BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2170570 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05020
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 IN THE GUIDE WIRE LUMEN, ON THE STENT IMPLANT, BALLOON AND CONTRAST IN THE INFLATION LUMEN AND BALLOON, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS RETURNED DISLODGED PROXIMALLY ON THE BALLOON. THE DISTAL END OF THE STENT WAS LOCATED 9MM PROXIMAL TO THE DISTAL MARKER. THE PROXIMAL AND DISTAL STRUTS WERE MANGLED. THERE WAS A BENT MIDDLE STRUT ON THE STENT IMPLANT. THE NOTED DAMAGED STENT IS LIKELY WHAT WAS PERCEIVED BY THE ACCOUNT AS THE BALLOON ACCORDIONED. 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 BENDS IN THE HYPOTUBE 12CM AND 36.5CM DISTAL TO THE STRAIN RELIEF TUBING. 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 OUTER DIAMETERS OF THE STENT WERE NOT MEASURED DUE TO THE DAMAGE NOTED TO THE STENT IMPLANT. FACTORS WHICH MAY CONTRIBUTE TO RESISTANCE WITH A GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE TO THE STENT, DAMAGE TO THE GUIDING CATHETER, OR PROCEDURAL TECHNIQUE. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, DURING MANUFACTURING, ALL SDS ARE 100% CHECKED FOR DAMAGE AND CRIMPED STENT PROFILE. IN THIS CASE, THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AS THE SDS MET RESISTANCE IN THE GUIDING CATHETER, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE STENT DAMAGE AND THE STENT DISLODGING PROXIMALLY ON THE BALLOON. THE INABILITY TO FULLY DEPLOY THE STENT/DIFFICULTY INFLATING THE SDS 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. THE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED AS AN INDEFLATOR, FILLED WITH WATER, WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) WITH NO DAMAGE NOTED TO THE BALLOON. IT WAS REPORTED THE PROMUS WAS INFLATED TO 20ATM, WHICH IS ABOVE THE RBP. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT EXCEED RBP AS INDICATED ON PRODUCT LABEL. BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION. APPLYING PRESSURES HIGHER THAN SPECIFIED ON THE PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE ARTERIAL DAMAGE AND DISSECTION. THE STENT INNER DIAMETER SHOULD APPROXIMATE 1.1 TIMES THE REFERENCE DIAMETER OF THE VESSEL. IT DOES NOT APPEAR THAT THE REPORTED OVER INFLATION OF THE SDS CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. 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 DIFFICULT TO POSITION, FAILURE TO DEPLOY, OR SHAFT BUNCHING FOR THIS LOT. THE REPORTED DIFFICULTY DEPLOYING THE STENT WAS UNABLE TO BE CONFIRMED, AND THE REPORTED DIFFICULTY ADVANCING THE SDS THROUGH THE GUIDING CATHETER APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL STENTING PROCEDURE WITH ONE 3.0 X 15 PROMUS STENT, THE BALLOON INFLATED TO 20 ATMOSPHERES AND WOULD NOT DEPLOY. THE PHYSICIAN REPORTED FEELING RESISTANCE AS HE WAS PASSING THE DEVICE THROUGH THE GUIDE LINER BUT NOT AT THE LESION. UPON REMOVAL OF THE DEVICE FROM THE ANATOMY, THE PHYSICIAN NOTED THAT THE BALLOON HAD "ACCORDIONED". ANOTHER PROMUS STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR SEQUELA. THE RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT DISLODGED PROXIMALLY ON THE BALLOON. ADDITIONAL INFORMATION CONFIRMED THAT THIS OCCURRED WHILE INSIDE THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION 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 1013161

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR