BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER SELECT

    MDR report key: 18426934 · Received January 2, 2024

    Report

    Report Number
    2124215-2023-74711
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 12, 2023
    Report Date
    March 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Removal / Correction Number
    97172244-FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REVIEW: A DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR THE PROMUS PREMIER SELECT REFERENCED BATCH (0031891839). THE MANUFACTURING REVIEW CONFIRMED THAT ALL DEVICES ASSOCIATED WITH THIS BATCH WERE THE CORRECT SIZE (16 MM X 2.75 MM) PER MANUFACTURING RECORDS AND BOX LABELLING. THE PROMUS PREMIER SELECT 16 MM X 2.75 MM HAS A MINIMUM STENT LENGTH SPECIFICATION OF 15.71 MM, AND A MAXIMUM STENT LENGTH SPECIFICATION OF 17.21 MM. ANY STENT LENGTH THAT FALLS OUTSIDE OF THESE LIMITS IS AUTOMATICALLY SCRAPPED. ALL DISTRIBUTED DEVICES FROM FINISHED GOODS BATCH (FGB) 0031891839 PASSED THIS INSPECTION AND WERE WITHIN THE SPECIFIED STENT LENGTH LIMITS. FROM THE THOROUGH INVESTIGATION OF ALL DATA GATHERED, IT IS NOT POSSIBLE FOR A FGB OF 16 MM X 2.75 MM DEVICES TO INCLUDE A 20 MM X 4.00 MM SIZED DEVICE. ALTHOUGH THE CURRENT MANUFACTURING CONTROLS CONFIRMED THAT ALL DEVICES IN BATCH 0031891839 WERE CORRECTLY MEASURED AS 16 MM X 2.75 MM STENTS, THE MISPRINT ON THE ACTUAL HUB WAS NOT IDENTIFIED DURING MANUFACTURING. DEVICE ANALYSIS: THE PROMUS PREMIER SELECT DEVICE WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE AND MICROSCOPIC ANALYSIS WAS PERFORMED ON THE DEVICE. PRINTED ON THE MANIFOLD NUMBER WAS THE STENT SIZE OF A 4.00 X 20MM STENT, HOWEVER THE ACTUAL DEVICE MEASURED CORRECTLY PER THE BOX LABELLING, WHICH WAS LABELLED AS A 16MM X 2.75 PROMUS PREMIER SELECT. NO OTHER DEVICE ISSUES WERE NOTED DURING ANALYSIS. LABELING REVIEW: BASED ON THE AVAILABLE INFORMATION, THERE WAS NO EVIDENCE OF DEVICE MISUSE, OFF-LABEL USE, OR FAILURE TO FOLLOW THE PROMUS PREMIER SELECT CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). UPON MEDICAL SAFETY REVIEW, IT APPEARS THE DEVICE WAS USED APPROPRIATELY AND AS INTENDED IN ACCORDANCE WITH THE IFU. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED EVENT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF 'MANUFACTURING DEFICIENCY', SINCE THE PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. THE PRINT SIZE ON THE HUB WAS A 4.00 X 20MM, HOWEVER THE ACTUAL DEVICE MEASURED CORRECTLY PER THE BOX LABELLING, WHICH WAS LABELLED AS A 16MM X 2.75 PROMUS PREMIER SELECT. AN NCEP INVESTIGATION HAS BEEN INITIATED TO IDENTIFY THE CAUSE OF THE INCORRECT PRODUCT SIZE ETCHED ON THE HUB MANIFOLDS FROM THIS BATCH (0031891839). IN ADDITION, BOSTON SCIENTIFIC INITIATED A MEDICAL DEVICE REMOVAL (97172244-FA) OF BATCH 0031891839 OF PROMUS PREMIER SELECT CORONARY STENT SYSTEMS ON 11 MARCH 2024 DUE TO AN INCORRECT PRODUCT SIZE PRINTED ON THE CATHETER MANIFOLD HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. DURING PROCEDURE PREPARATION, A DEVICE WITH PACKAGE LABEL OF PROMUS PREMIER SELECT 2.75X16 WAS SELECTED FOR USE. HOWEVER, AFTER OPENING THE PACKAGE, THE STENT ITSELF WAS NOTED TO BE 4.0X20 IN SIZE. THERE WAS NO ANOMALY NOTED WITH THE PACKAGING PRIOR TO USE. A REPLACEMENT DEVICE OF THE CORRECT SIZE WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) THAT THE REFERENCED 16 MM X 2.75 MM PROMUS PREMIER SELECT CORONARY STENT SYSTEM WAS SELECTED FOR USE. WHEN UNPACKAGING THE DEVICE, IT WAS NOTED THAT THE STENT WAS 20 MM X 4.0 MM. THERE WAS NO ANOMALY NOTED WITH THE PACKAGING PRIOR TO USE. A REPLACEMENT DEVICE OF THE CORRECT SIZE WAS SELECTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855699 PROMUS PREMIER SELECT STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 10663 0031891839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown