BEUDAMED
    FDA Adverse Event Other Summary report: N

    NESTER PLATINUM EMBOLIZATION COIL

    MDR report key: 1631237 · Received March 9, 2010

    Report

    Report Number
    1820334-2010-00122
    Event Type
    Other
    Date Received
    March 9, 2010
    Date of Event
    August 17, 2009
    Report Date
    February 15, 2010
    Manufacturer
    COOK, INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: THE MATERIALS THAT ARE USED TO MFR MWCE NESTER EMBOLIZATION COILS HAVE BEEN SHOWN TO BE BIOCOMPATIBLE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IN (B)(6) 2009, EIGHT WEEKS POST-PARTUM, COIL MOBILIZED BILATERAL OVARIAN AND ILIAC VEINS. SIX DAYS POST PROCEDURE, THE PT COMPLAINED OF PELVIC PAIN AND VARICOSITIES. LATER, THE PT COMPLAINED OF ONSET OF PROMINENT VEINS IN CHEST AND ARMS. INTERNAL JUGULAR PROCEDURE SHOWED NO PROBLEMS. PT COMPLAINT OF PAIN WHEN WALKING AND STANDING. PAIN WAS RELIEVED BY LYING DOWN. PT WAS VERY THIN - HOWEVER, SHE WAS BREASTFEEDING, AND VEINS WERE ENGORGED AT THAT TIME. PAIN MEDICATIONS WERE PRESCRIBED, BUT PT DECLINED DUE TO BREAST FEEDING. THE PT BEGAN ASKING TO HAVE THE COILS REMOVED. FIFTEEN DAYS AFTER PLACEMENT, SHE EXPERIENCED SYNCOPE, LIGHT-HEADED, DIAPHORESIS WHEN UPRIGHT. THREE WEEKS OUT, THE PT WAS EXPERIENCING GROIN PAIN, LEFT ABDOMINAL AND LOWER BACK PAIN. PT HAD A CONSULTATION WITH AN OB/GYN AND THOUGHT IT MAY HAVE BEEN NEUROMUSCULAR IN NATURE, THEY PRESCRIBED NEURONTIN. PT INDICATED SHE FELT VEINS WERE CONSTRICTING IN HER BODY. PHYSICIAN DID AN ULTRASOUND OF HER BILATERAL LOWER EXTREMITIES - IT WAS NEGATIVE. SHE REFUSED PRESCRIBED MEDS OF TRAMADOL AND NEURONTIN. ON (B)(6) 2009, THE PT WAS REFERRED TO A CARDIOLOGIST. THEY CONDUCTED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND IT WAS NEGATIVE. ON (B)(6) 2009, A CT SCAN OF CHEST/PELVIS/ABDOMEN WAS NEGATIVE. PT WAS COMPLAINING OF PALPITATIONS, HAIR LOSS, INSOMNIA - THE DOCTOR PRESCRIBED AMBIEN - AND PT USED ONCE. THE PHYSICIAN WANTED TO PRESCRIBE STEROIDS AFTER REVIEW OF ARTICLES ON NICKLE ALLERGIES, BUT THE PT REFUSED MEDICATION. PT HAD CONSULTATION WITH OB/GYN, HE RECOMMENDED HYSTERECTOMY AND REMOVAL OF COILS. SURGERY WAS SCHEDULED - THEN CANCELLED BY PT. ON (B)(6) 2009, PT WAS PURSUING ALLERGY TESTING. ON (B)(6) 2009, THE PHYSICIAN RECOMMENDED HORMONE THERAPY - PT DECLINED. ALSO SET UP HYSTERECTOMY PROCEDURE AGAIN - CANCELLED AGAIN. ON (B)(6) 2010, THE PT'S SPOUSE INDICATED THEY ARE WAITING OUT THE PROBLEM. ON (B)(6)2010, INJURY MADE FROM THE PT ABOUT THE COMPOSITION OF THE COIL TO THE PHYSICIAN. ON (B)(6) 2010, PT INQUIRED TO PHYSICIAN AND NURSE WHAT LOT NUMBERS WERE USED. PT OUTCOMES IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NESTER PLATINUM EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other