BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 1724240 · Received June 4, 2010

    Report

    Report Number
    2024168-2010-01111
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 12, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RX MULTI-LINK 8 (P.N. 1012165-15, LOT# 9121961) MENTIONED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD ON THE SHAFT, ON THE STENT IMPLANT AND ON THE BALLOON. 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 AND JACKET WERE SEPARATED 22.4 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVAL SHAPED AS IF THE HYPOTUBE WAS KINKED PRIOR TO SEPARATING. THE JACKET WAS JAGGED AND STRETCHED AT THE SEPARATION. THERE WERE TWO KINKS IN THE HYPOTUBE 1.4 CM AND 2.4 CM DISTAL TO THE SEPARATION. THERE WERE FOUR BENDS IN THE HYPOTUBE 1.5 CM PROXIMAL TO THE SEPARATION AND 23 CM, 51 CM AND 70 CM DISTAL TO THE SEPARATION. THERE WERE NO KINKS OR DAMAGE NOTED TO THE TIP OR INNER MEMBER. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. THE HYPOTUBE SEPARATIONS ON BOTH UNITS (151842-1-3 AND 151842-1-4) ARE IN THE SAME LOCATION OF THE SHAFT, FURTHER SUGGESTING THAT THE DIFFICULTY ADVANCING WAS MET WITHIN THE SAME LOCATION OF THE PATIENT'S ANATOMY. IF THE SDS IS NOT PROPERLY SUPPORTED DURING PUSHING OR ADVANCING AGAINST RESISTANCE, IT MAY CAUSE THE SHAFT TO KINK. ONCE THE SHAFT IS KINKED, AND UPON STRAIGHTENING, THE HYPOTUBE MATERIAL COULD SEPARATE. IT APPEARS THAT THE REPORTED RESISTANCE MET WITHIN THE GUIDING CATHETER ON ALL THREE UNITS IS ALSO A RESULT OF THE CHALLENGING ANATOMY CAUSING RESISTANCE DURING ADVANCEMENT. THE PRODUCT INSTRUCTION FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND / OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE OF THE STENT AND / OR DELIVERY SYSTEM COMPONENTS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. OVERALL THE REPORTED RESISTANCE WITH THE GUIDING CATHETER AND SHAFT DAMAGE TO ALL THREE STENT DELIVERY SYSTEMS APPEARS TO BE RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. AS THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCE, AND THERE IS NO INDICATION OF A PRODUCT RELATED DEFICIENCY, NO CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

    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 THE PROCEDURE WAS TO TREAT THE DISTAL LEFT ANTERIOR DESCENDING (LAD) LESION, WHICH WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. FEMORAL ACCESS WAS USED IN THE PATIENT AND THERE WAS ILEO-AORTIC TORTUOSITY. RESISTANCE WAS FELT WHEN ADVANCING THE PRE-DILATION BALLOON, BUT IT FINALLY REACHED THE LESION AND PRE-DILATED IT. THEN, A 2.5 X18 MULTI-LINK 8 WAS ADVANCED INTO THE GUIDING CATHETER, WHERE THERE IS ALSO RESISTANCE ENCOUNTERED, BUT DEVICE FINALLY REACHES THE LESION AND THE STENT IS SUCCESSFULLY DEPLOYED. WHEN THE SDS IS REMOVED FROM THE PATIENT, THE SHAFT IS NOTED TO BE BENT IN SEVERAL PLACES. THE PROCEDURE CONTINUED WITH A SECOND STENT PROXIMAL TO THE PREVIOUS ONE. A 2.5 X 15 MULTI-LINK 8 IS ADVANCED INTO THE GUIDING CATHETER, BUT THIS IS RESISTANCE AND A LOT OF FORCE IS USED DUE TO THE TORTUOSITY AND THE PROXIMAL SHAFT BREAKS ABOUT 20 CM DISTAL TO THE CONNECTOR, WHICH IS OUTSIDE THE PATIENT. THE DEVICE IS REMOVED. ANOTHER 2.5 X 18 MULTI-LINK 8 IS ADVANCED AND THE OUTCOME IS THE SAME, THE PROXIMAL SHAFT (HYPOTUBE) BROKE AT THE SAME EXACT PLACE. THE PROCEDURE WAS FINISHED USING A NON-ABBOTT STENT. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9122261

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR GUIDE CATH: EBU 6F| SHEATH: 6F| LOT# 9121961)| STENT: RX MULTI-LINK 8 (P.N. 1012165-15,| GUIDE WIRE: BHV