BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1932384 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02815
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    September 4, 2010
    Report Date
    November 23, 2010
    Manufacturer
    AV-CLONMEL
    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): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: VOYAGER NC; GUIDE WIRE: ALL STAR; INFLATION: MEDTRONIC; GUIDE CATH: CORDIS THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION IS A KNOWN PATIENT ADVERSE EVENT LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU). DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND INFERIOR WALL MYOCARDIAL INFARCT AND THE HIGHLY CALCIFIED LESION WAS PRE-DILATED WITH A 2.0 X 12 MM VOYAGER NC AND TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OF THE RIGHT CORONARY ARTERY. A 2.75 X 23 MM MULTILINK VISION STENT WAS DEPLOYED AT THE TARGET LESION; HOWEVER, THE PHYSICIAN NOTED A DISSECTION IN THE DISTAL PART OF THE STENT AND TREATED THE DISSECTION WITH A 2.5 X 18 MM MULTILINK VISION STENT. THERE WAS NO REPORTED PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-CLONMEL 0032241

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention