BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2862738 · Received December 10, 2012

    Report

    Report Number
    3003742446-2012-00540
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    February 23, 2010
    Report Date
    November 12, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATION INCLUDED ACETAMINOPHEN, ALEVE, ANGIOMAX, ASPIRIN, CALCIUM WITH VIT D, PLAVIX, COREG, LIPITOR, NITROSTAT, OMEPRAZOLE, OSTEO BI-FLEX, PREVACID, AND RANOLAZINE. (B)(4). COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED HYPOPERFUSION AT THE TIME OF INDEX PROCEDURE. THIS IS A (B)(6) PATIENT WITH MEDICAL HISTORY INCLUDING ANGINA, ISCHEMIA, CABG ((B)(6) 2009), TARGET VESSEL PREVIOUSLY REVASCULARIZED ((B)(6) 2010), FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, LVEF (> 50%), HISTORY OF SMOKING (GREATER THAN 30 DAYS), ALLERGIC TO PENICILLIN, HX OF BILATERAL HIP SURGERY; ONGOING PAIN, GASTROESOPHAGEAL REFLUX DISEASE, OSTEOPOROSIS. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED 80% STENOSIS IN THE 1ST OM THAT WAS DESCRIBED AS 8 MM IN LENGTH AND DE NOVO. THE REFERENCE VESSEL WAS 2.25 MM IN DIAMETER. A 2.25X133 MM CYPHER RX (LOT# 15077633) WAS IMPLANTED AT 11 ATMS. IT WAS REPORTED THAT THE STENT WAS POST-DILATED WITH A 2.25X20 MM BALLOON AT 15 ATMS DUE TO INSUFFICIENT FLOW. ANOTHER 2.25X8 MM CYPHER RX WAS IMPLANTED OVERLAPPING PROXIMAL FROM THE INITIAL STENT AT 12 ATMS TO FULLY COVER THE LESION. THE STENT WAS POST-DILATED WITH A 2.25X20 MM BALLOON AT 15 ATMS DUE TO INSUFFICIENT FLOW. FINALLY 3RD 2.50X13 MM CYPHER RX WAS IMPLANTED OVERLAPPING PROXIMAL FROM INITIAL STENT AT 12 ATMS TO FULLY COVER THE LESION. THE PATIENT WAS DISCHARGED ON SAME DAY. 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. REVIEW OF LOT 15062737 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. HYPOPERFUSION (NO REFLOW) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL STENT IMPLANTATION PROCEDURES. THIS EVENT IS NOTED IN THE CYPHER IFU. HYPOPERFUSION CAN BE ASSOCIATED WITH A COMBINATION OF FACTORS DURING AN INTERVENTIONAL PROCEDURE. THE PRESENCE OF DEBRIS FROM THE TARGET AREA, TARGET AREA COMPOSITION, PROLONGED MANIPULATION OF THE TARGET AREA, POOR DISTAL FLOW PAST THE INTERVENTIONAL EQUIPMENT AND TARGET VESSEL SPASM CAN ALL CONTRIBUTE TO THE FORMATION OF A HYPOPERFUSION SCENARIO. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED HYPOPERFUSION. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2012-00539 AND 3003742446-2012-00540.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED HYPOPERFUSION AT THE TIME OF INDEX. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED 80% STENOSIS IN THE 1ST OM THAT WAS DESCRIBED AS 8 MM IN LENGTH AND DE NOVO. THE REFERENCE VESSEL WAS 2.25 MM IN DIAMETER. A 2.25X133 MM CYPHER RX (LOT# 15077633) WAS IMPLANTED AT 11 ATMS. IT WAS REPORTED THAT THE STENT WAS POST-DILATED WITH A 2.25X20 MM BALLOON AT 15 ATMS DUE TO INSUFFICIENT FLOW. ANOTHER 2.25X8 MM CYPHER RX WAS IMPLANTED OVERLAPPING PROXIMAL FROM THE INITIAL STENT AT 12 ATMS TO FULLY COVER THE LESION. THE STENT WAS POST-DILATED WITH A 2.25X20 MM BALLOON AT 15 ATMS DUE TO INSUFFICIENT FLOW. FINALLY 3RD 2.50X13 MM CYPHER RX WAS IMPLANTED OVERLAPPING PROXIMAL FROM INITIAL STENT AT 12 ATMS TO FULLY COVER THE LESION. THE PATIENT WAS DISCHARGED ON SAME DAY.

    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) NA 15062737

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention