ORBIT GALAXY ENPOWER 641CF3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10878528009525), received between Dec 4, 2017 and Mar 30, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Premature Activation; Product Quality Problem; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE SHAPING MANDREL OF A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452200, LOT NUMBER: 9985737) WAS UNABLE TO INSERT INTO THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31691230) TO SHAPE, BUT THE MICRO-GUIDEWIRE COULD PASS THROUGH THE MICROCATHETER (MC). DURING THE PROCEDURE, DOCTOR DELIVERED THE MICROCATHETER IN PLACE. THE STENT WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR TRIED TO RETRACT THE STENT, BUT THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 30 MINUTES. THE SURGEON HAD AN EXTRA SET OF HANDS TO SUPPORT WHILE FLUSHING ALIGNING THE ENTERPRISE SYSTEM. A TWIST-TYPE PUSH PLUNGE ROTATING HEMOSTATIC VALVE (RHV) WAS USED. THE DOCTOR USED INCREASED FORCE TO REMOVE THE DELIVERY WIRE, BUT THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE REPLACEMENT STENT WAS AN ENTERPRIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727601 ↗
• MalfunctionMar 30, 2026Premature Activation; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, A 4.5MMD 22MML ENTERPRISE2 VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENC452200, LOT NUMBER: 10056839) WAS IMPEDED IN Y CONNECTOR AND COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER (MC) THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE Y CONNECTOR. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND REPLACED THEM WITH NEW DEVICES TO COMPLETE THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-MAR-2026 INDICATED THAT A GUIDEWIRE WAS USED IN THE MICROCATHETER PRIOR TO USING THE ENTERPRISE SYSTEM. THERE WAS FLUSHING DURING THE PROCEDURE. THEY WERE ABLE TO TORQUE THE DEVICE. IT IS UNKNOWN IF THERE WAS 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 24715279 ↗
• MalfunctionSep 20, 2022Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN EU ENT4.5MMD 22MML WNO DSTL TIP STENT (ENC452200, 7014926) ARRIVED AT THE TARGET POSITION AND THE PHYSICIAN STARTED TO RELEASE THE STENT, BUT THE STENT COULD NOT BE OPENED. THEN DOCTOR RETRACTED THE STENT AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. IT IS UNKNOWN IF THERE WERE VESSEL OR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THE PHYSICIAN TRIED TO OPEN THE STENT AGAIN, BUT STILL FAILED TO OPEN. THERE WAS NO BLOOD FLOW RESTRICTION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454423 ↗
• MalfunctionSep 6, 2022Activation Failure; Activation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452200 / 6441600) ARRIVED AT THE TARGET POSITION AND THE PHYSICIAN ATTEMPT TO RELEASE IT, BUT THE STENT COULD NOT BE OPENED. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A NEW STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR PATIENT COMPLICATION. ON 29-AUG-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET WAS A 4MM X 8MM UNRUPTURED ANEURYSM. THERE WERE NO VESSEL NOR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED INCOMPLETE EXPANSION. THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE EVENT. THE TEMPERATURE INDICATOR ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THE CONCOMITANT MICROCATHETER USED WAS A 150CM X 5CM PROWLER SELECT PLUS (606S255X / LOT# UNKNOWN). THE INFORMATION INDICATED THAT THERE HAD BEEN RESISTANCE DURING ADVANCEMENT OF THE STENT, THE STENT COULD NOT BE DEPLOYED IN THE MICROCATHETER. THERE WAS NO DAMAGE OBSERVED ON THE MICROCATHETER. THE REPLACEMENT STENT WAS ANOTHER 4.5M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364528 ↗
• MalfunctionAug 22, 2022Break; Failure to Advance; Break; Failure to Advance

  AS REPORTED BY THE FIELD, DURING THE USE OF A 4.5MMD X 22MML ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT WITH NO DISTAL TIP (ENC452200, 6441602), THE STENT WAS PUSHED INTO THE ANEURYSM. THE POSITION OF THE STENT WAS NOT ACCURATE. THE PHYSICIAN TRIED TO RETRACT THE STENT AND DELIVER IT AGAIN, BUT DURING THE PROCESS, THE STENT WAS IMPEDED IN THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE WITHIN IT. THE PHYSICIAN RETRACTED THE STENT AND FOUND IT WAS DEFORMED. THEN A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266068 ↗
