BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2193998 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05577
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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. EVALUATION SUMMARY: RETURNED GOODS ANALYSIS NOTED THAT THE PRODUCT WAS RETURNED IN AN UNOPENED TYVEK POUCH AND OPENED CHIPBOARD BOX. THE LABEL DESCRIPTION OF THE TYVEK POUCH READS; 3.5 X 18MM, LOT NUMBER: 0071941 AND PART NUMBER: 1007849-18. THE OPENED CHIPBOARD BOX READS; 3.0 X 18MM, LOT NUMBER: 0040241 AND PART NUMBER: 1007848-18. THE HUB LABEL DESCRIPTION OF THE STENT DELIVERY SYSTEM (SDS) READS; ML VISION 3.5 X 18 AND THE LOT NUMBER: 0071941. THIS CONFIRMS THE REPORTED INCIDENT AS THE LABELING ON THE POUCH AND SDS DO NOT CORRESPOND WITH THE LABEL AFFIXED TO THE CHIPBOARD BOX. FACTORS THAT CAN POTENTIALLY CONTRIBUTE TO A MISLABELING DISCREPANCY MAY INCLUDE, BUT ARE NOT LIMITED TO, MISLABELING DURING MANUFACTURING, A MIX-UP DURING REWORK, OR DUE TO A MIX-UP AT AN AFFILIATE, DISTRIBUTOR, OR THE ACCOUNT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) FOR THE 3.0 X 18 MM VISION LOT AND THE 3.5 X 18 MM VISION LOT DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH EITHER LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY SIMILAR INCIDENTS WITH THESE LOTS, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE LHR FOR THE 3.0 X 18 MM VISION LOT WAS MANUFACTURED AND PACKAGED IN CLONMEL IN APRIL 2011, WHEREAS THE 3.5 X 18 MM VISION NOTED THAT THE LOT WAS MANUFACTURED AND PACKAGED IN CLONMEL IN JULY 2010, 3 MONTHS AFTER PRODUCTION OF THE 3.00 X 18 MM VISION LOT WAS COMPLETED. REWORK WAS PERFORMED ON BOTH LOTS IN THE TEMECULA FACILITY; HOWEVER, REWORK WAS PERFORMED ON (B)(6) 2011 FOR THE 3.0 X 18 MM VISION AND ON (B)(6) 2011 FOR THE 3.5 X 18MM VISION. THUS, THIS INFORMATION INDICATES THAT THE 2 UNITS INVOLVED IN THIS INCIDENT NEVER CAME INTO CONTACT WITH ONE ANOTHER DURING PRODUCTION. FURTHER REVIEW OF THE SHIPMENT RECORDS VERIFIED THAT BOTH LOTS WERE SHIPPED TO THE HOSPITAL. BASED ON THE SHIPMENT RECORDS, THE HOSPITAL WAS SHIPPED 4 UNITS FROM THE 3.0 X 18 MM VISION LOT BETWEEN (B)(6) 2010 AND (B)(6) 2010 AND 1 UNIT FROM THE 3.5 X 18 MM VISION LOT ON (B)(6) 2010. THIS MAY SUGGEST THAT A POTENTIAL MIX-UP OCCURRED AT THE HOSPITAL. THERE IS NO INDICATION THAT THE MIX-UP OCCURRED DURING MANUFACTURING OR REWORK OF THE PRODUCTS AT ABBOTT VASCULAR. IT IS POSSIBLE THAT THE 3.0 X 18 MM VISION POUCH/DEVICE WAS INADVERTENTLY PLACED IN A 3.5 X 18 MM RX VISION CHIPBOARD BOX AT THE ACCOUNT, ALTHOUGH THIS COULD NOT BE CONFIRMED. ALTHOUGH THE EXACT CAUSE FOR THE MISLABELING/MIX-UP COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A MANUFACTURING OR PRODUCT QUALITY DEFICIENCY. ALL PRODUCTS ARE SUBJECT TO A 100% INSPECTION BY MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE BOX LABELED 3.0 X 18 RX VISION WAS OPENED; HOWEVER, THE DEVICE THAT WAS REMOVED FROM THE BOX WAS LABELED AS A 3.5 X 18 RX VISION ON THE POUCH, HUB, AND IDENTIFICATION CARD. THERE WAS NO PATIENT INVOLVEMENT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. ANOTHER UNSPECIFIED STENT SYSTEM WAS USED SUCCESSFULLY. NO ADDITIONAL INFORMATION HAS BEEN 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-TEMECULA-CT 0040241

    Patients

    Seq Age Sex Outcome Treatment
    1