PhenomTM 27 Catheter FG15150-0615-1S (UDI 00847536041868)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00847536041868), received between Mar 9, 2020 and Feb 13, 2026 — classified as 4 deaths, 7 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT PER SOURCE, THE INDEX PROCEDURE REPORT DATED (B)(6) 2021 STATES ¿ON FINAL INSPECTION WITH THE INJECTOR, FRONTAL AND LATERAL, THERE IS A LOSS OF OPACIFICATION OF THE RIGHT ANTERIOR CEREBRAL ARTERY DUE TO CONTRALATERAL FLOW COMPETITION. INJECTION BY HAND SHOWS PERFECT PATENCY OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA), INCLUDING THE A1 SEGMENT.¿ SITE HAS BEEN QUERIED TO CLARIFY FINDINGS AND REPORT ADVERSE EVENT IF APPLICABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 24338789 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED ONLY ONE RIST RADIAL ACCESS CATHETER WAS KNOWN TO BE USED IN THE INDEX PROCEDURE WHICH WAS THE DEVICE WITH LOT 17957-01. THE SITE ADJUDICATED ASSESSMENT OF THE EVENT TO INDICATE THAT THE EVENT HAD A CAUSAL RELATIONSHIP TO THE PROCEDURE AND POSSIBLY RELATED TO THE ANTIPLATELET MEDICAL, NAVIEN CATHETER AND/OR PHENOM 27 MICROCATHETER BUT WAS NOT CONSIDERED BY THE SITE TO BE RELATED TO THE IMPLANTED PIPELINE. THE STUDY SPONSOR ASSESSMENT CONCLUDES EVENT WAS POSSIBLY RELATED TO THE PROCEDURE, PIPELINE VANTAGE, AND/OR ANTIPLATELET MEDICATION.

  Patient problems: Embolism/Embolus; Hypokalemia; Ischemia; Ischemia Stroke; Paresis

  MAUDE report 23103297 ↗
• DeathNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PIPELINE STENT AND PHENOM27 HAD COMPLICATIONS AND DEATH. DEATH FROM POST-ISCHEMIC HEMORRHAGE DURING DUAL-ANTIPLATELET THERAPY.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 20606667 ↗
• InjuryMay 24, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS FAILURE TO OPEN IN THE DISTAL PORTION OF THE PIPELINE (LOT B645491). THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THERE WAS FAILURE TO OPEN IN THE MIDDLE PORTION OF THE PIPELINE (LOT B277254). THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE NOT PREPARED AS INDICATED IN THE IFU. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL LISTED AS NO. NO NEW INFORMATION: FROM (B)(4) (REP, HCP, FOR): MEDTRONIC RECEIVED A REPORT THAT  IN THE COURSE OF SECURING A LEFT CAROTID OPHTHALMIC ANEURYSM, HEALTHCARE P

  Patient problems: Nervous System Injury

  MAUDE report 19391119 ↗
• InjuryMar 5, 2024Material Deformation; No Apparent Adverse Event; Material Deformation; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT  IN THE COURSE OF SECURING A LEFT CAROTID OPHTHALMIC ANEURYSM, HEALTHCARE PROVIDER (HCP) ATTEMPTED PLACEMENT OF THE PIPELINE VANTAGE STENT. THE OPERATOR NOTICED A DEFORMATION ON THE PHENOM 27 MICROCATHETER AND HAD DIFFICULTY REPOSITIONING THE STENT. AFTER SEVERAL ATTEMPTS TO PLACE THE PIPELINE, THE STENT AND MICROCATHETER WERE REMOVED. THE STENT WAS SECURED BY COILING WITHOUT STENTING. ON AWAKENING, THE PATIENT REVEALED A NEUROLOGICAL DEFICIT WITH PROGRESSIVE IMPROVEMENT. AN EMERGENCY CEREBRAL MRI SHOWED NO ISCHEMIA AND NO POST-OPERATIVE HEMORRHAGIC POST-OPERATIVE COMPLICATIONS.

