BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1998220 · Received February 22, 2011

    Report

    Report Number
    2024168-2011-01079
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 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. STENT: 3.0 X 12 MM XIENCE V (1009541-12/0081742, (B)(4)). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD ON THE HUB, SHAFT, BALLOON STENT IMPLANT AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE SDS WAS INSERTED IN TO THE BODY. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO ADVANCE/REMOVE THE SDS MAY INCLUDE, BUT IS NOT LIMITED TO, PRODUCT PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER (ID) OF GUIDE WIRE LUMEN, RESISTANCE WITH THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE (DAMAGE DRIED BLOOD OR CONTRAST), DAMAGE TO THE DISTAL SHAFT OF THE SDS OR PATIENT ANATOMICAL CONDITIONS (TORTUOSITY, CALCIFICATION). ANALYSIS NOTED THE TIP LENGTH AND STENT IMPLANT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE TIP UNSEALED AND SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THERE WAS NO DAMAGE OR ABNORMALITIES NOTED TO THE TIP UNSEALED LENGTH OR TO THE DISTAL TAPER OF THE BALLOON. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE STENT IMPLANT HAD DISLODGED PROXIMALLY FROM THE TIGHTLY FOLDED BALLOON AND WAS LOCATED ON THE SHAFT. THERE WERE FLARED STENT STRUTS IN THE FIRST ROW OF THE DISTAL END OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS SUGGESTING THE STENT WAS POSITIONED PROPERLY ON THE BALLOON AT THE TIME OF MANUFACTURING. THE ANATOMICAL CONDITIONS WERE REPORTED TO BE MILDLY TORTUOUS AND MODERATELY CALCIFIED. ADDITIONALLY, IT WAS REPORTED THAT THE CATHETER WAS STUCK IN THE CALCIFICATION WHICH APPEARS TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULT TO POSITION THE STENT. THE ANATOMICAL CONDITIONS MAY HAVE ALSO CONTRIBUTED TO THE REPORTED DIFFICULTY SEEING THE STENT UNDER ANGIOGRAPHY; HOWEVER, THIS CAN NOT BE CONCLUSIVELY DETERMINED. IT WAS ALSO REPORTED THAT THERE WERE SEVERAL ATTEMPTS TO CROSS AND THE PHYSICIAN GAVE UP AND WITHDREW THE XIENCE. INTERACTION WITH THE CALCIFICATION DURING THE SEVERAL ATTEMPTS TO CROSS MAY HAVE SUBSEQUENTLY CONTRIBUTED TO THE REPORTED STENT DISLODGMENT AND NOTED FLARED STRUTS. THE 3.0 X 12 MM RX XIENCE WAS REPORTEDLY REMOVED FROM THE ANATOMY AND COMPARED TO ANOTHER XIENCE AND WAS SUSPECTED THAT THE TIP LENGTH, ALIGNMENT BETWEEN THE DISTAL MARKER AND THE DISTAL BALLOON SEAL SEEMED TO BE DIFFERENT. THE BALLOON WAS PRESSURIZED TO NOMINAL PRESSURE OF 9 ATMOSPHERES, THE BALLOON WORKING LENGTH MEASUREMENT WAS 13 MM AND MET MANUFACTURING CRITERIA. THE DISTAL BALLOON MARKER TO SHOULDER ALIGNMENT WAS MEASURED AND MET MANUFACTURING CRITERIA AND WAS LOCATED 0.5 MM PROXIMAL TO THE DISTAL BALLOON SHOULDER. BASED ON THE RETURNED DEVICE ANALYSIS, THE DIMENSIONAL TESTING MET MANUFACTURING REQUIREMENTS, THUS, DOES NOT SUGGEST A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, DUE TO THE TOLERANCE IN THE DIMENSIONAL SPECIFICATIONS SUCH AS THE TIP LENGTH, SEAL LENGTH AND THE UNSEALED LENGTH, LINING UP TWO DEVICE FOR COMPARISON WILL NOT ALWAYS NECESSARILY EQUALLY MACH UP. THEREFORE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ANALYSIS NOTED THERE WAS A KINK IN THE HYPOTUBE AT THE DISTAL END OF THE STRAIN RELIEF TUBING. THERE WAS A KINK IN THE SHAFT 19.