CERENOVUS ENTERPRISE ENF401612Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10886704075332), received between Jan 17, 2019 and Sep 15, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (19 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776612 ↗
• MalfunctionMay 20, 2026Premature Activation

  IT WAS REPORTED THAT THE 4.0MM DIA X 16MM ENTERPRISE®2 (ENF401612 / 8302888) WAS PREMATURELY DEPLOYED WITHIN THE CATHETER HUB THEREFORE, RENDERED IT UNUSABLE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE STENT WAS PREMATURELY DETACHED AND WAS NO LONGER ON THE DELIVERY WIRE. THE INFORMATION CONFIRMED THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 12-MAY-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236313 ↗
• MalfunctionSep 17, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9508484) WAS IMPEDED IN INTRODUCER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ADDED A LITTLE FORCE, THE STENT WAS RELEASED AUTOMATICALLY, AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. 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 15-SEP-2025 INDICATED THAT EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE INTRODUCER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074347 ↗
• MalfunctionSep 16, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ENTERPRISE2 4MMX16MM (ENCR401612/ 92621920) STENT WAS IMPEDED IN Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, AND SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE DELIVERY WIRE IS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066744 ↗
• MalfunctionAug 28, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9368820) WAS IMPEDED IN DISTAL END OF MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF Y CONNECTOR. THE DOCTOR SWITCHED TO 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 22912465 ↗
• InjuryAug 21, 2025Material Twisted/Bent; Activation Failure; Migration; Material Twisted/Bent; Activation Failure; Migration

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX16MM (ENCR401612/ 8779795) AND PROWLER SELECT PLUS 150/5CM (606S255X/ 31359810) WERE USED FOR AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED INCOMPLETE EXPANSION, MIGRATION AND KINKED/BENT - IN PATIENT OF THE ENTERPRISE2 STENT, AND TRACKING DIFFICULTY OF THE PROWLER MICROCATHETER. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿INCOMPLETE EXPANSION & MIGRATION & IMPEDED & KINKED/BENT. IT WAS REPORTED THAT BEFORE PROCEDURE, DEVICE PACKAGE AND DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION. DURING THE PROCEDURE, AFTER FINISHING REMOVING THE THROMBUS, STENT WAS PLACED IN TARGET POSITION AND WAS RELEASED, AND THE MICROCATHETER WAS REMOVED FROM THE PATIENT. DOCTOR FOUND THAT DISTAL MARKERS OF THE STENT OPENED WELL, BUT 3 PROXIMAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED AS INTENDED. AND THE STENT MIGRATED TO THE DISTAL END OF BASILAR ARTERY. THE DOCTOR DELIVERED THE ORIGINAL MICROCATHETER IN PATIENT, THE ORIGINAL MICROCATHETER WAS IMPEDED IN V3-V4 SEGMENT OF VERTEBRAL ARTERY AND COULD NOT REACH THE TARGET SITE. THE DOCTOR REMOVED THE ORIGINAL MICROCATHETER FROM THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863211 ↗
• MalfunctionAug 7, 2025Premature Activation; Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE DOCTOR OPENED THE DEVICE PACKAGING OF AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9309018) AND REMOVED THE DEVICE FROM DISPENSER HOOP, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-JUL-2025 INDICATED THAT BESIDES THE REPORTED PREMATURE DETACHMENT, THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS ANOTHER ENTERPRISE2 4MMX16MM® VASCULAR RECONSTRUCTION DEVICE. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736997 ↗
• MalfunctionJul 1, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9275830) WAS IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND THEN DELIVERED IT AGAIN, THE STENT HAD THE SAME ISSUE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372938 ↗
• MalfunctionJun 30, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9080736) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NON J&J DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359772 ↗
• MalfunctionJun 23, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANGIOPLASTY, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 8219134) WAS IMPEDED IN Y CONNECTOR AND COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER (MC). 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 WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUN-2025 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM ( 606S255X, UNKNOWN LOT). THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307323 ↗
• MalfunctionJun 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4MMX16MM ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9166991) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE. WHEN THE STENT WAS ABOUT 50% RELEASED, IT WAS OBSERVED THAT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR RETRACTED THE STENT AND DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE DISTAL STENT MARKERS STILL FAILED TO OPEN. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19-JUN-2025 INDICATING 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 WAS NO ADDITIONAL INTERVENTION PERFORMED TO ATTEMPT TO EXPAND THE STENT. THE 15 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301756 ↗
• MalfunctionJun 12, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (ENCR401612, 9309018) 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 TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JUN-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. THERE WAS NO PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196773 ↗
• MalfunctionMay 5, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 9080736) BECAME IMPEDED IN THE PROXIMAL OF A 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 FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). DOCTOR REMOVED THE MICROCATHETER AND STENT 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959620 ↗
• MalfunctionApr 21, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE HEALTH CARE PROFESSIONAL, DURING THE USE OF AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENF401612, 8640232) PRE-MATURELY DEPLOYED OUT OF THE MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873313 ↗
