BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 3201238 · Received July 2, 2013

    Report

    Report Number
    2953769-2013-00101
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN "L2 OSTEOPOROTIC COMPRESSION FRACTURE, AND ITS CRANIAL ENDPLATE HAD BEEN DAMAGED". DURING THE BKP, "CEMENT LEAKED FROM LEFT ANTERIOR OF THE VERTEBRA TO CRANIAL (THREADLIKE)" AND DELIVERY OF THE CEMENT WAS CEASED RIGHT AWAY. IT WAS ALSO REPORTED THAT A TOTAL OF 2.0ML (RIGHT) AND 1.5ML (LEFT) OF CEMENT WERE INSERTED IN THE PATIENT. DURING THE BKP, THE CEMENT WAS TAKEN OUT OF THE FRIDGE MORE THAN AN HOUR BEFORE MIXING. ACCORDING TO THE REPORT, THE DELIVERING SPEED WAS TWICE FASTER THAN USUAL AND THE CEMENT WAS "RUNNY" PRIOR TO BEING INJECTED INTO THE PATIENT. PER THE REPORT, "THE CEMENT SEEMED TO BE SOFTER" AND WHEN THE CEMENT WAS DELIVERED IN THE CAVITY, THE CEMENT FLOWED TOWARD THE POSTERIOR WALL. IT WAS ALSO REPORTED THAT "THE CEMENT WAS INSERTED AT BOTH CAVITIES AT THE SAME TIME BY TWO SURGEONS, AND ITS INSERTION SPEED WAS FASTER THAN NORMAL." IMMEDIATELY POST-OP, IT WAS CONFIRMED THAT "THREADLIKE" CEMENT EXTRAVASATION OCCURRED IN THE "VEIN FROM THE TREATED LEVEL L2 TO TH12 (APPROX. 4CM IN LENGTH)". DURING A FOLLOW-UP EXAM, THE "THREADLIKE CEMENT BECAME TWO PIECES AND THE PIECES WERE FOUND ON THE PATIENT'S CHEST (1-2CM, AROUND T5 LEVEL) AND NEAR THE TREATED VERTEBRA (APPROX. 2CM). THE CEMENT WAS FOUND IN THE HEART (LESS THAN 1CM), PULMONARY ARTERY (1-2 CM), AND NEAR THE TREATED VERTEBRA (APPROX. 2CM)." IT WAS REPORTED THAT THE TWO PIECES OF CEMENT HAD MIGRATED TO THE PATIENT'S RIGHT ATRIUM THROUGH THE AZYGOS VEIN AND SUPERIOR VENA CAVA, AND ONE PIECE OF THE CEMENT REMAINED IN THE RIGHT ATRIUM (RA) AND ANOTHER PIECE PASSED THROUGH THE RA AND REMAINED IN PULMONARY ARTERY (PA). A PART OF THE CEMENT, WHICH REMAINED IN THE RA, HAD PERFORATED THE PERICARDIUM AND LUNG FORMING A "PNEUMOTHORAX" AND THE PATIENT COMPLAINED OF MILD CHEST PAIN. IT WAS REPORTED THAT 16 DAYS POST-BKP, A REVISION SURGERY TO REMOVE THE CEMENT FROM THE HEART WAS PERFORMED BY A CARDIAC SURGEON. A SMALL INCISION WAS ADDED TO THE HEART, AND THE CEMENT WAS PULLED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING A FOLLOW UP VISIT 29 DAYS POST-BKP, THE PATIENT WAS "UNDER INTUBATION DUE TO DELIRIA" WHEN A CEREBRAL INFARCTION OCCURRED AND PARTIAL PARALYSIS WAS CONFIRMED. ADDITIONAL SURGERY TO REMOVE THE CEMENT FRAGMENT FROM THE PATIENT PULMONARY ARTERY WAS POSTPONED DUE TO THE CEREBRAL INFARCTION. ACCORDING TO THE REPORT, THE PHYSICIAN DOES NOT BELIEVE THAT BKP IS RELATED TO THE CEREBRAL INFARCTION BUT MAY BE RELATED TO THE PATIENT'S HISTORY OF HYPERTENSION AND HEPATIC CIRRHOSIS CONDITION. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) TO TREAT AN L2 COMPRESSION FRACTURE. REPORTEDLY, AFTER CREATING CAVITIES USING THE BALLOONS, THE CEMENT WAS INSERTED USING BONE FILLER DEVICES (BFDS) AND DURING DELIVERY OF THE CEMENT INTO THE CAVITIES, FLUOROSCOPIC IMAGE SHOWED A "CEMENT LEAK". THE PHYSICIAN "STOPPED FILLING THE CEMENT, AND THE PROCEDURE WAS COMPLETED". THE PATIENT'S "VITALS ARE STABLE" ACCORDING TO THE REPORT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303132 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC. NA EL40312

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| L| R BONE FILLER DEVICE, BALLOONS