Neurologic Adverse Events Associated with Absorbable Hemostatic Agents

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Neurologic Adverse Events Associated with
Absorbable Hemostatic Agents

• Daniel S. McGunagle
• FDA
• Center for Devices and Radiological Health
• Office of Surveillance and Biometrics
• Division of Postmarket Surveillance

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Hemostatic Agent Materials and Forms

• Collagen based products
• Pads, powders, foams, binary gel systems
• Oxidized cellulose products
• Woven sheets or pads, knitted sheets or pads

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Case Report
Surgery was performed to remove esophageal
diverticuli via a thoracotomy. The left T6 rib
was intentionally resected and the left T7 rib
fractured unintentionally. The surgeon packed an
absorbable hemostatic agent in the area to
control bleeding. Hemostatic agent was left in
place when the incision was closed. Following
surgery the patient was unable to move lower
extremities and was unresponsive to painful
stimuli from the nipple line down. A subsequent
CT scan found intra-canal, low attenuation image
at T5. Patient was taken to surgery for a T5-T8
laminectomy where a mass of hemostatic agent was
found to be displacing and compressing the
thoracic spinal cord. Patient did not recover
from paralysis after the laminectomy. Paralysis
appears to be permanent.
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Hemostatic Agent Labeling

• All absorbable hemostatic agents swell when
  wetted
• Risk of neurological adverse events from leaving
  hemostatic agents implanted on or near boney
  structures or neural tissue known
• All absorbable hemostatic agent labeling warns
  against leaving agent implanted on or near boney
  structures, neural tissues or inside enclosed
  spaces

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Neurological Adverse Events Associated with
Absorbable Hemostatic Agents 1992 - 2004
20 patient events of the following
types Paralysis 40 Cauda Equina
Syndrome 30 Numbness 25 Arachnoiditis 15
Blindness 1
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FDA Action

• On April 2, 2004, FDA published a Public Health
  Notification warning of potential for neurologic
  injury resulting from implanting absorbable
  hemostatic agents
• http//www.fda.gov/cdrh/safety/040204-hemostatics.
  html