DURASEAL, UNKNOWN
Report
- Report Number
- 3003418325-2018-00008
- Event Type
- Death
- Date Received
- March 15, 2018
- Report Date
- February 23, 2018
- Manufacturer
- INTEGRA LIFESCIENCES CORP
- Product Code
- NQR
- PMA / PMN Number
- P040034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTAL HYGIENIST
Narratives
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE SERIAL/LOT NUMBER WAS NOT PROVIDED THEREFORE A DHR REVIEW COULD NOT BE PERFORMED. HOWEVER, AT THE TIME OF MANUFACTURING, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. THE COMPLAINT IS UNCONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBER: 1121308-2018-00023 (SAME PATIENT) OTHER MFG. REPORT NUMBERS: 3003418325-2018-00006, 1121308-2018-00021, 3003418325-2018-00007, 1121308-2018-00022.
WORLD NEUROSURGERY (2017) PUBLISHED ¿CANDIDA MENINGITIS AFTER TRANSSPHENOIDAL SURGERY: A SINGLE INSTITUTION CASE-SERIES AND LITERATURE REVIEW¿ WHICH DISCUSSED THREE CASE PRESENTATIONS OF PATIENTS WITH GIANT SKULL BASE TUMORS WHO DEVELOPED POST-SURGICAL CANDIDA MENINGITIS, EACH WITH VASTLY DIFFERENT CLINICAL COURSES AND OUTCOMES. DURASEAL AND DURAGEN WERE USED FOR EACH OF THE PATIENTS. THIS IS A CASE OF A (B)(6) FEMALE WHO PRESENTED TO CLINIC WITH AN INCIDENTAL FINDING OF A GIANT SELLAR MASS, MEASURING 3.8 X 4.6 CM, EXTENDING INTO THE SUPRASELLAR CISTERN WITH INVASION OF THE CAVERNOUS SINUS BILATERALLY AND MASS EFFECT ON THE OPTIC CHIASM. THE TUMOR WAS DIAGNOSED DURING WORKUP FOR MENINGITIS IN THE SETTING OF STREPTOCOCCUS ANGINOSUS BACTEREMIA, HEPATIC PYOGENIC ABSCESS, HEPATIC VEIN THROMBOSIS, AND ACUTE DIVERTICULITIS REQUIRING PARTIAL COLECTOMY. SHE THEN UNDERWENT AN EXPANDED ENDOSCOPIC ENDONASAL TRANSSPHENOIDAL RESECTION WITH DEBULKING OF A CORTICOTROPH ADENOMA. DURASEAL AND NASOPORE WERE APPLIED UPON CLOSURE. PATHOLOGY CONFIRMED CORTICOTROPH ADENOMA WITH CROOKE CHANGES. PERIOPERATIVELY, SHE WAS ALSO TREATED WITH CEFUROXIME AND METRONIDAZOLE GIVEN HER PRIOR INFECTIONS. ONE WEEK POSTOPERATIVELY, THERE WAS CONCERN FOR CEREBROSPINAL FLUID (CSF) RHINORRHEA AND SHE RETURNED TO THE OPERATING ROOM FOR LUMBAR DRAIN PLACEMENT, INTRATHECAL INJECTION OF FLUORESCEIN, AND ENDOSCOPIC ENDONASAL EXPLORATION, AT WHICH TIME NO ACTIVE LEAKING WAS IDENTIFIED. CORTISOL POSTOPERATIVELY WAS NORMAL (HOWEVER, WITH NO ADRENAL INSUFFICIENCY POSTOPERATIVELY) AND WAS TREATED WITH STRESS DOSE GLUCOCORTICOIDS (GC) WITH SUBSEQUENT TAPER TO PHYSIOLOGIC DOSES AND A 1-MONTH COURSE OF PROPHYLACTIC CEFUROXIME AND METRONIDAZOLE. WHILE STILL ON PHYSIOLOGIC REPLACEMENT OF GC 1-MONTH AFTER SURGERY, SHE WAS READMITTED WITH ALTERED MENTAL STATUS AND FOUND TO HAVE SERRATIA MENINGITIS, FOR WHICH SHE WAS TREATED WITH 3 WEEKS OF MEROPENEM FOLLOWED BY CIPROFLOXACIN. A CSF LEAK WAS