• MalfunctionJan 8, 2025Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY, AN ENTERPRISE 2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8129980) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-JAN-2025 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 WAS 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 NO BLOOD FLOW RESTRICTION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103003 ↗
• MalfunctionJan 6, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8779787) BECAME IMPEDED WHEN THE STENT TIP PASSED THROUGH A PROWLER SELECT PLUS 150/5CM (606S255X, LOT UNKNOWN) TIP A SHORT SECTION, AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT, THEN SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-DEC-2024 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. THE 10 MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080209 ↗
• MalfunctionNov 5, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE PHYSICIAN OPENED THE DEVICE PACKAGING OF AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8997147) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-OCT-2024 INDICATED THAT THERE WAS NO PACKAGING ISSUE. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613839 ↗
• MalfunctionOct 17, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8645717) BECAME IMPEDED AT THE DISTAL END OF A MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN ONLY RETRACTED THE STENT, BUT THE STENT WAS RELEASED AUTOMATICALLY IN THE Y CONNECTOR. THE STENT BODY WAS FOUND TO BE SEPARATED PREMATURELY FROM DELIVERY WIRE. THE PHYSICIAN REMOVED THE STENT AND 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 09-OCT-2024 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A PROWLER SELECT MICROCATHETER (606S255X, LOT UNKNOWN). THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469934 ↗
• MalfunctionOct 15, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8907882) BECAME IMPEDED IN THE Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE STENT BUT THE STENT WAS RELEASED AUTOMATICALLY IN THE Y CONNECTOR AND THE STENT BODY WAS FOUND TO BE SEPARATED PREMATURELY FROM DELIVERY WIRE. THE PHYSICIAN REMOVED THE STENT AND PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) FROM THE PATIENT AND REPLACED WITH A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-OCT-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. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452459 ↗
• MalfunctionOct 15, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM (ENCR401612, 8878740) INTRACRANIAL STENT PASSED THROUGH THE MICROCATHETER TIP, AND THE PHYSICIAN RELEASED HALF OF 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 WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. 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 NO BLOOD FLOW RESTRICTION. THERE WAS NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449516 ↗
• MalfunctionOct 1, 2024Retraction Problem; Failure to Advance; Material Twisted/Bent; Retraction Problem; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX16MM (ENCR401612/8779787) AND A PROWLER SELECT PLUS 150/5CM (606S255X/31332484) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED MICROCATHETER - INADEQUATE SUPPORT AND OBSTRUCTION WHILE IN PATIENT WITH LOSS OF CEREBRAL TARGET POSITION, AND STENT - INABILITY TO RECAPTURE, IMPEDIMENT IN MICROCATHETER WITH LOSS OF CEREBRAL TARGET POSITION, AND KINKED/BENT WHILE IN PATIENT. THE EVENT WAS REPORTED AS SUCH, "MICROCATHETER MIGRATION & IMPEDED. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE STENT WAS PARTIALLY RELEASED BY THE PHYSICIAN, THE COIL WAS FILLED SUCCESSFULLY, THE PHYSICIAN FOUND THAT THE MICROCATHETER MIGRATED BACKWARDS AUTOMATICALLY. THE PHYSICIAN TRIED TO RETRACT THE STENT TO REPOSITION THE STENT, BUT THE STENT WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE RETRACTED. (THE STENT WAS NOT BEYOND THE RECAPTURE LIMIT POINT.) THE PHYSICIAN TRIED TO RELEASE THE STENT, BUT THE ATTEMPT STILL FAILED. EVENTUALLY THE PHYSICIAN HAD TO PULL BACK THE STENT WITH BIG FORCE AND REMOVED THE STENT AND MICROCATHETER TOGETHER FROM THE PATIENT. THE PHYSICIAN FOUND THAT THE STE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20345982 ↗
• MalfunctionSep 16, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8779787) BECAME IMPEDED IN Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT AND IT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-SEP-2024 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICES. THE MICROCATHETER DID NOT KINK/BENT. THE PROCEDURE WAS DELAYED BY 3 MINUTES DUE TO THE EVENT AND IT WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225419 ↗
• MalfunctionSep 9, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8137623) BECAME IMPEDED IN THE DISTAL END OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31028212) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED THEM WITH A NEW STENT AND A NEW MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170064 ↗
• MalfunctionSep 6, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8779795) BECAME IMPEDED IN Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT AND IT WAS PARTIALLY RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN 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 02-SEP-2024 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. NO OTHER DEVICES WERE USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160255 ↗
• MalfunctionSep 4, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 8846293) BECAME IMPEDED AT 1/3 OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31309382) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN TRIED TO RETRACT THE STENT, BUT THE STENT BODY WAS FOUND TO BE SEPARATED PREMATURELY FROM DELIVERY WIRE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND REPLACED THEM WITH A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MC DID NOT KINK OR BEND. THE UNSPECIFIED MICO-WIRE WAS SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE 10 MINUTES SURGERY PROLONGATION WAS NOT CLINICALLY SIGNIFICANT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136595 ↗