BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1974306 · Received January 31, 2011

    Report

    Report Number
    2024168-2011-00562
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PROMUS PRODUCT NOTED THAT THE STENT IMPLANT HAD BEEN EXPANDED AND WAS RETURNED STATIONARY ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS RETURNED PRESSURIZED WITH AIR AND IN THE INFLATED POSITION, CONSISTENT WITH THE SDS PRESSURIZED AFTER THE PROCEDURE. THE SHAFT OUTER MEMBER WAS SLIGHTLY PINCHED 8.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 1 CM. THERE WAS A KINK IN THE SHAFT 10.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. DIFFICULTY INFLATING THE SDS CAN BE AFFECTED BY, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE WHEN USING THE DEVICE, KINK IN THE SHAFT, ACCESSORY DEVICE SUPPORT, AND/OR CONTAMINATION IN THE INFLATION LUMEN AND INNER DIAMETER OF THE SHAFT. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON. THE BALLOON WAS PRESSURIZED TO THE NOMINAL PRESSURE OF 8 ATMOSPHERES (ATM) AND THE BALLOON HELD PRESSURE AND THERE WERE NO LEAKS NOTED ALTHOUGH THE BALLOON WAS NOT COMPLETELY FILLED WITH WATER, THERE WERE AIR POCKETS NOTED IN THE BALLOON. A NEW SYRINGE FILLED WITH WATER WAS USED TO PREPARE THE SDS PER THE INSTRUCTIONS FOR USE AND REMOVE ALL OF THE AIR FROM THE SDS. THE SDS WAS THEN PRESSURIZED AGAIN TO 8 ATM AND THERE WERE NO AIR POCKETS NOTED IN THE BALLOON. THE STENT IMPLANT WAS REMOVED FROM THE BALLOON AND THE SDS WAS PRESSURIZED TO THE RATED BURST PRESSURE AND THE BALLOON HELD PRESSURE AND THERE WERE NO LEAKS NOTED. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WHICH MAY HAVE AIDED IN THE INVESTIGATION; HOWEVER IT IS POSSIBLE THAT THE ANATOMY NARROWED THE INFLATION LUMEN, RESULTING IN THE PINCHING OF THE OUTER MEMBER AND FURTHER CONTRIBUTING TO THE REPORTED DIFFICULTY INFLATING THE BALLOON. ADDITIONALLY, IT WAS REPORTED THAT AFTER THE SDS WAS REMOVED FROM THE PATIENT ANATOMY, THE BALLOON WAS ABLE TO INFLATE WITH NO DIFFICULTIES AND THE STENT DEPLOYED. HANDLING DURING PACKAGING FOR RETURN TO ABBOTT VASCULAR FOR ANALYSIS LIKELY CONTRIBUTED TO THE NOTED BENDS AND KINKS AS THE NOTED DAMAGE DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE DIFFICULTY INFLATING THE BALLOON. 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 COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY INFLATING THE BALLOON COULD NOT BE DETERMINED HOWEVER THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO DEPLOY THE PROMUS STENT, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE BALLOON WAS ABLE TO INFLATE FINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE PROMUS STENT. THERE WERE NO PATIENT EFFECTS. 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 0012761

    Patients

    Seq Age Sex Outcome Treatment
    1 PROMUS 2.75 X 15 MM