BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2073342 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03051
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, SUGGESTING THAT THE DEVICE WAS ADVANCED OVER A GUIDE WIRE. THERE WAS BLOOD VISIBLE ON THE BALLOON AND CONTRAST ON THE HYPOTUBE, WHICH IS CONSISTENT WITH USE AND HANDLING DURING THE PROCEDURE. THE STENT IMPLANT WAS UNDAMAGED AND STATIONARY ON THE TIGHTLY-FOLDED BALLOON BETWEEN THE MARKERS. ADDITIONALLY, MEASUREMENTS OF THE ENTIRE TIP LENGTH AND THE OUTER DIAMETERS OF THE STENT IMPLANT WERE TAKEN AND ALL DIMENSIONS MET MANUFACTURING CRITERIA. THE ANALYSIS CONFIRMED THAT THE HYPOTUBE SHAFT, INCLUDING THE JACKET MATERIAL, WAS SEPARATED 29 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES OF THE SEPARATION WERE OVALED, INDICATING THAT THE HYPOTUBE LIKELY BENT OR KINKED PRIOR TO FRACTURING. ALSO, BOTH ENDS OF THE SEPARATED JACKET MATERIAL WERE JAGGED AND STRETCHED, WHICH IS USUALLY A RESULT OF TENSILE OVERLOAD. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS DURING INSPECTION PRIOR TO USE, THIS INDICATES THAT THE SHAFT SEPARATED DURING THE PROCEDURE, AS REPORTED. REPORTEDLY, THE SDS WAS PUSHED AS RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. IN THIS CASE, THE SDS LIKELY INTERACTED WITH THE TORTUOUS LESION DURING ADVANCEMENT SUCH THAT AS FORCE WAS APPLIED AGAINST RESISTANCE, THE SHAFT KINKED AND SEPARATED AS A RESULT. KINKS OR BENDS IN THE SHAFT CAN THEN LEAD TO WEAKENING OF THE SHAFT MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING (KINKING, STRAIGHTENING, KINKING) CAN RESULT IN THE EVENTUAL FRACTURE OF THE HYPOTUBE. THE INABILITY TO CROSS THE LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. FURTHERMORE, FACTORS THAT MAY CONTRIBUTE TO SHAFT SEPARATIONS DURING USE INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING PRIOR TO AND DURING THE PROCEDURE, REMOVAL TECHNIQUE FROM THE PACKAGING, AN INTERACTION WITH THE PATIENT ANATOMY OR ASSOCIATIVE DEVICE INTERACTION. BASED ON THE INFORMATION PROVIDED, THE LESION WAS TORTUOUS AND LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION RECEIVED AND THE RETURNED PRODUCT ANALYSIS, THE REPORTED FAILURE TO ADVANCE, SHAFT SEPARATION AND NOTED DAMAGE APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM FOR FAILURE TO CROSS OR SHAFT DETACHMENT/SEPARATIONS FROM THIS LOT. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS AT ABBOTT VASCULAR. ADDITIONALLY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED ONLINE FOR KINKS AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY SHAFT INTEGRITY AND TENSILE STRENGTH.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BALANCE MIDDLEWEIGHT. GUIDE CATHETER: TIGER. SHEATH: TERUMO. AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY, AN ATTEMPT WAS MADE TO ADVANCE A 3.5 X 18 MM MULTI-LINK 8 STENT SYSTEM THROUGH THE TORTUOUS ABDOMINAL AORTA WITH ANEURYSM. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY AND THE PHYSICIAN NOTED THAT THE SHAFT OF THE DEVICE WAS BENT (LIKE THE LETTER S). A NEW 3.5 X 18 MM MULTI-LINK 8 STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE ABDOMINAL AORTA. FORCE WAS APPLIED AND THE PROXIMAL SHAFT SEPARATED INTO TWO PARTS OUTSIDE OF THE ANATOMY. THE DEVICE WAS EASILY REMOVED WITHOUT INTERVENTION AND THE TARGET LESION WAS ULTIMATELY TREATED SUCCESSFULLY USING A NEW 3.5 X 12 MM MULTI-LINK 8 STENT SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 911166Q

    Patients

    Seq Age Sex Outcome Treatment
    1