BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 3130786 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03296
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. RELEVANT TESTS/LABORATORY DATA ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATE BASED ON DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED HEMORRHAGE (BLEEDING) IS LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU), AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. IT SHOULD BE NOTED THAT THE IFU STATES IN THE INDICATIONS SECTION THAT THE MULTI-LINK VISION RX AND MULTI-LINK VISION OTW CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 25 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 2.75 MM TO 4.0 MM. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH LITERATURE REVIEW THAT A SUBJECT WITH INCREASING SYMPTOMS OF GIDDINESS OVER A PERIOD OF 15 DAYS UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN WHICH REVEALED MULTIPLE AREAS OF DIFFUSED RESTRICTIONS IN THE CEREBELLUM AND A CT ANGIOGRAM SHOWED STENOSIS OF THE RIGHT VERTEBRAL ARTERY (VA) AND EVIDENCE OF A THROMBUS DISTAL TO THE STENOSIS. HE WAS REFERRED TO THE CENTRE FOR ENDOVASCULAR TREATMENT AS MEDICAL MANAGEMENT HAD FAILED. THE SUBJECT WAS TREATED WITH VARIOUS DEVICES INCLUDING A 3.5 X 23 MM VISION STENT WITH THE BALLOON INFLATED TO 8 ATMOSPHERE (ATM). THE POST-PROCEDURE ANGIOGRAM SHOWED NO RESIDUAL NARROWING AND NO EVIDENCE OF THROMBUS. THE SUBJECT WAS EXTUBATED AFTER THE PROCEDURE AND HAD NO WORSENING OF DEFICITS. TWELVE HOURS POST PROCEDURE HE BEGAN COMPLAINING OF HEADACHE AND WAS BECOMING DROWSY. A PLAIN COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN SHOWED EDEMA IN AND AROUND THE INFARCTED AREA OF THE CEREBELLUM WITH A SMALL AREA OF HEMORRHAGIC TRANSFORMATION OF THE INFARCT WITH HYDROCEPHALUS. HE UNDERWENT EMERGENCY POSTERIOR FOSSA DECOMPRESSION. HE WAS EXTUBATED ON POSTOPERATIVE DAY 1 AND HIS CONDITION PROGRESSIVELY IMPROVED. FOURTEEN DAYS AFTER ADMISSION HE WAS DISCHARGED. AT THE TIME OF DISCHARGE HE WAS CONSCIOUS, COOPERATIVE, ABLE TO SWALLOW BOTH SOLIDS AND LIQUIDS, HIS SPEECH HAD IMPROVED, HE WAS ABLE TO WALK WITH ONE PERSONS SUPPORT AND WAS INDEPENDENT FOR ACTIVITIES OF DAILY LIVING. HIS NIHSS SCORE AT DISCHARGE WAS 4. HIS BARTHEL INDEX IMPROVED FROM 5 TO 65 AT DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231702 MULTI-LINK VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R