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE TWO KINKS IN THE SOFT TIP 0.5 MM AND 1MM DISTAL TO THE CLEAR GAP. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE NOTED DAMAGE WAS NOT REPORTED AND MOST LIKELY RESULTED FROM HANDLING OF THE PRODUCT POST-PROCEDURE DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR INVESTIGATION. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT HAVE CONTRIBUTED OR TO BE RELATED TO THIS INCIDENT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO POSITION (UNABLE TO SEE STENT UNDER ANGIOGRAPHY) AND DEFECTIVE ITEM (THE REPORTED ALIGNMENT BETWEEN THE TWO XIENCE DEVICES) COULD NOT BE DETERMINE, THE STENT DISLODGEMENT APPEARS TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL SDS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, A QUALITY CONTROL (QC) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). TWO PHOTOS FROM THE PROCEDURAL CINE WERE RECEIVED AND REVIEWED. THE FIRST IMAGE IS BEFORE THE ATTEMPTS TO CROSS THE LESION. THERE IS A LONG LESION IN THE PROXIMAL RAMUS. THE SECOND IMAGE HAS AN ARROW POINTING TO WHERE THE TIP OF THE XIENCE STENT WAS REPORTED TO HAVE BECOME CAUGHT. UNFORTUNATELY, THE IMAGES DO NOT PROVIDE ENOUGH INFORMATION TO SUGGEST A CAUSE FOR THE REPORTED EVENT. IT IS POSSIBLE THAT THE REPORTED CALCIFICATION CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED STATING: THE XIENCE WAS DELIVERED TOWARD THE DISTAL HALF OF THE LESION AFTER A PRE-DILATATION AND INTRAVASCULAR ULTRASOUND (IVUS). THE TIP OF THE CATHETER WAS STUCK WITH THE CALCIFICATION IN THE PROXIMAL END OF THE LESION. AFTER WITHDRAWAL OF THE CATHETER, ADDITIONAL PRE-DILATATION WAS PERFORMED; IVUS WAS DELIVERED AGAIN, BUT WOULD NOT CROSS AND STUCK WITH THE PROXIMAL END OF THE LESION. THE PHYSICIAN ATTEMPTED TO REDELIVER THE XIENCE V; HOWEVER, NO STENT WAS ON THE BALLOON. THE STENT WAS FOUND ON THE DEVICE DISTAL SHAFT DISLODGED FROM THE BALLOON. A SAME PROFILE XIENCE WAS DELIVERED AND DEPLOYED IN THE DISTAL HALF OF THE LESION WITHOUT DIFFICULTY AND ANOTHER STENT WAS DEPLOYED IN THE PROXIMAL TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY, MODERATE CALCIFICATION WAS CONCENTRIC AND DE NOVO WITH A DIAMETER OF 3 MM. THE LESION WAS PRE-DILATED AND THE XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE TIP OF THE CATHETER BECAME STUCK IN THE CALCIFICATION. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT COULD NOT BE SEEN UNDER ANGIOGRAPHY. THE PHYSICIAN REMOVED THE SDS FROM THE PATIENT AND IT WAS FOUND THAT THE STENT HAD DISLODGED ONTO THE DISTAL SHAFT, COMPLETELY OFF OF THE BALLOON. A NEW XIENCE OF THE SAME SIZE WAS DEPLOYED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. OUTSIDE THE PATIENT ANATOMY, THE TIP OF THE XIENCE CATHETER WAS COMPARED WITH THAT OF THE OTHER XIENCE. IT IS SUSPECTED BY THE PHYSICIAN THAT THE TIP LENGTH AND ALIGNMENT BETWEEN THE DISTAL MARKER AND THE DISTAL BALLOON SEAL SEEMED TO BE DIFFERENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0081741

    Patients

    Seq Age Sex Outcome Treatment
    1