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OtherNQH

ENDOSURE S2 PRESSURE MEASUREMENT SYSTEM

Received Apr 22, 2009 · Event occurred Mar 23, 2009

Report 3004936110-2009-00001 · MDR key 1368453

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Catalog number

S2-2080

Product problems

  • Migration or Expulsion of Device

Patient

70 YR

  • Tissue Damage

Narrative

Description of Event or Problem

THE PATIENT PRESENTED WITH SMALL ILIAC ARTERIES WITH CALCIFICATION. THE SENSOR WAS IMPLANTED WITHOUT AN ISSUE. THE STENT GRAFT WAS DEPLOYED WHICH RESULTED IN RELOCATION OF THE SENSOR TO THE RIGHT ILIAC ARTERY. SINCE THE LOCATION OF THE SENSOR HAD CHANGED FROM THE ORIGINAL, OPTIMAL LOCATION, THE SURGEON DECIDED TO REMOVE THE SENSOR AND STENT GRAFT SHEATH. UPON REMOVAL OF BOTH THE SENSOR AND STENT GRAFT SHEATH, A DAMAGED PORTION OF THE ILIAC ARTERY WAS ALSO REMOVED. THE SURGEON REPAIRED THE ILIAC ARTERY AND ANEURYSM WITHOUT INCIDENT. THE PATIENT RECOVERED FROM THE ANEURYSM SURGERY AND WAS DISCHARGED.