BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1962038 · Received January 17, 2011

    Report

    Report Number
    9616099-2011-00042
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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 15162314 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. (B)(4) AND PROCESS MONITORING FOR CROSSING PROFILE AND STENT RETENTION TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND. CRIMPING MACHINE PARAMETERS WERE REVIEWED AND WERE FOUND WITHIN SPECIFICATION DURING MANUFACTURING PROCESS OF THIS LOT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A CYPHER SELECT + STENT BECAME DISLODGED DURING DELIVERY TO THE TARGET LESION. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE TARGET LESION WAS DESCRIBED AS CALCIFIED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DESCRIBED AS 90% STENOSED, 33MM IN LENGTH, ECCENTRIC, DE NOVO, ANGULATED, TYPE B, WITH CALCIFICATION. THE REFERENCE VESSEL WAS TORTUOUS. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING OR THE DEVICE PRIOR TO USE. THE LESION WAS PRE-DILATED WITH A NON-CORDIS 2.5X15MM BALLOON CATHETER AT 12ATMS FOR 30 SECONDS. THERE WAS RESISTANCE ENCOUNTERED DURING DELIVERY ATTEMPT. EXCESSIVE FORCE WAS USED WITH THE STENT DELIVERY SYSTEM TO DELIVER THE STENT. NO NEGATIVE PRESSURE WAS APPLIED TO THE DEVICE BEFORE REACHING THE LESION. THERE WAS DIFFICULTY TRACKING THE DEVICE TO THE LESION. THE STENT MIGRATED TO THE PROXIMAL LAD AND WAS RETRIEVED. THE STENT DELIVERY SYSTEM WAS NOT PULLED BACK INTO THE GUIDING CATHETER AT ANY TIME PRIOR TO THE DISLODGEMENT. THERE WAS NO PATIENT INJURY. A PROCEDURAL CD IS NOT AVAILABLE FOR REVIEW. THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A NON-CORDIS STENT. PRE-PROCEDURE TIMI FLOW WAS 1 AND POST-PROCEDURE TIMI FLOW WAS 3. THERE WAS NO REPORTED INJURY TO THE PATIENT. ONE NON-STERILE CYPHER SELECT + 3.00 X 33MM WAS RECEIVED COILED INSIDE 2 PLASTIC BAGS. THE BALLOON WAS NOT INFLATED. ONE BEND WAS DETECTED AT 23.2 CM FROM PROXIMAL END; THIS CONDITION COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. THE STENT WAS RECEIVED IN A SEPARATE BAG AND DAMAGE WAS NOTICED. NO OTHER DAMAGES WERE OBSERVED. MAGNIFIED PICTURES WERE TAKEN. STENT DAMAGE COULD BE OBSERVED. THE BALLOON PRESENTED BUMPING AND CRIMPING MARKS. THE CROSSING PROFILE COULD NOT BE PERFORMED DUE TO THE CONDITION THE STENT WAS RECEIVED. 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 STENT DAMAGED FAILURE WAS CONFIRMED. THE EXACT CAUSE OF THE FAILURES REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) INDICATES THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE STENT DELIVERY SYSTEM (SDS) AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE GUIDING CATHETER OR SHEATH. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT FAILURE. THE ATTEMPTS TO SNARE THE STENT OUT OF THE PATIENT MAY HAVE CONTRIBUTED TO THE DAMAGES FOUND ON THE STENT. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE ISSUE IS RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. CYPHER SELECT PRODUCT (CRA/CRB) IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IT IS SIMILAR TO U.S. DISTRIBUTED CYPHER PRODUCT (CXS).

    Description of Event or Problem · 1

    THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DESCRIBED AS 90% STENOSED, 33MM IN LENGTH, ECCENTRIC, DE NOVO, ANGULATED, TYPE B, WITH CALCIFICATION. THE REFERENCE VESSEL WAS TORTUOUS. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING OR THE DEVICE PRIOR TO USE. THE LESION WAS PRE-DILATED WITH AN NON-CORDIS 2.5X15MM BALLOON CATHETER AT 12ATMS FOR 30 SECONDS. THERE WAS RESISTANCE ENCOUNTERED DURING DELIVERY ATTEMPT. EXCESSIVE FORCE WAS USED WITH THE STENT DELIVERY SYSTEM TO DELIVER THE STENT. NO NEGATIVE PRESSURE WAS APPLIED TO THE DEVICE BEFORE REACHING THE LESION. THERE WAS DIFFICULTY TRACKING THE DEVICE TO THE LESION. THE STENT MIGRATED TO THE PROXIMAL LAD AND WAS RETRIEVED. THE STENT DELIVERY SYSTEM WAS NOT PULLED BACK INTO THE GUIDING CATHETER AT ANY TIME PRIOR TO THE DISLODGEMENT. THERE WAS NO PATIENT INJURY. A PROCEDURAL CD IS NOT AVAILABLE FOR REVIEW. THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A NON-CORDIS STENT. PRE-PROCEDURE TIMI FLOW WAS 1 AND POST-PROCEDURE TIMI FLOW WAS 3.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CYPHER SELECT + STENT BECAME DISLODGED FROM THE STENT DELIVERY SYSTEM AND WAS SUBSEQUENTLY RETRIEVED. THE TARGET LESION AS DESCRIBED AS CALCIFIED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    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 NA 15162314

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR