BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1604149 · Received February 8, 2010

    Report

    Report Number
    2024168-2010-00210
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 14, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VOYAGER NC 3.25 X 12 MM (PART# 1011755-12/LOT# 8082261); 3.25 X 15 (PART#1011755-12/LOT#9091261) ARE BEING FILED UNDER SEPARATE MANUFACTURER NUMBERS. EVALUATION SUMMARY: QUALITY ASSURANCE INVESTIGATION REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE HYPOTUBE, IN THE BALLOON, INFLATION LUMEN, AND THE HUB, WHICH IS CONSISTENT WITH A LEAK OR RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WAS CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION. THE BALLOON WAS LOOSELY FOLDED. FUNCTIONAL TESTING WAS ABLE TO CONFIRM THE REPORTED BALLOON RUPTURE AS A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE SDS WHEN FLUID LEAKED OUT OF A PINHOLE 2MM DISTAL TO THE PROXIMAL BALLOON MARKER. THERE WAS A SCRATCH IN THE BALLOON 3MM PROXIMAL TO THE PINHOLE FOR A LENGTH OF 2MM. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED PRODUCT. REPORTEDLY, DURING A CALCIFIED OSTIAL CIRCUMFLEX (CX) ARTERY STENTING PROCEDURE, A XIENCE V STENT WAS IMPLANTED AND THE BALLOON WAS INFLATED AT 18 ATMOSPHERES (ATMS) FOR 60 SECONDS. IT WAS NOTED THAT THE BALLOON WOULD NOT HOLD PRESSURE ON INFLATION. THE PHYSICIAN THEN ADVANCED A 3.25X12MM RX VOYAGER NC BALLOON CATHETER AND INFLATED THE BALLOON AT 18 ATMS FOR 35 SECONDS. AGAIN, IT APPEARED THAT THE BALLOON WOULD NOT HOLD PRESSURE. THE PHYSICIAN REPORTED THAT THE BALLOONS APPEARED NOT TO RUPTURE, BUT ACQUIRED PINHOLES POSSIBLY DUE TO THE CALCIFICATION WITHIN THE LESION. INFORMATION ON THE TWO VOYAGER NC BALLOON CATHETERS ARE FILED UNDER SEPARATE MEDWATCH REPORTS. BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MANUFACTURING DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM USE OF THE DEVICE. DURING USE, THERE CAN BE AN INTERACTION WITH ANATOMY AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF MANUFACTURING, ALL SDS ARE LEAK TESTED ON-LINE AND A SAMPLING OF UNITS FROM ALL CATHETER LOTS ARE RUPTURE TESTED PRIOR TO RELEASE. 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. REPORTEDLY, THE BALLOON RUPTURED AT 18 ATM, WHICH IS ABOVE THE RATED BURST PRESSURE (RBP) OF 16 ATM. BALLOON PRESSURE SHOULD NOT EXCEED THE RBP. THE RX XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: REPORTEDLY, THE LESION WAS MILDLY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, THE PATIENT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT 18 ATM. 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. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES OR THE USE ERROR OR INFLATION ABOVE RBP FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT DURING A CALCIFIED OSTIAL CIRCUMFLEX ARTERY STENTING PROCEDURE, THE XIENCE V STENT WAS IMPLANTED AND THE BALLOON WAS INFLATED AT 18 ATMOSPHERES (ATM) FOR 60 SECONDS. IT WAS NOTED THAT THE BALLOON WOULD NOT HOLD PRESSURE ON INFLATION. THE PHYSICIAN THEN PLACED A VOYAGER NC AND INFLATED THE BALLOON AT 18 ATMS FOR 35 SECONDS. AGAIN, IT APPEARED THAT THE BALLOON WOULD NOT HOLD PRESSURE. A SECOND VOYAGER NC WAS PLACED AND INFLATED AT 18 ATMS FOR 40 SECONDS. THIS BALLOON ALSO, WOULD NOT HOLD PRESSURE. THE PHYSICIAN REPORTED THAT THE BALLOONS APPEARED NOT TO RUPTURE, BUT ACQUIRED PIN HOLES POSSIBLY DUE TO THE CALCIFICATION WITHIN THE LESION. THE FINAL STENOSIS WAS 25% FROM 80%. THERE WAS NO FURTHER INTERVENTION NEEDED. THERE WERE NO REPORTED PATIENT EFFECTS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8031261

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT#9091261)| (PART#1011755-12/LOT#8082261)| DILATATION CATHETER: VOYAGER NC 3.25X12MM| VOYAGER NC 3.25X15MM (PART# 1011755-15/