BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

    MDR report key: 18485741 · Received January 10, 2024

    Report

    Report Number
    2024168-2024-00532
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    October 23, 2023
    Report Date
    January 10, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648232985
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF PAIN, EDEMA, HEADACHE AND HYPERSENSITIVITY ARE LISTED IN THE XIENCE SKYPOINT EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL XIENCE SKYPOINT STENT REFERENCED IN B5 AND D10 IS CAPTURED UNDER A SEPARATE MEDWATCH #. ATTACHMENT: MEDWATCH REPORT #MW5148624

    Description of Event or Problem · 0

    A MEDWATCH WAS RECEIVED WHICH STATES:HAD TWO CARDIAC STENTS IMPLANTED ON (B)(6) 2023, BY DR. (B)(6) AT (B)(6) HOSPITAL. THE DESCRIPTION OF STENTSIS AS FOLLOWS: STENT XIENCE SKYPOINT 2.75MMX23MM RAPID EXCHANGE EVEROLIMUS ELUTING CORONARY,MANUFACTURER ABBOTT LABORATORIES. MODEL NUMBER 1804275-23; LOT NUMBER 110184B; DESCRIPTION LAD 2(LEFT ANTERIOR DESCENDING, TYPE 2); STENT XIENCE SKYPOINT 2.25MMX12MMRAPID EXCHANGE EVEROLIMUSELUTING CORONARY, MANUFACTURER ABBOTT LABORATORIES. MODEL NUMBER 1804225-12; LOT NUMBER 3011941;DESCRIPTION LAD (LEFT ANTERIOR DESCENDING). A FEW DAYS AFTER THE PROCEDURE, I STARTED GETTINGSWELLING ON MY SCALP. THE SWELLING THEN PROGRESSIVELY EXTENDED TO EYES, FACE, EARS, NECK, CHEST, ANDHAND, AND TO LESS EXTENT ON OTHER PARTS OF THE BODY. I ALSO FEEL SWELLING IN INTERNAL ORGANS LIKE HEARTAND LUNGS, ETC. LATER, I STARTED GETTING HEADACHE, PAIN IN MY BACK AND WAIST AS WELL. I VISITED THE ER(EMERGENCY ROOM) AT (B)(6) ON (B)(6) 2023, WITH SEVERE SWELLING ON MY SCALP, FACE, EYES AND SHOULDERS. IWAS PRESCRIBED PREDNISONE, DIPHENHYDRAMINE AND AMOXICILLIN-CLAVULANATE. I WAS ADVISED TO MEET WITHMY CARDIOLOGIST AND ALLERGY SPECIALIST WHICH I DID. AFTER COMPLETING THE COURSE OF DRUGS PRESCRIBEDBY ER, I STARTED TAKING CETIRIZINE 20 MG TWICE DAILY AS RECOMMENDED BY DR. (B)(6) (ALLERGY SPECIALIST).AFTER TWO WEEKS OF TAKING CETIRIZINE 20 MG BD (TWICE PER DAY), THE SWELLING IS REDUCED. HOWEVER, ICONTINUE TO HAVE SWELLING OCCURRING IN DIFFERENT PARTS OF THE UPPER BODY AT DIFFERENT TIMES (IT COMESAND GOES IN EYES, FACE, SCALP, ARMS, EAR LOBES, THIGH ETC.). THE PAIN IN BACK AND WAIST AND HEADACHECONTINUES. DUE TO SWELLING IN EYES MY VISION IS ALSO IMPACTED. OVERALL, THIS HAS ADVERSELY IMPACTED MYLIFE. I ALSO HAVE ANOTHER CARDIAC STENT WHICH WAS IMPLANTED ON (B)(6) 2023. THE DESCRIPTION OF THE STENTIS AS FOLLOWS: STENT CORONARY 3X26MM ONYX FRONTIER RX DRUG ELUTING. MODEL: ONYXNG30026UX; LOT:0011654032. DESCRIPTION: RCA (RIGHT CORONARY ARTERY). I DID NOT GET AN ALLERGIC REACTION AFTER THIS STENTWAS IMPLANTED. REFERENCE REPORT: MW5148623.SUBSEQUENT TO RECEIVING THE MEDWATCH FORM, ADDITIONAL INFORMATION WAS PROVIDED: THE NON-ABBOTT STENT WAS IMPLANTED ON MAY 23, 2023. THE PATIENT WAS HOSPITALIZED FOR ONE DAY ON (B)(6) 2023 DUE TO THE SYMPTOMS. THE SYMPTOMS HAVE NOT RESOLVED AND THE PATIENT IS RECEIVING TREATMENT FOR THE ALLERGIC REACTION SYMPTOMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251693 XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 3011941 08717648232985

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| H 2.75X23 MM XIENCE SKYPOINT STENT| ONYX STENT