CERENOVUS ENTERPRISE ENF402312Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10886704075356), received between Sep 27, 2016 and May 20, 2026 — classified as 1 death, 17 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (38 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Premature Activation

  IT WAS REPORTED THAT THE 4.0MM DIA X 23MM ENTERPRISE®2 (ENF402312 / 10021142) WAS PREMATURELY DEPLOYED AT THE HUB AND SLIPPED OUT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 12-MAY-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 25232265 ↗
• MalfunctionApr 7, 2026Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0MM DIA X 23MM ENTERPRISE®2 (ENF402312 / 9584147) DEPLOYED EARLY. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, DURING THE DEVICE PREPARATION, THE STENT COMPONENT BECAME PREMATURELY DETACHED AND WAS NO LONGER ENGAGED / ATTACHED TO THE DELIVERY WIRE. THE TIP OF THE INTRODUCER CORRECTLY FIT INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND THE HUB OF THE MICROCATHETER. THE INTRODUCER WAS SECURELY PLACED IN THE HUB PRIOR TO THE ATTEMPT TO ADVANCE THE DELIVERY WIRE. THERE WAS NO DAMAGE NOTED ON THE ASSOCIATED MICROCATHETER. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 26-MAR-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 24806109 ↗
• MalfunctionMar 19, 2026Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE STENT COMPONENT OF THE 4.0MM DIA X 23MM ENTERPRISE® 2 (ENF402312 / LOT# UNKNOWN) WAS PREMATURELY SEPARATED FROM THE DELIVERY WIRE IN THE INTRODUCER SHEATH. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOT NUMBER OF THE 4.0MM DIA X 23MM ENTERPRISE® 2 (ENF402312) WAS 9854676. THE REPLACEMENT DEVICE WAS ANOTHER 4.0MM DIA X 23MM ENTERPRISE® 2 (ENF402312). THERE WAS NO NEGATIVE PATIENT IMPACT. ALL OTHER INFORMATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640665 ↗
• MalfunctionOct 15, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4 MM X 23 MM ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9493891) WAS IMPEDED IN THE MICROCATHETER HUB OF A PROWLER SELECT PLUS 150/5 CM MICROCATHETER (606S255X, 31561630) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A SECOND STENT, THE SECOND STENT WAS WITH THE SAME ISSUE. THE DOCTOR REMOVED THE SECOND STENT AND MICROCATHETER (MC) FROM THE PATIENT AND FOUND THE SECTION NEAR THE MICROCATHETER HUB WAS KINKED/BENT. THE DOCTOR SWITCHED TO A SECOND NEW MICROCATHETER TO DELIVER THE ORIGINAL SECOND STENT TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. THE OUTER PACKAGING AND THE DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291111 ↗
• InjurySep 18, 2025Premature Activation; Activation Failure; Premature Activation; Activation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT ENTERPRISE2 4MMX23MM (ENCR402312/ LOT: 9518157) AND PROWLER SELECT PLUS 150/5CM (606S255X/ 31351022) WERE USED FOR A VASCULAR STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED INCOMPLETE EXPANSION AND PREMATURE DETACHMENT OF THE ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿UNABLE TO OPEN & PREMATURE DETACHMENT. IT WAS REPORTED THAT DURING PROCEDURE, STENT WAS DELIVERED TO M1 SEGMENT OF MIDDLE CEREBRAL ARTERY FOR RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. DOCTOR RETRACTED THE STENT AND MICROCATHETER, THE STENT WAS DETACHED FROM THE DELIVERY WIRE DURING WITHDRAWAL, THE STENT REMAINED IN THE C3 SEGMENT OF INTERNAL CAROTID ARTERY. AFTER THE DOCTOR USED THE MICRO GUIDEWIRE TO MASSAGE THE STENT, THE STENT MARKERS EXPANDED WELL. THE DOCTOR RAISED THE MICROCATHETER TO TARGET POSITION AND DELIVERED A SECOND STENT, THEN RELEASED IT IN THE TARGET POSITION. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES.¿ NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-SEP-2025. SUMMARY: IT WAS REPORTED THAT THE TEMPERATURE INDICATOR LABEL O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085881 ↗
• MalfunctionAug 27, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 7660535) WAS IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND THE STENT FROM THE PATIENT. IT WAS FOUND THAT THE TIP OF STENT DELIVERY WIRE AND THE DISTAL END OF THE MICROCATHETER WERE KINKED/BENT. THE DOCTOR SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE PACKAGES AND DEVICES WERE INSPECTED IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-AUG-2025 INDICATED THAT THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904384 ↗
• MalfunctionAug 25, 2025Activation Failure; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9568625) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE. HOWEVER, THE DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR ONLY RETRACTED THE STENT ALONE, THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-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 THE 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 NOT DELAYED/PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886045 ↗
• MalfunctionAug 18, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING PROCEDURE, THE ENTERPRISE2 4 MM X 23 MM (ENCR402312/7682991) STENT WAS IMPEDED IN THE PROWLER SELECT PLUS MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION STATES THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE DELIVERY WIRE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828866 ↗
• MalfunctionAug 11, 2025Activation Failure; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9518158) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE. IT WAS FOUND THAT 3 DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED AS INTENDED. THE DOCTOR RETRACTED THE STENT AND DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE DISTAL STENT MARKERS STILL FAILED TO OPEN COMPLETELY. THE DOCTOR REMOVED THE STENT AND THE PROWLER SELECT PLUS 150/5CM (606S255X, LOT UNKNOWN) MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY WITH THE ORIGINAL MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-JUL-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 THE 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 MIGRAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22775637 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA HEALTH AUTHORITY, THAT AN ENTERPRISE2 4MMX23MM (ENCR402312/ 9095777) WAS USED FOR AN ANGIOPLASTY PROCEDURE FOR A PATIENT WITH SEVERE STENOSIS OF THE V4 SEGMENT OF THE LEFT VERTEBRAL ARTERY. APPROXIMATELY SIX HOURS AFTER THE PROCEDURE, ON THE SAME DAY, THE PATIENT DEVELOPED SLURRED SPEECH AND RIGHT LIMB WEAKNESS. A REEXAMINATION WITH HEAD CT SHOWED NO EVIDENCE OF A HEMORRHAGE. HOWEVER, A THROMBUS, INVOLVING THE PONS PERFORATOR ARTERY, WAS SUSPECTED. SYSTEMIC HEPARINIZATION AND INTENSIVE ANTITHROMBOTIC THERAPY WITH TEICOPLANIN WERE RECOMMENDED, AND AFTER DISCUSSING WITH THE AFFECTED PARTY, THE PATIENT CONSENTED TO THIS TREATMENT. HOWEVER, THE PATIENT'S RIGHT LIMB WEAKNESS GRADUALLY WORSENED. SUBSEQUENTLY, CRANIAL MRI WAS PERFORMED, AND TEICOPLANIN WAS DISCONTINUED. BEDSIDE REHABILITATION WAS INITIATED, LOW-DOSE STEROIDS WERE ADMINISTERED TO REDUCE EDEMA, AND CLOSE OBSERVATION WAS MAINTAINED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿POST-OP THROMBUS. THIS CASE IS FROM THE HEALTH AUTHORITY. THE PATIENT HAD THE SURGERY OF IMPLANTING THE STENT. THE OPERATION ENDED AT 10:00. AT ABOUT 16:00 OF THE SURGERY DAY, THE PATIENT HAD SLURRED SPEECH AND WEAKNESS OF RIGHT LIMB

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus; Unspecified Nervous System Problem

  MAUDE report 22771976 ↗
• MalfunctionAug 7, 2025Premature Activation; Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO USE, THE DOCTOR OPENED THE DEVICE PACKAGING OF AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9061888) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. THE STENT WAS 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 24-JUL-2025 INDICATED THAT THERE WAS NO OTHER PHYSICAL DAMAGE TO THE DEVICE BESIDES THE REPORTED PREMATURE DETACHMENT. THE REPLACEMENT STENT WAS ANOTHER ENTERPRISE2 4MMX23MM® 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 22737199 ↗
• MalfunctionAug 6, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9104194) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31289217) 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. THE SURGERY WAS PROLONGED BY ABOUT 20 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUL-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. AFTER REMOVAL OF THE MICROCATHETER, IN VITRO OBSERVATION REVEALED PARTIAL BENDING AND DEFORMATION AT THE MIDDLE SITE. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 20 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730116 ↗
• MalfunctionAug 6, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN OPENED THE PACKAGING OF THE ENTERPRISE2 4MMX23MM (ENCR402312, 9061791) AND REMOVED THE DEVICE FROM DISPENSER HOOP, IT WAS FOUND THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE PATIENT. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-AUG-2025 INDICATED THAT BESIDES THE REPORTED PREMATURE DETACHMENT, THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM APPEAR DAMAGED. THE REPLACEMENT STENT WAS ANOTHER ENTERPRISE2 4MMX23MM® 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 22728548 ↗
• MalfunctionAug 5, 2025Activation Failure; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9061883) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, IT WAS FOUND THAT 3 DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED OR EXPANDED AS INTENDED. THE DOCTOR RETRACTED THE STENT AND DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE DISTAL STENT MARKERS STILL FAILED TO OPEN COMPLETELY. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT, THEN SWITCHED TO A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716034 ↗
