BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLARYN PLUS INJECTABLE IMPLANT

    MDR report key: 15615052 · Received October 17, 2022

    Report

    Report Number
    3013840437-2022-00128
    Event Type
    Injury
    Date Received
    October 17, 2022
    Report Date
    October 17, 2022
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    KHJ
    PMA / PMN Number
    K013243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT OBLITERATION OF THE PYRIFORM SINUS (PT: SINUS DISORDER), WAS DEEMED TO MEET THE SERIOUS CRITERIA OF HOSPITALIZATION AND REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. THE DEVICE HISTORY RECORD OF PROLARYN PLUS INJECTABLE IMPLANT WAS NOT REVIEWED, AS THE LOT NUMBER WAS NOT REPORTED. MEHDIZADEH, O., BORRELLI, M., NASROLLAHI, T., RASKIN, J., KHAN, S. (2022). SEVERE AIRWAY EDEMA FOLLOWING CALCIUM HYDROXYLAPATITE (CAHA) INJECTION AUGMENTATION. EAR, NOSE, AND THROAT JOURNAL, 1-4. DOI: DOI: 10.1177/01455613221127584.

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO MDR 3013840437-2022-00126 AND 3013840437-2022-00127, REFERRING TO THE SAME PATIENT. THIS LITERATURE REPORT FROM UNITED STATES OF AMERICA CONCERNS A 73-YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH A TOTAL OF 0.6 ML OF PROLARYN PLUS, INTO THE RIGHT TRUE VOCAL FOLD, IN (B)(6) 2021. THE PATIENT UNDERWENT A FLEXIBLE LARYNGOSCOPY AND INJECTION AUGMENTATION. PRIOR TO THE INJECTION, THE PATIENT PRESENTED WITH A WEAK AND BREATHY VOICE TO THE CLINIC. AS REPORTED, THE PATIENT HAD SEVERE DYSPHONIA AND HYPOPHONIA. SHE UNDERWENT A TOTAL THYROIDECTOMY, RIGHT MODIFIED NECK DISSECTION (BILATERAL NECK DISSECTION), AND RIGHT LATERAL NECK DISSECTION WITH SACRIFICE OF THE RIGHT RECURRENT LARYNGEAL NERVE (RLN) DUE TO AN INVASIVE DISEASE WITH ANOTHER PROVIDER (FOR A PAST HISTORY OF METASTATIC PAPILLARY THYROID CARCINOMA). SHE ALSO HAD A NEUROPLASTY OF THE VAGUS NERVE AND RECURRENT LARYNGEAL NERVE AND REIMPLANTATION OF THE RIGHT INFERIOR PARATHYROID. RECURRENT LARYNGEAL NERVE MONITORING WAS PERFORMED IN (B)(6) 2020. INTRA-OPERATIVE NEURORRHAPHY OF THE RECURRENT LARYNGEAL NERVE WAS NOT PERFORMED. FOLLOWING THE THYROIDECTOMY, THE RIGHT VOCAL FOLD WAS IN A PARAMEDIAN POSITION, AND THE LEFT VOCAL FOLD WAS ATROPHIED AND MOBILE. HER PAST MEDICAL HISTORY WAS SIGNIFICANT FOR BREAST CANCER, WHERE SHE UNDERWENT A LUMPECTOMY WITHOUT RADIATION, VOCAL FOLD ATROPHY WITH GLOTTIC INSUFFICIENCY, AND HYPOTHYROIDISM. SHE HAD A KNOWN ALLERGY TO PENICILLIN. HER POSTOPERATIVE VIDEOSTROBOSCOPY WAS SIGNIFICANT FOR BILATERAL VOCAL FOLD ATROPHY, RIGHT UNILATERAL VOCAL FOLD IMMOBILITY, AND SEVERE GLOTTIC INSUFFICIENCY WITH SECONDARY SUPRAGLOTTIC HYPERFUNCTION. THE PATIENT STATED THAT SHE HAD A BREATHY VOICE FOR YEARS