CERENOVUS ENTERPRISE ENF452812Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886704044031), received between Mar 6, 2017 and Sep 11, 2025 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (23 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD X 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9080734) WAS IMPEDED WHEN THE STENT PASSED A PROWLER SELECT PLUS 150/5CM MICROCATHETER TIP (606S255X, LOT UNKNOWN) A SHORT SECTION, AND COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE STENT INTO THE MICROCATHETER (MC) AND DELIVERED IT AGAIN, THE STENT HAD THE SAME ISSUE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-SEP-2025 INDICATED THAT NO DEVICE WAS USED TO APPLY TORQUE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027457 ↗
• MalfunctionSep 2, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9597728) WAS IMPEDED AT THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31557195) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937748 ↗
• MalfunctionAug 11, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9061878) WAS IMPEDED IN DISTAL END OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31567760) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE STENT; THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-AUG-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS NOT PROLONGED OR DELAYED BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770622 ↗
• MalfunctionAug 5, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22M VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9236678) WAS IMPEDED IN MICROCATHETER HUB AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A SECOND STENT. THE SECOND STENT, A 4.5X28MM VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9597728) ENCOUNTERED THE SAME ISSUE. THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE Y CONNECTOR. THE DOCTOR REMOVED THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31432567) FROM THE PATIENT AND SWITCHED TO A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 40 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUL-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. IT IS UNKNOWN IF THE 40 MINUTES PROCEDURE DELAY RESULTED IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716688 ↗
• MalfunctionAug 5, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4.5X28MM VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9584139) IMPEDED IN THE Y CONNECTOR AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN Y CONNECTOR. THE DOCTOR REMOVED THE Y CONNECTOR AND REMOVED THE STENT AND THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER (MC) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 31-JUL-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN). THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716413 ↗
• MalfunctionJul 17, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION, A 4.5X28MM 12 MM DW TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8640237) IMPEDED IN PROXIMAL OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS HALF RELEASED AUTOMATICALLY IN Y CONNECTOR AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE Y CONNECTOR. THE DOCTOR REMOVED THE MICROCATHETER (MC) AND STENT FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530189 ↗
• MalfunctionJul 15, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8697640) WAS IMPEDED IN THE MIDDLE SECTION OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE Y CONNECTOR. THE DOCTOR SWITCHED A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511545 ↗
• MalfunctionJun 16, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4.5X28MM DW TIP VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8645714) WAS IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT, AND SWITCHED A SECOND STENT, AN ENTERPRISE2 4.5X28MM DW TIP VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8640237) TO BE DELIVERED WITH THE SAME MICROCATHETER, BUT THE SECOND STENT HAD THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE SECOND STENT ALONE AND SWITCHED TO A THIRD STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-JUN-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. IT WAS NOTED THAT THERE WAS A PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT, HOWEVER, THERE WAS NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212214 ↗
• MalfunctionJun 16, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4.5X28MM DW TIP VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8645714) WAS IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT, AND SWITCHED A SECOND STENT, AN ENTERPRISE2 4.5X28MM DW TIP VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8640237) TO BE DELIVERED WITH THE SAME MICROCATHETER, BUT THE SECOND STENT HAD THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE SECOND STENT ALONE AND SWITCHED TO A THIRD STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-JUN-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. IT WAS NOTED THAT THERE WAS A PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT, HOWEVER, THERE WAS NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212067 ↗
• MalfunctionMar 25, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE INTRACRANIAL STENT (ENC452812, 9309015) BECAME IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31454975) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689497 ↗
• MalfunctionMar 12, 2025Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, 4.5X28MM ENTERPRISE INTRACRANIAL STENT (ENC452812, 8219112) PASSED THROUGH THE TIP OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, (B)(6)) AND DOCTOR STARTED TO RELEASE THE STENT. IT WAS FOUND THAT PARTIAL DISTAL MARKERS OF THE STENT WERE CONVERGED AND DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE DOCTOR ONLY RETRACTED THE STENT, THEN DELIVERED IT TO RELEASE THE STENT AGAIN, BUT IT WAS STILL UNABLE TO OPEN COMPLETELY. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-MAR-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NORMAL RESISTANCE DURING ADVANCEMENT OF THE DEVICE WITH THE MICROCATHETER. THERE WAS NO STENT DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS NO BLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585849 ↗
• MalfunctionMar 5, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE INTRACRANIAL STENT (ENC452812, 8878742) BECAME IMPEDED IN DISTAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR ONLY RETRACTED THE STENT, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER THE STENT WAS RETRACTED OUT FROM Y CONNECTOR. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-MAR-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER WAS A PROWLER SELECT PLUS (606S255X, 31359805). THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS DELAYS 2-2 MINUTES DUE TO THE EVENT. THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526444 ↗
• MalfunctionMar 5, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 8639207) BECAME IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31408911) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-MAR-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS DELAYS FOR APPROXIMATELY 5-10 MINUTES; THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526226 ↗
• MalfunctionJan 2, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AFTER A NON J&J MICROCATHETER (MC) WAS IN PLACE, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 9020416) PASSED THROUGH THE MICROCATHETER AND STARTED TO RELEASE. SUDDENLY, THE MICROCATHETER MIGRATED, THEN THE PHYSICIAN RETRACTED THE STENT INTO THE MICROCATHETER AND ADJUSTED THE MICROCATHETER POSITION. THE PHYSICIAN DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE STENT WAS IMPEDED AT THE TIP OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 20-DEC-2024 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WERE NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060104 ↗
• MalfunctionDec 12, 2024Premature Activation; Material Separation; Material Twisted/Bent; Premature Activation; Material Separation; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY PROCEDURE, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8639208) PASSED THROUGH THE TIP OF AN UNSPECIFIED MICROCATHETER AND STARTED TO RELEASE. THE PHYSICIAN OBSERVED THAT DISTAL TIP (DELIVERY WIRE) OF THE STENT WAS KINKED/BENT UNDER X-RAY. THE PHYSICIAN ONLY RETRACTED THE STENT, BUT THE STENT WAS DETACHED FROM THE DELIVERY WIRE PREMATURELY ON THE Y CONNECTOR. THE DOCTOR REMOVED THE STENT BODY FROM Y CONNECTOR FOR INSPECTION, BUT AT THIS TIME, THE KINKED/BENT SECTION OF DISTAL TIP (DELIVERY WIRE) BROKE IN TWO SEPARATE PIECES. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 20 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917759 ↗
• MalfunctionDec 2, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8878725) PASSED THROUGH AN UNSPECIFIED THE MICROCATHETER TIP, AND PHYSICIAN TRIED TO RELEASE THE STENT. IT WAS FOUND THAT 3 DISTAL MARKERS OF THE STENT CONVERGED AND THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN ONLY RETRACTED THE STENT AND THEN DELIVERED THE STENT AGAIN. AFTER THREE ATTEMPTS, THE STENT WAS STILL UNABLE TO OPEN COMPLETELY. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER (MC). THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. VESSEL OR ANEURYSM FACTORS CANNOT BE COMPLETELY RULED OUT AS BEING A CONTRIBUTED TO THE INCOMPLETE EXPANSION, BUT OPERATOR DESCRIBED VESSEL STATUS AS FINE. NO ADDITIONAL INTERVENTION WAS PERFORMED TO ATTEMPT TO EXPAND THE STENT. THE INCOMPLETE EXPANSION DID NOT RESULT IN STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820294 ↗