• MalfunctionAug 5, 2025Premature Activation; Stretched; Failure to Advance; Premature Activation; Stretched; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9392925) WAS IMPEDED IN THE MIDDLE OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, IT WAS FOUND THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC) AND THE DELIVERY WIRE OF THE STENT WAS UNRAVELED/STRETCHED. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUL-2025 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 PROCEDURE WAS PROLONGED WITHIN FIVE MINUTES WITH NO RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714106 ↗
• MalfunctionAug 4, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCESS OF DELIVERING THE ENTERPRISE2 4MMX23MM (ENCR402312, 9403138), THE STENT COMPONENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE Y-CONNECTOR. THE PHYSICIAN REMOVED THE Y-CONNECTOR AND STENT. THE STENT WAS SWITCHED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED. ON 24-JUL-2025, ADDITIONAL EVENT INFORMATION INDICATED THAT NO RESISTANCE WAS FELT. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM. NO PROCEDURE PROLONGATION NOR CONSEQUENCES FOR PROCEDURE PROLONGATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701274 ↗
• MalfunctionAug 4, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE ( ENCR402312, 9403138) WAS IMPEDED IN THE MIDDLE OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER ( 606S255X, LOT UNKNOW) 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 SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-JUL-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 PROLONGED WITHIN A FIVE MINUTES EXTENSION DUE TO THE EVENT RESULTING WITH NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700426 ↗
• MalfunctionJul 23, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9236682) WAS 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 FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUL-2025 INDICATED THAT NO TORQUE DEVICE WAS USED. 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 22578031 ↗
• MalfunctionJul 16, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, (B)(6)) WAS IMPEDED IN THE PROWLER SELECT PLUS 150/5CM MICROCATHETER HUB (606S255X, (B)(6)) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522699 ↗
• MalfunctionJul 7, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9104195) WAS IMPEDED IN THE Y CONNECTOR AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE Y CONNECTOR. THE DOCTOR REMOVED THEY 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 07-JUL-2025 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, UNKNOWN LOT). THE MICROCATHETER DID NOT KINK/BENT. THERE WAS A PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT, HOWEVER, THE DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22415420 ↗
• MalfunctionJul 7, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, THE DELIVERY WIRE TIP OF AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9477854) PASSED THROUGH THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) BUT THE STENT WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413243 ↗
• MalfunctionJul 7, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9426817) WAS IMPEDED IN DISTAL END OF A NON J&J MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR SWITCHED NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412136 ↗
• MalfunctionJul 2, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY, AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9477853) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANYMORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER (MC). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385693 ↗
• MalfunctionJul 1, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY AN ENTERPRISE2 4MMX23MM VASCULAR RECONSTRUCTION DEVICE (ENCR402312, 9368823) WAS IMPEDED IN THE DISTAL END OF A NON J&J MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO SECOND MICROCATHETER TO DELIVER THE SAME STENT, BUT THE STENT WAS WITH THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED A SECOND NEW STENT TO COMPLETE THE PROCEDURE. THE SECOND MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) WAS ALSO USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372595 ↗
• MalfunctionJun 30, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX23MM (ENCR402312/ 9368823) WAS USED FOR A COILING ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANEURISM. DURING THE PROCEDURE, THE STENT WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT. AFTER COMPLETING THE FILLING OF THE ANEURYSM AND DETACHMENT OF THE COIL IN THE ANEURYSM, THE DOCTOR GAVE UP STENT IMPLANTATION AND FINALIZED THE SURGERY. THERE WAS NO REPORT OF PATIENT INJURY. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿IMPEDED IN MICROCATHETER. IT WAS REPORTED THAT DURING PROCEDURE, STENT WAS IMPEDED IN DISTAL END OF MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT. AFTER FINISHING THE FILLING OF THE ANEURYSM AND DETACHMENT OF THE COIL IN THE ANEURYSM, THE DOCTOR GAVE UP STENT IMPLANTATION AND COMPLETED THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.¿ NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364963 ↗