Avigo™ Hydrophilic Guidewire 103-0606-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00763000338275), received between Oct 14, 2021 and Aug 31, 2026 — classified as 2 deaths, 6 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Integrity Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533922 ↗
• MalfunctionNov 26, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE GUIDEWIRE WAS ABLE TO PASS THROUGH THE CATHETER HUB WITHOUT ISSUE, AND NO DAMAGE WAS OBSERVED TO THE CATHETER HUB. THE GUIDEWIRE TIP HAD BEEN SHAPED PRIOR TO USE. NO KINK OR DAMAGE WAS FOUND ON THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660775 ↗
• DeathJul 16, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE X STENT RETRIEVER (SFR4-6-40-10, LOT: B791192) THAT BROKE DURING A PROCEDURE. IT WAS REPORTED THAT PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT A NON-HEMORRHAGIC STROKE. THE SOLITAIRE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SOLITAIRE WAS DEPLOYED FOR CLOT RETRIEVAL. HOWEVER, DURING RETRIEVAL, THERE WAS RESISTANCE IN THE DISTAL END OF THE CATHETER (REBAR, 105-5081-153, LOT: B813957) AND THE SOLITAIRE BROKE AND REMAINED IN THE CLOT. THE SURGEON USED ANOTHER SOLITAIRE X (SFR4-4-40-10, LOT: B777662) TO RETRIEVE THE BROKEN SOLITAIRE ALONG WITH THE CLOT. IT APPEARS THE BROKEN DEVICE WAS SUCCESSFULLY RETRIEVED. HOWEVER, IT WAS NOTED THAT THE PATIENT ULTIMATELY HAD AN OUTCOME OF DEATH.

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521522 ↗
• MalfunctionJun 17, 2025Break; Material Separation; Break; Material Separation

  MEDTRONIC RECEIVED A REPORT THAT THE DOCTOR CURVED/PRE-SHAPED THE TIP, AND WHEN ATTEMPTING TO CATHETERIZE THE ARTERY DISTAL TO THE ANEURYSMAL SAC, IT WAS OBSERVED THAT THE TIP OF THE GUIDEWIRE DETACHED. AT NO TIME WAS IT EVIDENT THAT THE GUIDEWIRE HAD KINKED OR BENT. HOWEVER, A PIECE OF THE GUIDEWIRE REMAINED INSIDE THE ANEURYSMAL SAC. THIS DID NOT POSE FURTHER ISSUES, AS A FLOW DIVERTER WAS PLACED. ANOTHER AVIGO GUIDEWIRE WAS USED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THIS EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22233894 ↗
• MalfunctionJun 3, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT WHEN TREATING A STENOTIC LESION, THE GUIDEWIRE TIP WAS FOUND TO BE BROKEN WHEN IT WAS INTRODUCED TO THE LESION. ANOTHER GUIDEWIRE WAS USED AND THE OPERATION WENT SMOOTHLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130864 ↗
• MalfunctionMar 13, 2025Break; Material Separation; Break; Material Separation

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDEWIRE'S SOFT TIP WIRE WAS BROKEN OFF INSIDE THE MICROCATHETER (REBAR 18). IT WAS BROKEN WHEN USED TO PULL OFF CLOT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597618 ↗
• MalfunctionFeb 6, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT DISCHARGED. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THE AVIGO WAS STUCK INSIDE AND THERE IS A RESISTANCE FELT. THE GUIDEWIRE TIP WAS NOT SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322721 ↗
• MalfunctionJan 27, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE BASILAR TOP SACCULAR ANEURYSM DOME MEASURED 4MM AND THE NECK WAS 3.5MM. PATIENT VESSEL TORTUOSITY WAS MODERATE. THE CAUSE OF THE GUIDEWIRE SEPARATION WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21239544 ↗
• MalfunctionJan 23, 2024Break; Material Separation; Break; Material Separation

  MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) NEEDED TO OPEN ANOTHER MICROGUIDE, OPEN A SNARE AND SOLITAIRE TO TRY TO REMOVE THE DEMARCATED MICROGUIDE WHICH WAS UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18567168 ↗
• InjurySep 29, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE DISTAL PART OF THE AVIGO GUIDEWIRE BROKE AND WAS LODGED INTO A SEGMENT OF THE RIGHT CAROTID ARTERY. AN ATTEMPT TO REMOVE IT WITH A SNARE AND A SOLITAIRE X WAS UNSUCCESSFUL. THE PROCEDURE WAS PROLONGED AND MORE MATERIALS WERE USED. THE EVENT LEAD TO OR EXTENDED THE PATIENT'S HOSPITALIZATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17844098 ↗
• MalfunctionAug 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE AVIGO GUIDEWIRE LET LOOSE. A PATIENT WITH ENDOLEAK TIPO 2 WAS BEING REFERRED FOR TREATMENT WITH ONYX AND CONCERTO SPRINGS. AFTER SELECTING THE NOURISHING VESSEL WITH A DIAGNOSTIC CATHETER, AVIGO AND REBAR MICROCATHETER18, BY THE NOURISHING PEDICLE. THEY REMOVED THE MICRO GUIDEWIRE TO MAKE A SELECTIVE ANGIOGRAPHY OF THE VESSEL THAT FILLED THE ENDOLEAK, AND WENT TO RETURN WITH THE AVIGO TO ADVANCE CLOSER TO THE NIDUS OF THE ANEURYSM AND IT RELEASED THE TIP AT THE TIME THEY WERE INTRODUCING IT INTO THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665550 ↗
• InjuryAug 21, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT AT 4:30 P.M. ON (B)(6) 2023, DURING INTERVENTIONAL THROMBECTOMY FOR THE PATIENT, THE TIP OF THE EV3 AVIGO MICRO-GUIDE WIRE BROKE WITH A LENGTH OF ABOUT 4 CM. AFTER ACTIVE TREATMENT, IT WAS STILL UNABLE TO REMOVE THE BROKEN MICRO-GUIDE WIRE TIP. AFTER REQUESTING A CONSULTATION, A VASCULAR STENT WAS ADDED TO FIX THE BROKEN MICRO-GUIDE WIRE ON THE VESSEL WALL, CAUSING SECONDARY INJURY TO THE PATIENT, AND AN IMAGING EXAMINATION SHOWED THAT THE MICRO-GUIDE WIRE AT THE BREAK DID NOT AFFECT THE SURROUNDING BLOOD VESSELS. THE PATIENT'S BLOOD VESSELS ARE TORTUOUS. WHEN PUSHING THE MICRO-GUIDE WIRE AND MICRO-CATHETER IN PLACE, BECAUSE OF MANY BENDS, HIGH TENSION, OR THE TIP OF THE MICROCATHETER WAS ADHERED IN THE THROMBUS, THE JUNCTION OF THE MICRO-GUIDEWIRE WAS BROKEN. A STENT WAS USED TO PRESS THE MICRO-GUIDE WIRE TO STICK TO THE VESSEL WALL, AND THE BLOOD FLOW WAS SMOOTH AFTER THE OPERATION, AND THE MICRO-GUIDE WIRE WAS STABLE IN THE BLOOD VESSEL. THE PATIENT WAS UNDERGOING SURGERY FOR ACUTE RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION TREATMENT. PREVENTION OF BLOOD CLOTS, TREATMENT OF CEREBRAL INFARCTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17587307 ↗
• InjuryAug 15, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP WAS SHAPED. ADDITIONAL INTERVENTIONS TO RETRIEVE THE PART OF THE GUIDEWIRE FROM THE PATIENT WERE PLANED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17548546 ↗
• MalfunctionAug 9, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE AVIGO GUIDEWIRE BROKE INSIDE OF THE REBAR 18 MICROCATHETER. THE PHYSICIAN DID NOT PERCEIVE ANY RESISTANCE TO THE ADVANCEMENT OF THE GUIDEWIRE, BUT IMMEDIATELY AFTER THE GUIDEWIRE BROKEN INSIDE OF THE MICROCATHETER, THE PHYSICIAN MADE CAUTIOUS MANEUVERS TO REMOVE THE ENTIRE SYSTEM. ANOTHER GUIDEWIRE WAS USED FOR THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A DISTAL MIDDLE CAROTID ARTERY ANEURYSM. ANCILLARY DEVICES INCLUDE A REBAR 18 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487522 ↗
• MalfunctionJul 24, 2023Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LESION WAS LOCATED IN THE LEFT POSTERIOR SEGMENT. VESSEL TORTUOSITY WAS MODERATE. IT WAS DIFFICULT TO ACCESS THE ANEURYSM. IT WAS NOTED THAT THE GUIDE WIRE LOST HYDROPHILICITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385970 ↗
• MalfunctionMay 11, 2023Break; Break

  MEDTRONIC RECEIVED REPORT THAT DURING THE PROCEDURE, THE AVIGO GUIDEWIRE TIP BROKE OFF AND REMAINED IN THE PATIENT'S ARTERY. THERE WERE NO PATIENT SYMPTOMS OR OTHER COMPLICATIONS ASSOCIATED WITH THE EVENT. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT. THE EVENT DID NOT LEAD TO OR PROLONG THE PATIENT'S HOSPITALIZATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16911205 ↗
• MalfunctionApr 17, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN AVIGO GUIDEWIRE HAD BROKEN. ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS AN ANEURYSM OF THE POSTERIOR COMMUNICATING ARTERY SEGMENT, THE PARENT ARTERY WAS 4.6MM, THE ANEURYSM SIZE WAS 6.4*3.9, AND THE ANEURYSM DIAMETER WAS 5.1. THE SURGICAL PLAN WAS TO USE STENT-ASSISTED EMBOLIZATION, THE AVIGO MICRO-GUIDE WIRE WITH MICRO-CATHETER REBAR 18, THE MICRO-CATHETER REACHED THE EXPECTED POSITION, AND THE AVIGO MICRO-GUIDE WIRE WITH ECHELON-10 IN PLACE ANEURYSM. AFTER WITHDRAWING AVIGO, IT WAS FOUND THAT THE TIP OF THE GUIDE WIRE WAS INCOMPLETE, AND THEN THE MICROCATHETER WAS ALSO WITHDRAWN, AND PART OF THE GUIDE WIRE WAS FOUND TO BE BROKEN IN THE MICROCATHETER. REPLACED THE GUIDE WIRE AND MICROCATHETER AND PUT THEM IN PLACE AGAIN. FILLED IN THE FIRST COIL, EMBOLIZED WITH APB-6-15-3D-SS, DEPLOYED PART OF THE COIL IN THE ANEURYSM, AND THE SFR-6-30 STENT WAS SEMI-DEPLOYED. THEN CHOSE APB-4-8-3D-SS, APB-2-4-3D-ES, APB-1.5-3-3D, APB-1-2-3D FOR EMBOLIZATION IN SEQUENCE, DENSE EMBOLIZATION OF ANEURYSM BODY, THE STENT WAS DEPLOYED, AND THE OPERATION ENDED SUCCESSFULLY. NO PATIENT INJURY OR SYMPTOSM WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753474 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH AN AVIGO GUIDEWIRE HAD A CEREBRAL HEMORRHAGE. THE HEAD CT WAS REEXAMINED ON (B)(6), AND THE REPORT INDICATED CEREBRAL HEMORRHAGE IN THE LEFT CEREBRAL HEMISPHERE, WHICH WAS TREATED WITH SYMPTOMATIC CRANIAL PRESSURE REDUCTION. ADVERSE EVENT HEMORRHAGE AFTER CEREBRAL INFARCTION, STARTING ON (B)(6) 2023. CTCAE GRADE II, PROBABLY UNRELATED TO TEST INSTRUMENTS, IS A COMMON POSTOPERATIVE COMPLICATION. THE HEAD CT WAS REEXAMINED ON (B)(6), AND THE REPORT SUGGESTED: CEREBRAL HEMORRHAGE IN THE LEFT CEREBRAL HEMISPHERE; COMPARED WITH THE IMAGE ON (B)(6), THE PATIENT WAS RELIEVED BUT STILL NEEDED TO BE HOSPITALIZED FOR SYMPTOMATIC TREATMENT. THE EVENT IS RESOLVING THE EVENT WAS POSSIBLY RELATED TO PROCEDURE AND AVIDO GUIDEWIRE.

  Patient problems: Intracranial Hemorrhage; Unspecified Nervous System Problem

  MAUDE report 16300794 ↗
• MalfunctionJan 4, 2023Break; Material Deformation; Break; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE AVIGO GUIDEWIRE WAS KINKED AND BROKEN FROM THE GUIDEWIRE INSIDE THE MICROCATHETER WHEN DOCTOR ACCESSED THE GUIDEWIRE TO THE LESION. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096522 ↗
• InjuryDec 7, 2022Break; Difficult or Delayed Activation; Material Deformation; Break; Difficult or Delayed Activation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AVIGO GUIDEWIRE BROKE AND PART OF IT REMAINED IN THE PATIENT. IT WAS REPORTED THAT THERE WAS LEFT CAVERNOUS SINUS SEGMENT COLLAR ARTERY STENOSIS, AND STENT IMPLANTATION SURGERY WAS PERFORMED ON THE PATIENT. DURING THE SURGERY, THE MICRO-GUIDEWIRE WAS BROKEN, AND AFTER REPEATED ATTEMPTS IT WAS INEFFECTIVELY TAKEN OUT AND IT WAS FORCED TO REMAIN IN THE BODY. THE STENT WAS IMPLANTED, AND THE BROKEN GUIDEWIRE WAS ATTACHED TO THE WALL OF THE BLOOD VESSEL AND COVERED THE STENOSIS SEGMENT FOR THE WHOLE TIME. THE PROBLEM OF THE BROKEN GUIDEWIRE SWINGING WAS SOLVED AND THE STENOSIS OF THE BLOOD VESSEL WAS SOLVED, AND SYMPTOMATIC TREATMENTS SUCH AS ANTIPLATELET AND LIPID LOWERING WERE GIVEN. AFTER THE SURGERY, THE PATIENT WAS AWAKE FROM ANESTHESIA, WITH GOOD MOVEMENT OF THE EXTREMITIES AND NO SIGNS OF SECONDARY NEUROLOGICAL DEFICITS. THE REPEAT CRANIAL CT WAS PERFORMED AND THERE WAS NO NEW BLEEDING OR CEREBRAL INFARCTION. AFTER THE SURGERY, ANTIPLATELET AND LIPID-LOWERING TREATMENT WERE PERFORMED FOR 8 DAYS, AND THE PATIENT DID NOT SHOW ANY SIGNS OF SECONDARY NEUROLOGICAL IMPAIRMENT. THE PATIENT'S CONDITION WAS STABLE AND HE WAS DISCHARGED FROM THE HOSPIT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15933758 ↗
• MalfunctionOct 31, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED LESION CHARACTERISTICS: LEFT POSTERIOR COMMUNICATING ARTERY WIDE-NECKED ANEURYSM, SIZE 9.1MM*10.2MM. MODERATE TORTUOSITY OF BLOOD VESSELS WAS REPORTED. THE GUIDE WIRE COULD PASS THROUGH THE CATHETER TIP NORMALLY. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP WAS SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699971 ↗
• MalfunctionOct 31, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED LESION CHARACTERISTICS: LEFT POSTERIOR COMMUNICATING ARTERY WIDE-NECKED ANEURYSM, SIZE 9.1MM*10.2MM. MODERATE TORTUOSITY OF BLOOD VESSELS WAS REPORTED. THE GUIDE WIRE COULD PASS THROUGH THE CATHETER TIP NORMALLY. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP WAS SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699964 ↗
• InjuryOct 25, 2022Break; Difficult or Delayed Activation; Break; Difficult or Delayed Activation

  MEDTRONIC RECEIVED A REPORT THAT ANGIOGRAPHY REVEALED SEVERE STENOSIS IN THE CAVERNOUS SINUS OF THE LEFT INTERNAL CAROTID ARTERY, AND SEVERE STENOSIS OF THE LEFT MIDDLE CEREBRAL ARTERY, WHICH WAS CLOSE TO OCCLUSION. THE MICRO-GUIDE WIRE PASSED THROUGH THE STENOTIC SEGMENT TO REACH THE LEFT ANTERIOR CEREBRAL ARTERY A3 SEGMENT, AND THE FAST EXCHANGE BALLOON 3.0MM 15MM (SANOFI) TO THE STENOTIC SEGMENT. AFTER DILATION, THE DIAMETER OF THE TUBE WAS SIGNIFICANTLY IMPROVED. IT WAS DIFFICULT FOR THE QUICK-EXCHANGE BALLOON-EXPANDING STENT 3.5MM 15MM (APOLLO STENT) TO REACH THE CAVERNOUS SINUS SEGMENT. DURING THE ADJUSTMENT PROCESS, IT WAS FOUND THAT THE TIP OF THE MICRO-GUIDE WIRE WAS BROKEN. THE STENT WAS WITHDRAWN, AND REPEATED ATTEMPTS WERE MADE USING THE SELF-MADE CATCHER AND THE THROMBECTOMY STENT, BUT THE BROKEN END OF THE GUIDE WIRE COULD NOT BE GRASPED. ANGIOGRAPHY SHOWED THAT THE BLOOD FLOW RATE WAS NORMAL. CONSIDERING THAT THE OPERATION TIME WAS TOO LONG, THE POSSIBILITY OF TAKING OUT THE BROKEN END WAS SMALL, AND THE TIP END OF THE STENT WAS USED TO COVER THE TAIL OF THE BROKEN END TO PREVENT IT FROM ESCAPING. THE STENT BODY COVERED THE STENOSIS OF THE CAVERNOUS SINUS. AFTER 20 M

  Patient problems: Device Embedded In Tissue or Plaque; Stenosis

  MAUDE report 15666775 ↗
• DeathJul 15, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT WHEN FIRST USING THE APB-5-15-3D-SS AND APB-3-10-HX-ES THERE WAS SUCCESS WITH BOTH PRODUCTS. THE PROXIMAL LOBE WAS FRAMED WITH APB-4-8-3D-SS AND HAD NO ISSUES, THE BASKET WAS FILLED WITH APB-3-8-HX-ES AND THIS IS WHEN A COMPLICATION WAS ENCOUNTERED. THE APB-3-8-HX-ES WAS FILLING THE SAC WELL UNTIL ABOUT 2CM WAS LEFT TO GO IN WHEN SUDDENLY IT STARTED TO PROTRUDE INTO THE PARENT ARTERY SO IT WAS PULLED BACK AND TRIED TO REPOSITION THE MICROCATHETER IN THE ANEURYSM. THEN THEY PROCEEDED TO ADVANCE THE COIL AGAIN AND PROTRUSION OCCURRED AGAIN. AN ATTEMPT WAS MADE TO PUSH IN THE REMAINDER OF THE COIL WHEN ALL OF SUDDEN THE DOCTOR SAID THAT THE REMAINDER OF THE COIL INSIDE THE MICROCATHETER WAS NOT MOVING. THEY REMOVED THE MICROCATHETER OUT OF THE ANEURYSM SAC AND IT WAS DISCOVERED THAT THE COIL HAD DETACHED THUS REMAINDER OF THE COIL REMAINED IN A2. THEY TRIED TO SNARE THE COIL OUT FOR SEVERAL HOURS WITH NO LUCK, THEY THEN TRIED GIVING THE AVIGO A SHAPE AND ENTANGLING IT WITH THE OUTSIDE PIECE OF THE COIL TO TRY AND SNARE IT OUT THAT WAY BUT IT TOO WAS UNSUCCESSFUL. WHILE ATTEMPTING TO HOOK THE COIL, THE AVIGO WIRE BROKE IN A2 LEADING TO THE ICA SO NOW TH

  Patient problems: Device Embedded In Tissue or Plaque; Stroke/CVA

  MAUDE report 15033927 ↗
• MalfunctionApr 8, 2022Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AVIGO GUIDEWIRE THAT HAD RESISTANCE IN THE CATHETER AND WAS NOTED TO HAVE COATING REMOVED. IT WAS REPORTED THAT DURING PREPARATION FOR AN ENDOVASCULAR PROCEDURE, WHEN TRYING TO ADVANCE THE GUIDEWIRE IN THE MICROCATHETER, IT BECAME STUCK ABOUT HALFWAY THROUGH. THE GUIDEWIRE WAS REMOVED AND IT WAS FOUND THAT SOME OF THE COATING WAS REMOVED AND SOME OF THE COATING WAS LOOSE. THE GUIDEWIRE WAS REPLACE AND USED WITH THE SAME CATHETER WITHOUT ISSUE TO COMPLETE THE PROCEDURE SO IT WAS CONSIDERED THAT THE ISSUE WAS WITH THE GUIDEWIRE AND NOT THE CATHETER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053029 ↗