inforMED
InjuryNOY

EMBOSPHERES MICROSPHERES

Received Jul 1, 2019 · Event occurred Jun 13, 2019

Report MW5087773 · MDR key 8755474

Device

Generic name

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Model number

S420GH

Catalog number

S420GH/A

Lot number

X1168511-5

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

65 YR

  • Abdominal Pain
  • Tachycardia
  • Thrombosis
  • Lethargy
  • Test Result
  • Abdominal Pain
  • Tachycardia
  • Thrombosis
  • Lethargy
  • Test Result

Narrative

Description of Event or Problem

SUBJECT REPORTED TO CLINIC FOR SCHEDULED RESEARCH VISIT. COMPLAINED OF ABDOMINAL PAIN, LETHARGY. HAD STOPPED TAKING LASIX AND ALDACTONE FOR "SEVERAL DAYS" BEFORE. WAS TACHYCARDIC (HR 118) WITH DECREASED NA, POTASSIUM AND INCREASED TOTAL BILIRUBIN. PT ADMITTED TO HOSP VIA ED. CT ABDOMEN SHOWED PORTAL VEIN AND SUPERIOR MESENTERIC VEIN THROMBOSIS. PUT ON ANTICOAGULANTS (HEPARIN). UNDERWENT THROMBOLYSIS ON (B)(6) 2019. ON CT ABD PELVIS FROM (B)(6) 2019, "UNCHANGED PORTAL AND SUPERIOR MESENTERIC VENOUS THROMBOSIS." REMAINS ADMITTED AT TIME OF REPORT.