BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 14913564 · Received July 5, 2022

    Report

    Report Number
    9612164-2022-02509
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    April 2, 2022
    Report Date
    July 5, 2022
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: MSB_UNK_BKP_CEMENT, LOT #: UNKNOWN, UBD: N/A , UDI#: (B)(4) THE AVERAGE AGE OF PATIENTS IN THIS EVENT IS 39 YEARS. THE GENDER MAJORITY OF PATIENTS IN THIS EVENT IS FEMALE. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: OTHER- PULMONARY CEMENT EMBOLISM, DATE OF PUBLICATION IS USED AS EVENT DATE. PRODUCT IDENTIFIERS ARE UNKNOWN. PRODUCT IDENTIFIER IS UNKNOWN, HENCE 510K# IS NOT AVAILABLE. GUMUSAY, O., HUPPERT, A., L., BEHR, C., S., RUGO, S., H. THE ROLE OF PERCUTANEOUS VERTEBRAL AUGMENTATION IN PATIENTS WITH METASTATIC BREAST CANCER: LITERATURE REVIEW INCLUDING REPORT OF TWO CASES. 2022. THE BREAST. 63:149¿156. DOI.10.1016.2022.03.016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    SUMMARY: PATIENTS WITH METASTATIC BREAST CANCER ARE AT HIGH RISK FOR DEVELOPING VERTEBRAL COMPRESSION FRACTURES DUE TO UNDERLYING BONE METASTASES AND BONE DENSITY LOSS. VERTEBRAL AUGMENTATION TECHNIQUES INCLUDING PERCUTANEOUS VERTEBROPLASTY AND PERCUTANEOUS BALLOON KYPHOPLASTY ARE TECHNIQUES USED TO STABILIZE COMPRESSION FRACTURES AND IMPROVE PAIN. ONE POTENTIAL COMPLICATION OF THESE PROCEDURES IS THE DEVELOPMENT OF PULMONARY CEMENT EMBOLI (PCE). WE PROVIDE CASE REPORTS OF TWO PATIENTS WITH METASTATIC BREAST CANCER THAT DEVELOPED VASCULAR COMPLICATIONS AFTER INJECTION OF PMMA, INCLUDING A CASE OF PCE AND RENAL VEIN CEMENT EMBOLISM AFTER PERCUTANEOUS BALLOON KYPHOPLASTY (PKP) AND A CASE OF PCE AFTER A PERCUTANEOUS VERTEBROPLASTY (PVP) PROCEDURE. REPORTED EVENTS: 1. IN THE FIRST CASE, 4 WEEKS POST-OP, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, AND SHE WAS FOUND TO BE HYPOXIC. SHE WAS ALSO TACHYCARDIC WITH NORMAL BLOOD PRESSURE ON MEDICATION. CT OF HER SPINE DEMONSTRATED A SPINAL FLUID COLLECTION AND A CT OF HER CHEST REVEALED LINEAR HIGH-DENSITY FILLING DEFECTS WITHIN MULTIPLE SEGMENTAL AND SUBSEGMENTAL PULMONARY ARTERIES, COMPATIBLE WITH PCE. CT OF HER ABDOMEN/PELVIS SHOWED LUMBAR AND LEFT RENAL VEIN CEMENT THROMBI EXTENDING TO THE IVC. HER SHORTNESS OF BREATH AND HYPOXIA WERE ATTRIBUTED TO THE PCE. IMAGING WAS ALSO NOTABLE FOR CEMENT DEPOSITION IN THE LEFT RENAL VEIN, WHICH WAS THOUGHT TO EXPLAIN HER NEW-ONSET HYPERTENSION. TWO YEARS AFTER HER KYPHOPLASTY, THE BILATERAL LOBAR AND SEGMENTAL EMBOLI ARE STILL VISIBLE AND UNCHANGED ON CHEST CT BUT SHE HAS NO PULMONARY SYMPTOMS. 2. IN THE SECOND CASE, 1 WEEK AFTER SURGERY, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN, DYSPNEA, AND MILD HYPOXIA. A CHEST CT REVEALED NUMEROUS PULMONARY ARTERY CEMENT EMBOLI INVOLVING THE RIGHT UPPER LOBAR PULMONARY ARTERY AND ADDITIONAL SEGMENTAL PULMONARY ARTERY BRANCHES THROUGHOUT ALL PULMONARY LOBES. SHE WAS TREATED WITH PAIN MEDICATIONS AND HYDRATION WITH GRADUAL RESOLUTION OF HER SYMPTOMS. AFTER DISCHARGE SHE WAS STARTED ON MEDICATIONS AND RECEIVED PALLIATIVE RADIATION THERAPY. HER PULMONARY SYMPTOMS RESOLVED OVER THE COURSE OF ONE MONTH. TWENTY-EIGHT MONTHS AFTER HER SURGERY, BILATERAL SEGMENTAL CEMENT EMBOLI ARE STILL NOTED ON CHEST CT BUT SHE DOES NOT HAVE ANY PULMONARY SYMPTOMS. 3. CASE DISCUSSIONS- WE REPORT THE CASES OF 2 PATIENTS WITH METASTATIC BREAST CANCER WHO DEVELOPED SYMPTOMATIC PCE FOLLOWING PKP AND PVP INCLUDING LONG-TERM FOLLOW-UP DATA. IN BOTH CASES, AT OVER 2 YEARS OF FOLLOW-UP, THERE IS STILL RADIOGRAPHIC EVIDENCE OF PCE ON SURVEILLANCE IMAGING. NEITHER PATIENT HAS LONG-TERM PULMONARY SYMPTOMS. THE FIRST PATIENT ALSO HAD DEPOSITION OF CEMENT IN THE RENAL VASCULATURE, CAUSING NEW ONSET HYPERTENSION AND PROMPTING THE INITIATION OF MEDICATION. AT OVER 2 YEARS OF FOLLOW-UP, SHE STILL REQUIRES MEDICATION TO MAINTAIN NORMAL BLOOD PRESSURE. 4. CONCLUSION- THE DEPOSITION OF CEMENT EMBOLI IN THE VASCULATURE IS A COMPLICATION THAT CAN OCCUR WITH PKP AND PVP. WHILE MOST PATIENTS ARE ASYMPTOMATIC, LONG-TERM RADIOGRAPHIC AND CLINICAL CONSEQUENCES ARE POSSIBLE. MEDTRONIC PRODUCTS ARE NOT MENTIONED SPECIFICALLY BUT MAY HAVE BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397971 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC MEXICO MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other