• MalfunctionJun 10, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN ENTERPRISE 4.5MMD 22MML INTRACRANIAL NEUROVASCULAR STENT (ENC452200, 6259376) BECAME IMPEDED IN AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE STENT AND FOUND STENT BODY WAS NOT CONNECTED TO THE DELIVERY WIRE. THE STENT WAS FOUND TO BE RELEASED IN MICROCATHETER, AFTER FLUSHED MICROCATHETER WITH SALINE, DOCTOR OBSERVED THE DELIVERY WIRE BROKE. A NEW STENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. PICTURES WERE RECEIVED WITH THE COMPLAINT FILE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655369 ↗
• MalfunctionJan 11, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED COIL EMBOLIZATION, A 4.5MMD 22MML WITH NO DISTAL TIP ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT (ENC452200, 6441602) BECAME IMPEDED AND RELEASED IN THE UNSPECIFIED MICROCATHETER (MC). THE STENT WAS RETRACTED, AND IT WAS FOUND TO BE RELEASED IN A MICROCATHETER. THE PHYSICIAN SWITCHED TO A NEW DEVICE AND THE SAME ISSUE OCCURRED. THEN THE THIRD STENT WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SWITCHED DEVICE WAS ALSO A 4.5MMD 22MML WITH NO DISTAL TIP ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT (ENC452200, 6441602). THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. THERE WAS NO TORQUING OF THE DEVICES. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE RESISTANCE WAS FELT IN THE BODY/SHAFT. A SYNCHRO GUIDEWIRE WAS USED SUCCESSFULLY WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS (LOT: 30593202). THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. THE REPLACED STENT WAS OF THE SAME SIZE AS THE ORIGINAL ONE. THE DIAMETER OF THE VESSEL BEING TREATED WAS 3.2MM. ADEQUATE FLUSH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225552 ↗
• MalfunctionDec 6, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED COIL EMBOLIZATION, AN 4.5MMD 22MML WITH NO DISTAL TIP ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT (ENC452200, 6441602) BECAME IMPEDED AND RELEASED IN THE UNSPECIFIED MICROCATHETER (MC). THE STENT WAS RETRACTED, AND IT WAS FOUND TO BE RELEASED IN MICROCATHETER. THE PHYSICIAN SWITCHED TO A NEW DEVICE AND THE SAME ISSUE OCCURRED. THEN THE THIRD STENT WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938982 ↗
• MalfunctionNov 29, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE TARGETING AN INTRACRANIAL ARTERIAL STENOSIS, THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452200 / 6441601) WAS IMPEDED IN THE MICROCATHETER AND COULD NO LONGER BE ADVANCED, THE PHYSICIAN RETRACTED THE STENT AND FOUND THAT IT WAS RELEASED IN THE MICROCATHETER. THE PHYSICIAN REPLACED THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888748 ↗
• MalfunctionAug 12, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRACRANIAL ISCHEMIC PROCEDURE WITH THE TARGET POSITION AT THE MIDDLE CEREBRAL ARTERY (MCA), THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 6253765) COULD NOT BE ADVANCED NOR WITHDRAWN IN THE 150CM X 5CM, 2 MARKERS PROWLER SELECT PLUS MICROCATHETER (606S255X / 30447565) AFTER THE STENT ARRIVED IN THE TARGET POSITION THROUGH THE MICROCATHETER. THE PHYSICIAN WITHDREW THE STENT AND THE MICROCATHETER TOGETHER FROM THE PATIENT. A NEW MICROCATHETER AND A NEW STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316816 ↗
• MalfunctionJun 30, 2021Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION OF ANEURYSM OF A RIGHT INTERNAL CAROTID ARTERY PETROUS SEGMENT WITH A DISSECTING ANEURYSM, THE DISTAL STENT OF A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD) WITH NO DISTAL TIP (ENC452200, 6259374) COULDN'T DEPLOY. THE USER ADJUSTED THE STENT BUT FAILED AND THE PHYSICIAN WITHDREW THE STENT OUTSIDE OF THE PATIENT BODY. THE DEVICE WAS CHANGED TO A 4.5MMD X 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WITH NO DISTAL TIP (ENC452800, 6218824) BUT THE DISTAL OF THE STENT COULDN'T DEPLOY EITHER. THE USER ADJUSTED THE STENT BUT FAILED AND THEN SWITCHED TO A THIRD ONE TO COMPLETE THE SURGERY. THERE WAS NO INJURY REPORT. THE SIZE OF ANEURYSM WAS 7.5MM X 3.7MM X 3.5MM, DIAMETER OF PROXIMAL PARENT ARTERY WAS 3MM. MEDICAL IMAGING WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092723 ↗
• MalfunctionJun 30, 2021Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION OF ANEURYSM OF A RIGHT INTERNAL CAROTID ARTERY PETROUS SEGMENT WITH A DISSECTING ANEURYSM, THE DISTAL STENT OF A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD) WITH NO DISTAL TIP (ENC452200, 6259374) COULDN¿T DEPLOY. THE USER ADJUSTED THE STENT BUT FAILED AND THE PHYSICIAN WITHDREW THE STENT OUTSIDE OF THE PATIENT BODY. THE DEVICE WAS CHANGED TO A 4.5MMD X 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WITH NO DISTAL TIP (ENC452800, 6218824) BUT THE DISTAL OF THE STENT COULDN¿T DEPLOY EITHER. THE USER ADJUSTED THE STENT BUT FAILED AND THEN SWITCHED TO A THIRD ONE TO COMPLETE THE SURGERY. THERE WAS NO INJURY REPORT. THE SIZE OF ANEURYSM WAS 7.5MM X 3.7MM X 3.5MM, DIAMETER OF PROXIMAL PARENT ARTERY WAS 3MM. MEDICAL IMAGING WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092714 ↗
• MalfunctionJun 8, 2021Retraction Problem; Retraction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, AFTER THE PHYSICIAN IMPLANTED A MEDTRONIC COIL, HE INSERTED THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 6253757) AND DELIVERED IT TO THE TARGET POSITION VIA THE 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30487605). WHEN THE STENT COMPONENT WAS HALF DEPLOYED, THE PHYSICIAN THOUGHT THE POSITION SHOULD BE ADJUSTED. HE PLANNED TO WITHDRAW THE STENT BACK INTO THE MICROCATHETER, BUT THE ATTEMPT WAS NOT SUCCESSFUL. THE PHYSICIAN WITHDREW THE STENT AND THE MICROCATHETER FROM THE PATIENT. OUTSIDE THE PATIENT¿S BODY, THE MICROCATHETER WAS OBSERVED BENT. THE PHYSICIAN SWITCHED TO A NEW STENT (MEDTRONIC) AND MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958009 ↗
• MalfunctionApr 21, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL LARGE VESSEL OCCLUSION AND RECANALIZATION IN THE NON-ACUTE STAGE, A 4.5MMD 22MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WITH NO DISTAL TIP (ENC452200, 5852763) BECAME IMPEDED. THE STENT COULDN¿T ADVANCE WITHIN THE UNSPECIFIED MICROCATHETER (MC) WHEN IT ARRIVED AT THE MIDDLE OF THE MC. IT COULDN¿T ADVANCE OR MOVE BACK. THEREFORE, THE PHYSICIAN REMOVED THE STENT SYSTEM AND MICROCATHETER TOGETHER OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED BY ANOTHER NEW STENT SYSTEM AND MICROCATHETER (SAME CODE AS THEM). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699730 ↗
• MalfunctionMar 1, 2021Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED COIL EMBOLIZATION, THE STENT BODY OF A 4.5MMD 22MML ENTERPRISE WITH NO DISTAL TIP (ENC452200, 5874652) DETACHED IN THE UNSPECIFIED MICROCATHETER (MC) WITHOUT EXPECTATION. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT SYSTEM OUTSIDE OF THE PATIENT. THE CEREBRAL TARGET POSITION WAS LOST. THEN THE PHYSICIAN SWITCHED TO ANOTHER NEW MC AND STENT SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NOT PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392406 ↗
• MalfunctionJan 21, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING THE STENTING FOR INTRACRANIAL ARTERY STENOSIS, A 4.5X22MM ENTERPRISE STENT (ENC452200, 5852769) WAS NOT ABLE TO ADVANCE OR BACK WITHIN A HEADWAY 21 MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT SYSTEM AND MICROCATHETER OUTSIDE OF THE PATIENT BODY TOGETHER. THE STENT DEPLOYED WHEN IT WAS WITHDRAWN WITHIN THE MICROCATHETER. THE PHYSICIAN SWITCHED TO ANOTHER NEW STENT SYSTEM (SAME CODE AS THE COMPLAINT PRODUCT) AND A NEW MICROCATHETER (SAME CODE AS THE ORIGINAL ONE) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207302 ↗
• InjuryDec 4, 2020Difficult to Advance; Difficult to Advance

