BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BKP BALLOONS

    MDR report key: 11191720 · Received January 19, 2021

    Report

    Report Number
    2953769-2021-00002
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    January 12, 2012
    Report Date
    January 19, 2021
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    HXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE - MEDIAN AGE OF 18 PATIENTS IS 64 (43-73). SEX - 8 MALE AND 10 FEMALE. COUNTRY(B)(6). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: TINA REIS, FRANK SCHNEIDER, GRIT WELZEL, RENÈ SCHMIDT, FREDERIC BLUDAU, UDO OBERTACKE AND FREDERIK WENZ. INTRAOPERATIVE RA DIOTHERAPY DURING KYPHOPLASTY FOR VERTEBRAL METASTASES (KYPHO-IORT): FIRST CLINICAL RESULTS. TUMORI JOURNAL, 2012;98:434-440. DOI.ORG/10.1177/030089161209800406. EVENT SUMMARY: IN A LITERATURE ARTICLE INTRAOPERATIVE RADIOTHERAPY DURING KYPHOPLASTY FOR VERTEBRAL METASTASES (KYPHO-IORT): FIRST CLINICAL RESULTS, FOR KYPHO-IORT, A 50 KV X-RAY SOURCE WITH A SPECIALLY DESIGNED APPLICATOR WAS USED. A RADIATION DOSE OF 8 GY IN 5 MM DISTANCE WAS DELIVERED. AFTER RADIATION THE DEVICE WAS REMOVED AND THE KYPHOPLASTY WAS COMPLETED ACCORDING TO THE STANDARD PROCEDURE. SINCE AUGUST 2009, 18 ELIGIBLE PATIENTS WITH SYMPTOMATIC OR INSTABLE SPINAL METASTASES WERE ENROLLED WITH A TOTAL OF 21 VERTEBRAL LESIONS. OF THESE 18 PATIENTS, THREE UNDERWENT PROCEDURES AT TWO VERTEBRAL BODIES. ALL PATIENTS MET THE FOLLOWING ELIGIBILITY CRITERIA: 1) PATHOLOGICALLY OR CYTOLOGICALLY PROVEN PRIMARY TUMOR, 2) PAINFUL OR INSTABLE LESIONS BETWEEN T 4/5 AND L5, 3) AGE =18 YEARS, 4) KARNOFSKY INDEX =60%. 10 WERE FEMALE AND 8 WERE MALE AND THE MEDIAN AGE WAS 63 YEARS (RANGE, 43-73) WITH 14 THORACIC VERTEBRAE AND 7 LUMBAR VERTEBRAE. AFTER INTRAOPERATIVE RADIOTHERAPY, THE BALLOON (KYPHX® INFLATABLE BONE TAMPS, KYPHON, INC., SUNNYVALE, CA, USA) WAS INSERTED INTO THE VERTEBRAL BODY VIA THE WORKING CANNULA, UNDER FLUOROSCOPIC GUIDANCE. AFTER DEFLATION AND REMOVAL OF THE BALLOON, THE SAME TUBE WAS USED TO INJECT PMMA CEMENT (KYPHX, KYPHON). REPORTED EVENTS: THE MEDIAN SURGICAL TIME WAS 70 MIN (RANGE, 53-173) INCLUDING A RADIATION TIME OF APPROXIMATELY 2 MIN. 1. OVERALL, 5 PATIENTS (28%) DIED, 3 FROM UNCONTROLLED PRIMARY DISEASE, 1 FROM UROSEPSIS AND 1 FOR UNKNOWN REASONS. MEDIAN DURATION FROM TREATMENT TO DEATH WAS 4 MONTHS(RANGE, 1-11). 2. ONE PATIENT EXPERIENCED AN ASYMPTOMATIC FRACTURE OF THE LEFT PEDICLE OF THE TREATED VERTEBRA. A COMPRESSION FRACTURE OF ADJACENT VERTEBRAE WAS SEEN IN ONE PATIENT. SPINAL CORD COMPRESSION AND NERVE ROOT COMPRESSION WERE NOT DETECTED. NO DELAYED WOUND HEALING OR RADIATION-INDUCED SKIN TOXICITY WAS OBSERVED. 3. ASYMPTOMATIC PARAVERTEBRAL PMMA CEMENT LEAKAGE WAS OBSERVED IN 78% OF THE PATIENTS. AN ASYMPTOMATIC PULMONARY CEMENT EXTRAVASATION WAS SEEN IN ONE PATIENT. 4. KYPHO-IORT WAS SUCCESSFULLY PERFORMED IN 18 OF 21 VERTEBRAL LESIONS. NO TECHNICAL PROBLEMS APPEARED DURING THE TREATMENT OF THE 7 LUMBAR LESIONS. DURING TREATMENT OF THE THORACIC LESIONS, BENDING OF THE DRIFT TUBE OCCURRED IN 2 OF THE FIRST 9 CASES (22%) AND IORT COULD NOT BE COMPLETED. THEREFORE, 1 PATIENT RECEIVED AN EBRT (10 × 3 GY) OF THE AFFECTED VERTEBRAL BODY. EBRT WAS PLANNED FOR ANOTHER PATIENT, WHO DIED OF UROSEPSIS BEFORE EBRT. THE THIRD PATIENT HAS REFUSED EBRT. AFTER ADDITIONAL MODIFICATION OF THE SLEEVES, BENDING OF THE DRIFT TUBE WAS ONLY SEEN IN 1 OF 12 FURTHER TREATED VERTEBRAE (8%). NO SEVERE COMPLICATIONS OCCURRED DURING OR EARLY AFTER SURGERY. IN ONE PATIENT THERE WASAN INCREASED INTRAOPERATIVE BLEEDING WITHOUT HEMODYNAMIC RELEVANCE. 5. STABLE DISEASE WITHIN THE IRRADIATED VERTEBRAL BODY WAS SEEN IN 14 PATIENTS (93%) UNTIL THEIR LAST FOLLOW- UP OR DEATH. CT IMAGES OF OUR FIRST TREATED PATIENT ARE SHOWN IN FIGURE 5. LOCAL PROGRESSIVE DISEASE WAS SEEN IN ONE PATIENT (7%) 6 WEEKS AFTER KYPHO-IORT. THE PATIENT HAD A SOLITARY METASTASIS OF THE 12TH THORACIC VERTEBRA WITH ASYMPTOMATIC PROGRESSIVE INTRASPINAL TUMOR GROWTH, WHICH HAS REMAINED UNCHANGED FOR 3 MONTHS UP TO THIS WRITING. 11 OF 15 PATIENTS (73%) DEVELOPED PROGRESSIVE VISCERAL METASTASES OR FURTHER BONE METASTASES. SIX OF 7 PATIENTS WITH ADDITIONAL BONE METASTASES WERE TREATED WITH EBRT TO THE NEW LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93949 BKP BALLOONS TAMP HXG MDT KYPHON SUNNYVALE MFG KY_UNK_BKP_IBT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening