BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1142745 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00728
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. FACTORS THAT CAN AFFECT PERFORATION INCLUDE, BUT ARE NOT LIMITED TO, BENT OR BROKEN STENT STRUTS, EXPANDING THE STENT ABOVE RBP, OR POST DILATING ONLY THE PROXIMAL HALF OF THE STENT. THE ARTERY WAS CALCIFIED AND THE TWO GRAFTMASTERS WERE UNABLE TO CROSS WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. PERFORATION AS LISTED IN THE DEVICE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EFFECT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED. THE GRAFTMASTERS ARE BEING FILED UNDER DIFFERENT MFG NUMBERS.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT A VISION STENT WAS IMPLANTED AND A PERFORATION WAS OBSERVED IN THE RIGHT CORONARY ARTERY (RCA). A JOSTENT GRAFTMASTER 4.0 X 16 MM WAS USED AS TREATMENT; HOWEVER, IT WOULD NOT CROSS AND WAS REMOVED. ANOTHER GRAFTMASTER 3.0 X 16 WAS USED AND AN ATTEMPT WAS MADE TO INSERT IT BUT, IT WAS UNABLE TO CROSS AS WELL AND WAS IMPLANTED PROXIMAL TO THE PERFORATION SITE, AT AN UNINTENDED SITE. A MAVERICK BALLOON CATHETER WAS THEN USED TO SEAL THE PERFORATION. PROTAMINE WAS ALSO ADMINISTERED TO THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8050231

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention JOSTENT GRAFTMASTER 3.0 X 16 (PART#12744-16 /| LOT# 440262)| LOT# 342987)| JOSTENT GRAFTMASTER 4.0 X 16 (PART# 12746-16 /