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, A 5MM X 15CM ORBIT GALAXY TDL COMPLEX FILL (640CF0515/30298966) COIL PREMATURELY DETACHED AND RELEASED TO THE MIDDLE AND ANTERIOR CEREBRAL ARTERY. A SAB640 STENT RETRIEVER WAS USED IN ATTEMPT TO RETRIEVE THE COIL BUT WAS UNSUCCESSFUL. THEREFORE, A 4.5MM X 22 ENTERPRISE NO TIP ENTERPRISE (ENC452200/11213047) STENT WAS IMPLANTED VIA A PROWLER SELECT PLUS (606-S255X/30378173) MICROCATHETER AT THE MIDDLE CEREBRAL ARTERY (MCA) TO SECURE THE COIL TO THE VESSEL WALL. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE COIL THROUGH THE HEADWAY 17 (MICROVENTION) MICROCATHETER AND THE 6F ENVOY (67025800/30232241) GUIDE CATHETER SUBSEQUENTLY MOVED FROM THE C2 TO THE M1. IT WAS FURTHER STATED THAT THIS MAY HAVE CAUSED THE COIL TO UNINTENDEDLY RELEASE. THE PATIENT HAS BEEN AWAKE. THE VESSELS WERE CONSIDERED NORMAL, WITHOUT ACUTE BENDS OR EXCESSIVE TORTUOSITY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT POST-PROCEDURE ANGIOGRAPHY SHOWED SMOOTH BLOOD FLOW IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND THE ORIGINAL ANEURYSM WAS NO LONGER DEVELOPED. THROMBOSIS WAS NOTED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10948917 ↗
• MalfunctionNov 2, 2020Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL STENT ASSIST ANEURYSM EMBOLIZATION, WHILE ADVANCING A 4.5MM ENTERPRISE STENT (ENC452200, 11195613), THE STENT DEPLOYED PREMATURELY WITHIN THE UNKNOWN MICROCATHETER (MC). THE PHYSICIAN WITHDREW THE STENT SYSTEM AND MICROCATHETER OUTSIDE OF THE PATIENT. CHANGED TO A NEW STENT AND MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURED REPORTED. A DEVICE PHOTO WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10770888 ↗
• MalfunctionAug 3, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT IMPLANTATION PROCEDURE FOR AN INTRACRANIAL ATHEROSCLEROSIS TARGETING THE RIGHT INTERNAL CAROTID ARTERY (ICA) COMMUNICATING SEGMENT IN THE (B)(6) YEAR OLD MALE PATIENT WHO PRESENTED WITH CEREBRAL INFARCTION, RIGHT INTERNAL CAROTID ARTERY OCCLUSION, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 11140854) BECAME DETACHED FROM ITS DELIVERY WIRE WHEN THE STENT WAS INSIDE THE PROWLER SELECT PLUS MICROCATHETER (UNKNOWN CATALOG/LOT NUMBER). ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ANOTHER SIMILAR DEVICE WENT THROUGH THE MICROCATHETER WITHOUT ANY DIFFICULTY. IT WAS REPORTED THAT THE STENT COULD NOT REACH THE TARGET POSITION. THE PHYSICIAN WITHDREW THE STENT FROM THE PATIENT AND REPLACED IT WITH A NEW 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE TO COMPLETE THE PROCEDURE USING THE SAME PROWLER SELECT PLUS MICROCATHETER. THE STENT AND THE STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGE. THE DEVICE WAS PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU); THERE WAS NOTHING UNUSUAL NOTED ON THE COMPLAINT DEVICE PRIOR TO USE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10358453 ↗
• MalfunctionJun 8, 2020Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL ANEURYSM EMBOLIZATION, THE DELIVERY WIRE OF A 4.5MMD 22MML ENTERPRISE STENT DELIVERY SYSTEM (ENC452200, 11186590) WAS DETACHED FROM STENT BODY. IT WAS REPORTED THAT WHEN THE STENT WAS ADVANCING IN THE 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255X, 30272527), THE PHYSICIAN FOUND THE DELIVERY WIRE WAS TOTALLY DETACHED FROM THE STENT. THEN HE WITHDREW THE STENT AND MICROCATHETER (MC) TOGETHER OUTSIDE OF THE PATIENT. THE PHYSICIAN USED A NEW ENTERPRISE STENT (CODE: ECR452212) AND A NEW PROWLER SELECT MC (CODE: 606S255X) TO COMPLETE THE PROCEDURE. THE TARGET CEREBRAL POSITION WAS LOST. THERE WAS NO PATIENT INJURY REPORTED. THE BLOOD VESSELS ARE ABNORMALLY TORTUOUS. THE PHYSICIAN THOUGHT THE STENT WAS DETACHED FROM ITS DELIVERY WIRE WHEN IT CROSSED A SHARP BEND OF BLOOD VESSELS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128552 ↗
• MalfunctionDec 4, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COILING OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN WAS NOT ABLE TO RESHEATH TWO G2 COMPLEX COIL (641CF0308/C17353 AND 641CF3509/P11743). THE RESHEATHING TOOL BECAME "STUCK". THE COILS HAD ALREADY BEEN INSIDE THE ANEURYSM, BUT DID NOT FIT AS WISHED SO THEY HAD TO PULL IT BACK. THE EVENT RESULTED IN A 10 MINUTE PROCEDURE DELAY. THERE WAS NO REPORTED DIFFICULTY DURING UNSHEATHING THE COIL AND EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE PRESCORE DID NOT OPEN AND THE COIL AND DPU DID NOT PROTRUDE FROM THE INTRODUCER. THERE WAS NO EVIDENCE OF DAMAGE TO THE ACTUAL COIL. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE PRODUCT. DURING PRODUCT ANALYSIS, IT WAS DETERMINED THAT THE COIL WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7080967 ↗