BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN OTOLOGIC REPAIR GRAFT

    MDR report key: 11440713 · Received March 8, 2021

    Report

    Report Number
    1835959-2021-00001
    Event Type
    Injury
    Date Received
    March 8, 2021
    Report Date
    March 2, 2021
    Manufacturer
    COOK BIOTECH
    Product Code
    KHJ
    PMA / PMN Number
    K150594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC DEVICE RPN AND LOT NUMBER WERE NOT REPORTED BY THE AUTHORS. IMPLANT / EXPLANT DATE WERE NOT REPORTED BY THE AUTHORS. 510(K) UPDATED TO K161000 (B)(4). INVESTIGATION INTO THIS FEEDBACK INCLUDED, A REVIEW OF THE PUBLICATION AND, A REVIEW OF THE BIODESIGN OTOLOGIC REPAIR GRAFT IFU FP0108-01E. PER THE IFU, THE DEVICE SHOULD NOT BE USED FOR PATIENTS WITH KNOWN SENSITIVITY TO PORCINE MATERIAL. THE FOLLOWING COMPLICATIONS ARE POSSIBLE WITH THE USE OF SURGICAL DEVICE MATERIALS IN OTOLOGIC PROCEDURES: ABSCESS FORMATION, ALLERGIC REACTION, CALCIFICATION, CHOLESTEATOMA, EXCESSIVE REDNESS, PAIN, SWELLING, OR BLISTERING, FEVER, INFECTION, INFLAMMATION, MASTOIDITIS, MIGRATION, PERSISTENCE, RECURRENCE, RETRACTION POCKETS, SEROMA, SQUAMOUS CYSTS, AND THICKENING OF THE TYMPANIC MEMBRANE. ACCORDING TO THE PUBLICATION, REPARATIVE GRANULOMAS ARE A KNOWN POTENTIAL COMPLICATION OF STAPES SURGERY. THE GRANULOMA CAN THEN LEAD TO INNER EAR SYMPTOMS AND HEARING LOSS. THE ROOT CAUSE OF THE OF THE HEARING LOSS WAS INDICATED TO BE DUE TO THE FORMATION OF A GRANULOMA. THE ROOT CAUSE OF THE GRANULOMA IS INCONCLUSIVE. HOWEVER, THE AUTHORS REPORTED "THE HYPOTHESIS FOR THE PATHOGENESIS OF REPARATIVE GRANULOMA IS THAT IT IS A FOREIGN BODY REACTION WITHIN THE OVAL WINDOW, EITHER IN RESPONSE TO CERTAIN MATERIALS USED FOR AN OVAL WINDOW SEAL (E.G. FAT OR GELFOAM) OR FOR THE STAPES PISTON PROSTHESIS (E.G. TEFLON, STAINLESS STEEL, OR GOLD). UNINTENTIONAL FOREIGN BODIES MAY ALSO BE THE CULPRIT, INCLUDING COTTON WOOL FIBERS, LINEN FIBERS, FRACTURED INSTRUMENTS, OR TALC OR STARCH FROM GLOVE POWDER. THE MECHANISM FOR THIS REACTION MAY BE AN IMBALANCED HEALING PROCESS. OTHER HYPOTHESES OF PATHOGENESIS IN THE LITERATURE INCLUDE OVERUSE OF LASER, LOCAL AUTOIMMUNE OR ALLERGIC PROCESS, PYOGENIC INFLAMMATION, OR MIDDLE EAR IRRITATION FROM A PERILYMPHATIC FISTULA. TOPSAKAL ET AL. SUGGEST IT COULD BE AN EXACERBATION OF OTOSCLEROSIS AS STAPES SURGICAL MANIPULATION DOES NOT CURE THE PATHOLOGICAL CAUSE OF OTOSCLEROSIS, BUT RATHER ACTS AS A BYPASS METHOD FOR CONDUCTIVE HEARING LOSS." "WHILE IT IS IMPOSSIBLE TO ASCERTAIN WHETHER THE APSIS WAS THE CAUSE OF THE GRANULOMA IN THIS PARTICULAR CASE, RATHER THAN THE BUCKET-HANDLE PROSTHESIS OR FROM A POSSIBLE EPISODE OF POST-SURGICAL LABYRINTHITIS, THE GRANULOMA WAS NOTED TO BE CENTERED AROUND AND ARISING FROM THE AREA OF APSIS PACKING AROUND THE OVAL WINDOW FOOTPLATE, MAKING IT HIGHLY LIKELY FOR THE APSIS TO BE THE CAUSE. SINGLE CASE REPORTS ARE CLEARLY UNDERPOWERED TO MAKE SUCH DETERMINATIONS; HOWEVER, FUTURE REPORTS ON THE USE OF SIS IN STAPES SURGERY MAY FURTHER ELUCIDATE A CLEAR ASSOCIATION.

    Description of Event or Problem · 1

    PUBLICATION POST-STAPEDOTOMY REPARATIVE GRANULOMA FOLLOWING USE OF ACELLULAR PORCINE SMALL INTESTINAL SUBMUCOSA. ABSTRACT PURPOSE: THERE HAVE BEEN MULTIPLE PROPOSED ETIOLOGIES OF REPARATIVE GRANULOMA FOLLOWING STAPES SURGERY. IN THIS REPORT, WE PRESENT THE FIRST CASE OF POST-STAPEDECTOMY REPARATIVE GRANULOMA FOLLOWING THE USE OF BIODESIGN (COOK MEDICAL, BLOOMINGTON, IN) OTOLOGIC GRAFT MATERIAL, AN ACELLULAR MATRIX DERIVED FROM PORCINE SMALL INTESTINAL SUBMUCOSA, AND REVIEW THE LITERATURE OF POST-STAPES SURGERY REPARATIVE GRANULOMA. PATIENT (B)(6) YEAR-OLD WOMAN WHO DEVELOPED A REPARATIVE GRANULOMA FOLLOWING STAPEDOTOMY WITH ACELLULAR PORCINE INTESTINAL SUBMUCOSA PRESENTING WITH PROFOUND HEARING LOSS AND VERTIGO. INTERVENTION: MIDDLE EAR EXPLORATION WITH EXCISION OF GRANULOMA AND REVISION STAPEDOTOMY. MAIN OUTCOME MEASURES: AUDIOLOGIC OUTCOMES AS MEASURED BY PURE-TONE AIR AND BONE CONDUCTION THRESHOLDS AND WORD RECOGNITION SCORES. IMPROVEMENT IN VERTIGO. MAIN FINDINGS: SURGICAL EXCISION OF THE REPARATIVE GRANULOMA WITH REVISION STAPEDOTOMY RESOLVED VERTIGO. HEARING HAS IMPROVED PROGRESSIVELY POSTOPERATIVELY. CONCLUSIONS: WE REPORT THE FIRST CASE OF POST-STAPEDOTOMY REPARATIVE GRANULOMA FOLLOWING THE USE OF ACELLULAR PORCINE INTESTINAL SUBMUCOSA. ALTHOUGH EXACT ETIOLOGY CANNOT BE DETERMINED FROM A SINGLE CASE REPORT, THIS ILLUSTRATES THE NEED FOR CAREFUL USE OF NOVEL FOREIGN GRAFT MATERIAL. THIS CASE ADDITIONALLY CONFIRMS THAT REMOVAL OF GRANULOMA AND INCITING MATERIALS CAN SALVAGE SERVICEABLE HEARING. A (B)(6) YEAR-OLD WOMAN DEVELOPED SPINNING VERTIGO AND HEARING LOSS IN HER RIGHT EAR IMMEDIATELY FOLLOWING STAPEDOTOMY FOR OTOSCLEROSIS AT AN OUTSIDE INSTITUTION. SHE PRESENTED TO OUR CLINIC 2 WEEKS POST OPERATIVELY FOR A 2ND OPINION DUE TO PERSISTENCE OF HER DEBILITATING SYMPTOMS, AT WHICH TIME AN AUDIOGRAM CONFIRMED RIGHT SENSORINEURAL HEARING LOSS WITH SERVICEABLE WORD UNDERSTANDING. REVIEW OF OPERATIVE REPORTS INDICATED STAPEDOTOMY WAS PERFORMED WITH A CARBON DIOXIDE LASER AND PLACEMENT OF A 4 MM BUCKET-HANDLE STYLE PROSTHESIS. BIODESIGN OTOLOGIC GRAFT MATERIAL WAS USED TO PACK AROUND THE FENESTRATION AND PROSTHESIS. SHE WAS INITIALLY MANAGED CONSERVATIVELY WITH ORAL STEROIDS FOR PRESUMED LABYRINTHITIS. HEARING SUBJECTIVELY IMPROVED AND HER VERTIGO RESOLVED FOR APPROXIMATELY 4 WEEKS UNTIL SHE DEVELOPED SUDDEN RECURRENCE OF VERTIGO AND PROFOUND SENSORINEURAL HEARING LOSS EXACTLY TWO MONTHS FOLLOWING HER INITIAL SURGERY. MIDDLE EAR EXPLORATION WITH REVISION STAPEDOTOMY WAS PERFORMED THE FOLLOWING DAY REVEALING A GRANULOMA OVERLYING THE FOOTPLATE AND ENVELOPING PART OF THE PISTON. THE PROSTHESIS AND GRANULATION TISSUE WERE REMOVED, FASCIA LAID OVER THE FOOTPLATE, AND A NEW IDENTICAL SIZED 4 MM MATRIX STAPES PISTON (B)(6) WAS PLACED. DEXAMETHASONE WAS BATHED OVER THE OVAL AND ROUND WINDOWS, AND ADDITIONAL FASCIA WAS LAID OVER THE FOOTPLATE AND AROUND THE PROSTHESIS. POSTOPERATIVELY THE PATIENT¿S VERTIGO RESOLVED, AND HEARING CONTINUED TO IMPROVE AT 4 MONTHS FOLLOWING REVISION STAPEDOTOMY, THOUGH A SIGNIFICANT DEGREE OF SENSORINEURAL HEARING LOSS PERSISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330612 BIODESIGN OTOLOGIC REPAIR GRAFT OTOLOGIC REPAIR GRAFT KHJ COOK BIOTECH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention