CERENOVUS ENTERPRISE ENF402300Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10886704075363), received between Nov 1, 2016 and Apr 27, 2026 — classified as 2 deaths, 5 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (27 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENF402300, LOT NUMBER: UNKNOWN) WAS SEPARATED FROM THE WIRE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002199 ↗
• MalfunctionApr 10, 2026Failure to Advance

  IT WAS REPORTED THAT THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING ENTERPRISE2 4MMX23MM NO TIP (ENF402300/ 9508489) THROUGH THE HUB OF AN UNSPECIFIED MICROCATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845464 ↗
• MalfunctionMar 10, 2026Material Separation

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT THE STENT AND WIRE WERE OF AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENF402300, LOT NUMBER: UNKNOWN) WERE SEPARATED INSIDE THE ENCLOSED SHEATH, AND ONLY THE WIRE SLIPPED OUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559023 ↗
• MalfunctionDec 22, 2025Premature Activation; Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE ENF402300, LOT NUMBER 9508489) PREMATURELY DEPLOYED OUT TO DISPENSER. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863113 ↗
• MalfunctionDec 9, 2025Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE WIRE ON THE 4.0MM DIA X 23MM WITH NO TIP ENTERPRISE® 2 (ENF402300 / 8640233) WAS BROKEN BEFORE THE DEVICE WAS USED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764318 ↗
• MalfunctionSep 17, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4 MM X 23 MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9368821) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31471121) 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 10-SEP-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THE MICROCATHETER WAS 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 23073123 ↗
• MalfunctionAug 27, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.0MM DIA X 23MM WITH NO TIP ENTERPRISE® 2 (ENF402300 / 9061894) WAS STUCK IN THE MIDDLE OF THE CONCOMITANT PHENOM¿ 21 MICROCATHETER (MEDTRONIC). THE PHYSICIAN SAFELY REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED THE DEVICES TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906570 ↗
• MalfunctionAug 11, 2025Product Quality Problem; Component Missing; Product Quality Problem; Component Missing

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 8997148) WAS NOT VISUALIZED UNDER THE IMAGE AFTER IT WAS DELIVERED TO THE DISTAL END OF MICROCATHETER (THE STENT DID NOT PASS THROUGH THE MICROCATHETER). THE DOCTOR ONLY RETRACTED THE STENT ALONE, AND THE STENT BODY WAS NOTED TO BE ABSENT FROM THE STENT DELIVERY SYSTEM. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUL-2025 INDICATED THAT IT IS POSSIBLE THAT THE STENT WAS NOT VISIBLE DUE TO INADEQUATE RADIOPACITY. THE STENT DID NOT PREMATURELY DETACH INADVERTENTLY. THERE WAS NO DAMAGE TO THE PACKAGING, OR ANY DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM THE DISPENSER. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772320 ↗
• MalfunctionAug 11, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 8697563) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31459271) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE Y CONNECTOR. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770816 ↗
• MalfunctionAug 4, 2025Activation Failure; Activation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 8470639) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. 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 EVENT INFORMATION RECEIVED ON 25-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. THERE WAS ¿SLIGHT TORTUOSITY AND VESSEL CALCIFICATION¿. 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 PROCEDURE DELAYED/PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701510 ↗
• MalfunctionJul 18, 2025Difficult to Advance; Activation Failure; Migration; Difficult to Advance; Activation Failure; Migration

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 8891120) WAS PLACED IN THE TARGET SITE AND TRIED TO RELEASE. DURING THE PROCESS OF RELEASING THE STENT, THE DISTAL END OF THE STENT MIGRATED TO PROXIMAL END AUTOMATICALLY ALONG WITH THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN). THE DOCTOR RETRACTED THE STENT BACK TO THE MICROCATHETER (MC) AND THEN DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT, THEN SWITCHED TO A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-JUL-2025 INDICATED THAT AN UNSPECIFIED LEFT VESSEL WAS BEING TREATED. THE ENTERPRISE STENT LENGTH SELECTED WAS AT LEAST 10MM LONGER THAN THE ANEURYSM NECK TO MAINTAIN A MINIMUM OF 5MM ON EITHER SIDE OF THE ANEURYSM NECK. THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE EVENT. THERE WAS RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541587 ↗
• MalfunctionJul 16, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 8470639) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31289210) 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522027 ↗
• MalfunctionJun 24, 2025Fracture; Failure to Advance; Material Twisted/Bent; Fracture; Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9392923) WAS IMPEDED IN THE PROXIMAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, AND IT WAS FOUND THAT DELIVERY WIRE WAS KINKED/BENT. 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 16-JUN-2025 INDICATED THAT THE MICROCATHETER USED WAS A WAS PROWLER SELECT PLUS (606S255X, UNKNOWN LOT). A MICRO GUIDE WIRE WAS PASSED THROUGH MICROCATHETER SUCCESSFULLY. THERE WAS VESSEL TORTUOSITY. IT WAS NOTED THAT THERE WAS A BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT, SUCH AS CRACKING OR FRACTURE. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. UPON IN-VITRO INSPECTION, IT WAS NOTED THAT THE PUSHER WAS BENT. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318822 ↗
• InjuryJun 17, 2025Activation Failure; Activation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9391498) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR REMOVE THE STENT AND THE PROWLER SELECT MICROCATHETER (MC21160C2, 31301011) FROM THE PATIENT, THEN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO REPORTED ALLEGED PRODUCT MALFUNCTION WITH THE MICROCATHETER.

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

  MAUDE report 22234733 ↗
• MalfunctionJun 16, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4X23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9095775) IMPEDED IN PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31365451) AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER (MC) AND STENT FROM THE PATIENT AND SWITCHED TO 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 22213049 ↗
• MalfunctionJun 16, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX23MM NO TIP (ENCR402300/ 9392923) AND A PROWLER SELECT PLUS 150/5CM (606S255X/ 31492230) WERE USED FOR AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED STENT IMPEDIMENT IN THE MICROCATHETER WITH LOSS OF CEREBRAL TARGET POSITION AND PREMATURE DETACHMENT IN THE MICROCATHETER. THIS EVENT OCCURRED AFTER USING A BALLOON CATHETER (COMPETITOR BRAND) FOR BALLOON DILATATION. THE STENT WAS IMPEDED IN PROXIMAL OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND GAVE UP STENT IMPLANTATION AND COMPLETED THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. THERE WAS NO REPORT OF A SURGICAL DELAY RESULTING FROM THE EVENT. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211474 ↗
• MalfunctionMay 27, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANEURYSM COILING), THE PHYSICIAN TRIED TO DEPLOY AN ENTERPRISE2 4MMX23MM NO TIP INTRACRANIAL STENT (ENC402300, 9166989) THROUGH A PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE, LOT NUMBER) IN A COMMUNICATING ARTERY ANEURYSM. THEY KEPT THE SHEATH IN THE HUB AND TRIED TO ADVANCE THE STENT AFTER SEEING THE FLUSH DROPS AT THE PROXIMAL END OF THE SHEATH, BUT THE DOCTOR FACED SEVERE RESISTANCE WHILE ADVANCING THROUGH MIDWAY. THEN, THE DOCTOR DECIDED TO PULL THE STENT BACK AND FOUND THE STENT STUCK IN THE HUB OF THE MICROCATHETER (MC). THE DOCTOR REMOVED BOTH THE DEVICES AND FINISHED THE CASE WITH ANOTHER PROWLER SELECT PLUS AND ANOTHER ENTERPRISE STENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 21-MAY-2025 INDICATING 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 WAS NO PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089904 ↗
• MalfunctionMay 21, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE LEFT MAIN CORONARY ARTERY (LMCA), A NON J&J MICROCATHETER WAS PLACED AND A GALAXY G3 MINI 2MM X 6CM COIL (GLM920060, 31136265) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TWO NEW COILS CONSECUTIVELY, A GALAXY G3 MINI 1MM X 1CM COIL (GLM910010, 30889337) AND A GALAXY G3 4MM X 7CM (GLY120407, 3162410S). HOWEVER, BOTH COILS HAD THE SAME ISSUE. THE DOCTOR SWITCHED TO A FOURTH COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED AT ALL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-MAY-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED WITH ALL INVOLVED COILS. THE SAME DETACHMENT CONTROL BOX (DCB) AND THE SAME CABLE WERE USED SUCCESSFULLY WITH THE FOURTH COIL. NO NECK REMODELING WAS UTILIZED. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE TO THE COILS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT, RESULTING IN NO PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065317 ↗
• MalfunctionMay 19, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9095776) 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 TO 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 22043988 ↗
• MalfunctionMay 15, 2025Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, PRIOR TO USE, THE DOCTOR OPENED PACKAGING OF AN ENTERPRISE2 4MMX23MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR402300, 9426816) 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 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-MAY-2025 INDICATED THAT THERE WAS NO PHYSICAL DAMAGE NOTED ON THE STENT/STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS ANOTHER 4MMX23MML ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029122 ↗
• MalfunctionMay 12, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING PROCEDURE, THE ENTERPRISE2 4MMX23MM NO TIP (ENCR402300/9246447) WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED INTO MICROCATHETER. THE PHYSICIAN 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 RECEIVED ON 15-APR-2025 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. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER. CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE DELIVERY WIRE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004334 ↗
• MalfunctionMay 5, 2025Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN OPENED THE PACKAGING OF A ENTERPRISE2 4MMX23MM NO TIP INTRACRANIAL STENT (ENCR402300, 9392923) AND REMOVED THE DEVICE FROM DISPENSER HOOP. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959873 ↗
• MalfunctionApr 29, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, ANENTERPRISE2 4MMX23MM NO TIP (ENCR402300, 8907909) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, UNKNOWN LOT) COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-APR-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. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926367 ↗
• MalfunctionApr 4, 2025Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE 4.0MM DIA X 23MM WITH NO TIP ENTERPRISE® 2 (ENF402300 / 8697604) WAS PREMATURELY DEPLOYED OUT OF THE MICROCATHETER. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778996 ↗
• MalfunctionMar 27, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX23MM NO TIP INTRACRANIAL STENT (ENCR402300, 8639211) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31359805) 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. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708678 ↗