CERENOVUS ENTERPRISE ENF403012Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886704075370), received between Oct 3, 2016 and Apr 9, 2026 — classified as 1 death, 10 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS EARLY DEPLOYMENT AT THE CATHETER HUB OF AN ENTERPRISE2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENF403012, LOT NUMBER: 9664724). ADDITIONAL EVENT INFORMATION RECEIVED ON 24-MAR-2026 INDICATED THAT THE STENT PREMATURELY DETACHED AND NO LONGER ENGAGED ON DELIVERY WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832824 ↗
• MalfunctionNov 7, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, A 4.0MM DIA X 30MM ENTERPRISE®2 (ENF403012 / 8994896) WAS USED, AND THE STENT WAS PREMATURELY DEPLOYED IN THE HUB OF THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 07-NOV-2025. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503599 ↗
• MalfunctionOct 15, 2025Activation Failure; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4MMX30MM ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 9508486) WAS ADVANCED TO THE TARGET POSITION AND STARTED TO RELEASE, BUT 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, 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 13-OCT-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 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. THE PROCEDURE WAS DELAYED BY FIVE MINUTES DUE TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281531 ↗
• MalfunctionSep 3, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 7469243) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE ORIGINAL MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-SEP-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 NOT PROLONGED /DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952491 ↗
• MalfunctionAug 19, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY, AN ENTERPRISE2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 9508485) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-AUG-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 PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840972 ↗
• MalfunctionAug 7, 2025Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 8878731) WAS ENCOUNTERED WITH SOME RESISTANCE DURING THE PROCESS OF DELIVERING IT TO MICROCATHETER. THE STENT WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT IT WAS FOUND THAT 3 DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED AS INTENDED. THE DOCTOR ONLY RETRACTED THE STENT ALONE, THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUL-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. 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. THE 10 MINUTES PROCEDURE PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737143 ↗
• MalfunctionJul 18, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TO A RIGHT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, AN ENTERPRISE2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 8907989) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 20 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-JUL-2025 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER WAS NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 20 MINUTES PROCEDURE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THE PRESENTED WITH AN ANEURYSM AT THE BIFURCATION OF THE RIGHT MIDDLE CEREBRAL ARTERY, AND M1 STENOSIS ON THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542008 ↗
• MalfunctionJun 24, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4MMX30MM ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 9123418) WAS IMPEDED IN THE MIDDLE SECTION 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 18-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. THE PROCEDURAL WAS DELAYED BY THREE MINUTES, RESULTING IN NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319156 ↗
• MalfunctionMay 15, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE 2 4MMX30MM VASCULAR RECONSTRUCTION DEVICE (ENCR403012, 7393958) BECAME IMPEDED IN THE 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 NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029608 ↗
• MalfunctionMay 12, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE 2 4MMX30MM INTRACRANIAL STENT (ENCR403012, 9262194) BECAME IMPEDED IN THE 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 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-MAY-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10-MINUTES PROCEDURE PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THE DELAY WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002534 ↗
• MalfunctionMar 19, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM INTRACRANIAL STENT (ENCR403012, 8907989) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31469833) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-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. THERE WAS NO PROCEDURE DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642400 ↗
• MalfunctionMar 17, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE DOCTOR OPENED THE DEVICE PACKAGING OF AN ENTERPRISE2 4MMX30MM INTRACRANIAL STENT (ENCR403012, 8799355) AND REMOVED THE DEVICE FROM DISPENSER HOOP, IT WAS FOUND THAT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619490 ↗
• MalfunctionJan 6, 2025Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM INTRACRANIAL STENT (ENCR403012, 8779788) PASSED THROUGH THE TIP OF A NON-J&J MICROCATHETER (MC). THE PHYSICIAN STARTED TO RELEASE THE STENT AND FOUND THAT 3 DISTAL MARKERS OF THE STENT CONVERGED AND THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079668 ↗
• MalfunctionOct 28, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM INTRACRANIAL STENT BECAME IMPEDED IN Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT BUT 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 REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-OCT-2024 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 EVENT WAS DELAYED BY 3 MINUTES DUE TO THE EVENT. THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545054 ↗
• MalfunctionSep 16, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM INTRACRANIAL STENT (ENCR403012, 8848352) BECAME IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO 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 20224901 ↗
• MalfunctionAug 22, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM INTRACRANIAL STENT (ENCR403012, 6610181) BECAME IMPEDED IN A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31211763) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES (BOTH OF OTHER BRAND) TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041203 ↗
• MalfunctionMay 28, 2024Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.0MM DIA X 30MM ENTERPRISE®2 (ENF403012 / 7178222) WAS PREMATURELY DEPLOYED IN THE HUB OF THE PROWLER SELECT PLUS MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19410974 ↗
• MalfunctionMay 15, 2023Retraction Problem; Retraction Problem

