BSIR Incident report guidance

Any adverse incident involving a medical device should be reported to the MHRA.

What to report

Any adverse incident involving a medical device should be reported to the MHRA, including problems with the instructions for use, packaging or the use of the device itself, especially if the incident has led, or might have led to:

  • death, life-threatening illness or injury
  • deterioration in health or permanent impairment of body structure or function
  • the necessity for further or prolonged medical or surgical intervention (including implant revision)
  • hospitalisation or prolongation of existing hospitalisation
  • concerns about: design; unfit user information or training; user/device interface problems

      For interventional devices such as "stent-grafts", this may include:

  • Physical problems with the implant or delivery system identified prior to implant
  • Difficulties experienced with the delivery system, deployment or placement of the stent-graft
  • Stent-graft occlusion or kinking
  • Graft fabric tearing/rupture
  • Stent fracture or displacement from graft
  • Migration of device or separation of components
  • Injury to patient vasculature / anatomy during or post placement

      For interventional devices such as "IVC Filter's" this may include:

  • Physical problems with the implant or delivery system identified prior to implant
  • Difficulties experienced with the delivery system, deployment or placement of the filter during implant
  • Structural deformation / damage to the implant identified at any point post procedure
  • Injury to patient vasculature / anatomy during or post deployment
  • Migration / embolisation of the filter
  • Post implant fracture of device
  • Perforation of the IVC (>3mm)
  • Recurrent/fatal pulmonary embolism
  • Progressive angulation/tilting
  • Retrieval difficulties

      For interventional devices such as "peripheral stents" this may include:

  • Problems with the device or delivery system identified prior to implant
  • Difficulties experienced with the delivery system, deployment or placement of the implant
  • Structural deformation / damage e.g. fracture,  to the stent during deployment
  • Structural deformation / damage e.g. fracture, to the stent identified post procedure
  • Injury to patient vasculature / anatomy during or post deployment
  • Thrombus / blockage of stent
  • Migration / embolisation of the stent

Best Wishes

Dr Iain Robertson