BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2883847 · Received December 21, 2012

    Report

    Report Number
    2024168-2012-08267
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. AS OF (B)(6) 2012, THE GUIDE WIRE PIECE WAS SUCCESSFULLY REMOVED, THE DISSECTION WAS TREATED, AND BYPASS GRAFTS WERE PERFORMED VIA THE SURGERY. REVIEW OF A RECEIVED CINE OF THE PROCEDURE REVEALED THAT THE TIP OF THE WHISPER MS GUIDE WIRE HAD PROLAPSED, AFTER BALLOON DILATATION, BUT BEFORE GUIDE WIRE SEPARATION. THE CINE REVIEW ALSO CONFIRMED THAT THE DISTAL 9 TO 10 CENTIMETERS OF THE GUIDE WIRE HAD SEPARATED FROM ITS SHAFT. THOUGH THIS ISSUE CAUSED A CLINICALLY SIGNIFICANT DELAY, THERE WERE NO ADVERSE PATIENT SEQUELAE. GUIDE WIRE: HI-TORQUE WHISPER MS. GUIDE CATHETER: 7FR RB4. THE HI-TORQUE WHISPER MS GUIDE WIRE MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2012, AN 014 WHISPER MS GUIDE WIRE WAS ADVANCED THROUGH A 7-FRENCH NON-ABBOTT GUIDING CATHETER AND PAST A HEAVILY CALCIFIED LESION IN THE DIFFUSELY DISEASED, HEAVILY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED USING A 3.0X12 TREK BALLOON DILATATION CATHETER. A 3.0X15 VISION STENT DELIVERY SYSTEM (SDS) (LOT NUMBER 2081141) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION AND WAS WITHDRAWN. ANOTHER 3.0X15 VISION SDS (LOT NUMBER 2081841) WAS ALSO ADVANCED, BUT WAS UNABLE TO CROSS THE LESION; WHILE WITHDRAWING THE 2ND VISION SDS, RESISTANCE WAS FELT, BUT NO FORCE WAS APPLIED, AND THE WHISPER GUIDE WIRE SEPARATED INSIDE OF THE DISTAL RCA. THE REMAINING PROXIMAL PART OF THE WHISPER GUIDE WIRE WAS WITHDRAWN FROM THE ANATOMY. SNARING WAS NOT ATTEMPTED AT THE SITE DUE TO A LACK OF SNARING EQUIPMENT. THE PROCEDURE WAS NOT COMPLETED, MEDICATION (BLOOD THINNER) WAS ADMINISTERED TO THE PATIENT, AND THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL ON (B)(6) 2012, FOR ATTEMPTED SNARING OF THE REMAINING DISTAL PIECE OF THE WHISPER GUIDE WIRE FROM THE ANATOMY. ATTEMPTED SNARING OF THE WHISPER USING A NON-ABBOTT SNARE DEVICE OVER A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS UNSUCCESSFUL; A NON-ABBOTT GUIDING CATHETER USED DURING THE SNARING ATTEMPT REPORTEDLY CAUSED A DISSECTION. ON THE SAME DAY, THE PATIENT SUBSEQUENTLY UNDERWENT CORONARY ARTERY BYPASS (CABG) SURGERY TO TREAT THE DISSECTION, REMOVE THE REMAINING WHISPER PIECE, AND TO PERFORM BYPASS GRAFT OF THE RCA DUE TO DIFFUSE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2081841

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S