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Medical Device

Dr. Parnell has been retained in medical device litigation cases that are in the news and in class actions. Products include Stents, Stent-Grafts, IVC Filters (Inferior Vena Cava Filters), Orthotics, Spinal Bracing, Surgical Bracing, Prosthetic Limbs, Orthopedic Devices, Intragastric Abdominal Balloon Weight Loss Systems, Back Pain Reduction Systems, Spinal Surgical Tools, and others.

PEC has significant Medical Device experience including both implantable (PMA) and non-implantable (510K) components.  We often apply nonlinear finite element analysis for design validation, design improvement, FDA regulatory submissions, and failure investigation.

Some example applications from earlier projects (see figures below) include:

  • Stents
  • Stent-grafts
  • Closure devices (arterial access for minimally invasive procedures; catheter access)
  • Surgical Clips, Ligation Clips, Ligature (minimally invasive)
  • Spinal devices; spinal surgical devices; spinal fixation
  • Orthopedic devices, foot & ankle staples, plates

Materials include Nitinol (shape memory alloy), Stainless Steel, MP35N, Titanium, Elgiloy, various polymers, and plastics.

AAA_StentGrafts_Dietrich-AAA_MultipleDevice AAA_StentGrafts_Dietrich-AAA_Ancure_CrossSection

multi_duo2         Palmaz-Schatz_Delivery_01



Heart_Elastomeric_Model_01      Heart_AHA_200     Atsina_Clip_Large_R0_Beam_Rad_NL_SS3_T0.00_Mesh

Stent_Artery_Refined1   Stent_Artery_Refined2

Parnell_IVS_Starclose_Medical_Materials_Nitinol_IVS_Starclose_TAB_110518 CrossRoads_Extremity_Nitinol_2015_ACFAS_Poster_150125-Final3
ACFAS_2015_Booth_IMG_0563 ACFAS_2015_Booth_IMG_0577
 CrossRoads Extremity Systems 
 Nitinol fixation devices for foot & ankle applications