NO-REACT DURA SHIELD PRODUCT NUMBER 555-DS- *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-10 for NO-REACT DURA SHIELD PRODUCT NUMBER 555-DS- * manufactured by Shelhigh, Inc..

Event Text Entries

[287926] In 2002: pt admitted for surgery of posterior fossa brain tumor. Well until one year prior when they developed headaches. Headaches progressed over time. Head ct and mri in nov. Revealed tumor. Pmh: no previous surgeries, no chemotherapy. Meds: decadron given prior to procedure followed by taper after procedure. Preoperative diagnosis: posterior fossa brain tumor and hydrocephalus. Operation: right frontal ventriculostomy; suboccipital craniotomy & resection of posterior fossa fourth ventricular and skull base tumor with c1 laminectomy; microdissection. Tumor cavity lined with surgicel; timesh cranial planning; dural patch graft of bovine pericardium -no- react dura shield, product number 555-ds; shelhigh, inc. -. Pt transferred to picu in satisfactory condition. In 12/02: pt transferred to medical floor with ventriculostomy. One week later, ventriculostomy removed. The next day, pt transferred to rehab unit. Post-op ataxia, dysphagia, cn vi & vii palsies, diplopia & dysconjugate gaze. In 2003: pt was noted to have leakage of csf from the former ventriculostomy site -enough leakage to make their hair and bed wet-. Sutures placed with subsequent resolution of the csf leak. In 03: pt developed fever and neck pain and stiffness. Csf: rbc =212, 160, wbc=9,123 -81% pmns-, protein=710, glucose=38, no organisms were seen. Ceftriaxone and vancomycin were initiated. Subsequently pt complained of severe lower back pain and neurological status declined. Csf cultures and bacterial pcr were negative. Two days later: transfered back to neurosurgery service. Mri of spine and brain revealed abnormal nerve root clumping and enhancement within the lumbar sacral spine as well as linear dural enhancement throughout the spine. Differential included arachnoiditis/post operative change, infection, and csf spread of tumor though tumor was considered much less likely. Three days later: increased somnolence, ct: acute hydrocephalus. To or for ventriculostomy. Preop diagnosis: acute hydrocephalus; posterior fossa tumor, status post resection. Operation: placement of right frontal ventriculostomy with rickham reservoir for external ventricular drainage; lumbar puncture attempted at 3 different levels did not produce fluid. Ventric fluid: rbc=43, wbc= 7 -57% pmns-, protein=12, glucose=75. Bacterial & fungal cx negative. Increasing leg pain, decreasing neurological function. Eventually total paralysis of lower extremities and loss of bowel and bladder control. Two days later to or for exploration/biopsy of abnormality around nerve roots. Preop diagnosis: intraspinal process tumor versus infection. Procedure: l4/5 laminectomy, intradural and extramedullary exploration. Intraoperative description: thick, white mucoid material, poor to partially organized, coating nerve roots in subdural space. Cultures obtained. Postop diagnosis: intradural spinal infection consistent with a subdural empyema. Two days later culture of dural tissue during or in january 2003 grew aspergillus fumigatus. Ctx and vanco stopped. Antifungal therapy initiated -ambisome and voriconazole-. The next day, neck surgical wound breakdown. Culture subsequently grew aspergillus spp from broth only. Four days later mri: markedly increased nodular dural enhancement thoroughout spine, most severe mid-thoracic to sacrum; new enhancing fluid collection within suprasellar cistern, possible abscess. Ct scan of neck/thorax/abd/pelvis showed no other areas of involvement with aspergillus. Echo: no vegetations. Ophtho exam normal. Subsequent cultures have showed no growth of fungus. Three days later it ampho started. Eventually on a regimen of ambisome -10/kg/day-, voriconazole, it amphotericin -1mg/day-. In 3/03: continues on antifungal therapy. Radiologically disease has stabilized. Clinically, the pt appears to be regaining some strength in lower extremities.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1027822
MDR Report Key447954
Date Received2003-03-10
Date of Report2003-03-10
Date of Event2003-01-09
Date Added to Maude2003-03-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNO-REACT DURA SHIELD PRODUCT NUMBER 555-DS-
Generic NameBOVINE PERICARDIUM
Product CodeMFX
Date Received2003-03-10
Model Number*
Catalog Number*
Lot Number*
ID NumberPRODUCT NUMBER 555-DS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key449995
ManufacturerSHELHIGH, INC.
Manufacturer Address* * *
Baseline Brand NameSHELHIGH DURASHIELD
Baseline Generic NamePERICARDIAL PATCH USE TO REPLACE THE DURA
Baseline Model NoSHP-555-DS
Baseline Catalog NoSHP-555-68-DS
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit 2003-03-10

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