BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SSYTEM

    MDR report key: 1581019 · Received December 22, 2009

    Report

    Report Number
    2024168-2009-02440
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 1, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS : PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE MISLABELED BOX. EVALUATION SUMMARY: QUALITY ASSURANCE REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD ON THE STENT IMPLANT, BALLOON, AND SHAFT. THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THERE WAS A KINK IN THE DISTAL SHAFT 1 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED. THERE WAS A CHIPBOARD BOX AND A FOIL POUCH RETURNED WITH THE SDS. THE LABEL ON THE CHIPBOARD BOX WAS FOR 3.0X28MM RX XIENCE V, PART#1009541-28, LOT#9073141, (B)(4). THE FOIL POUCH LABEL WAS FOR A 3.0X15MM RX XIENCE V, PART#1009541-15, LOT#9090361, (B)(4). THE INFLATION PORT OF THE SDS WAS LABELED 3.0X15MM, LOT # 9090361. THE STENT IMPLANT WAS 15.5MM IN LENGTH. PRODUCT PERFORMANCE ENGINEERING NOTED THAT THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH HANDLING, BUT NOT USING OR INFLATING THE DEVICE AS REPORTED. THE ONLY DAMAGE NOTED TO THE DEVICE WAS A KINK IN THE DISTAL SHAFT 1 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THIS DAMAGE WAS NOT REPORTED AS PART OF THE COMPLAINT AND LIKELY OCCURRED AS A RESULT OF HANDLING THE DEVICE DURING PACKAGING FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. THE ANALYSIS OF THE PACKAGING AND THE DEVICE CONFIRMED THE REPORTED DISCREPANCY BETWEEN THE CHIPBOARD BOX AND THE DEVICE AND OTHER PACKAGING COMPONENTS. A MISLABELED PRODUCT COULD RESULT FROM A MANUFACTURING DISCREPANCY OR FROM A MIX-UP AT AN AFFILIATE, DISTRIBUTOR OR ACCOUNT. THE LOT HISTORY RECORDS FOR BOTH LOTS INVOLVED IN THIS INCIDENT WERE REVIEWED. NEITHER LOT HAD ANY REWORK PERFORMED AND NEITHER LOT HAD ANY NON-CONFORMING MATERIAL RECORDS ISSUED FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. LOT#9073141 WAS MANUFACTURED IN CLONMEL AND HAD CHIPBOARD BOXING PERFORMED ON (B)(6) 2009. LOT#9090361 WAS MANUFACTURED IN TEMECULA AND HAD CHIPBOARD BOXING PERFORMED ON (B)(6) 2009. THERE WAS NO TIME DURING MANUFACTURING OR SECONDARY PACKAGING WHERE THESE TWO LOTS WOULD HAVE BEEN IN CONTACT WITH ONE ANOTHER. ADDITIONALLY A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR MISLABELING FOR EITHER LOT. A SAP SHIPMENT QUERY WAS RUN AND CONFIRMED THAT BOTH UNITS IN QUESTION (B)(4) WERE SOLD TO THIS ACCOUNT ON (B)(4) 2009 AND (B)(4) 2009 RESPECTIVELY. IN THIS CASE, THERE IS NO INDICATION THAT THE MIX-UP OCCURRED DURING THE MANUFACTURE OF PRODUCTS AND SINCE THIS ACCOUNT IS IN THE UNITED STATES, THERE IS NO INVOLVEMENT OF AN AFFILIATE OR A DISTRIBUTOR. THE PRODUCT IS SHIPPED AND SOLD DIRECTLY TO THE HOSPITAL. IT IS MOST LIKELY THAT THE MIX-UP OCCURRED AT THE ACCOUNT. ALTHOUGH THE ACCOUNT REPORTED THAT THERE WAS ONLY ON XIENCE V PRODUCT BEING USED AT THE TIME THE MIX-UP WAS NOTED; IT IS POSSIBLE THAT THE CHIPBOARD BOXES INVOLVED IN THIS INCIDENT WERE OPENED PREVIOUSLY FOR USE DURING ANOTHER PROCEDURE AND ONE OR BOTH DEVICES WERE NOT USED AND THE 3.0X15MM DEVICE WAS INADVERTENTLY PLACED BACK INSIDE THE INCORRECT CHIPBOARD BOX, THE 3.0X28MM CHIPBOARD BOX. ALTHOUGH THE EXACT CAUSE OF HOW THE MIX-UP OCCURRED CANNOT BE DETERMINED, THERE IS NO INDICATION OF A MANUFACTURING OR PRODUCT QUALITY DEFICIENCY. PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. PRODUCT LABELING IS SUBJECT TO A VISUAL INSPECTION AND VERIFICATION DURING MANUFACTURING OF THE LOT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: MISLABELING MAY IMPACT DEVICE TRACKING. DEVICE ISSUE: MISLABELED BOX. IT WAS REPORTED THAT THE BOX WAS LABELED A 3.0 X 28 MM XIENCE V; HOWEVER, THE FOIL POUCH WAS LABELED AS 3.0 X 15 MM XIENCE V, AND THE DEVICE INSIDE THE FOIL POUCH WAS A 3.0 X 15 MM XIENCE V, LOT NUMBER 9090361, (B)(4). THIS WAS NOT NOTICED UNTIL THE DEVICE WAS BEING LOADED ONTO THE GUIDE WIRE. THE DEVICE WAS NOT USED ON THE PATIENT. THE PACKAGING WAS CHECKED AND THE DISCREPANCY WAS FOUND. THE FOIL POUCH AND THE DEVICE DO NOT MATCH. THIS WAS REPORTED TO BE THE ONLY XIENCE V DEVICE OPENED AT THE TIME THE ISSUE WAS NOTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SSYTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9073141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK