HyperSoft Advanced 8510-0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811425027738), received between Jun 2, 2017 and Jun 2, 2017 — classified as 4 deaths.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED ON AN UNRUPTURED ACOM ANEURYSM. THE PATIENT WAS ANTICOAGULATED PRIOR TO THE PROCEDURE WITH ASPIRIN, PLAVIX, AND HEPARIN. THE LVIS JR. STENT WAS SUCCESSFULLY DEPLOYED WITHOUT DIFFICULTY ACROSS THE NECK AND SEVEN (7) COILS WERE PLACED IN THE ANEURYSM. AFTER THE FINAL COIL WAS PLACED, CONTRAST EXTRAVASATION FROM THE DOME OF THE ANEURYSM WAS NOTED. THE HEMORRHAGE STOPPED TEMPORARILY, BUT WHEN THE MICROCATHETER WAS WITHDRAWN, THE BLEEDING CONTINUED. PROTAMINE WAS ADMINISTERED. BALLOON INFLATIONS WERE PERFORMED IN THE BILATERAL ACAS AND THE BLEEDING STOPPED; HOWEVER, UPON DEFLATION OF THE BALLOONS, THE EXTRAVASATION CONTINUED. ULTIMATELY, THE PATIENT'S INTRACRANIAL PRESSURE ROSE AND HER CONDITION DETERIORATED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT DIED. THE SURGEON STATED THAT THE STENT DID NOT CAUSE THE ANEURYSM RUPTURE, AND ALSO STATED THAT "THE CAUSE OF THE RUPTURE WAS COIL PROTRUSION THROUGH THE DOME OF THE ANEURYSM. THE PATIENT WAS ON ASPIRIN, PLAVIX, AND HEPARIN. DESPITE ATTEMPTS TO ARREST FLOW WITH 2 BALLOONS, THE BLEEDING DID NOT STOP."

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 6610129 ↗
• DeathJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED ON AN UNRUPTURED ACOM ANEURYSM. THE PATIENT WAS ANTICOAGULATED PRIOR TO THE PROCEDURE WITH ASPIRIN, PLAVIX, AND HEPARIN. THE LVIS JR. STENT WAS SUCCESSFULLY DEPLOYED WITHOUT DIFFICULTY ACROSS THE NECK AND SEVEN (7) COILS WERE PLACED IN THE ANEURYSM. AFTER THE FINAL COIL WAS PLACED, CONTRAST EXTRAVASATION FROM THE DOME OF THE ANEURYSM WAS NOTED. THE HEMORRHAGE STOPPED TEMPORARILY, BUT WHEN THE MICROCATHETER WAS WITHDRAWN, THE BLEEDING CONTINUED. PROTAMINE WAS ADMINISTERED. BALLOON INFLATIONS WERE PERFORMED IN THE BILATERAL ACAS AND THE BLEEDING STOPPED; HOWEVER, UPON DEFLATION OF THE BALLOONS, THE EXTRAVASATION CONTINUED. ULTIMATELY, THE PATIENT'S INTRACRANIAL PRESSURE ROSE AND HER CONDITION DETERIORATED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT DIED. THE SURGEON STATED THAT THE STENT DID NOT CAUSE THE ANEURYSM RUPTURE, AND ALSO STATED THAT "THE CAUSE OF THE RUPTURE WAS COIL PROTRUSION THROUGH THE DOME OF THE ANEURYSM. THE PATIENT WAS ON ASPIRIN, PLAVIX, AND HEPARIN. DESPITE ATTEMPTS TO ARREST FLOW WITH 2 BALLOONS, THE BLEEDING DID NOT STOP."

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 6610125 ↗
• DeathJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED ON AN UNRUPTURED ACOM ANEURYSM. THE PATIENT WAS ANTICOAGULATED PRIOR TO THE PROCEDURE WITH ASPIRIN, PLAVIX, AND HEPARIN. THE LVIS JR. STENT WAS SUCCESSFULLY DEPLOYED WITHOUT DIFFICULTY ACROSS THE NECK AND SEVEN (7) COILS WERE PLACED IN THE ANEURYSM. AFTER THE FINAL COIL WAS PLACED, CONTRAST EXTRAVASATION FROM THE DOME OF THE ANEURYSM WAS NOTED. THE HEMORRHAGE STOPPED TEMPORARILY, BUT WHEN THE MICROCATHETER WAS WITHDRAWN, THE BLEEDING CONTINUED. PROTAMINE WAS ADMINISTERED. BALLOON INFLATIONS WERE PERFORMED IN THE BILATERAL ACAS AND THE BLEEDING STOPPED; HOWEVER, UPON DEFLATION OF THE BALLOONS, THE EXTRAVASATION CONTINUED. ULTIMATELY, THE PATIENT'S INTRACRANIAL PRESSURE ROSE AND HER CONDITION DETERIORATED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT DIED. THE SURGEON STATED THAT THE STENT DID NOT CAUSE THE ANEURYSM RUPTURE, AND ALSO STATED THAT "THE CAUSE OF THE RUPTURE WAS COIL PROTRUSION THROUGH THE DOME OF THE ANEURYSM. THE PATIENT WAS ON ASPIRIN, PLAVIX, AND HEPARIN. DESPITE ATTEMPTS TO ARREST FLOW WITH 2 BALLOONS, THE BLEEDING DID NOT STOP."

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 6609890 ↗
• DeathJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED ON AN UNRUPTURED ACOM ANEURYSM. THE PATIENT WAS ANTICOAGULATED PRIOR TO THE PROCEDURE WITH ASPIRIN, PLAVIX, AND HEPARIN. THE LVIS JR. STENT WAS SUCCESSFULLY DEPLOYED WITHOUT DIFFICULTY ACROSS THE NECK AND SEVEN (7) COILS WERE PLACED IN THE ANEURYSM. AFTER THE FINAL COIL WAS PLACED, CONTRAST EXTRAVASATION FROM THE DOME OF THE ANEURYSM WAS NOTED. THE HEMORRHAGE STOPPED TEMPORARILY, BUT WHEN THE MICROCATHETER WAS WITHDRAWN, THE BLEEDING CONTINUED. PROTAMINE WAS ADMINISTERED. BALLOON INFLATIONS WERE PERFORMED IN THE BILATERAL ACAS AND THE BLEEDING STOPPED; HOWEVER, UPON DEFLATION OF THE BALLOONS, THE EXTRAVASATION CONTINUED. ULTIMATELY, THE PATIENT'S INTRACRANIAL PRESSURE ROSE AND HER CONDITION DETERIORATED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT DIED. THE SURGEON STATED THAT THE STENT DID NOT CAUSE THE ANEURYSM RUPTURE, AND ALSO STATED THAT "THE CAUSE OF THE RUPTURE WAS COIL PROTRUSION THROUGH THE DOME OF THE ANEURYSM. THE PATIENT WAS ON ASPIRIN, PLAVIX, AND HEPARIN. DESPITE ATTEMPTS TO ARREST FLOW WITH 2 BALLOONS, THE BLEEDING DID NOT STOP."

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 6609888 ↗