PRIOR TO HER SURGERY, A SYMPTOMATIC CORRELATE TO BILATERAL FOLD ATROPHY. PREOPERATIVE EVALUATION PRIOR TO (B)(6) 2020 DEMONSTRATED BILATERAL VOCAL FOLD ATROPHY WITH MOBILE CORDS. THIS WAS SIGNIFICANT AS THE PATIENT HAD A HISTORY OF PRE-EXISTING GLOTTIC INSUFFICIENCY AND A GAP THAT WAS EXACERBATED BY VOCAL FOLD PARALYSIS. IN RETROSPECT, GIVEN THE LARGE SIZE OF THE GAP (APPROXIMATELY 4 MM), INJECTION AUGMENTATION HAD A LOWER PROBABILITY OF IMPROVEMENT IN VOICE. AFTER DISCUSSION OF HER OPTIONS, INCLUDING MEDIALIZATION, SHORT-TERM FILLERS, AND CALCIUM HYDROXYLAPATITE, THE PATIENT WAS ELECTED FOR CALCIUM HYDROXYLAPATITE INJECTION AUGMENTATION. IN 2021, AFTER THE PROLARYN PLUS INJECTION, THE PATIENTS RESPONSE WAS SUBOPTIMAL AND SHE PROCEEDED WITH MICRODIRECT LARYNGOSCOPY AND INJECTION AUGMENTATION OF THE BILATERAL TRUE VOCAL FOLDS WITH A SIMILAR MATERIAL (AS REPORTED). IN (B)(6) 2021, SHE WAS INJECTED WITH A TOTAL OF 0.9 ML OF CALCIUM HYDROXYLAPATITE, INTO THE RIGHT AND LEFT TRUE VOCAL FOLD. SHE WAS INJECTED WITH 0.3 ML INTO THE RIGHT TRUE VOCAL FOLD (TVC) AND WITH 0.6 ML INTO THE LEFT TRUE VOCAL FOLD. THE PROCEDURE WAS TOLERATED WELL, AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY. ON POSTOPERATIVE DAY 2, THE PATIENT DEVELOPED STRIDOR AND SHORTNESS OF BREATH. SHE WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND WAS AFEBRILE, AND HER OXYGEN SATURATION WAS 100% ON A 5 L NASAL CANNULA. ON ARRIVAL, HER LABORATORY TESTS WERE AS FOLLOWS: WHITE BLOOD COUNT (4.4), HEMOGLOBIN (13.1), HEMATOCRIT (40.9), PLATELET (THROMBOCYTE) COUNT (205), AND BLOOD GLUCOSE (128). THE PATIENTS COMPREHENSIVE METABOLIC PANEL WAS OTHERWISE WITHIN NORMAL LIMITS. HER EXAMINATION WAS SIGNIFICANT FOR INSPIRATORY STRIDOR, ROUGH, STRAINED VOICE, AND SUPRASTERNAL RETRACTION. THE NECK EXAMINATION WAS NORMAL. FLEXIBLE LARYNGOSCOPY REVEALED SEVERE WATERY BAG EDEMA OF THE LEFT ARYTENOID EDEMA AND OBLITERATION OF THE PYRIFORM SINUS. THE INJECTION WAS SLIGHTLY SUBGLOTTIC AS WELL AS SUPERIORLY POSITIONED. GLOTTIC STENOSIS WAS APPRECIATED. THERE WAS AN ABUNDANCE OF MATERIAL IN BOTH THE LEFT AND RIGHT CORDS. THE LIMITED AIRWAY WAS ALSO SEEN. THE LEFT VOCAL FOLD WAS SEVERELY HYPOMOBILE SECONDARY TO THE EDEMA. THE RIGHT VOCAL FOLD WAS EDEMATOUS, ERYTHEMATOUS, AND IMMOBILE PER PREVIOUS RECURRENT LARYNGEAL NERVE SACRIFICE. IT WAS FURTHER DESCRIBED AS SEVERE LARYNGEAL EDEMA, LIMITED VOCAL CORD MOBILITY, OBLITERATION OF THE PYRIFORM, AND A SIGNIFICANTLY REDUCED AIRWAY APERTURE REQUIRING INTENSIVE CARE MONITORING. THE PATIENT WAS GIVEN RACEMIC EPINEPHRINE AND 6 MG OF DEXAMETHASONE (DECADRON) EVERY 6 HOURS. GIVEN HER PENICILLIN ALLERGY, CEFTRIAXONE WAS STARTED AS AN INPATIENT, AND SHE WAS TRANSITIONED TO CEFDINIR ORALLY (PER