BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073344 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03053
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE DISTAL SHAFT AND IN THE GUIDE WIRE LUMEN AND THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH INFLATION ATTEMPTS. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE SDS. THE DISTAL HALF OF THE STENT IMPLANT WAS FLARED. THERE WAS A BENT STRUT IN THE FIRST ROW OF THE PROXIMAL END OF THE STENT IMPLANT. THE MIDDLE PORTION OF THE STENT IMPLANT WAS SMASHED. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WERE TWO KINKS IN THE HYPOTUBE, 24 AND 25.5 CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A NEW INDEFLATOR FILLED WITH GASTROGRAFIN, DILUTED 1:1 WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER TO THE RATED BURST PRESSURE (RBP). THE BALLOON INFLATED AND HELD PRESSURE. THE PATIENT ANATOMICAL INFORMATION WAS NOT REPORTED WITH THE CASE INFORMATION WHICH MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE THE ANATOMY NARROWED THE INFLATION LUMEN, CONTRIBUTING TO THE INABILITY TO DEPLOY THE STENT; HOWEVER THIS COULD NOT BE CONFIRMED. ADDITIONALLY, AS AN ATTEMPT WAS MADE TO DEPLOY THE STENT, THE DISTAL END OF THE STENT WOULD INFLATE FIRST, CONTRIBUTING TO THE NOTED FLARED STRUTS AT THE DISTAL END. THIS POSITIVE PRESSURE APPLIED TO THE STENT WOULD HAVE THEN SLIGHTLY EXPANDED THE STENT, THEREFORE CAUSING THE STENT TO BECOME LOOSE ON THE BALLOON AS THE STENT WAS UNABLE TO BE FULLY DEPLOYED. FURTHER INTERACTION WITH THE LESION/ANATOMY DURING RETRACTION AND HANDLING DURING PACKAGING FOR RETURN TO ABBOTT VASCULAR MAY HAVE CONTRIBUTED TO THE NOTED DAMAGE AND STENT ULTIMATELY DISLODGING; HOWEVER, THIS COULD NOT BE CONFIRMED. THE INABILITY TO DEPLOY THE STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: INSUFFICIENT CRIMPING DURING MANUFACTURING, INCORRECT POSITION OF THE STENT ON THE BALLOON, BALLOON ENTRAPMENT (STICKING), A BALLOON PINHOLE OR RUPTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, CONTRAST DILUTION AND ACCESSORY DEVICE SUPPORT. TO ENSURE THAT THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION, DEPLOYED STENT OUTER DIAMETER AND UNIFORMITY OF EXPANSION. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO DEPLOY OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROMUS RX STENT WOULD NOT DEPLOY OFF OF THE BALLOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT DISLODGED OFF OF THE BALLOON AND WAS RETURNED OVER THE TIP OF THE PROMUS STENT DELIVERY SYSTEM.

    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 1010641

    Patients

    Seq Age Sex Outcome Treatment
    1