BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2183040 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05365
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE MINI VISION STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE SHAFT, BALLOON AND STENT IMPLANT, CONSISTENT WITH THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BUT WAS NOT BETWEEN THE MARKERS. THE PROXIMAL END OF THE STENT WAS LOCATED 1.5 MM PROXIMAL TO THE PROXIMAL MARKER. THE DISTAL END OF THE STENT WAS LOCATED 1 MM PROXIMAL TO THE DISTAL MARKER. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED SECURELY AT THE TIME OF MANUFACTURE. THE DISTAL TAPER OF THE BALLOON WAS WRINKLED. THE OUTER MEMBER WAS SEPARATED FROM THE PROXIMAL SEAL, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACE HAD STRETCHED EDGES WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE SDS WAS STILL INTACT AND NOT IN TWO PIECES. THE OUTER MEMBER WAS BUNCHED 3.5 CM PROXIMAL TO THE SEPARATION FOR A LENGTH OF 5 MM AND 9.5 CM PROXIMAL TO THE SEPARATION FOR A LENGTH OF 8 MM. THE OUTER MEMBER WAS WRINKLED 7.3 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE INNER MEMBER WAS BUNCHED DISTAL TO THE DISTAL MARKER FOR LENGTH OF 1.5 MM AND PROXIMAL TO THE PROXIMAL MARKER FOR A LENGTH OF 1.5 MM, WHICH LIKELY CONTRIBUTED TO THE STENT NOT BEING LOCATED BETWEEN THE MARKERS. THE INNER MEMBER WAS TWISTED AND WRINKLED 1.5 CM PROXIMAL TO THE PROXIMAL MARKER FOR A LENGTH OF 4 MM. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE FOR A LENGTH OF 49 CM. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. IT IS LIKELY THAT AS RESISTANCE WAS MET WITH THE GUIDE WIRE, AS FORCE WAS APPLIED, THE SHAFT LIKELY BUNCHED CREATING FURTHER RESISTANCE DURING RETRACTION 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. ADDITIONALLY, IF FURTHER FORCE WAS APPLIED IN THE ATTEMPTS TO REMOVE THE SDS AS RESISTANCE WAS ENCOUNTERED, THIS COULD CONTRIBUTE TO THE SHAFT SEPARATING AND NOTED DAMAGE TO THE SDS; HOWEVER, THE INITIAL CAUSE OF THE RESISTANCE WITH THE GUIDE WIRE COULD NOT BE DETERMINED. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NONCONFORMING MATERIAL RECORDS FOR THE LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE INDICATED NO OTHER INCIDENTS. THERE IS NO INDICATION OF A 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, NEW INFORMATION WAS RECEIVED STATING THAT THE DISTAL SHAFT OF THE CATHETER SEPARATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN A PREDILATED, 80% STENOSED LESION, THE STENT BECAME TANGLED IN A 0.014 FLOPPY GUIDE WIRE. IN THE ATTEMPT TO REMOVE IT, THE CATHETER BROKE. IT WAS NECESSARY TO USE ANOTHER DEVICE TO CONCLUDE THE PROCEDURE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 9091041

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 0.014 FLOPPY WIRE