BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE INSTALIFT

    MDR report key: 7211663 · Received January 23, 2018

    Report

    Report Number
    3007009755-2018-00001
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    December 20, 2017
    Report Date
    December 29, 2017
    Manufacturer
    SILHOUETTE LIFT INC.
    Product Code
    GAM
    PMA / PMN Number
    K163676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A REVIEW IT WAS NOTED THAT THE DATE OF THE INITIAL REPORT WAS INCORRECT. THIS WAS DUE TO A MISUNDERSTANDING OF THE FDA GUIDANCE AND ACTIONS HAVE BEEN TAKEN TO PREVENT RECURRENCE OF THIS ERROR. THIS CORRECTIVE REPORT IS BEING SUBMITTED TO CORRECTLY REFLECT.

    Additional Manufacturer Narrative · 1

    ON THE (B)(6) 2017, THE TREATING PHYSICIAN REPORTED A MEDICAL DIAGNOSIS OF NEUROPRAXIA OF THE BUCCAL BRANCHES OF A FACIAL NERVE ON THE LEFT SIDE OF THE FACE. HE REPORTED THAT THE ASYMMETRY IS A RESULT OF THE NEUROPRAXIA WHICH IN HIS OPINION MOST LIKELY RELATED FROM SWELLING AROUND THE ENTRY SITE. HE ALSO ADVISED THAT THE PATIENT HAD NOT RECEIVED ANY TREATMENT FOR THE EXPERIENCED ISSUE. THE TREATING PHYSICIAN IS OF THE OPINION THAT THE EVENT DID NOT RESULT IN ANY POTENTIAL OR ACTUAL PERMANENT DAMAGE OR IMPAIRMENT TO THE PATIENT. THE REPORTED EVENT OF ASYMMETRY WAS LATER CONFIRMED THROUGH PATIENT PHOTOGRAPHS. THE COMPANY MEDICAL ADVISOR ASSESSED THE AVAILABLE INFORMATION AND ADVISED THAT HAD THE NEUROPRAXIA BEEN A RESULT OF A PRE-EXISTING MEDICAL CONDITION, THE PALSY WOULD HAVE BEEN NOTED. THE PATIENT HAS NO PRE-EXISTING MEDICAL CONDITIONS OR RELEVANT MEDICAL HISTORY. IN HIS OPINION, THE NEUROPRAXIA IS A RESULT OF THE INSERTION OF THE SILHOUETTE INSTALIFT THREADS, WITH POSSIBLY A TOO DEEP POSITIONING. FOLLOWING THE PROVISION OF FURTHER INFORMATION AND PATIENT PHOTOGRAPHS, THE COMPANY MEDICAL ADVISOR STATED THAT HE IS OF THE OPINION THAT THE ISSUE RELATES TO TRAUMA TO A SMALL BRANCH OF THE FACIAL NERVE AND THAT USUALLY THIS TYPE OF ISSUE WILL RESOLVE SPONTANEOUSLY WITHIN A FEW WEEKS. HE IS OF THE OPINION TO MONITOR THE EVOLUTION. IN ADDITION, UPON ASSESSING THE PATIENT PHOTOGRAPHS, HE OBSERVED AN EXTRUDING THREAD AT THE RIGHT, LOWER LIP BELOW THE ORAL COMMISSURE THAT COULD BE CLOSE TO THE EXIT POINT OF THE THREAD AND THAT THERE IS A RISK OF EXTRUSION OF THE THREAD WHICH WOULD NEED TO BE CUT SHORTER. AN EXTRUDING THREAD MAY RESULT IN A MORE OBVIOUS EXTRUSION AND COULD POTENTIALLY LEAD TO INFECTION OR A FOREIGN BODY REACTION OVER TIME. THE SILHOUETTE INSTALIFT INSTRUCTIONS FOR USE STATES TO TRIM THE EXCESS ENDS OF THE SUTURES AND THAT IT IS DESIRABLE TO BURY THE END OF THE SUTURES EITHER UNDER ADJACENT, MOBILIZED SOFT ISSUE OR FASCIA TO AVOID POSSIBLE EROSION OF THE DEVICE THROUGH THE SKIN. A DEFINITIVE ROOT CAUSE INTO THE REPORTED EVENT CANNOT BE CONFIRMED, BUT WOULD APPEAR TO RELATE TO PHYSICIAN ERROR IN THE PLACEMENT OF THE THREADS AND IN NOT TRIMMING THE EXCESS ENDS OF THE THREADS SHORT ENOUGH. A REVIEW OF THE BATCH RECORDS FOR THE REPORTED LOT NUMBER CONFIRM THAT THE PRODUCT WAS MANUFACTURED AND RELEASED PER SET SPECIFICATIONS. THERE IS NO RELATIONSHIP BETWEEN THE MANUFACTURING OR BATCH HISTORY WITH THE REPORTED EVENT OF ASYMMETRY. BASED ON THE CURRENT OCCURENCE RATE, RISK TO THE PATIENT AND NO EVIDENCE OF A PRODUCT DEFECT, THERE APPEARS TO BE NO NEED FOR CORRECTIVE AND/OR PREVENTIVE ACTIONS. WE HAVE RECEIVED NO OTHER REPORTED EVENTS OF NEUROPRAXIA FOR SILHOUETTE INSTALIFT AND THIS APPEARS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON THE 28TH DECEMBER 2017 THAT THE PATIENT, A PHYSICIAN, RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT AT A PIP TRAINING EVENT AND LATER EXPERIENCED LEFT SIDED ASYMMETRY SEVERAL DAYS POST PROCEDURE. FOLLOWING FURTHER INFORMATION FROM THE TREATING PHYSICIAN ON THE (B)(6) 2017, IT WAS CONFIRMED THAT THE PATIENT RECEIVED TREATMENT WITH SILHOUETTE INSTALIFT ON THE(B)(6) 2017 AND ACCORDING TO THE TREATING PHYSICIAN, FIRST EXPERIENCED ISSUES ONE DAY AFTER TREATMENT. A TOTAL OF FOUR THREADS, TWO THREADS TO EACH SIDE, WERE USED DURING TREATMENT WITH ENTRY IN THE MID CHEEKS WITH THE THREAD EXITS JUST MEDIAL TO THE MARIONETTE FOLD NEAR THE "SIDEBURN AREA". NO OTHER AESTHETIC PRODUCTS WERE USED AT THE TIME OF TREATMENT OR BEFORE TREATMENT. THE TREATING PHYSICIAN REPORTED A MEDICAL DIAGNOSIS OF NEUROPRAXIA OF THE BUCCAL BRANCHES OF THE FACIAL NERVE ON THE LEFT SIDE WHICH IN HIS OPINION RESULTED IN THE INITIALLY REPORTED ASYMMETRY. ON THE (B)(6) 2018, THE PATIENT PROVIDED A PHOTOGRAPH THAT DEMONSTRATED THE REPORTED EVENT OF ASYMMETRY. ON THE (B)(6) 2018, THE PATIENT REPORTED EXPERIENCING A SHARP PAIN DURING INSERTION ON THE AFFECTED SIDE WHICH RESOLVED AFTER 1-2 DAYS. APPROXIMATELY 2 HOURS AFTER INSERTION OF THE THREADS, THE PATIENT NOTED INTERMITTENT SHARP PAIN INFERIOR ALONG THE INSERTION PATTERN OF THE AFFECTED SIDE, THAT APPEARED TO WORSEN WITH FACIAL MOVEMENT. IT WOULD APPEAR THAT AS PER INSTRUCTIONS FROM THE TREATING PHYSICIAN, THE PATIENT LIMITED HER MOVEMENTS. SHE REPORTED THAT HER FACE SEEMED A LITTLE ASYMMETRICAL BUT SHE ATTRIBUTED THIS TO SWELLING AND TO HER BASIC ASYMMETRY. FIVE DAYS AFTER TREATMENT, THE PATIENT REPORTED OBSERVING A LACK OF LIFTING OF THE OUTER SIDE OF THE MOUTH WHEN ATTEMPTING TO SMILE. SHE ALSO REPORTED THAT THE RIGHT THREAD APPEARED TO BE PROTRUDING SLIGHTLY. THE PATIENT REPORTED ON THE "(B)(6) 2019" THAT THERE APPEARS TO BE A LITTLE IMPROVEMENT WITH THE NEUROPRAXIA. UP TO THE (B)(6) 2018, IT APPEARS THAT NO MEDICAL INTERVENTION HAS BEEN CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55979 SILHOUETTE INSTALIFT SILHOUETTE INSTALIFT GAM SILHOUETTE LIFT INC. 0307-28

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other