CERENOVUS ENTERPRISE ENF452200Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886704071761), received between May 31, 2018 and Sep 3, 2025 — classified as 1 injury, 24 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Failure to Advance; Contamination /Decontamination Problem; Failure to Advance; Contamination /Decontamination Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200, 9682206) 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 SECOND MICROCATHETER TO DELIVER THE ORIGINAL STENT, BUT THE ORIGINAL STENT HAD THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE ORIGINAL STENT ALONE, THEN SWITCHED A SECOND NEW STENT TO COMPLETE THE SURGERY. THE SECOND MICROCATHETER WAS NOT REPLACED. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-2025 INDICATED THAT THERE WAS EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK OR BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-AUG-2025 NOTED THAT IT¿S UNKNOWN WHICH OF THE TWO DEVICES HAD THE PHYSICAL MATERIAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953378 ↗
• MalfunctionAug 7, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, THE DOCTOR OPENED THE DEVICE PACKAGING OF A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND REMOVED THE DEVICE FROM DISPENSER HOOP. WHEN RINSING THE DEVICE, IT WAS FOUND THAT THE DISTAL END OF THE STENT BODY WAS ROUGH (WITH BURRS). THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUL-2025 INDICATED THAT THERE HAD BEEN NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED, REMOVED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). NORMAL FORCE WAS USED WHEN RINSING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737365 ↗
• MalfunctionJul 16, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4.5MMD X22MML WNO DISTAL TIP VASCULAR RECONSTRUCTION DEVICE (ENC452200, 9568617) WAS IMPEDED IN THE PROWLER SELECT PLUS 150/5CM MICROCATHETER HUB (606S255X, 31540342) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT ALONE; IT WAS FOUND THAT 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 NEW DEVICES TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522310 ↗
• MalfunctionJun 26, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 22MML WNO DSTL TP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200, 8848353) WAS IMPEDED AT THE MIDDLE SECTION OF 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 22338437 ↗
• MalfunctionJun 26, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANGIOPLASTY, A 4.5MMD 22MML WNO DSTL TP ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200, 9477848) WAS IMPEDED IN THE Y CONNECTOR AND COULD NOT BE PUSHED INTO PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31537083). 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 22337933 ↗
• MalfunctionJun 12, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452200, 9353564) WAS IMPEDED IN THE MIDDLE SECTION OF A PROWLER SELECT PLUS MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE MICROCATHETER (MC) AND STENT FROM THE PATIENT FOR INSPECTION, NO ISSUES WERE FOUND. THE DOCTOR DELIVERED THE STENT AND MICROCATHETER AGAIN, BUT THE STENT WAS STILL IMPEDED IN THE MIDDLE SECTION OF THE MICROCATHETER, AND THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195204 ↗
• MalfunctionJun 10, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, THE DOCTOR OPENED THE PACKAGING OF A 4.5MMD 22MML WNO DSTL TP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200, 391494) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. 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. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 29-MAY-2025 INDICATING THAT THERE WAS NO OTHER DAMAGE NOTED ON THE DEVICE. THE STENT WAS REPLACED WITH ANOTHER 4.5MMD 22MML 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 22177789 ↗
• MalfunctionMay 27, 2025Premature Activation; Premature Activation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN OPENED THE PACKAGING OF A 4.5MMD 22MML WNO DSTL TP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200/9208250) TO REMOVE THE DEVICE FROM DISPENSER HOOP, AND IT WAS FOUND THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE PHYSICIAN SWITCHED TO NEW STENT TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-MAY-2025 INDICATED THAT NO OTHER PHYSICAL DAMAGE WAS NOTED ON THE STENT/STENT DELIVERY SYSTEM. THE REPLACEMENT STENT WAS ANOTHER 4.5MMD 22MML 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 22090541 ↗
• MalfunctionApr 22, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHILE PROCESSING THE DELIVERY OF A 4.5MMD 22MML ENTERPRISE INTRACRANIAL STENT (ENC452200, 9392919) TO A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31365450), THE STENT WAS IMPEDED AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT FOR INSPECTION, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. A NEW STENT AND A NEW MICROCATHETER WERE SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-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 WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883581 ↗
• MalfunctionMar 31, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE DOCTOR OPENED THE PACKAGING OF A 4.5 MMD 22 MML ENTERPRISE INTRACRANIAL STENT 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 21-MAR-2025 INDICATED THAT THERE WAS NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731531 ↗
• MalfunctionMar 24, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD X 22MML ENTERPRISE WITH NO DISTAL TIP (ENC452200, 9236677) BECAME IMPEDED IN PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31469829) 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. THE DOCTOR REMOVED THE MICROCATHETER (MC) AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-MAR-2025 INDICATED THAT THE MC DID NOT KINK/BENT. THE 20 MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678246 ↗
• MalfunctionMar 10, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD 11MML ENTERPRISE INTRACRANIAL STENT (ENC452200, 9208258) WITH NO DISTAL TIP BECAME IMPEDED IN PROXIMAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE STENT AND RETRACTED IT INTO THE INTRODUCER, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. 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 05-MAR-2025 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560418 ↗
• MalfunctionFeb 26, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE DOCTOR OPENED THE PACKAGING OF AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9236677) 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 AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-FEB-2025 INDICATED THAT THERE WERE NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469873 ↗
• MalfunctionFeb 19, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9123411) BECAME IMPEDED IN THE DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31411538) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-FEB-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 PROCEDURAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411981 ↗
• MalfunctionFeb 3, 2025Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, PRIOR TO USE, THE DOCTOR OPENED THE PACKAGING AND REMOVED AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9166985) FROM THE DISPENSER HOOP, THE STENT BODY WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE DOCTOR SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294047 ↗
• MalfunctionFeb 3, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9208258) BECAME IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31395320) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR RETRACTED THE STENT AND MICROCATHETER FROM THE PATIENT, AND FOUND THAT THE TIP OF THE MICROCATHETER WAS COMPRESSED/FLAT. THE DOCTOR SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. PRIOR TO SURGERY, THE DEVICES PACKAGING WAS INSPECTED, THEY WERE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293830 ↗
• MalfunctionJan 21, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9208251) BECAME IMPEDED IN PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN 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 SWITCH TO A NEW STENT TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 16-JAN-2025 INDICATED THAT NO TORQUING 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. THE 10 MINUTES PROCEDURAL DELAY WERE NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197116 ↗
• MalfunctionJan 21, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9208251) BECAME IMPEDED IN PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN 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 SWITCH TO A NEW STENT TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 16-JAN-2025 INDICATED THAT NO TORQUING 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. THE 10 MINUTES PROCEDURAL DELAY WERE NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196996 ↗
• MalfunctionNov 18, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, THE PHYSICIAN OPENED THE DEVICE PACKAGING OF AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 8878727) AND REMOVED THE DEVICE FROM DISPENSER HOOP. IT WAS FOUND THAT THE STENT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN PATIENT. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706128 ↗
• MalfunctionNov 14, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9020399) BECAME IMPEDED IN MICROCATHETER HUB OF A PROWLER SELECT PLUS 150/5CM (606S255X, 31351018) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-NOV-2024 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. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687772 ↗
• MalfunctionNov 8, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 9061784) BECAME IMPEDED IN THE PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31309396) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN TRIED TO RETRACT THE STENT BUT IT WAS RELEASED AUTOMATICALLY. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND REPLACED THEM WITH NEW DEVICES TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640233 ↗
• MalfunctionNov 1, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 8697595) BECAME IMPEDED IN THE DISTAL END OF THE MICROCATHETER (OTHER BRAND) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE STENT WAS RELEASED AUTOMATICALLY AT THE SAME TIME. THE STENT BODY WAS FOUND TO BE SEPARATED PREMATURELY FROM DELIVERY WIRE. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT FROM PATIENT, THEN SWITCHED TO A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587448 ↗
• MalfunctionSep 3, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 8484762) BECAME IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN ONLY RETRACTED THE STENT AND OBSERVED THAT THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127461 ↗
• MalfunctionAug 14, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TP INTRACRANIAL STENT (ENC452200, 8779772) WAS BECAME IMPEDED IN A NON J&J MICROCATHETER¿S HUB AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE STENT WAS RELEASED AUTOMATICALLY IN Y CONNECTOR. THE STENT BODY WAS SEPARATED PREMATURELY FROM THE DELIVERY WIRE. THE PHYSICIAN 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 14-AUG-2024 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982082 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION ¿STENT-ASSISTED COILING OF CEREBRAL ANEURYSMS: A SINGLE-CENTER CLINICAL AND ANGIOGRAPHIC ANALYSIS¿ WANG J, VARGAS J, SPIOTTA A, ET AL. J NEUROINTERVENT SURG 2017; 0: 1-6. DOI: 10. 1136/NEUROINTSURG-2017-013272. THE PURPOSE OF THE STUDY WAS TO RETROSPECTIVELY COMPARE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF TWO HUNDRED FORTY-THREE CEREBRAL ANEURYSMS FROM 229 PATIENTS TREATED WITH STENT-ASSISTED ENDOVASCULAR COILING BETWEEN MARCH 2009 AND FEBRUARY 2016, USING THREE TYPES OF SELF-EXPANDING NITINOL STENTS NEUROFORM (NEU; STRYKER), ENTERPRISE (EP, CODMAN & SHURTLEFF), AND LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS/LVIS JR; MICROVENTION). ANEURYSM SIZES WERE CLASSIFIED AS SMALL (= 5 MM), MEDIUM (> 5 TO < 15 MM), LARGE (= 15 TO < 25 MM), AND GIANT ANEURYSMS (= 25 MM). AN ANEURYSM WAS CONSIDERED TO HAVE A WIDE NECK IF THE NECK SIZE WAS > 4 MM AND/OR IF THE DOME-TO-NECK RATIO WAS < 2. THE PATIENT IN QUESTIONNAIRE #9, A (B)(6)-YEAR-OLD FEMALE PATIENT EXPERIENCED A THROMBOSIS EVENT ON (B)(6) 2013. THE EVENT RESOLVED WITH INTRAVENOUS (IV) THROMBOLYSIS AND TISSUE PLASMINOGEN ACTIVATOR (TPA). THERE WAS REPORTEDLY NO CHANGE IN HEALTH ST

  Patient problems: Thrombosis

  MAUDE report 7559226 ↗