MAUDE manufacturer profile

W. L. GORE & ASSOCIATES, INC. · PFV

MAUDE profile for System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Key facts

Manufacturer W. L. GORE & ASSOCIATES, INC.
Manufacturer group MEDICAL ECHO RIDGE B/P
Product code PFV
Product code name System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Occlusion, Activation Failure, Complete Blockage, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Patient-Device Incompatibility Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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