CERENOVUS ENTERPRISE ENF401600Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10886704075349), received between Dec 16, 2020 and May 14, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Premature Activation

  IT WAS REPORTED THAT THE 4.0MM DIA X 16MM WITH NO TIP ENTERPRISE®2 (ENF401600 / 8697625) 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 25175294 ↗
• MalfunctionFeb 26, 2026Retraction Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ENTERPRISE2 4MMX16MM NO TIP (PRODUCT CODE: ENF401600, LOT NUMBER: 9493904) RECAPTURE FAILED WHEN DEPLOYED AT THE M1 SEGMENT STENOSIS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455393 ↗
• MalfunctionNov 5, 2025Migration; Migration

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENF401600, LOT UNKNOWN) MIGRATED FROM THE DISTAL INTERNAL CAROTID ARTERY (ICA) TO THE PROXIMAL ICA, WHERE IT HAD BEEN INITIALLY DEPLOYED SUCCESSFULLY. AT 1 YEAR FOLLOW UP, IMAGING DEMONSTRATED THE MIGRATION OF THE STENT. THE PATIENT REMAINS ASYMPTOMATIC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477158 ↗
• MalfunctionAug 26, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 9140079) WAS IMPEDED IN THE MIDDLE SECTION OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT: UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO RETRACT THE STENT; THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-AUG-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 PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896851 ↗
• MalfunctionAug 4, 2025Premature Activation; Premature Activation

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENF401600, 9493904) WAS DETACHED INSIDE THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698960 ↗
• MalfunctionJul 23, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 9392921) WAS IMPEDED IN THE 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 TO COMPLETE THE PROCEDURE WITH THE ORIGINAL MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUL-2025 INDICATED THAT 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 22578928 ↗
• MalfunctionJul 21, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 9403134) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31537082) 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 BY ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-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 I0 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554482 ↗
• MalfunctionJul 16, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X) 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. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521765 ↗
• InjuryJul 7, 2025Failure to Advance; Activation Failure; Failure to Advance; Activation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX16MM NO TIP (ENCR401600/ 9403134) AND PROWLER SELECT PLUS 150/5CM (606S255X/ 31471114) WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT BEFORE THE DEVICES WERE USED ON THE PATIENT, THE STENT BECAME IMPEDED AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH. UPON INSPECTION, THE DISTAL END OF THE MICROCATHETER WAS FOUND TO BE COMPRESSED AND FLAT. THE DOCTOR RETRACTED THE STENT AND SWITCHED TO A SECOND MICROCATHETER TO ATTEMPT DELIVERY OF THE SAME STENT. ONCE THE STENT WAS IN THE TARGET POSITION AND THE RELEASE WAS INITIATED, IT WAS OBSERVED THAT THE DISTAL MARKERS OF THE STENT CONVERGED AND COULD NOT BE OPENED. THE DOCTOR RETRACTED THE STENT AGAIN AND TRIED TO RELEASE IT, BUT THE DISTAL MARKERS STILL FAILED TO OPEN. ULTIMATELY, THE DOCTOR RETRACTED ONLY THE STENT AND OPTED TO USE A NEW STENT TO COMPLETE THE SURGERY. THE SECOND MICROCATHETER WAS NOT REPLACED, AND THE SURGERY WAS PROLONGED BY APPROXIMATELY 15 MINUTES. NO PATIENT HARM WAS REPORTED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿IMPEDED IN MICROCATHETER & COMPRESSED & UNABLE TO OPEN. IT WAS

  Patient problems: Transient Ischemic Attack

  MAUDE report 22418927 ↗
• MalfunctionJul 3, 2025Premature Activation; Migration; Premature Activation; Migration

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX16MM NO TIP (ENCR401600/ 9275829) WAS USED FOR A COILING ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM. DURING THE PROCEDURE, COILS FROM ANOTHER BRAND WERE PLACED IN THE ANEURYSM. THE STENT WAS POSITIONED AT THE TARGET SITE AND AN ATTEMPT TO RELEASE IT WAS MADE. HOWEVER, DURING THE RELEASE PROCESS, THE STENT DETACHED FROM THE DELIVERY WIRE PREMATURELY AND MIGRATED TO THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, FAILING TO COVER THE ANEURYSM NECK. THE DOCTOR SUBSEQUENTLY REMOVED THE MICROCATHETER AND DELIVERY WIRE FROM THE PATIENT BEFORE COMPLETING THE SURGERY. THERE WAS NO REPORT OF PATIENT INJURY. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿PREMATURE DETACHMENT & MIGRATION. IT WAS REPORTED DURING THE PROCEDURE, COILS (OTHER BRAND) WERE FILLED IN THE ANEURYSM. THE STENT WAS PLACED IN TARGET SITE AND TRIED TO RELEASE. DURING THE PROCESS OF RELEASING THE STENT, THE STENT WAS DETACHED FROM THE DELIVERY WIRE PREMATURELY. THE STENT MIGRATED TO M3 SEGMENT OF MIDDLE CEREBRAL ARTERY WITHOUT COVERING THE ANEURYSM NECK. THE DOCTOR REMOVED MICROCATHETER AND DELIVERY WIRE FROM THE PATIENT AND THEN COMPLETED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395899 ↗
• MalfunctionJun 23, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE 4MMX16MM NO TIP (ENCR401600, 9392921) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31540340) AND 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 20-JUN-2025 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309976 ↗
• MalfunctionJun 17, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 9403134) BECAME IMPEDED IN PROXIMAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233157 ↗
• MalfunctionJun 16, 2025Activation Failure; Activation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 8907850) PASSED THROUGH THE UNSPECIFIED MICROCATHETER TIP AND STARTED TO RELEASE THE STENT. IT WAS FOUND THAT THE PLACEMENT OF THE STENT WAS NOT IDEAL, THEN THE DOCTOR ONLY RETRACTED THE STENT AND TRIED TO RELEASE IT AGAIN, BUT THE DOCTOR OBSERVED THAT 3 DISTAL MARKERS OF THE STENT CONVERGED AND THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE DOCTOR ONLY RETRACTED THE STENT AND THEN RELEASED IT AGAIN, BUT THE STENT WAS STILL UNABLE TO OPEN COMPLETELY. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A NEW STENT (OTHER BRAND) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211684 ↗
• MalfunctionJun 12, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY, AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 9403134) WAS IMPEDED AT THE DISTAL END OF A PROWLER SELECT PLUS 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-JUN-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. THERE WAS NO PROCEDURAL DELAY/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196450 ↗
• MalfunctionJun 11, 2025Component Missing; Failure to Advance; Component Missing; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, THE STENT OF AN ENTERPRISE2 4MMX16MM NO TIP (ENCR401600, 9403134) WAS NOT VISUALIZED UNDER THE IMAGE AFTER IT WAS DELIVERED TO THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31471117), THE STENT DID NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT, AND THE STENT BODY WAS NOTED TO BE ABSENT FROM THE STENT DELIVERY SYSTEM. THERE WAS NO STENT BODY IN THE MICROCATHETER. NEW DEVICES WERE SWITCHED TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-JUN-2025 INDICATED THAT IT CANNOT BE CONFIRMED IF THE STENT WAS NOT DISLODGED INTO PATIENT. THE STENT WAS NOT PREMATURELY DETACHED INADVERTENTLY. THERE WAS NO DAMAGE TO THE PACKAGING, OR ANY DIFFICULTY REMOVING DEVICE FROM PACKAGE. THERE WAS NO DIFFICULTY IN REMOVING DEVICE FROM DISPENSER. THE 20-MINUTES PROCEDURE PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187801 ↗
• MalfunctionJun 10, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, IT WAS REPORTED THAT THE DOCTOR OPENED THE PACKAGING OF AN ENTERPRISE2 4MMX16MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR401600, 9185284) 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. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-MAY-2025 INDICATED THAT THE REPLACEMENT STENT WAS ANOTHER 4MMX16MM ENTERPRISE® 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 22177873 ↗
• MalfunctionJun 9, 2025Premature Activation; Premature Activation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE 2 4MMX16MM NO TIP (ENF401600, 8946025) PREMATURELY DEPLOYED OUT OF THE UNSPECIFIED MICROCATHETER HUB. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166524 ↗
• MalfunctionMar 31, 2025Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 8697618) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE PHYSICIAN ONLY RETRACTED THE STENT AND RELEASED IT AGAIN, AFTER SUCH ATTEMPTS SEVERAL TIMES, THE DISTAL STENT MARKERS STILL FAILED TO OPEN. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-MAR-2025 INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE 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, RESULTING IN NO CLINICAL SIGNIFICANCE. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-MAR-2025 CLARIFIED THAT THE ADDITIONAL INTERVENTION PERFORMED WAS REMOVING THE STENT FROM THE MICROCATHETER, AND ADJUST THE ANGLE, RELEASE THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731001 ↗
• MalfunctionMar 26, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 8639212) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697933 ↗
• MalfunctionMar 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 8697618) BECAME IMPEDED IN THE PROXIMAL 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618912 ↗
• MalfunctionMar 17, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 8697618) BECAME IMPEDED IN THE PROXIMAL 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. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618678 ↗
• MalfunctionFeb 26, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 9166990) BECAME IMPEDED IN THE HUB OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ADDED FORCE TO DELIVER THE STENT, 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 A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-FEB-2025 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (606S255X, 31469833). THE MC WAS NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE PROCEDURE WAS DELAYED BY 10 MINUTES DUE TO THE EVENT; THE DELAY WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471177 ↗
• MalfunctionFeb 25, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 8945947) BECAME 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 FROM THE PATIENT FOR INSPECTION. THEN THE SAME STENT WAS DELIVERED WITH THE SAME MICROCATHETER AGAIN, BUT THE SAME ISSUE OCCURRED. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER (MC). NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 18-FEB-2025 INDICATING 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 DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458406 ↗
• MalfunctionJan 14, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENCR401600, 9042461) BECAME IMPEDED IN PROXIMAL OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO RETRACT THE STENT ALONE, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR USED A MICRO-GUIDE WIRE TO REMOVE THE STENT OUT AND SWITCH TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-JAN-2025 INDICTED 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 DELAYS BY 15 MINUTES DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150206 ↗
• MalfunctionDec 11, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, AN ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL STENT (ENF401600, 7258224) PRE-MATURELY DEPLOYED IN THE HUB OF A PROWLER SEL PLUS 150/5CM J TIP MICROCATHETER (606S255JX, 30763321). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903604 ↗