TARGET M0035442030Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613252600312), received between Jun 1, 2016 and Apr 13, 2024 — classified as 16 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 13, 2024Migration; Premature Separation; Migration; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL WOULD NOT DETACH AFTER DEPLOYMENT IN THE ANEURYSM. WHEN THE PHYSICIAN WAS REMOVING THE SUBJECT COIL, IT GOT STUCK AND THEN DETACHED AND TRAVELED TO THE PATIENTS MIDDLE CEREBRAL ARTERY (MCA) DISTAL BRANCH. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED COIL BY PERFORMING ASPIRATION, BUT THE SUBJECT COIL CONTINUED TO TRAVEL FURTHER IN THE PATIENTS MCA AND WAS UNABLE TO BE REMOVED. THE SUBJECT COIL MIGRATED FAR ENOUGH THAT IT DID NOT IMPACT THE PATIENT OR THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENTS CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19102778 ↗
• MalfunctionOct 31, 2023Premature Separation; Premature Separation

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE COIL (SUBJECT DEVICE) PREMATURELY DETACHED/SEPARATED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037430 ↗
• MalfunctionAug 16, 2023Fracture; Fracture

  THE COIL (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE MAIN COIL (SUBJECT DEVICE) WAS BROKEN/FRACTURED DURING USE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559540 ↗
• MalfunctionMar 23, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AFTER INSERTING AND ADVANCING THE SUBJECT COIL INTO THE MICROCATHETER, THE SUBJECT COIL SUDDENLY COULD NOT BE TORQUED. WHEN RETRACTED, IT WAS FOUND THAT THE SUBJECT COIL WAS PREMATURELY DETACHED. THE SUBJECT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603179 ↗
• MalfunctionMar 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL COULD NOT BE DETACHED FOLLOWING THREE ATTEMPTS WITH ONE INZONE DEVICE AND ONE ATTEMPT WITH A NEW INZONE DEVICE. THE COIL WAS FOUND TO BE BROKEN AND REMOVED FROM THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545171 ↗
• MalfunctionJan 9, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION WAS PERFORMED FOR SAH (SUBARACHNOID HEMORRHAGE) AT IC-PC. THE MICROCATHETER WAS PLACED IN AN ANEURYSM AND 6 TARGET COILS WERE PLACED IN THE ANEURYSM. AFTER THAT, 7TH SUBJECT COIL WAS INSERTED AND TRIED TO DETACH THE SUBJECT COIL AFTER ALIGNING THE SECOND MARKER AND INSERTING THE DELIVERY WIRE INTO THE INZONE DETACHMENT SYSTEM DEVICE. WHEN THREE BEEPS WERE HEARD FROM THE INZONE DETACHMENT SYSTEM, THE OPERATOR PULLED THE DELIVERY WIRE, AND IT WAS FOUND THAT THE SUBJECT COIL FAILED TO DETACH IN THE ANEURYSM AND IT WAS PREMATURELY DETACHED IN THE CATHETER. THE MICROCATHETER AND THE SUBJECT COIL WERE REMOVED TOGETHER. THE NEW MICROCATHETER WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127308 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE STUDY PROCEDURE ABOUT 9 HOURS, THE PATENT HAD AN ISCHEMIC STROKE AT THE RIGHT PARIETAL LOBE. PATIENT WAS ESSENTIALLY BACK TO BASELINE BY THE FOLLOWING DAY, WITH THE EXCEPTION OF MINIMAL NUMBNESS. 8 DAYS POST PROCEDURE, PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) WITH THE SAME INITIAL SYMPTOMS IN ADDITION TO TRANSIENT BLURRED VISION IN THE LEFT EYE. PATIENT WAS KEPT FOR 12 HOURS FOR OBSERVATION. HAD CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) DONE WHICH BOTH REFLECTED NO CHANGE. PER NEUROLOGIST, "SUSPECT SYMPTOMS ARE RELATED TO RECRUDESCENCE OF PREVIOUS PUNCTATE INFARCT EARLIER THIS MONTH. THE CAUSE OF STROKE POST PROCEDURE WAS THROMBOEMBOLISM. PATIENT WAS STARTED ON CLOPIDOGREL AND ATORVASTATIN WHEN RELEASED TO HOME. THE OUTCOME OF THIS ADVERSE EVENT IS ¿ONGOING¿ AT THIS MOMENT. IN PHYSICIAN¿S OPINION, THERE WERE NO ANY DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S STROKE POST PROCEDURE AS THE SUBJECT COIL DEVICE WAS PERFORMED AS INTENDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Ischemia Stroke; Numbness; Thromboembolism

  MAUDE report 15984106 ↗
• MalfunctionJul 9, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE EMBOLISM PROCEDURE, THE SUBJECT COIL COULD NOT DETACH AT THE ANEURYSM WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY IT. HOWEVER, THE SUBJECT COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER WHEN IT WAS BEING REMOVED FROM THE PATIENT¿S ANATOMY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147641 ↗
• InjuryJun 23, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SUBJECT COIL WAS PERFORMED FOR BA (BASILAR ARTERY) -SCA CEREBRAL ANEURYSM. THE SUBJECT COIL WAS USED AS THE 29TH COIL. AFTER PLACING THE SUBJECT COIL IN THE ANEURYSM AND PERFORMED THE DETACHMENT WITH INZONE DEVICE: HEARING 3 BEEP SOUND FROM INZONE DEVICE, THE DELIVERY WIRE OF THE SUBJECT COIL WAS PULLED. AT THAT TIME ABOUT 2 CM OF THE SUBJECT COIL PULLED INTO THE TIP OF THE MICROCATHETER. SO, DETACHMENT WITH INZONE DEVICE WAS DONE AGAIN AT THE TIP OF THE MICROCATHETER. THEN, THE SURGEON TRIED TO PUSH THE SUBJECT COIL INTO THE ANEURYSM WITH THE DELIVERY WIRE, BUT HE COULDN'T PUSH THE DELIVERY WIRE. SO, HE TRIED TO REMOVE THE SUBJECT COIL TOGETHER WITH THE MICROCATHETER, BUT THE SUBJECT COIL DID NOT COME OUT. THEREFORE, THE SUBJECT COIL WAS REMOVED USING A GOOSENECK SNARE AND COMPLETED THE PROCEDURE. SURGICAL DELAY OF 40 MINUTES WAS REPORTED DUE TO THE EVENT WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. ACCORDING TO THE PHYSICIAN, THE DELIVERY WIRE WAS CAREFULLY REMOVED AFTER THE SUBJECT COIL DETACHED WITH INZONE DETACHMENT DEVICE, BUT IT THE SUBJECT COIL WAS NOT SEEMED TO BE PULLED AT THAT TIME. WHEN THE DELIVERY WIRE WAS PULLED OUT ABOUT 2 CM, THE COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054578 ↗
• InjuryJun 18, 2021Migration; Migration

  IT WAS REPORTED THE SUBJECT COIL WAS USED AS THE SECOND COIL FOR UNRUPTURED CEREBRAL ANEURYSMS. AFTER DETACHING THE SUBJECT COIL THEN THE DELIVERY WIRE WAS REMOVED. AFTER THAT, WHEN THE MICROCATHETER MIGRATED FROM THE EMBOLIZED COIL MASS IN THE ANEURYSM, THE SUBJECT COIL WAS ALSO MIGRATED ABOUT A LITTLE OVER 0.1". THEREFORE, THE SNARE WAS USED TO RETRIEVE THE SUBJECT COIL. THE PHYSICIAN SPECULATES THAT THE EVENT WAS CAUSED BY DETACHMENT FAILURE OR REVERSE INFLOW OF THE DISTAL END OF THE SUBJECT COIL INTO THE CATHETER AFTER THE SUBJECT COIL WAS DETACHED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12028789 ↗
• MalfunctionSep 18, 2020Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR CEREBRAL ANEURYSM EMBOLIZATION, THE SUBJECT COIL AND DELIVERY WIRE WAS SUSPECTED OF BEING STUCK WITHIN THE MICROCATHETER WHEN ATTEMPTING TO COLLECT THE DELIVERY WIRE AND WAS NOT COLLECTED. PHYSICIAN ATTEMPTED TO ADVANCE THE SUBJECT DELIVERY WIRE AGAIN TO THE DETACH POINT AND WAS MET WITH STRONG RESISTANCE. PHYSICIAN THEN FELT THE SUBJECT COIL SEPARATE FROM THE MICROCATHETER AND ATTEMPT THE DETACHMENT PROCESS AGAIN TO COLLECT THE DELIVERY WIRE. PHYSICIAN THEN NOTED THAT THE FRAMING COIL THAT HAD BEEN PLACED BEFORE HAD SLIGHTLY MOVED AND WAS DISPLACED TO THE PARENT ARTERY SIDE. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553849 ↗
• InjuryDec 17, 2019Migration; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS DETACHED TO FRAME THE ANEURYSM; HOWEVER, THE COIL COMPLETELY CHANGED ITS SHAPED AND BECAME STRETCHED THEN WENT THROUGH THE FIRST STENT THAT WAS PLACED AND INTO THE PARENT VESSEL. ANOTHER STENT WAS PLACED SUCCESSFULLY TO PUSH BACK THE STRETCHED COIL INTO THE ANEURYSM. THE PROCEDURE WAS NOT COMPLETED ENTIRELY, THE PATIENT NEEDS MORE COIL AND THE PHYSICIAN IS PLANNING TO TREAT THE ANEURYSM IN SEVERAL MONTHS. THE PATIENT IS CURRENTLY DOING GOOD AND NO KNOWN CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9485204 ↗
• InjuryNov 7, 2019Expulsion; Unintended Movement; Expulsion; Unintended Movement

  IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE FOR THE RUPTURED ANEURYSM IN THE POSTERIOR CEREBRAL ARTERY, A STENT WAS DEPLOYED AND THEN A COIL(SUBJECT DEVICE) WAS DEPLOYED. HOWEVER, THE COIL WAS NOT ABLE TO DETACHED BY THE INZONE POWER SUPPLY. THE PHYSICIAN TRIED TO CHANGE THE POWER SUPPLY BUT THE COIL WAS STILL NOT ABLE TO DETACH. THEREFORE, THE PHYSICIAN TRIED TO APPLY TORQUE AND DETACH THE COIL MECHANICALLY. HOWEVER, A PART OF THE SUBJECT COIL FROM PROXIMAL END PROTRUDED FROM THE ANEURYSM. A STENT WAS USED TO FIX THE PROTRUDED COIL AGAINST THE VESSEL WALL. THERE WERE OTHER DIFFICULTIES EXPERIENCED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE EVENT. ONE MORE COIL WAS DEPLOYED AFTER THE REPORTED EVENT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 9292948 ↗
• InjuryAug 19, 2019Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE FINISHING FOURTH COIL (SUBJECT DEVICE) DID NOT DETACHED INSIDE THE ANEURYSM. THE PHYSICIAN PULLED THE DELIVERY WIRE AND THE COIL ALTOGETHER AND THE COIL DETACHED. THE SUBJECT COIL WAS PROTRUDING FROM THE ANEURYSM INTO THE PARENT VESSEL AND WAS FIXED BY STENTING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908458 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTH POST STENT-ASSISTED COIL EMBOLIZATION OF RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC ARTERY, THE PATIENT EXPERIENCED DIZZINESS THAT WAS RESOLVED THE SAME DAY WITHOUT RESIDUAL EFFECT. MRI WAS DONE AND THE PATIENT WAS REFERRED TO FOLLOW UP AT BALANCE CENTER. THE PHYSICIAN ESTABLISHED THAT THE DIZZINESS WAS RELATED TO THE PROCEDURE, TO THE STENT, AND TO COILS (SUBJECT DEVICES). THE PATIENT WAS ASSESSED NEUROLOGICALLY AFTER PROCEDURE AND AT 2 MONTH POST-PROCEDURE WITH MRS OF 0. AT 6 MONTH AND 12 MONTH POST PROCEDURE, NIHSS AND MRS WERE 0.

  Patient problems: Dizziness

  MAUDE report 7192165 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTH POST STENT-ASSISTED COIL EMBOLIZATION OF RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC ARTERY, THE PATIENT EXPERIENCED DIZZINESS THAT WAS RESOLVED THE SAME DAY WITHOUT RESIDUAL EFFECT. MRI WAS DONE AND THE PATIENT WAS REFERRED TO FOLLOW UP AT BALANCE CENTER. THE PHYSICIAN ESTABLISHED THAT THE DIZZINESS WAS RELATED TO THE PROCEDURE, TO THE STENT, AND TO COILS (SUBJECT DEVICES). THE PATIENT WAS ASSESSED NEUROLOGICALLY AFTER PROCEDURE AND AT 2 MONTH POST-PROCEDURE WITH MRS OF 0. AT 6 MONTH AND 12 MONTH POST-PROCEDURE, NIHSS AND MRS WERE 0.

  Patient problems: Dizziness

  MAUDE report 7192157 ↗
• InjuryJan 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE BASILAR APEX. POST-PROCEDURE THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING A MRS OF 1. ONE DAY POST-PROCEDURE, THE PATIENT EXPERIENCED HEADACHE THAT IS ONGOING. MEDICATION (NON-SPECIFIED) WAS REQUIRED. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE, TO THE STENT, AND TO THE COILS (SUBJECT DEVICES).

  Patient problems: Headache

  MAUDE report 7156432 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STENT ASSISTED COIL EMBOLIZATION OF THE UN-RUPTURED ANEURYSM, THE PATIENT EXPERIENCED HEADACHE WHICH RESOLVED WITHOUT RESIDUAL EFFECT THE NEXT DAY. POST PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AND THE ANEURYSM OCCLUSION STATUS WAS ASSESSED AS 2 - RESIDUAL NECK/DOG EAR DEFINED AS THE PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL. THE STUDY FACILITY ASSESSED THE HEADACHE AS BEING POSSIBLY RELATED TO THE STENT AND PROCEDURE; HOWEVER, UNKNOWN TO THE IMPLANTED COILS (SUBJECT DEVICE) AND MICROCATHETERS. DURING PATIENT FOLLOW UP VISITS AT 2 AND 6 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6939369 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 9 MONTHS POST PROCEDURE, THE PATIENT EXPERIENCED BILATERAL WEAKNESS. THE BILATERAL WEAKNESS WAS ONGOING AND A MRI PROCEDURE WAS PERFORMED SHOWING STABLE FINDINGS CONSISTENT WITH CHRONIC SMALL VESSEL ISCHEMIC WHITE MATTER CHANGE. NO INFARCTION WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE BILATERAL WEAKNESS WAS UNRELATED TO THE PROCEDURE AND STENTS. HOWEVER IT IS UNKNOWN IF THE BILATERAL WEAKNESS WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2, 6 AND 12 MONTHS AND A NIHHS OF 0 AT 12 MONTHS POST THE INDEX PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 6870486 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 9 MONTHS POST PROCEDURE, THE PATIENT EXPERIENCED BILATERAL WEAKNESS. THE BILATERAL WEAKNESS WAS ONGOING AND A MRI PROCEDURE WAS PERFORMED SHOWING STABLE FINDINGS CONSISTENT WITH CHRONIC SMALL VESSEL ISCHEMIC WHITE MATTER CHANGE. NO INFARCTION WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE BILATERAL WEAKNESS WAS UNRELATED TO THE PROCEDURE AND STENTS. HOWEVER IT IS UNKNOWN IF THE BILATERAL WEAKNESS WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). THE PATIENT WAS ASSESSED HAVING A MRS OF 0 AT 2, 6 AND 12 MONTHS AND A NIHHS OF 0 AT 12 MONTHS POST THE INDEX PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 6870459 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN UN-RUPTURED ANEURYSM LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MODIFIED RANKING SCALE (MRS) OF 0. AT TWO MONTHS FOLLOW-UP VISIT, THE PATIENT WAS ASSESSED HAVING A MRS OF 0. IT WAS REPORTED THAT 6 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE, THE PATIENT EXPERIENCED HEADACHE. THE HEADACHE WAS REPORTED AS ONGOING AND MEDICATION (UNKNOWN TYPE AND DOSE) WAS ADMINISTERED. ACCORDING TO THE PHYSICIAN, THE HEADACHE WAS POSSIBLY RELATED TO THE PROCEDURE AND TO THE STENT. HOWEVER IT IS UNKNOWN IF THE HEADACHE WAS RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). AT THE 6 MONTHS FOLLOW-UP THE PATIENT WAS ALSO ASSESSED HAVING A NIHSS AND MRS OF 0. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Headache

  MAUDE report 6870328 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE BASILAR ARTERY APEX. THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING POST-PROCEDURE A MRS OF 1 AND NIHSS 0. IT WAS REPORTED THAT 5-DAY POST-PROCEDURE THE PATIENT NOTICED A BRIGHT "JELLY" TYPE LIGHT IN BOTH EYES. THE ADVERSE EVEN WAS RESOLVED WITHOUT RESIDUAL EFFECTS. 10 DAYS POST-PROCEDURE, THE PATIENT REPORTED A SIMILAR EPISODE OF VISUAL DISTURBANCE IN THE LEFT EYE DESCRIBED AS A BRIGHT LIGHT AT THE BOTTOM OF HER VISUAL FIELD THAT LASTED FOR 5 MINUTES. MRI WAS UNDERTAKEN AND MRI IMPRESSION WERE NEGATIVE (NO INTRACRANIAL ARTERIAL STENOSIS OR INFARCTION IDENTIFIED). ACCORDING TO THE PHYSICIAN, THE VISUAL DISTURBANCE WAS PROBABLY RELATED TO THE PROCEDURE, STENT, AND UNKNOWN IF RELATED TO THE IMPLANTED COILS (SUBJECT DEVICES). THE PATIENT WAS NEUROLOGICALLY ASSESSED AS HAVING A MRS OF 0 AT 2-MONTHS, A NIHSS AND MRS OF 0 AT 6 AND 12 MONTHS FOLLOW-UP POST THE INDEX PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 6850742 ↗
• InjuryJul 6, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING REPOSITIONING OF THE COIL INTO MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, A PORTION OF THE COIL STRETCHED. IT WAS REPORTED THAT THE STRETCHED PORTION MIGRATED TO THE M2 SEGMENT RESULTING IN OCCLUSION OF THE BLOOD FLOW. THE PHYSICIAN DEPLOYED AN ENTERPRISE STENT TO SECURE THE STRETCHED PORTION AGAINST THE VESSEL WALL. IN ADDITION, UROKINASE (DOSE UNKNOWN) WAS ARTERIAL INJECTED RESULTING IN RECANALIZATION OF BLOOD FLOW. IT WAS REPORTED THAT POST PROCEDURE A MILD INFARCTION WAS CONFIRMED AND ADDITIONAL UROKINASE (DOSE UNKNOWN) WAS ADMINISTERED. THE PHYSICIAN INDICATED THAT DURING THE PROCEDURE TWO COILS WERE DEPLOYED; HOWEVER, THE PHYSICIAN COULD NOT DETERMINED WHICH OF THE TWO COILS (SAME SIZE WITH DIFFERENT LOT #) HAD PARTIALLY MIGRATED TO THE M2 SEGMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Occlusion; Stroke/CVA; Thrombosis

  MAUDE report 5772198 ↗
• InjuryJul 6, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING REPOSITIONING OF THE COIL INTO MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, A PORTION OF THE COIL STRETCHED. IT WAS REPORTED THAT THE STRETCHED PORTION MIGRATED TO THE M2 SEGMENT RESULTING IN OCCLUSION OF THE BLOOD FLOW. THE PHYSICIAN DEPLOYED AN ENTERPRISE STENT TO SECURE THE STRETCHED PORTION AGAINST THE VESSEL WALL. IN ADDITION, UROKINASE (DOSE UNKNOWN) WAS ARTERIAL INJECTED RESULTING IN RECANALIZATION OF BLOOD FLOW. IT WAS REPORTED THAT POST PROCEDURE A MILD INFARCTION WAS CONFIRMED AND ADDITIONAL UROKINASE (DOSE UNKNOWN) WAS ADMINISTERED. THE PHYSICIAN INDICATED THAT DURING THE PROCEDURE TWO COILS WERE DEPLOYED; HOWEVER, THE PHYSICIAN COULD NOT DETERMINED WHICH OF THE TWO COILS (SAME SIZE WITH DIFFERENT LOT #) HAD PARTIALLY MIGRATED TO THE M2 SEGMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Occlusion; Stroke/CVA; Thrombosis

  MAUDE report 5772113 ↗
• MalfunctionJun 1, 2016Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE MAIN COIL PREMATURELY DETACHED WITHIN THE CATHETER INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5693505 ↗