BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1911900 · Received December 1, 2010

    Report

    Report Number
    3003742446-2010-00428
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 4, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. STENT DISLODGMENT, TRACKING DIFFICULTY AND WITHDRAWAL DIFFICULTY ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. TRACKING DIFFICULTY THROUGH ANOTHER DEVICE IS A COMMON PROCEDURAL OCCURRENCE THAT CAN RESULT IN STENT DISLODGMENT AND IS RELATED TO THE PATIENT ANATOMY, OPERATOR TECHNIQUE AND APPROPRIATE DEVICE SELECTION AND IF ANOTHER DEVICE IS INVOLVED THE APPROPRIATE APPOSITION AND EXPANSION OF THE OTHER DEVICE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL FACTORS AND OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE TARGET LESION WAS IN THE PROXIMAL RCA AND WAS DESCRIBED AS SLIGHTLY CALCIFIED. DURING THE PROCEDURE THE PHYSICIAN DEPLOYED A 2.5 X 28 XIENCE STENT IN THE TARGET LESION. FOLLOWING DEPLOYMENT A SMALL DISSECTION WAS NOTED DISTAL TO THE XIENCE STENT. HE ATTEMPTED TO ADVANCE A CYPHER 2.25 X 13MM STENT THROUGH THE XIENCE; HOWEVER, IT BECAME STUCK AND WOULD NOT MOVE FORWARD. WHEN HE ATTEMPTED TO PULL THE DEVICE BACK, THE STENT CAME OFF THE DELIVERY CATHETER. THE PHYSICIAN WENT BACK IN WITH A 2.5 X 15 BALLOON AND DILATED THE STENT IN THE VESSEL. THE DISSECTION WAS COVERED BY THE CYPHER STENT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT. THE STENT CATHETER WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EYECARE PROFESSIONAL THAT A PATIENT EXPERIENCED IRRITATION, REDNESS, AN INFILTRATE AND A CENTRAL CORNEAL ULCER IN HIS RIGHT EYE. EXAMINATION REVEALED A 1 MM CENTRAL CORNEAL ULCER, A 3 MM INFILTRATE AND LESS THAN 50% CORNEAL STAINING. THE PATIENT WAS TREATED AGGRESSIVELY WITH ANTIBIOTIC DROPS AND CORTICOSTEROIDS OVER SEVERAL DAYS. EVENT RESOLVED WITH PERMANENT SCARRING NOTED BUT NO SIGNIFICANT DECREASE IN VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) 15249974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention