PROXIMAL SHAFT BECAME SEPARATED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 0021161

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW UII