• MalfunctionNov 18, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8219132) BECAME IMPEDED IN THE PROXIMAL OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO RETRACT THE STENT BUT IT WAS RELEASED AUTOMATICALLY IN Y CONNECTOR. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DOCTOR REMOVED THE STENT AND REPLACED IT WITH A NEW STENT TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706226 ↗
• MalfunctionNov 8, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8546184) BECAME IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO MICROCATHETER. THE PHYSICIAN REMOVED THE STENT AND THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31211760) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 08-NOV-2024 INDICATING THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641086 ↗
• MalfunctionNov 8, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY PROCEDURE, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8697640) BECAME IMPEDED IN MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31342751) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640452 ↗
• InjuryOct 21, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8878736) PASSED THROUGH THE MICROCATHETER TIP OF A PROWLER SELECT PLUS 150/5CM, AND THE PHYSICIAN TRIED TO RELEASE THE STENT. IT WAS FOUND THAT 3 DISTAL MARKERS OF THE STENT CONVERGED AND THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (MC) WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-OCT-2024 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. NO ADDITIONAL INTERVENTION WAS PERFORMED TO ATTEMPT TO EXPAND THE STENT. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. THERE WAS A 10-MINUTE PROCEDURAL DELAY DUE TO THE EVENT, NOT CLINICALLY SIGNIFICANT. IT WAS NOTED THAT THERE WAS BLOOD FLOW RESTRICTION (PENDING FURTHER CLARIFICATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Transient Ischemic Attack

  MAUDE report 20493227 ↗
• MalfunctionOct 15, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8546184) BECAME IMPEDED AT THE DISTAL END OF A NON J&J MICROCATHETER (MC) AND COULD NOT ADVANCE TO PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449650 ↗
• MalfunctionOct 1, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8878736) BECAME IMPEDED IN THE PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31351019) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND REPLACED A SECOND MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (606S255X, 31352680) TO DELIVER THE SAME STENT, BUT THEY HAD THE SAME PROBLEM. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A SECOND STENT, AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 8640237) TO BE DELIVERED IN THE SECOND MICROCATHETER, BUT IT HAD THE SAME PROBLEM. THE PHYSICIAN REMOVED THE SECOND STENT AND THE SECOND MICROCATHETER FROM THE PATIENT, AND THEN DELIVER THE SECOND STENT WITH THE FIRST MICROCATHETER, THE SAME PROBLEM HAPPENED AGAIN. THE PHYSICIAN HAD TO REMOVE THE STENT AND MICROCATHETER TOGETHER FROM THE PATIENT AND SWITCH NEW DEVICES (BOTH NON J&J) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 45 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-SEP-2024 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347511 ↗
• MalfunctionOct 1, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8878736) BECAME IMPEDED IN THE PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31351019) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND REPLACED A SECOND MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (606S255X, 31352680) TO DELIVER THE SAME STENT, BUT THEY HAD THE SAME PROBLEM. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A SECOND STENT, AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 8640237) TO BE DELIVERED IN THE SECOND MICROCATHETER, BUT IT HAD THE SAME PROBLEM. THE PHYSICIAN REMOVED THE SECOND STENT AND THE SECOND MICROCATHETER FROM THE PATIENT, AND THEN DELIVER THE SECOND STENT WITH THE FIRST MICROCATHETER, THE SAME PROBLEM HAPPENED AGAIN. THE PHYSICIAN HAD TO REMOVE THE STENT AND MICROCATHETER TOGETHER FROM THE PATIENT AND SWITCH NEW DEVICES (BOTH NON J&J) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 45 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-SEP-2024 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346687 ↗
• MalfunctionSep 30, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452812, 8878736) BECAME IMPEDED IN PROXIMAL OF A NON J&J MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. BESIDES, THE STENT WAS FOUND TO BE DEPLOYED PREMATURELY IN MICROCATHETER. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM PATIENT BODY AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334486 ↗
• MalfunctionSep 16, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 8640237) WAS PLACED IN TARGET SITE AND TRIED TO RELEASE. THE 3 DISTAL MARKERS OF THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE UNSPECIFIED MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226042 ↗