BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1920043 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00935
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED. 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. CYPHER SELECT PRODUCT (CRA/CRB/CJB) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    UPON RETURN OF THE PRODUCT ON (B)(4) 2010, IT WAS NOTED THAT THE BALLOON WAS LEAKING. PRODUCT ANALYSIS REVEALED ONE NON STERILE 2.5 X 12 MM CYPHER SELECT + WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THREE KINKS WERE FOUND AT 10.4, 14.6 AND 15 CM FROM DISTAL END; THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. THE STENT WAS NOT RECEIVED AND BALLOON WAS ALREADY INFLATED. A LEAKAGE COULD BE OBSERVED NEAR OF DISTAL AREA OF THE BALLOON. SEM RESULTS SHOWED THAT THE BALLOON EXHIBITED EVIDENCE OF EXTERNAL MINOR ABRASIONS NEAR THE LEAK-HOLE; THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE BALLOON LEAK COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BAND EXHIBITED NO ANOMALIES. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A PCI, THERE WAS DIFFICULTY EXPERIENCED WHILE INFLATING A CYPHER STENT FOR DEPLOYMENT. THE CYPHER SELECT + 2.50X13MM STENT INFLATED TO 9ATM, BUT THE INDEFLATOR READING GRADUALLY CHANGED TO ZERO. THE PHYSICIAN CHANGED TO A NEW INDEFLATOR, HOWEVER THE BALLOON COULD NOT BE INFLATED. THERE WAS NO LEAKAGE NOTED AND THE BALLOON DEFLATED NORMALLY. THE SDS WAS REMOVED WITHOUT DIFFICULTY. THE PHYSICIAN USED A NEW NON-COMPLIANCE BALLOON (2.5 X 8MM) TO POST-DILATE THE STENT SUCCESSFULLY. THE TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS. THE DEVICE APPEARED NORMAL PRIOR TO USE AND HAD PREPPED NORMALLY. THERE WAS NO PROBLEM ENCOUNTERED ADVANCING, TRACKING OR REMOVING THE DEVICE FROM THE PATIENT. THE MANUFACTURER OF THE INFLATION DEVICE WAS NOT INDICATED. INFORMATION ABOUT THE TYPE OF CONTRAST AND SALINE RATIO USED WAS NOT AVAILABLE. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS CLINICALLY USED AND WAS RETURNED FOR ANALYSIS. ONE NON-STERILE 2.5 X 12 MM CYPHER SELECT + WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THREE KINKS WERE FOUND AT 10.4, 14.6 AND 15 CM FROM THE DISTAL END. THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR ANALYSIS. THE STENT WAS NOT RECEIVED AND THE BALLOON WAS OBSERVED IT WAS ALREADY INFLATED. A LEAKAGE COULD BE OBSERVED NEAR THE DISTAL AREA OF THE BALLOON. SEM RESULTS SHOWED THAT THE BALLOON EXHIBITED EVIDENCE OF EXTERNAL MINOR ABRASIONS NEAR THE LEAK-HOLE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE BALLOON LEAK COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BAND EXHIBITED NO ANOMALIES. 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. THE REPORTED FAILURE WAS CONFIRMED. THE EXACT CAUSE FOR THE CONFIRMED BALLOON LEAKAGE COULD NOT CONCLUSIVELY BE DETERMINED, HOWEVER NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT REPORTER ISSUE ARE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN. BASED ON THE PRESENCE OF SURFACE ABRASIONS ON THE RETURNED BALLOON, IT APPEARS THAT VESSEL CHARACTERISTICS AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CYPHER SELECT + 2.50X13MM STENT INFLATED TO 9ATM, BUT THE INDEFLATOR READING GRADUALLY CHANGED TO ZERO. THE PHYSICIAN CHANGED TO A NEW INDEFLATOR AND INFLATED THE STENT; HOWEVER, IT STILL COULD NOT INFLATE THE BALLOON. THERE WAS NO LEAKAGE NOTED AND THE BALLOON DEFLATED NORMALLY. THE SDS WAS REMOVED WITHOUT DIFFICULTY. THE PHYSICIAN USED A NEW NON-COMPLIANCE BALLOON (2.5 X 8MM) TO POST-DILATE THE STENT BECAUSE THE STENT WAS IMPLANTED UNDER 9ATM. THE TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND WITH 90% STENOSIS. THE DEVICE APPEARED NORMAL PRIOR TO USE AND HAD PREPPED NORMAL. NO RESISTANCE/FRICTION WAS NOTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO 15153822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention