CERENOVUS ENTERPRISE ENF452212Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886704044024), received between May 31, 2018 and Oct 23, 2025 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (33 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9123412) WAS IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31509779) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND FOUND THE DELIVERY WIRE OF THE STENT AND THE DISTAL END OF THE MICROCATHETER WAS KINKED/BENT. THE DOCTOR SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT REPORTED. THE DEVICE OUTER PACKAGING AND THE DEVICES WERE INSPECTED AND FOUND IN GOOD CONDITION, PRIOR TO USE. ADDITIONAL EVENT INFORMATION RECEIVED ON 16-OCT-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. 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 23367949 ↗
• MalfunctionOct 21, 2025Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EU 4.5X22MM STENT 12 MM DW TIP (ENC452212/ 8697584) WAS USED FOR AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED INCOMPLETE EXPANSION OF THE ENTERPRISE STENT. THE EVENT WAS REPORTED AS SUCH, ¿UNABLE TO OPEN. IT WAS REPORTED THAT DURING PROCEDURE, AFTER BALLOON CATHETER (OTHER BRAND) WAS USED FOR DILATION, STENT WAS ADVANCED TO TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. DOCTOR RETRACTED THE STENT AND DELIVERED THE STENT TO RELEASE IT AGAIN, BUT THE DISTAL STENT MARKERS WERE STILL FAILED TO OPEN. THE DOCTOR RETRACTED THE STENT FROM PATIENT AND OBSERVED THAT THE BLOOD FLOW WAS SMOOTH. THE DOCTOR GAVE UP STENT IMPLANTATION AND COMPLETED THE SURGERY.¿ THERE WERE NO REPORTS OF PATIENT HARM NOR SURGICAL DELAY. ADDITIONAL INFORMATION WAS RECEIVED ON 28-SEP-2025. SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT APPEARED UNDAMAGED. VESSEL OR ANEURYSM FACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347821 ↗
• MalfunctionSep 18, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4.5MMX22MM (ENC452212, 9616876) WAS IMPEDED IN PROXIMAL END OF AN UNSPECIFIED MICROCATHETER AND COULD NOT ADVANCE ANY MORE. 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 WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 18-SEP-2025 INDICATED THAT MICROCATHETER USED WAS A PROWLER SELECT PLUS (PRODUCT CODE, LOT UNKNOWN). 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 23086125 ↗
• MalfunctionAug 20, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9335199) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31557196) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND FOUND THE PROXIMAL END OF THE MICROCATHETER WAS KINKED/BENT. THE DOCTOR SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852294 ↗
• MalfunctionAug 19, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8756361) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31530960) 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-AUG-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 10 MINUTES PROCEDURAL DELAY DID NOT RESULT A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840041 ↗
• MalfunctionAug 11, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212/9166986) WAS IMPEDED IN THE PROXIMAL END OF THE PROWLER SELECT PLUS 150/5CM (606S255X, 31471109) 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. ADDITIONAL INFORMATION RECEIVED ON 29-JUL-2025 INDICATED THAT THE DEVICE WAS ABLE TO BE TORQUED. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. NO EXCESSIVE FORCE WAS USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772488 ↗
• MalfunctionAug 11, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9568619) WAS IMPEDED IN PROXIMAL END OF AN UNSPECIFIED MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN 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 28-JUL-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER WAS A CERENOVUS PRODUCT. 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 22771849 ↗
• MalfunctionJul 24, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM STENT 12 MM DW TIP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9368817) WAS IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER 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 22-JUL-2025 INDICATED THAT A TORQUEING DEVICE WAS NOT 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. THE PROCEDURE WAS NOT PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589555 ↗
• MalfunctionJul 16, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT DURING AN ENDOVASCULAR EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY, A 4.5X22 MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS IMPEDED AT THE PROXIMAL END OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE 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 25-JUN-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (606S255X, LOT UNKNOWN). THE VESSEL WAS NOTED AS ¿NORMA¿. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A 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. BASED ON THE PRODUCT ANALYSIS, THE STENT WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520938 ↗
• MalfunctionJul 7, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 4.5X22MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9426811) 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 (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 22413491 ↗
• MalfunctionJun 17, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5X22 12MM DW TIP (ENC452212, 9449929) WAS PLACED IN TARGET SITE AND TRIED TO RELEASE, BUT THE PLACEMENT OF THE STENT WAS NOT IDEAL. THE DOCTOR ONLY RETRACTED THE STENT AND THEN DELIVERED THE STENT AGAIN, BUT THE STENT WAS IMPEDED IN THE TIP OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31444527) AND COULD NOT PASSED THROUGH THE MICROCATHETER (MC). THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW STENT AND A NEW MICROCATHETER TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUN-2025 INDICATED THAT THERE WERE NO POSITIONING DIFFICULTIES WITH THE STENT. 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 15-MINUTES PROCEDURE PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235651 ↗
• InjuryJun 10, 2025Activation Failure; Activation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE EU 4.5X22MM STENT 12 MM DW TIP (ENC452212/ 9550016) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED INCOMPLETE EXPANSION OF THE STENT. THE PHYSICIAN THEN USED A MICRO- DELIVERY WIRE TO MASSAGE THE THREE CONVERGED PROXIMAL MARKERS OF STENT, BUT THE PROXIMAL MARKERS WERE STILL UNABLE TO OPEN. THEN THE DOCTOR RELEASED THE SECOND STENT IN THE FIRST STENT AND COMPLETED THE SURGERY. NO PATIENT HARM WAS REPORTED. NO DELAY TO THE SURGICAL PROCEDURE WAS REPORTED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿INCOMPLETE EXPANSION. IT WAS REPORTED THAT DURING PROCEDURE, STENT WAS PLACED AND RELEASED IN TARGET SITE. DOCTOR OBSERVED THAT 3 PROXIMAL MARKERS OF STENT WERE CONVERGED WHICH COULD NOT EXPAND AS EXPECTED. THE DOCTOR USED MICRO- DELIVERY WIRE TO MASSAGE THE PROXIMAL MARKERS, BUT THE PROXIMAL MARKERS WERE STILL UNABLE TO OPEN. THEN THE DOCTOR RELEASED THE SECOND STENT IN THE FIRST STENT AND COMPLETED THE SURGERY. THE MICROCATHETER WAS NOT REPLACED.¿ NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175491 ↗
• MalfunctionMay 23, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8872358) BECAME IMPEDED IN THE UNSPECIFIED MICROCATHETER HUB 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 PLACE BETWEEN THE MICROCATHETER HUB AND 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 22-MAY-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 WERE NO PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078066 ↗
• MalfunctionMay 12, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 8945940) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. DOCTOR ONLY RETRACTED THE STENT ALONE; THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. THE DOCTOR SWITCHED A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAY-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002879 ↗
• MalfunctionMay 1, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9449929) WAS IMPEDED AT THE PROXIMAL END OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE BUT FOUND THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE AFTER IT WAS RETRACTED OUT OF THE 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 30-APR-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE BRAND OF THE MICROCRATER WAS RUIKANGTONG. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942575 ↗
• MalfunctionApr 30, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9477849) BECAME IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT PLUS MICROCATHETER 150/5CM (606S255X, 31432572) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A SECOND NEW STENT, BUT THE SECOND STENT WAS WITH THE SAME ISSUE. THE DOCTOR REMOVED THE SECOND STENT AND MICROCATHETER FROM THE PATIENT, THEN SWITCHED A NEW MICROCATHETER TO COMPLETE THE SURGERY WITH THE SECOND STENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 20-APR-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 DELAY CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935804 ↗
• MalfunctionApr 28, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212, 9320822) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER ((B)(6), (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 21918353 ↗
• MalfunctionMar 17, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5X22MM ENTERPRISE INTRACRANIAL STENT (ENC452212, 9368817) BECAME IMPEDED IN PROXIMAL OF A PROWLER SELECT PLUS (606-S255X, 31411526) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT OUT OF THE Y CONNECTOR ALONE, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. 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 17-MAR-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 EVENT WAS PROLONGED FOR APPROXIMATELY 4 MINUTES CAUSING NO CLINICAL SIGNIFICANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620360 ↗
• MalfunctionFeb 10, 2025Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 9166987) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED COULD NOT BE OPENED. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE UNSPECIFIED MICROCATHETER (MC) WAS NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343662 ↗
• MalfunctionFeb 3, 2025Premature Activation; Product Quality Problem; Failure to Advance; Premature Activation; Product Quality Problem; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 9208265) WAS NOT VISUALIZED UNDER THE IMAGE AFTER IT WAS DELIVERED TO THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31432572). THE STENT DID NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND OBSERVED THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN PROXIMAL OF THE MICROCATHETER. A MICRO GUIDEWIRE (OTHER BRAND) WAS USED TO REMOVE THE STENT BODY FROM THE MICROCATHETER. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293228 ↗
• MalfunctionJan 27, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 8028680) BECAME IMPEDED IN THE PROXIMAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE OUT OF THE Y CONNECTOR AND RETRACTED BACK TO THE INTRODUCER, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER (MC) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241809 ↗
• MalfunctionJan 13, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT ( ENC452212, 9061785) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER ( 606S255X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE PHYSICIAN 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 12-JAN-2025 INDICATED THAT THE MICROCATHETER DID NOT KINK/BENT. THE PROCEDURE BY DELAYED BY 5 MINUTES DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139863 ↗
• MalfunctionJan 7, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 8907846) BECAME IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31276211) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 31-DEC-2024 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO DEVICE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 15 MINIUTES PROCEDURAL DELAY WERE NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092637 ↗
• MalfunctionJan 6, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 9208260) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31392022) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN 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 (B)(6) 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. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS DELAYED BY 10MINUTES, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079934 ↗
• MalfunctionDec 30, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ANGIOPLASTY PROCEDURE, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 9208260) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT MICROCATHETER (606S55X, LOT UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR ONLY RETRACTED THE STENT ALONE, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE PREMATURELY 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 25-DEC-2024 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WERE NOT PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035781 ↗