BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2364805 · Received December 9, 2011

    Report

    Report Number
    2024168-2011-08301
    Event Type
    Injury
    Date Received
    December 9, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED. IN THIS CASE, THE REPORTED DEVICE DAMAGE BY ANOTHER DEVICE, MATERIAL DEFORMATION (STENT DAMAGE) AND ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY ASSOCIATED NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR STENT DAMAGE OR DAMAGE RESULTING FROM OTHER DEVICE INTERACTION FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEM ARE INSPECTED FOR STENT DAMAGE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY PRIOR TO RELEASE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: GUIDE WIRE: ASAHI PROWATER; ASAHI PILOT 200; ASAHI PILOT 50; ASAHI MIRACLE BRO 6; ASAHI GRANDSLAM; STENT: 2.5 X 38, 3.0 X 38 XIENCE PRIME; 3.5 X 23, 3.5X28 XIENCE V THE ENTIRE VESSEL WAS REWIRED AND VERIFIED TO BE IN THE TRUE LUMEN OF THE ARTERY. A 1.20 MM X 12 MM MINI TREK, 2.0 MM X 15 MM MINI TREK, AND A 3.0 MM X 15 MM RX TREK WERE USED FOR BALLOON DILATATION OF THE VESSEL. ALL WERE USED WITHIN RATED BURST PRESSURE AND THERE WAS NO REPORTED DEVICE ISSUE. POST BALLOON DILATATION, A 3.5 MM X 28 MM XIENCE V WAS DEPLOYED IN THE MID TO DISTAL RCA, AND A 3.5 MM X 28 MM XIENCE V WAS DEPLOYED MID RCA AS TREATMENT OF THE DEPLOYED 3.5 MM X 38 MM XIENCE PRIME. IT WAS NOTED THAT THE ARTERY LOOKED VERY NICE EXCEPT WHERE THE 3.5 MM X 38 MM XIENCE PRIME AND 3.0 MM X 38 MM XIENCE PRIME OVERLAPPED. IT WAS FURTHER NOTED THAT THE VESSEL HAD GREAT TIMI 3 FLOW AND DISTAL VESSEL FILLING WAS GOOD. THE PATIENT WAS REPORTED AS STABLE THROUGHOUT THE PROCEDURE AND HAD A GOOD OUTCOME. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER XIENCE PRIME IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A CHRONIC TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA), A 2.5 MM X 38 MM XIENCE PRIME STENT WAS DEPLOYED IN THE DISTAL RCA. THEN A 3.0 MM X 38 MM XIENCE PRIME STENT WAS DEPLOYED PROXIMAL TO THE FIRST STENT, BUT IN THE DISTAL RCA. GUIDE WIRES WERE LOCATED IN THE PDA AND RCA. THE GUIDE WIRE LOCATED IN THE PDA WAS PULLED BACK TO THE DISTAL MID RCA WITH THE INTENTION OF DEPLOYING A THIRD STENT IN THE VESSEL. UNKNOWN AT THE TIME, THE THIRD STENT, A 3.5 MM X 38 MM XIENCE PRIME STENT DELIVERY SYSTEM, WAS BACKLOADED ONTO THE GUIDE WIRE LOCATED IN THE MID RCA RATHER THAN THE GUIDE WIRE USED IN THE PDA. THE 3.5 MM X 38 MM XIENCE PRIME STENT WAS ADVANCED AND DEPLOYED INTO THE PROXIMAL END OF THE 3.0 MM X 38 MM DEPLOYED STENT. A 3.5 MM X 23 MM XIENCE V WAS DEPLOYED IN THE PROXIMAL RCA. ANGIOGRAPHY SHOWED THAT THE VESSEL DID NOT APPEAR SMOOTH IN THE MID TO DISTAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1101961

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention