BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 20470707 · Received October 17, 2024

    Report

    Report Number
    2021898-2024-00106
    Event Type
    Death
    Date Received
    October 17, 2024
    Date of Event
    December 7, 2022
    Report Date
    October 17, 2024
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K063117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    SARAH EDMINSTER, TAI-WEI WU, ALEXANDER VAN SPEYBROECK, JASON CHU, DENISE A. LAPA, RAMEN H. CHMAIT & LINDA J. SZYMANSKI (2023) NEUROPATHOLOGY EVALUATION OF IN UTERO CORRECTION OF MYELOMENINGOCELE AND COMPLICATIONS OF LATE-ONSET GBS INFECTION, FETAL AND PEDIATRIC PATHOLOGY, 42:4, 535-544, DOI: 10.1080/15513815.2022.2150528. ABSTRACT BACKGROUND: MYELOMENINGOCELE (MMC) CAUSES SIGNIFICANT MORBIDITY AND MORTALITY. EFFORTS HAVE BEEN DIRECTED TO CORRECT THIS DEFECT IN UTERO. THE NEUROPATHOLOGY LITERATURE ON ANTENATALLY REPAIRED MMC AND ASSOCIATED COMPLICATIONS IN HUMANS IS LIMITED. CASE REPORT: A 12-DAY-OLD FEMALE, WHO UNDERWENT PRENATAL MMC REPAIR VIA A TWO-LAYER CLOSURE (DURAL REPLACEMENT PATCH, PRIMARY SKIN CLOSURE), WAS BORN AT 34 WEEKS¿ GESTATION. HER GROUP B STREPTOCOCCUS POSITIVE MOTHER RECEIVED APPROPRIATE ANTEPARTUM PROPHYLACTIC ANTIBIOTICS. SHE REMAINED STABLE UNTIL DAY 11 OF LIFE WHEN SHE UNDERWENT RAPID CLINICAL DETERIORATION. DESPITE AGGRESSIVE INTERVENTION, SHE EXPIRED ON DAY 12. REVIEW OF PLACENTAL PATHOLOGY SHOWED MATERNAL AND FETAL INFLAMMATORY RESPONSE. AUTOPSY REVEALED GRAM-POSITIVE COCCI AND INFLAMMATION WITHIN THE BASILAR LEPTOMENINGES AND LUMBOSACRALREGION. NEURAL AND DERMAL ELEMENTS WERE PRESENT WITHIN THE MMC REPAIR. CONCLUSION: THIS CASE DOCUMENTS INTEGRATION OF THE DERMAL MATRIX PATCH TO NEURAL ELEMENTS, ADHERING THE SPINAL CORD TO SCAR TISSUE, THE CLINICAL IMPLICATIONS OF WHICH REMAIN UNCLEAR. REPORTED EVENT - A FEMALE FETUS WAS DIAGNOSED WITH A FLAT MMC (WITH THE UPPER LEVEL OF THE LESION AT S1, TRAVERSING TO THE LOWER SACRUM), CEREBRAL VENTRICULOMEGALY, CHIARI II MALFORMATION, AND GRADE 3 HINDBRAIN HERNIATION. AT 27WEEKS¿ GESTATION, SHE UNDERWENT FETOSCOPIC REPAIR VIA A TWO-LAYER CLOSURE THAT ENTAILED RELEASE OF THE NEURAL PLACODE WITH RETURN INTO THE SPINAL CANAL, PLACEMENT OF A TRIMMED COLLAGEN MATRIX DURAL SUBSTITUTE PATCH OVER THE NEURAL PLACODE, AND PRIMARY CLOSURE OF THE FETAL SKIN DEFECT. AN INTERVENING MYOFASCIAL FLAP STEP WAS NOT PERFORMED IN THIS CASE. OF NOTE, A GBS CULTURE WAS PERFORMED ON THE MOTHER AT THE TIME OF PRENATAL REPAIR AND WAS NEGATIVE. THE POSTOPERATIVE COURSE WAS UNREMARKABLE, WITH FOLLOW-UP IMAGING DOCUMENTING COMPLETE REVERSAL OF HINDBRAIN HERNIATION. ALMOST 2 MONTHS AFTER THE MMC REPAIR, THE MOTHER PRESENTED TO AN OUTSIDE HOSPITAL WITH LEAKING AMNIOTIC FLUID AND WAS NOTED TO BE GBS POSITIVE. FOUR DAYS LATER, A FEMALE INFANT WEIGHING 1940 G WAS DELIVERED VAGINALLY AT 34 WEEKS¿ GESTATION TO THIS 35-YEAR-OLD G4P4 MOTHER, WITH THE DELIVERY COURSE COMPLICATED BY PROLONGED PRETERM PREMATURE RUPTURE OF MEMBRANES (PPROM). THE MOTHER WAS TREATED WITH ANTIBIOTICS DURING LABOR. THERE WAS NEITHER MATERNAL FEVER NOR CLINICAL EVIDENCE OF CHORIOAMNIONITIS. APGAR SCORES WERE 8 AND 9, AT 1 MIN AND 5 MIN OF LIFE, RESPECTIVELY. THE INFANT RECEIVED EMPIRICAL ANTIBIOTICS, AMPICILLIN AND GENTAMICIN, WHICH WERE DISCONTINUED AFTER BLOOD CULTURE REMAINED NEGATIVE FOR 48 H. THE BABY WAS THEN TRANSFERRED TO (B)(6) HOSPITAL NEONATAL INTENSIVE CARE UNIT IN STABLE CONDITION ON DAY 2 OF LIFE FOR MULTI-DISCIPLINARY CARE. ON EVALUATION, HER BACK INCISION WAS WELL-HEALED WITHOUT ANY EVIDENCE OF WOUND DEHISCENCE OR CEREBROSPINAL FLUID (CSF) LEAK. FOR MOST OF HER HOSPITAL STAY, SHE WAS WELL-APPEARING WITH PROGRESSIVE IMPROVEMENT IN RESPIRATORY STATUS. SERIAL CRANIAL ULTRASOUNDS REVEALED REDUCTIONS IN HER VENTRICLE SIZE. DURING HER SECOND WEEK OF LIFE, SHE WAS WEANED OFF ALL RESPIRATORY SUPPORT, BEGAN TO COMPLETE HER ORAL FEEDING GOALS, AND WAS PREPARING TO BE DISCHARGED HOME. HOWEVER, ON DAY 11 OF LIFE, SHE BECAME LETHARGIC WITH FREQUENT APNEIC AND BRADYCARDIC EVENTS. ON PHYSICAL EXAMINATION, SHE WAS PALE AND MOTTLED. RESPIRATORY SUPPORT WAS ESCALATED RAPIDLY FOR HYPERCAPNIC AND HYPOXEMIC RESPIRATORY FAILURE. MULTIPLE VASOPRESSOR-INOTROPIC AGENTS AND BLOOD PRODUCTS WERE ADMINISTERED FOR CIRCULATORY COLLAPSE, SEVERE METABOLIC ACIDOSIS, AND DISSEMINATED INTRAVASCULAR COAGULATION. DESPITE AGGRESSIVE MEDICAL INTERVENTION, SHE DIED AFTER CARDIOPULMONARY ARREST ON DAY 12 OF LIFE. THE BLOOD CULTURE DRAWN ON THE DAY OF DETERIORATION SUBSEQUENTLY GREW GBS. REVIEW OF THE PLACENTAL PATHOLOGY SHOWED EVIDENCE OF MATERNAL AND FETAL INFLAMMATORY RESPONSE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301282 DUREPAIR DURA SUBSTITUTE DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY 62100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Female Death