OS). SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), WHERE STEROIDS AND ANTIBIOTICS WERE CONTINUED. AN EMERGENT AIRWAY CART, INCLUDING A TRACHEOSTOMY TRAY AND AN INTUBATION CART WITH SMALL BORE ENDOTRACHEAL TUBES WERE KEPT AT THE BEDSIDE. THERE WERE NO EVENTS OVERNIGHT AND FLEXIBLE LARYNGOSCOPY SHOWED SIGNIFICANTLY IMPROVED AIRWAY EDEMA AND LEFT VOCAL FOLD MOBILITY ON HOSPITAL DAY 2. THE PATIENTS STRIDOR AND RETRACTIONS RESOLVED, AND FIBEROPTIC ENDOSCOPIC EVALUATION OF SWALLOWING (FEES) SHOWED SHE WAS UNREMARKABLE FOR PENETRATION, ASPIRATION, OR POST-SWALLOW RESIDUE. SHE WAS DISCHARGED HOME WITH A PUREE DIET, PREDNISONE, CEFDINIR, AND CLOSE OUTPATIENT FOLLOW-UP. UPON COMPLETE ABSORPTION OF CALCIUM HYDROXYLAPATITE, SHE WAS GOING TO PROCEED WITH TYPE I THYROPLASTY. MEDIALIZATION THYROPLASTY WAS DISCUSSED WITH THE PATIENT AS WELL AS SHORTER-TERM INJECTABLES (HYALURONIC ACID AND CARBOXYMETHYLCELLULOSE), HOWEVER, THE PATIENT DID NOT WISH TO PROCEED WITH OPEN SURGERY IN THE NEAR FUTURE, WHICH GAVE REASON FOR THE USE OF A LONG-TERM INJECTABLE BEING UTILIZED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS GLOTTIC STENOSIS/ LIMITED AIRWAY/ SIGNIFICANTLY REDUCED AIRWAY AND WATERY BAG EDEMA (LEFT ARYTENOID EDEMA)/ SEVERE LARYNGEAL EDEMA, WAS CONSIDERED AS RESOLVING. THE OUTCOME OF THE EVENTS RESPONSE WAS SUBOPTIMAL, OBLITERATION OF THE PYRIFORM SINUS AND ERYTHEMATOUS WAS UNKNOWN. IN THE OPINION OF THE AUTHORS, ALTHOUGH UNCOMMON, INJECTABLE FILLERS HAD THE POSSIBILITY TO RESULT IN COMPLICATIONS WHICH WERE SEVERE. GIVEN THE RELATIVELY SHORT DURATION BETWEEN THE 2 INJECTIONS, THE PATIENT MAY HAVE DEVELOPED A HYPERSENSITIVITY REACTION. THERE WERE DIFFERENT HYPERSENSITIVITIES ASSOCIATED WITH CALCIUM HYDROXYLAPATITE TO CONSIDER. THE PATIENTS INDURATION AND TIMING BEFORE THE REACTION TOOK PLACE SUPPORTED A DELAYED TYPE HYPERSENSITIVITY. HER IMMEDIATE RESPONSE TO STEROIDS FURTHER SUPPORTED THIS. OTHERS HAVE POSTULATED THAT OVER-INJECTION MIGHT CAUSE VASCULAR COMPRESSION AND RESULTANT EDEMA. ALTHOUGH THE RESULTANT TISSUE CHANGES AND EDEMA MAY RESULT IN VASCULAR COMPRESSION, CALCIUM HYDROXYLAPATITE WAS ALSO NOXIOUS STIMULI. THE SUBSEQUENT INFLAMMATION, WHEN ADMINISTERED, HAD THE POSSIBILITY TO WORSEN VASCULAR EDEMA. THE TIMING OF THE PATIENTS PRESENTATION MEANT FOREIGN BODY INJECTION ALSO HAD TO BE CONSIDERED. THE VOLUME OF INJECTION, POSITION, AND DURATION BETWEEN INJECTIONS NEEDED TO BE CONSIDERED IN ORDER TO MINIMIZE THE LIKELIHOOD OF A COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047627 PROLARYN PLUS INJECTABLE IMPLANT POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) KHJ MERZ NORTH AMERICA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R DURAPATITE (GEL FOR INJECTION)