BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2192963 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05541
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENT ANATOMY. THE BALLOON WAS TIGHTLY FOLDED, WHICH IS CONSISTENT WITH ONLY SLIGHT PRESSURE APPLIED TO THE SDS. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WAS A TEAR IN THE BALLOON IN THE DISTAL TAPER ON ONE OF THE FOLDS AT THE DISTAL EDGE OF THE DISTAL MARKER BAND. THERE WERE SCRATCHES ON THE BALLOON PROXIMAL TO THE TEAR. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE LESION/ANATOMY AND/OR GUIDING CATHETER/GUIDE WIRE. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE PROTECTIVE SHEATH IS PLACED OVER THE BALLOON. ADDITIONALLY, ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE RATED BURST PRESSURE (RBP) PRIOR TO RELEASE. THERE WAS NO REPORT OF ANY LEAK OR DAMAGE TO THE SDS NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE AND THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO USE AND THE SDS WAS MOVED SEVERAL TIMES WITHIN THE LESION TO OBTAIN THE CORRECT SITE FOR IMPLANTING THE STENT WHICH LIKELY CONTRIBUTED TO THE TEAR IN THE BALLOON. AS SLIGHT POSITIVE PRESSURE WAS APPLIED TO THE BALLOON IN THE ATTEMPTS TO INFLATE, THIS WOULD RESULT IN THE STENT SLIGHTLY EXPANDING AND BECOMING LOOSE ON THE BALLOON; THEREFORE DURING RETRACTION, THE STENT WOULD DISLODGE. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIL CATH: RYUJIN PLUS 1.5 X 20, 3.0 X 15 MM , NC QUANTUM 5.0 AND MAVERICK XL5.5-1. GUIDE WIRE: RUNTHROUGH NS. GUIDE CATH: HEARTRAIL 6 F IL4.0SH. DEVICE (B)(4) - NO PRE-DILATATION. 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. FACTORS THAT CAN CONTRIBUTE TO MATERIAL RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES AND/OR STENTS, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. THERE WAS REPORTEDLY NO CALCIFICATION IN THE PATIENT ANATOMY; HOWEVER, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM (SDS) WAS MOVED BACK AND FORTH IN THE LESION IN ORDER TO CORRECTLY POSITION THE STENT WHICH MAY HAVE CAUSED DAMAGE OR MOVED THE STENT ON THE BALLOON SUCH THAT THE BALLOON MATERIAL WAS PINCHED, FURTHER CONTRIBUTING TO THE REPORTED DIFFICULTIES. AS THE BALLOON RUPTURED PRIOR TO FULLY INFLATING, THIS WOULD RESULT IN THE STENT SLIGHTLY EXPANDING AND BECOMING LOOSE ON THE BALLOON; THEREFORE DURING RETRACTION, THE STENT WOULD DISLODGE. ADDITIONALLY, IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO USE OF THE PROMUS SDS WHICH ALSO MAY HAVE CONTRIBUTED TO THE REPORTED RUPTURE. IT SHOULD BE NOTED THE PROMUS INSTRUCTIONS FOR USE STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. 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 OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENTS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED; HOWEVER, THE STENT DISLODGEMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN THE LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND NO CALCIFICATION WAS CONFIRMED. AS THE IVUS CATHETER CROSSED THE LESION SMOOTHLY, A 3.0 X 28 MM PROMUS STENT WAS CHOSEN FOR USE. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SDS). THE SDS WAS MOVED A COUPLE OF TIMES WHILE DECIDING ON WHERE TO IMPLANT THE STENT AT THE LESION SITE. WHEN INFLATION WAS ATTEMPTED, THE BALLOON SLIGHTLY INFLATED; HOWEVER, BLOOD WAS SEEN COMING BACK INTO THE INFLATION DEVICE. IT WAS THOUGHT THAT A BALLOON RUPTURE HAD OCCURRED AND AN ATTEMPT WAS MADE TO RETRACT THE SDS FROM THE PATIENT. DURING RETRACTION, THE STENT IMPLANT DISLODGED FROM THE BALLOON INTO THE LEFT MAIN CORONARY ARTERY. A NON-ABBOTT DILATATION BALLOON WAS INSERTED THROUGH THE DISLODGED STENT; HOWEVER, RETRIEVAL OF THE STENT FAILED. THE DILATATION BALLOON WAS EXCHANGED FOR ANOTHER NON-ABBOTT DILATATION BALLOON AND INFLATED TO 4 ATMOSPHERES INSIDE THE DISLODGED STENT, WHICH WAS BROUGHT TO THE LEVEL OF THE BRACHIUM; HOWEVER, RETRIEVAL OF THE STENT IMPLANT FAILED AGAIN. REMOVAL OF THE SYSTEM WAS CONSIDERED; HOWEVER, IT WAS THOUGHT THAT THE SYSTEM COULD POSSIBLY GET STUCK WITH THE SHEATH IN THE RADIAL, SO THE DECISION WAS MADE TO IMPLANT THE DISLODGED STENT IN THE BRACHIUM AROUND CUBITAL (ELBOW). NON-ABBOTT BALLOONS WERE USED IN AN ATTEMPT TO IMPLANT THE STENT; HOWEVER, THE STENT IMPLANT WAS UNABLE TO BE DEPLOYED. IT WAS CONFIRMED THAT THE STENT COULD MOVE IN THE BLOOD VESSEL, AND IT WAS ALSO CONFIRMED THAT THE STENT WAS NOT BENT WHEN THE ELBOW WAS BENT; THEREFORE, THE PROCEDURE WAS ENDED. 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 0102261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention