ORBIT GALAXY ENPOWERRecalls & reported problems across all models

We found 16 models of ORBIT GALAXY ENPOWER by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Sep 2, 2016 and Mar 30, 2026 — classified as 8 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ORBIT GALAXY ENPOWER problems

ORBIT GALAXY ENPOWER models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORBIT GALAXY ENPOWER 641CF3509

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• ORBIT GALAXY ENPOWER 641CF3575

  DEVICE, NEUROVASCULAR EMBOLIZATION
  14 reports
• ORBIT GALAXY ENPOWER 641CF2505

  Device, Vascular, for Promoting Embolization
  9 reports
• ORBIT GALAXY ENPOWER 641CF0925

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• ORBIT GALAXY ENPOWER 641CF0620

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• ORBIT GALAXY ENPOWER 641CF1230

  Device, Vascular, for Promoting Embolization
  6 reports
• ORBIT GALAXY ENPOWER 641CF0412

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• ORBIT GALAXY ENPOWER 641CF0515

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• ORBIT GALAXY ENPOWER 641CF0721

  Device, Vascular, for Promoting Embolization
  3 reports
• ORBIT GALAXY ENPOWER 641CF1030

  Device, Vascular, for Promoting Embolization
  3 reports
• ORBIT GALAXY ENPOWER 641CF0308

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• ORBIT GALAXY ENPOWER 641CF0824

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• ORBIT GALAXY ENPOWER 641CF0201

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY ENPOWER 641CF0304

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY ENPOWER 641CF0306

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY ENPOWER 641CF0615

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent ORBIT GALAXY ENPOWER adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionApr 4, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 8582189) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED ONLY THE STENT AND FOUND THAT IT HAD DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. THE PHYSICIAN REPLACED THE STENT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21776042 ↗
• MalfunctionDec 2, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 14MML WNO DSTL TP INTRACRANIAL STENT (ENC451400, 8878743) WAS PLACED IN THE TARGET SITE AND TRIED TO RELEASE. THE 3 DISTAL MARKERS OF THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN ONLY RETRACTED THE STENT AND DELIVERED IT AGAIN TO RELEASE, BUT THE 3 DISTAL STENT MARKERS WERE STILL FAILED TO OPEN. MICRO-GUIDEWIRE WAS USED TO MASSAGE THE STENT, BUT THE MARKERS WERE STILL UNABLE TO OPEN. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 21-NOV-2024 INDICATING 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 STENT DID NOT APPEAR DAMAGED. IT WAS NOTED THAT THE RELEASE SITE AT THE HEAD END IS STRAIGHT BLOOD VESSEL. MASSAGE WAS APPLIED TO THE HEAD END GUIDE WIRE. THERE WAS NO STENT MIGRATION OR EMBOLIZATION OF THE STENT. THE PROCEDURE WAS DELAYED BY 5 MINUTES DUE TO THE EVENT BUT WAS NOT CLINICALLY SIGNIFICANT. ADDITIONAL EVENT INFORMATION WAS RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821097 ↗
• MalfunctionOct 21, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452212 / 8878724) WAS IMPEDED IN THE PROXIMAL AREA OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31342751) AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 14-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION CONFIRMED THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS NO LONGER STILL ON THE DELIVERY WIRE. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE ADDITIONAL INFORMATION CONFIRMED THERE WAS NO NEGATIVE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500683 ↗
• MalfunctionAug 6, 2024Product Quality Problem; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 14MML WNO DSTL TP INTRACRANIAL STENT (ENC451400, 8337176) WAS PLACED IN TARGET SITE AND STARTED TO RELEASE. THE PHYSICIAN COULD NOT OBSERVE THE STENT POSITIONING MARKER AND THE STENT DISTAL MARKERS. THE DOCTOR RETRACTED THE STENT AND GAVE UP IMPLANTING A STENT AND COMPLETED THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JUL-2024 INDICATED THAT THE RADIOPAQUE OF DEVICE WAS WORSE THAN EXPECTED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918247 ↗
• MalfunctionAug 5, 2024Material Separation; Material Separation

  AS REPORTED BY THE FIELD, DURING A ENDOVASCULAR EMBOLIZATION, AT THE TIME OF DELIVERING AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 8697557) IN A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN), THE FORCE (TO DELIVER THE STENT) FELT BY THE PHYSICIAN REDUCED SUDDENLY. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND OBSERVED THE DELIVERY WIRE BROKE AND THE REST OF THE STENT WAS REMAINED IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE REST OF THE STENT FROM THE MICROCATHETER WITH OTHER DEVICES. AND THEN THE SAME MICROCATHETER WAS USED TO DELIVER A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JUL-2024 INDICATED THAT THERE WAS NO EVIDENCE OF FRAGMENTS REMAINING IN THE PATIENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS EXAMINED PRIOR TO USE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906406 ↗
• 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 11, 2022Break; Failure to Advance; Break; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452212 / 7044261) WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE STENT BODY WAS DEFORMED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE; THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 06-SEP-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE MICROCATHETER USED WAS A 150/5CM PROWLER SELECT PLUS (606S255X / 30772057). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. DURING THE PROCEDURE THE STENT WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE STENT AND FOUND THE STENT BODY WAS DEFORMED. DETAILS ON THE REPORTED DAMAGE / DEFORMATION WAS NOT PROVIDED. THE STENT COMPONENT WAS REPORTED TO STILL BE ATTACHED TO THE DELIVERY WIRE WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE NOTED ON THE MICROCATHETER. THE REPLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15398152 ↗
• 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 ↗
• InjuryJul 18, 2022Malposition of Device; Difficult to Advance; Malposition of Device; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LESION ON THE RIGHT VERTEBRAL ARTERY (VA), A 4.0MM X 39MM NO DISTAL TIP ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC403900 / 6920525) WAS USED; THE JAILING TECHNIQUE WAS ATTEMPTED AT FIRST, BUT THE MICROCATHETER FOR COIL EMBOLIZATION COULD NOT BE SET AT THE IDEAL POSITION, AS A RESULT, THE COIL EMBOLIZATION WAS ABANDONED. AFTER SETTING UP THE 7FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC), A SYNCHRO SELECT¿ 14 GUIDEWIRE (STRYKER), AND A CONCOMITANT PROWLER SELECT PLUS (CATALOG/LOT# UNKNOWN) AT THE DISTAL VA, WHEN THE GUIDEWIRE WAS REMOVED AND THE ENTERPRISE STENT WAS BEING DELIVERED, THERE WAS A HEAVY RESISTANCE FELT AND THE ENTERPRISE STENT COULD NOT BE ADVANCED, EVEN WHEN PUSHED WITH CONSIDERABLE FORCE. THE ENTERPRISE STENT WAS REMOVED ONCE AND RE-FLUSHED. IT WAS DELIVERED AGAIN, BUT STILL COULD NOT ADVANCE. IT WAS REPORTED THAT ¿THE COMPLAINT PRODUCT WAS PUSHED SOMEHOW AND DEPLOYED.¿ DURING DEPLOYMENT, THE STENT COMPONENT SLIPPED AND SLID DOWN FROM THE DISTAL SIDE. THE FINAL DEPLOYMENT WAS COMPLETED WITH THE STENT COMPONENT A LITTLE CLOSER TO THE INSERTION SITE THAN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048626 ↗
• MalfunctionJun 15, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH A PREOPERATIVE DIAGNOSIS OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, CEREBRAL ISCHEMIC LESION, AND EMPHYSEMA UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM USING AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400/6920527). PER THE EVENT DESCRIPTION, TRANSFEMORAL PUNCTURE, WHOLE CEREBRAL ANGIOGRAPHY, AND STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM WERE PERFORMED. A MICROCATHETER WAS PLACED IN POSITION AND THE PHYSICIAN PUSHED THE STENT INTO THE MICROCATHETER. THE DELIVERY WIRE WAS IN GOOD CONDITION DURING ITS DELIVERY, BUT IT DID NOT REACH THE REFERENCE MARKERS ON THE DELIVERY WIRE. AT THAT MOMENT, UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE STENT HAD BEEN RELEASED TO THE DISTAL END OF THE LESION SITE WITHOUT INTENTION, AND THAT THE STENT DID NOT COVER THE LESION SITE CORRECTLY. THE PHYSICIAN THEN RELEASED A NEW ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400) AND IT COMPLETELY COVERED THE ANEURYSM. AFTER SOME TIME, THE ANGIOGRAM SHOWED THAT THE STENT HAD MIGRATED ANTERIORLY. THE PROCEDURE WAS PROLONGED FOR ABOUT AN HOUR AND A HALF. THE PATIENT IS CURRENTLY ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697005 ↗
• InjuryJun 15, 2022Premature Activation; Migration; Premature Activation; Migration

  IT WAS REPORTED THAT A PATIENT WITH A PREOPERATIVE DIAGNOSIS OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, CEREBRAL ISCHEMIC LESION, AND EMPHYSEMA UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM USING AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400/6920527). PER THE EVENT DESCRIPTION, TRANSFEMORAL PUNCTURE, WHOLE CEREBRAL ANGIOGRAPHY, AND STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM WERE PERFORMED. A MICROCATHETER WAS PLACED IN POSITION AND THE PHYSICIAN PUSHED THE STENT INTO THE MICROCATHETER. THE DELIVERY WIRE WAS IN GOOD CONDITION DURING ITS DELIVERY, BUT IT DID NOT REACH THE REFERENCE MARKERS ON THE DELIVERY WIRE. AT THAT MOMENT, UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE STENT HAD BEEN RELEASED TO THE DISTAL END OF THE LESION SITE WITHOUT INTENTION, AND THAT THE STENT DID NOT COVER THE LESION SITE CORRECTLY. THE PHYSICIAN THEN RELEASED A NEW ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400) AND IT COMPLETELY COVERED THE ANEURYSM. AFTER SOME TIME, THE ANGIOGRAM SHOWED THAT THE STENT HAD MIGRATED ANTERIORLY. THE PROCEDURE WAS PROLONGED FOR ABOUT AN HOUR AND A HALF. THE PATIENT IS CURRENTLY ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696964 ↗
• 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 ↗

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