CERENOVUS ENTERPRISE ENF403000Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886704075387), received between Sep 21, 2016 and Sep 15, 2025 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (13 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENCR403000, 9020409) WAS IMPEDED IN INTRODUCER, AND THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS NOT USED IN THE 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 23051130 ↗
• MalfunctionJul 17, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE ON (B)(6) 2025, THE 4.0MM X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000 / 9320829) BECAME IMPEDED IN THE CONCOMITANT 150CM X5CM PROWLER SELECT PLUS / 45 TIP (606S255FX / 31471103) WHEN THE PHYSICIAN TRIED TO ADVANCE THE STENT IN THE MIDPOINT OF THE MICROCATHETER. THE DEVICES WERE REPLACED WITH ANOTHER 4.0MM X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000) AND ANOTHER 150CM X5CM PROWLER SELECT PLUS / 45 TIP (606S255FX) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE DEVICES WERE REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537925 ↗
• MalfunctionJul 17, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP VASCULAR RECONSTRUCTION DEVICE (ENC403000, 8779779) WAS STUCK IN THE INTRODUCER AND SEPARATED FROM THE PUSH WIRE, SO IT CANNOT BE PUSHED INTO THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531294 ↗
• InjuryJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX30MM NO TIP (ENCR403000/ 8994894) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE STENT WAS PLACED AT THE TARGET SITE, BUT DURING THE RELEASE ATTEMPT, THE TIP OF THE DELIVERY WIRE BROKE INTO TWO SEPARATE PIECES. THE DOCTOR RETRACTED ONLY THE STENT ALONE AND SWITCHED TO A SECOND STENT FROM ANOTHER BRAND TO CAPTURE THE FRACTURED DELIVERY WIRE AND REMOVING IT FROM THE PATIENT. THE SECOND STENT WAS THEN DELIVERED AND RELEASED AT THE TARGET SITE, AND THE MICROCATHETER FROM ANOTHER BRAND WAS NOT REPLACED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿FRACTURED/SEPARATED-DURING USE. IT WAS REPORTED THAT BEFORE PROCEDURE, DEVICE PACKAGE AND DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION. DURING THE PROCEDURE, STENT WAS PLACED IN TARGET SITE AND TRIED TO RELEASE. IT WAS FOUND THAT THE TIP OF THE DELIVERY WIRE BROKE INTO TWO SEPARATE PIECES. THE DOCTOR ONLY RETRACTED THE STENT ALONE AND SWITCHED A SECOND STENT (OTHER BRAND) TO CAPTURE THE FRACTURED DELIVERY WIRE AND THEN REMOVED IT FROM PATIENT. THEN THE SECOND STENT WAS DELIVERED AND RELEASED IN TARGET SITE. THE MICROCATHETER (OTHER BRAND)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359344 ↗
• InjuryJun 17, 2025Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN ENTERPRISE2 4MMX30MM NO TIP (ENC403000/ 8994889) WAS USED FOR A VASCULAR STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED RESISTANCE/FRICTION WITH NO LOSS OF MICROCATHETER CEREBRAL TARGET POSITION AND PREMATURE DETACHMENT AT AN UNINTENTIONAL LOCATION (DEPLOYED BEYOND THE LESION). THE PHYSICIAN WAS REQUIRED TO DEPLOY A SECOND ENTERPRISE STENT TO FULLY COVER THE TARGET LESION. NO PATIENT HARM WAS REPORTED. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. THE DEVICE REMAINS IMPLANTED FOR CONTINUED USE, THUS, WILL NOT BE RETURNED FOR FURTHER ANALYSIS. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE DOCTOR TRIED TO DEPLOY ENTERPRISE 4X30 IN A STENOTIC SEGMENT IN PCA. WHILE ADVANCING IT THROUGH THE PROWLER SELECT PLUS, THE OPERATOR FACED RESISTANCE TO ADVANCE THE STENT, ESPECIALLY AT THE DISTAL END OF THE CATHETER. AFTER SOME TIME, THE DR TRIED TO RECAPTURE THE STENT INSIDE THE SHEATH BUT FOUND OUT THAT THE STENT HAS BEEN DEPLOYED BEYOND THE LESION. THE DR TOOK ANOTHER STENT AND DEPLOYED ANOTHER ENTERPRISE 4X30 AT THE SITE OF THE LESION AND FINISHED THE PROCEDURE. SINCE THE FIRST STENT HAS ALREADY BEEN DEPLOYED INSIDE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235768 ↗
• MalfunctionMay 1, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP INTRACRANIAL STENT (ENCR403000, 9236683) WAS IMPEDED IN THE HUB OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31471111) 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 A NEW STENT TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943365 ↗
• MalfunctionJan 28, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE HEALTH AUTHORITY, DURING A CEREBRAL THROMBECTOMY, AN ENTERPRISE2 4MMX30MM NO TIP INTRACRANIAL STENT (ENCR403000, 8546200) BECAME IMPEDED IN AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JAN-2025 INDICATED THAT THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (606S255X, UNKNOWN LOT). THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254466 ↗
• MalfunctionDec 10, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN EMERGENCY VASCULAR STENT PLACEMENT, AFTER APPROACHED WITH AN UNSPECIFIED MICROCATHETER TO THE TARGET LESION, AN ENTERPRISE2 4MMX30MM NO TIP INTRACRANIAL STENT (ENC403000, 6979043) WAS INSERTED INTO THE MICROCATHETER (MC). DURING INSERTION, RESISTANCE WAS FELT AT THE HUB OF THE MICROCATHETER. THE WHOLE SYSTEM WAS PULLED FROM THE PATIENT¿S BODY AND CONFIRMED THERE WAS A RESISTANCE. REPLACED WITH ANOTHER NEW ENTERPRISE2, WHICH COULD BE INSERTED INTO THE MICROCATHETER AND IMPLANTED AT THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893749 ↗
• MalfunctionDec 9, 2024Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ENTERPRISE2 4MMX30MM NO TIP (ENC403000/8700152) ¿GOT JUMPED¿ INTO THE HUB AND GOT DEPLOYED IN THE MICROCATHETER (PROWLER SELECT PLUS). NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20882532 ↗
• MalfunctionNov 5, 2024Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.0MM DIA X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000 / 6708331) WAS PREMATURELY DEPLOYED IN THE HUB OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THE ENVOY DA XB, 6F, 105CM, MPD (67125805DB / 31062595) WAS REPORTEDLY KINKED IN THE BODY. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE STENT WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605896 ↗
• MalfunctionOct 15, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, AN ENTERPRISE2 4MMX30MM NO TIP INTRACRANIAL STENT (ENF403000, 8848362) PREMATURELY DEPLOYED ON THE INTRODUCER SHEATH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449739 ↗
• MalfunctionSep 17, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP INTRACRANIAL STENT (ENCR403000, 8799373) IMPEDED AT THE TIP OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER ( 606S255X, 31328287) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED IT WITH A NEW STENT AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-SEP-2024 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. NO OTHER DEVICES WERE USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE MICROCATHETER DID NOT KINK/BENT. THERE WERE NO PROCEDURAL DELAYS DUE TO THE VENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236807 ↗
• MalfunctionSep 16, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ENTERPRISE2 4MMX30MM NO TIP INTRACRANIAL STENT (ENCR403000, 8697635) WAS PLACED IN TARGET POSITION AND STARTED TO RELEASE, BUT THE DISTAL MARKERS OF THE STENT WERE CONVERGED WHICH COULD NOT BE OPENED. THE DOCTOR REMOVED THE STENT AND MICROCATHETER (OTHER BRAND) FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225452 ↗
• MalfunctionMar 4, 2024Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.0MM DIA X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000 / 7057096) WAS PRE-DEPLOYED IN THE HUB OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30871574). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828314 ↗
• InjuryNov 27, 2023Break; Break

  IT WAS REPORTED, VIA EMAIL, THAT TWO ENTERPRISE2 4MMX30MM NO TIP (ENF403000/8129994) STENTS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE, DURING WHICH THE USER REPORTED STENT DEPLOYMENT DIFFICULTY-INACCURATE PLACEMENT FOR THE FIRST USED STENT, WHICH RESULTED IN THE STENT NAVIGATING INTO THE ANEURYSM. THIS STENT WAS REMOVED. THE USER ALSO REPORTED A FAILED STENT PLACEMENT ATTEMPT FOR THE SECOND ENTERPRISE2 STENT, WHICH WAS ALSO REMOVED. AN ANGIOGRAPHY CONFIRMED NO INJURY WAS DONE TO THE PATIENT AS A RESULT OF THE EVENTS. THE ANEURYSM EMBOLIZATION PROCEDURE WAS THEN ABORTED. A NEW ENDOVASCULAR EMBOLIZATION PROCEDURE WAS ¿PROGRAMMED¿, WHERE THE PHYSICIAN UTILIZED A COMPETITOR STENT INSTEAD. THE EVENT WAS REPORTED AS SUCH: ¿ENDOVASCULAR EMBOLIZATION ATTEMPT WITH ENTERPRISE2 (X2) USED. AFTER ENTERPRISE2 PLACEMENT DEPLOYMENT, THE STENT NAVIGATED TO ANEURISM. STENT WAS REMOVED. A SECOND ATTEMPT TO EMBOLIZATION WITH ENTERPRISE2 FAILED. THE STENT WAS REMOVED. A CEREBRAL ANGIOGRAPHY WAS PERFORMED TO REVIEW, NO DAMAGE ON ARTERY. NO COMPLICATION OR LACERATIONS IN ARTERY CONFIRMED. DUE THIS INCIDENT THE ANEURISM EMBOLIZATION WAS ABORT. CEREBRAL ANGIOGRAPHY PERFORMED COMPLETELY TO CONFIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212035 ↗
• InjuryNov 27, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED, VIA EMAIL, THAT TWO ENTERPRISE2 4MMX30MM NO TIP (ENF403000/8129994) STENTS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE, DURING WHICH THE USER REPORTED STENT DEPLOYMENT DIFFICULTY-INACCURATE PLACEMENT FOR THE FIRST USED STENT, WHICH RESULTED IN THE STENT NAVIGATING INTO THE ANEURYSM. THIS STENT WAS REMOVED. THE USER ALSO REPORTED A FAILED STENT PLACEMENT ATTEMPT FOR THE SECOND ENTERPRISE2 STENT, WHICH WAS ALSO REMOVED. AN ANGIOGRAPHY CONFIRMED NO INJURY WAS DONE TO THE PATIENT AS A RESULT OF THE EVENTS. THE ANEURYSM EMBOLIZATION PROCEDURE WAS THEN ABORTED. A NEW ENDOVASCULAR EMBOLIZATION PROCEDURE WAS ¿PROGRAMMED¿, WHERE THE PHYSICIAN UTILIZED A COMPETITOR STENT INSTEAD. THE EVENT WAS REPORTED AS SUCH: ¿ENDOVASCULAR EMBOLIZATION ATTEMPT WITH ENTERPRISE2 (X2) USED. AFTER ENTERPRISE2 PLACEMENT DEPLOYMENT, THE STENT NAVIGATED TO ANEURISM. STENT WAS REMOVED. A SECOND ATTEMPT TO EMBOLIZATION WITH ENTERPRISE2 FAILED. THE STENT WAS REMOVED. A CEREBRAL ANGIOGRAPHY WAS PERFORMED TO REVIEW, NO DAMAGE ON ARTERY. NO COMPLICATION OR LACERATIONS IN ARTERY CONFIRMED. DUE THIS INCIDENT THE ANEURISM EMBOLIZATION WAS ABORT. CEREBRAL ANGIOGRAPHY PERFORMED COMPLETELY TO CONFIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211503 ↗
• MalfunctionJun 30, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FELT STRONG RESISTANCE DURING THE ATTEMPT TO ADVANCE THE 4.0MM DIA X 30MM WITH NO TIP ENTERPRISE®2 (ENF403000 / 11175283) THROUGH THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND). THE STENT WAS REMOVED AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 30-JUN-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881810 ↗
• MalfunctionJun 2, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0MM DIA X 30MM WITH NO TIP ENTERPRISE®2 STENT (ENF403000 / 11089436) WAS IMPEDED IN THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30333005). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926034 ↗
• MalfunctionApr 22, 2020Fracture; Fracture

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE STENT TIP OF A 4MMX30MM ENTERPRISE2 (ENF403000, 11160236) CRACKED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985844 ↗
• MalfunctionApr 15, 2019Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) FEMALE PATIENT FROM THE (B)(6) IDE STUDY UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) / MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AT THE 24-MONTH FOLLOW-UP VISIT AND THERE WAS STENT MIGRATION OBSERVED IN THE 4 MM X 30 MM WITH NO TIP ENTERPRISE® 2 STENT (ENF403000C / 10665775). THE FOLLOW-UP IMAGING RESULTS WERE DOCUMENTED IN THE CASE REPORT FORM (CRF). THE COIL MASS POSITION WAS MAINTAINED WITHIN THE SAC, PARENT ARTERY PATENCY WAS MAINTAINED, 100% ANEURYSM OCCLUSION WAS OBSERVED. THE ASSESSMENT RAYMOND CLASS WAS A 1, WHICH TRANSLATES TO COMPLETE OCCLUSION. NO EVIDENCE OF PARENT VESSEL STENOSIS WAS OBSERVED. THERE IS COMPLETE STENT COVERAGE ACROSS THE ANEURYSM NECK, AND COMPARISON TO POST-PROCEDURE STATUS IS STABLE. AT THE TIME OF THE INDEX PROCEDURE ON 09 JAN 2017, THE PATIENT PRESENTED WITH A LEFT SIDE WALL, SACCULAR, 10 MM X 6.4 MM PARACLINOID ANEURYSM WITH A 7 MM NECK WIDTH AND A 1.4 DOME-TO-NECK RATIO. THE PARENT VESSEL DIMENSIONS ARE AS FOLLOWING: PARENT VESSEL INTERNAL DIAMETER SIZE PROXIMAL TO ANEURYSM WAS 3.2 MM, TO DISTAL ANEURYSM WAS 3.8 MM. THE PATIENT WAS TREATED WITH NON-CERENOVUS COILS AND THE 4 MM X 30 MM WITH NO TIP ENTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514946 ↗
• MalfunctionApr 2, 2019Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT ASSISTED COILING PROCEDURE, THE 4.0 MM DIA X 30 MM ENTERPRISE®2 STENT (ENF403000 / 10955438) WAS REPORTED AS PREMATURELY DEPLOYED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE ASSOCIATED WITH THE REPORTED EVENT. IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474429 ↗
• MalfunctionApr 1, 2019Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0 MM DIA X 30 MM WITH NO TIP ENTERPRISE®2 STENT (ENF403000 / LOT#: UNKNOWN) BECAME DEPLOYED IN THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470969 ↗
• MalfunctionApr 1, 2019Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0 MM DIA X 30 MM WITH NO TIP ENTERPRISE®2 STENT (ENF403000 / LOT#: UNKNOWN) BECAME DEPLOYED IN THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470966 ↗
• MalfunctionSep 14, 2018Premature Activation; Physical Resistance/Sticking; Premature Activation; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT LEFT OPHTHALMIC ARTERY ANEURYSM, THE 4 MM X 30 MM ENTERPRISE 2 NO TIP (ENF403000/10689189) STENT WAS LOADED, FLUSHED, AND ADVANCED THROUGH THE 0.021¿ RAPID TRANSIT 150 CM (601251X/30042646) DUAL MARKER MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED ABOUT HALFWAY THROUGH THE MICROCATHETER AND THE STENT COULD NO LONGER BE ADVANCED. THE STENT BECAME STUCK IN THE MICROCATHETER HUB DURING REMOVAL; THEREFORE, THE MICROCATHETER WAS REMOVED FROM THE PATIENT. THE MICROCATHETER AND STENT WERE REPLACED, AND TARGET POSITION WAS EASILY RE-OBTAINED. THE ENTERPRISE 2 STENT WAS IMPLANTED ACROSS THE NECK OF THE ANEURYSM AND FOUR COMPETITOR COILS WERE PLACED IN THE ANEURYSM. POST ANGIOGRAPHY REVEALED GOOD RESULT AND THE CASE WAS CONCLUDED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS DELAYED 5-10 MINUTES DUE TO THE EVENT. THE PATIENT DID WELL POST-OP AND WAS DISCHARGED THE FOLLOWING DAY. THE RIGHT FEMORAL ARTERY WAS ACCESSED WITH A 6F SHEATH. THE TARGET ANEURYSM WAS PREVIOUSLY COILED WITH COMPETITOR COILS ONE YEAR PRIOR. THE VESSEL TORTUOSITY WAS LOW. NO VISIBLE PRODUCT DA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876761 ↗
• MalfunctionJul 30, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF A WIDE-NECKED BASILAR TIP ANEURYSM, A 4MM X 30MM ENTERPRISE 2 STENT (ENF403000/10882814) BECAME STUCK IN THE UNSPECIFIED MICROCATHETER. THE ENTERPRISE 2 STENT AND MICROCATHETER WERE EASILY REMOVED FROM THE PATIENT, RESULTING IN A LOSS OF CEREBRAL TARGET POSITION, AND REPLACED WITH NEW DEVICES. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE DEVICE WAS USED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE ENTERPRISE 2 STENT AND THE UNSPECIFIED MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. NO VISIBLE PRODUCT DAMAGE WAS NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PATIENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730987 ↗