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, THE TIP OF AN ENTERPRISE2 4MMX23MM INTRACRANIAL STENT (ENF402312, 7507670) PRE-MATURELY DEPLOYED IN A PHENOM 21 OF MEDTRONIC MICROCATHETER (MC). THE STENT WAS LOST AS THE ASSISTANT TRIED TO SAVE IT FOR COMPLAINT REPORT. THE REST OF THE DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS. ON THE USER¿S SECOND TRY, THE PHYSICIAN EXPERIENCED RECAPTURE FAILURE WITH ENTERPRISE2 4MMX30MM (ENF403012, 6451023). THE USER TRIED TO RECAPTURE THE STENT BUT WAS NOT ABLE TO. THEREFORE, HE REMOVED THE STENT AND THE MC FROM THE PATIENT'S BODY. THE PHYSICIAN USED A SAME LIKE PRODUCT. EVENTUALLY THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16933765 ↗
• MalfunctionJan 12, 2023Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0MM DIA X 30MM ENTERPRISE®2 (ENF403012 / 7178222) WAS PRE-DEPLOYED OUT OF THE DISPENSER. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE. ONE (1) PHOTO OF THE COMPLAINT STENT COMPONENT WAS INCLUDED IN THE FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16152854 ↗
• MalfunctionSep 29, 2022Premature Activation; Retraction Problem; Activation Failure; Premature Activation; Retraction Problem; Activation Failure

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, A 4MM X 30MM ENTERPRISE2 INTRACRANIAL NEUROVASCULAR STENT (ENF403012, LOT UNKNOWN) FAILED TO BE RECAPTURED BEFORE 80% DEPLOYED. THEN TRIED AGAIN, BUT ALREADY DEPLOYED IN THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508501 ↗
• MalfunctionAug 30, 2022Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 6920544) ARRIVED AT THE TARGET POSITION AND THE PHYSICIAN TRIED TO RELEASE IT, BUT THE STENT COULD NOT BE OPENED. THE DOCTOR CHANGED TO A NEW 4MMX30MM ENTERPRISE 2 INTRACRANIAL NEUROVASCULAR STENT (ENCR403012, 6610181) BUT THE SAME ISSUE OCCURRED. THE THIRD STENT WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319436 ↗
• MalfunctionJun 27, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET AT THE INTERNAL CAROTID ARTERY (ICA), WHEN THE 4.0M DIA X 30MM ENTERPRISE®2 STENT (ENF403012 / 6451023) WAS ADVANCING THROUGH A PROWLER SELECT PLUS 45 DEGREE MICROCATHETER, STRONG RESISTANCE WAS ENCOUNTERED AT THE MICROCATHETER HUB. THE STENT WAS FULLY RETRACTED AND REMOVED WITHOUT REMOVING THE MICROCATHETER. THE STENT WAS REPLACED WITH ANOTHER 30MM ENTERPRISE. THE DEVICE WAS REPORTED TO BE WITHOUT DAMAGE. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2022, THE STENT WAS RETURNED SEPARATED FROM THE DELIVERY WIRE. THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION." ON (B)(6) 2022, CLARIFYING INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830341 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING CITATION WAS REVIEWED: ROH H, KIM J, SUH SI, KWON TH, YOON W. IS STENT-ASSISTED COIL EMBOLIZATION FOR THE TREATMENT OF RUPTURED BLOOD BLISTER-LIKE ANEURYSMS OF THE SUPRACLINOID INTERNAL CAROTID ARTERY EFFECTIVE? : AN ANALYSIS OF SINGLE INSTITUTIONAL EXPERIENCE WITH POOLED DATA. J KOREAN NEUROSURG SOC. 2021 MAR;64(2):217-228. DOI: 10.3340/JKNS.2020.0174. EPUB 2021 FEB 26. PMID: 33715324; PMCID: PMC7969050. OBJECTIVE AND METHODS: THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF STENT-ASSISTED COIL EMBOLIZATION (SAC) FOR THE TREATMENT OF RUPTURED BLOOD BLISTER-LIKE ANEURYSMS (BBAS) OF THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). A TOTAL OF 8 PATIENTS WITH RUPTURED BBAS WHO WERE TREATED BETWEEN JANUARY 2008 AND DECEMBER 2017 WERE ENROLLED IN THE STUDY. LOT NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: PROWLER SELECT PLUS MICROCATHETER. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 6 OR 7-F SHUTTLE GUIDING CATHETER; NEU

  Patient problems: Aneurysm

  MAUDE report 13515715 ↗
• MalfunctionJun 19, 2019Defective Component; Defective Component

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL, THAT DURING A PROCEDURE, AN ENTERPRISE2 STENT 4MMX30MM (ENF403012, 10933220) BROKE WITHIN THE MICROCATHETER. THERE WAS NO HARM REPORTED TO THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712324 ↗
• MalfunctionApr 2, 2019Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT ASSISTED COILING PROCEDURE, THE 4.0 MM DIA X 30 MM ENTERPRISE®2 STENT (ENF403012 / 11020342) WAS REPORTED AS PREMATURELY DEPLOYED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THE REPORTED EVENT. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474425 ↗