BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2152266 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04799
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE WIRE: SION BLUE, FIELDER FC. GUIDE CATH: TERUMO 6 F IL 3.5. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, ON THE STENT, BALLOON, SHAFT AND CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON, CONSISTENT WITH PREPARATION AND THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE STRETCHED STRUTS ON THE FIRST ROW AT THE DISTAL END OF THE STENT IMPLANT, CONFIRMING THE REPORTED STENT DAMAGE. THE PROXIMAL END OF THE BALLOON WAS WRINKLED. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 80 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE GUIDING CATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NEW 6 FR GUIDING CATHETER AND REMOVED WITH NO RESISTANCE NOTED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS MODERATELY TORTUOUS, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. DAMAGE TO THE DISTAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE ANATOMY AND/OR ACCESSORIES DURING ADVANCEMENT OF THE DEVICE. IT IS LIKELY THAT THE STENT INTERACTED WITH THE LESION, DAMAGING THE STRUTS, AND CONTRIBUTING TO THE DIFFICULTY REMOVING THE SDS THROUGH THE GUIDING CATHETER DURING RETRACTION AND ALSO CONTRIBUTING TO THE NOTED WRINKLED PROXIMAL END OF THE BALLOON. TO HELP ENSURE THE REPORTED DIFFICULTIES ARE NOT RELATED TO A MANUFACTURING DEFICIENCY, THE BALLOON IS CHECKED FOR PROPER FOLD CONFIGURATION, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE DURING THE MANUFACTURING PROCESS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR DIFFICULT TO REMOVE FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY, PRE-DILATATION WAS PERFORMED. AN ATTEMPT WAS MADE TO ADVANCE A 2.5 X 28 RX PROMUS STENT SYSTEM; HOWEVER, THE DELIVERY CATHETER COULD NOT CROSS. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY WITH SLIGHT RESISTANCE FELT BETWEEN THE GUIDING CATHETER. UPON REMOVAL, IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. THE PHYSICIAN COMMENTED THAT THE FLARED STRUTS MAY HAVE BEEN CAUSED DURING REMOVAL OF THE STENT SYSTEM THROUGH THE GUIDING CATHETER. THE TARGET LESION WAS SUCCESSFULLY TREATED WITH ANOTHER 2.5 X 28 PROMUS STENT SYSTEM. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1020741

    Patients

    Seq Age Sex Outcome Treatment
    1