APPARENT ON NASAL ENDOSCOPY AND CLINICALLY, AND SHE UNDERWENT ENDOSCOPIC REPAIR OF A CSF LEAK WITH DURAGEN, ABDOMINAL FAT GRAFT AND A LUMBAR DRAIN. THE NASOSEPTAL FLAPS REMAINED VIABLE AND WERE REPOSITIONED. TWELVE DAYS LATER, A CSF LEAK BECAME CLINICALLY APPARENT AGAIN AND FURTHER SURGICAL REPAIR INCLUDED ABDOMINAL FAT GRAFTING, AND FASCIA LATA FOR BOTH UNDERLAY AND OVERLAY COVERAGE, FOLLOWED BY REPOSITIONING OF THE TWO NASOSEPTAL FLAPS. DUE TO PERSISTENT LEAKAGE, APPROXIMATELY 2 MONTHS AFTER INITIAL SURGERY, SHE UNDERWENT PLACEMENT OF A VENTRICULOPERITONEAL SHUNT FOR PERMANENT CSF DIVERSION. THIS PROVED INSUFFICIENT TO CEASE HER RHINORRHEA AND SHE SUBSEQUENTLY UNDERWENT HARVEST OF A PEDICLED PERICRANIAL FLAP VIA BICORONAL APPROACH, TUNNELED THROUGH A TRANSNASAL OSTEOTOMY, AND ENDOSCOPICALLY POSITIONED. THE ABDOMINAL FAT GRAFT HARVEST SITES REQUIRED DEBRIDEMENT FOR POOR HEALING AND THE VENTRICULOPERITONEAL SHUNT FAILED, REQUIRING REVISION. THREE MONTHS AFTER HER INITIAL SURGERY, AND 1 MONTH AFTER HER PERICRANIAL FLAP, CSF OBTAINED IN THE SETTING OF FEVER WAS POSITIVE FOR CANDIDA TROPICALIS, FOR WHICH SHE WAS STARTED ON FLUCONAZOLE; NEUROLOGIC EXAM WAS NORMAL. TWO DAYS LATER, SHE DEVELOPED SUDDEN ONSET SEVERE HEADACHE AND WAS FOUND TO HAVE INTRAVENTRICULAR HEMORRHAGE. A CEREBRAL ANGIOGRAM WAS PERFORMED DEMONSTRATING A WIDE NECKED 7X8X9 MM MID-BASILAR ARTERY ANEURYSM WITH PROXIMAL AND DISTAL STENOSIS AS WELL AS FUSIFORM ENLARGEMENT OF THE PROXIMAL RIGHT ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) AND NARROWING OF THE M1 SEGMENTS, CONSISTENT WITH INFECTIOUS VASCULITIS AND MYCOTIC ANEURYSM. THE INTERVENTIONAL NEURORADIOLOGY TEAM DETERMINED THIS WAS NOT AMENABLE TO ENDOVASCULAR TREATMENT. THE PATIENT CONTINUED TO DECLINE NEUROLOGICALLY, AND REPEAT BRAIN CT DEMONSTRATED PROGRESSIVELY WORSENING HEMORRHAGE AND HYDROCEPHALUS, DESPITE PLACEMENT OF BILATERAL EXTERNAL VENTRICULAR DRAINS. ULTIMATELY, SHE LOST BRAINSTEM REFLEXES AND IMAGING WAS CONSISTENT WITH INFARCTION INVOLVING THE BRAINSTEM AND BILATERAL SUPERIOR CEREBELLAR HEMISPHERES AS WELL AS AREAS OF THE BILATERAL CEREBRAL HEMISPHERES AND THALAMI. FOUR MONTHS AFTER HER INITIAL SURGERY, AND 1 MONTH FROM HER CANDIDA DIAGNOSIS, SHE DIED. AN AUTOPSY WAS PERFORMED, DURING WHICH FUNGAL ORGANISMS IN THE FORM OF YEASTS AND PSEUDOHYPHAE WERE IDENTIFIED WITHIN THE SUPRASELLAR CAVITY AND THE BASILAR ARTERY ANEURYSM WALL. THERE WAS NO REPORT OF BACTERIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183542 | DURASEAL, UNKNOWN | DURASEAL CRANIAL | NQR | INTEGRA LIFESCIENCES CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Death | ABDOMINAL FAT GRAFT| DURAGEN| LUMBAR DRAIN| NASOPORE| NASOSEPTAL FLAP| PERICRANIAL FLAP| VENTRICULOPERITONEAL SHUNT |