  Patient problems: Nervous System Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18840678 ↗
• DeathFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS UNKNOWN IF THE DEATH WAS THOUGHT TO BE RELATED TO THE MEDTRONIC DEVICE OR THERAPY. THE PATIENT WAS ADMITTED WITH A SYMPTOMATIC MID BASILAR ANEURYSM PRIOR TO THEIR PASSING. THEY WERE HEMIPARETIC AND HAD SLURRED SPEECH. THE PATIENT WAS UNSTABLE WITH A PARTIALLY THROMBOSED BASILAR ANEURYSM, THE INTERVENTIONAL RADIOLOGIST USED A PIPELINE DEPLOYED WITH NO ADVERSE EVENTS THROUGH A PHENOM 27 TO FLOW DIVERT. DEVICE PATENT ON FINAL ANGIO RUN. CASE COMPLETED ON (B)(6) 2024. THE PATIENT WAS EXTUBATED 24HRS AFTER THE CASE WITH NO NEW INFARCTS AND SAME SYMPTOMS AS BEFORE THE CASE. THE PATIENT HAD A DELAYED CATASTROPHIC HEMORRHAGE AND PASSED AWAY ON THE (B)(6) 2024. THE EXACT LOCATION OF THE BLEED IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18800389 ↗
• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN IN THE MIDDLE DURING DEPLOYMENT, THEN HAD RESISTANCE IN THE PHENOM MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION AND COIL EMBOLIZATION OF AN UNRUPTURED SACCULAR ANEURYSM OF A RIGHT INTERNAL CAROTID ARTERY (ICA) CLINOID SEGMENT. THE ANEURYSM MAX DIAMETER WAS 25.3MM AND THE NECK DIAMETER WAS 7.8MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER THE DISTAL TIP OF THE PIPELINE WAS DEPLOYED AND ANCHORED, THE MIDDLE SECTION OF THE PIPELINE COULD NOT BE OPENED. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED AND THE STENT WAS NOT POSITIONED IN A VESSEL BEND. THE PHYSICIAN TRIED TO SWING THE PIPELINE TO OPENED IT AND THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES BUT THE PROBLEM COULD NOT BE RESOLVED. FINALLY, IT WAS DECIDED TO REPLACE THE STENT AND IT WAS RESHEATHED AND TRIED TO REMOVED WITH THE MICROCATHETER. HOWEVER, THE PIPELINE COULD NOT EXIT THE PHENOM MICROCATHETER DURING RETRIEVAL SO BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427251 ↗
• InjuryJul 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE SHIELD (PED2) FAILED TO OPEN AT THE DISTAL END. IT WAS NOTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT'S BODY WITH THE MICROCATHETER. THE PIPELINE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED INTRACRANIAL ANEURYSM. ANCILLARY DEVICES: TERUMO 8F SHEATH, ENVOY 7F GUIDE CATHETER, PHENOM 27 MICROCATHETER, SYNCHRO 0.014 GUIDEWIRE ADDITIONAL INFORMAITON RECEIVED REPORTED THE LESION CHARACTERISTICS WAS ACI, LEFT, PERIOPHTHALMISCH, LENGHT 8MM, 3,5-4,6MM. VESSEL TORTUOSITY WAS NORMAL. THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317819 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH 2 PED3 PIPELINE FLOW DIVERTERS, A NAVIEN SUPPORT CATHETER, A HYPERGUIDE BALLOON, AND A PHENOM CATHETER HAD SYMPTOMS OF DISTAL EMBOLIZATION WHICH WERE DIAGNOSED TYPE OF POLYMERIC EMBOLIZATION. PATIENT HAD SEVERE SYMPTOMS WHICH REQUIRED CORTICOSTEROIDS. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING FLOW DIVERTER TREATMENT. DUAL ANTIPLATELET THERAPY WAS ADMINISTERED. ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD.  ANCILLARY DEVICES: PENUBRA NEURON MAX SHEATH, SYNCHRO SELECT GUIDEWIRE ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED FROM THE SUBARACHNOID HEMORRHAGE (SAH) VERY WELL AND WAS DISCHARGED (B)(6) 2023 WITHOUT DEFICITS, ONLY A SLIGHT HEADACHE. THEY RETURNED BACK TO THE ED ON (B)(6) 2023 DUE TO PROGRESSING HEADACHE, VERTIGO AND NAUSEA WITHOUT NEUROLOGIC DEFICITS. THE PATIENT WAS GIVEN DEXAMETHASON 4MG X3 FROM (B)(6) 2023, AND AT THE MOMENT DOSE DECREASED TO 4MG X2. THE PATIENT WAS UNDERGOING TREATMENT FOR A LESION LOCATED IN THE RIGHT SUPRATENTORIAL (FRONTAL, TEMPORAL, PARIETAL, OCCIPITAL LOBES) MULTIFOCAL AREAS OF VASOGENIC EDEMA WITH MICROHEMORRHA

  Patient problems: Dizziness; Embolism/Embolus; Foreign Body Reaction; Headache; Intracranial Hemorrhage; Nausea

  MAUDE report 16424056 ↗
• MalfunctionDec 27, 2022Break; Difficult to Remove; Device Damaged by Another Device; Physical Resistance/Sticking; Break; Difficult to Remove; Device Damaged by Another Device; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE STENT'S MICROCATHETER WAS PUT IN PLACE SMOOTHLY, THE SURGEON STARTED TO DEPLOY THE DENSE MESH STENT. DUE TO THE UNSATISFACTORY LANDING POSITION OF THE DISTAL END, THE STENT WAS RETRIEVED, BUT THE STENT COULD NOT BE RETRIEVED. IT WAS ALSO VERY DIFFICULT TO WITHDRAW THE STENT'S MICROCATHETER. FINALLY, AFTER SEVERAL OPERATIONS, THE STENT'S MICROCATHETER AND THE DENSE MESH STENT WERE WITHDRAWN AS A WHOLE. AFTER CAREFUL INSPECTION IN VITRO, THE TIP OF THE MICROCATHETER WAS OBVIOUSLY BROKEN AND WRAPPED THE DENSE MESH STENT, RESULTING IN THE FAILURE OF THE OVERALL OPERATING SYSTEM. THEN A NEW STENT'S MICROCATHETER AND A DENSE MESH STENT WERE SELECTED FOR OPERATION, AND FINALLY, IT WAS SUCCESSFULLY DETACHED. THE CATHETER DAMAGE WAS LOCATED ON THE DISTAL END. THE STENT WAS STUCK IN THE DISTAL SECTION OF THE CATHETER DURING DELIVERY. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE ISSUE DID NOT RESOLVE. THE PUSHWIRE WAS NOT DAMAGED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057695 ↗
• MalfunctionOct 4, 2022No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE TIP END COULD NOT BE OPENED FROM BEGINNING TO END. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE NORMAL. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE CAVERNOUS SINUS SEGMENT. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4MM DISTAL AND 4MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE WAS PLACED IN A STRAIGHT SEGMENT OF THE BLOOD VESSEL WHEN IT FAILED TO OPEN. THEY HAD ATTEMPTED TO RETRACT AND RE-DEPLOY, AND PUSHED THE CATHETER TO REPEATEDLY INCREASE AND DECREASE TENSION TO TRY TO OPEN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539879 ↗
• MalfunctionAug 11, 2022No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT CAROTID ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3.6MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.1MM DISTAL AND 5.11MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS NOT ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE NEVER OPENED ON THE DISTAL PART AND THE MIDDLE PART. PART OF IT OPENED, AND IT LOOKED LIKE AN HOURGLASS. THE DOCTOR PERFORMED A VARIETY OF MANEUVERS WITHOUT SUCCESS. AT THE MOMENT OF REMOVING THE PIPELINE IT FREED ITSELF FROM THE CATHETER. THE PIPELINE HAD NOT BEEN POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REMOVED AND REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, EXTENDED HOSPITALIZATION, OR ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214557 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH MULTIPLE DEVICES DURING A FLOW DIVERSION (FD) PROCEDURE HAD A RUPTURE OF THE INTERNAL CAROTID ARTERY. PERFORMED AN EMBOLIZATION OF AN LEFT INTERNAL CAROTID ANEURYSM (OPHTHALMIC SEGMENT) TREATED WITH A FD JAILING TECHNIQUE (VANTAGE 4.5*20MM FLOW DIVERTER WITH PHENOM 27 MICROCATHETER AND A 2X TARGET 11*30 COILS WITH ECHELON 10 45° MICROCATHETER AND NAVIEN 6F DISTAL ACCESS CATHETER). AFTER FLOW DIVERTER DEPLOYMENT, THE PHYSICIAN DECIDED TO USE A HYPERGLIDE 5*20MM BALLOON TO PERFORM A TPA, FIRST PROXIMALLY AND THEN DISTALLY. THE ANGIOGRAPHIC CHECK AFTER THE TPA SHOWED A DISTAL BLEEDING CAUSED BY THE RUPTURE OF THE LEFT INTERNAL CAROTID. A VESSEL TAKEDOWN WITH COILS WAS PERFORMED TO ARREST THE BLEEDING. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETERS WERE FLUSHED AS PER IFU. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURISM IN THE LEFT INTERNAL CAROTID- OPHTHALMIC SEGMENT C6. THE MAX DIAMETER WAS 12.84MM AND THE NECK DIAMETER WAS 9MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED.

  Patient problems: Intracranial Hemorrhage; Rupture

  MAUDE report 15100384 ↗
• MalfunctionMay 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT COULD NOT BE PUSHED FURTHER DURING THE DEPLOYMENT PROCESS. WHEN IT WAS WITHDRAWN FROM THE BODY, IT WAS NOTICED THAT THE FRONT TIP OF THE STENT WAS ACCORDIONED. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED SLOWED DOWN BLOOD FLOW. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANUERYSM LOCATED IN THE LEFT OPTHALMIC ARTERY. THE MAX DIAMETER WAS 4.1MM, AND THE NECK DIAMETER WAS 3.7MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 2.85MM DISTAL AND 3.52MM PROXIMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WHICH WAS 12.1MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED FOR THE REGULAR TREATMENT COURSE OF 7 DAYS. ANCILLARY DEVICES INCLUDE A COOK 6 SHEATH, NAVIEN 5F GUIDE CATHETER, SYNCHRO 2 GUIDEWIRE, AND PHENOM 27 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE OVERALL RESISTANCE WAS GREAT. THERE WAS NO DAMAGED OBSERVED TO THE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14438007 ↗
• MalfunctionMay 19, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE PROXIMAL PART OF THE PHENOM 27 MICROCATHETER AND COULDN'T BE PUSHED OUT. IT WAS REPORTED THAT THE PROXIMAL PART OF THE CATHETER WAS KINKED, AND THERE WAS NO DAMAGE TO THE PUSHWIRE. A CONTINUOUS FLUSH WAS ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED COMPLETE EMBOLIZATION. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED ON THE PATIENT'S LEFT SIDE. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.1MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 5MM IN DIAMETER. ANCILLARY DEVICES INCLUDE A 6F LONG SHEATH, 5F NAVIEN GUIDE CATHETER, AND SY14 GUIDEWIRE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INITIAL REPORT WAS NOT CORRECT AND THAT THERE WAS NO PROBLEM WITH THE PIPELINE; IT WAS IMPLANTED SUCCESSFULLY. THE ISSUE WAS WITH THE PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437006 ↗
• MalfunctionApr 26, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE STENT WAS DAMAGED DURING THE PROCEDURE. IT WAS INDICATED THE SURGEON NORMALLY FLUSHED THE STENT AND THEN DELIVERED IT. AFTER THE STENT WAS IN PLACE, IT WAS PLANNED TO OPEN THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY AND PULLED IT BACK TO C7. THE CATHETER WAS WITHDRAWN TO EXPOSE 7-10MM OF THE TIP OF THE STENT AND WAITED FOR 30 SECONDS, THE STENT OPENED. THEN THE STENT WAS SLOWLY WITHDRAWN AND FOUND THAT THE STENT HAD FALLEN OFF A LITTLE, SO THE SURGEON RETRIEVED THE STENT INTO THE MICROCATHETER. THE PLANNED IN-SITU DEPLOY WAS NOT PULLED BACK, AND THERE WERE MORE RIVETS AT THE TIP. LIKE WITH PREVIOUS OPERATIONS, THEY OPENED THE STENT 7-10MM, WAITED, AND FOUND THAT THE TIP OF THE STENT WAS NOT OPEN, GENTLY RETRACTED THE SMALL WINGS ON THE TOP, AND WITHDREW THE MICROCATHETER. IT WAS FOUND THAT THE TIP OF THE STENT WAS IN THE SHAPE OF A FISH MOUTH AND NEVER OPENED. ATTEMPTED THE RETRIEVE AGAIN FOUND THE STENT STUCK IN THE TUBE. CONSIDERING THE SAFETY OF THE OPERATION, THE STENT AND THE CATHETER WERE WITHDRAWN TO THE OUTSIDE OF THE BODY, AND IT WAS SEEN WITH THE NAKED EYE THAT THE BURR AT THE TIP OF THE STENT WAS SERIOUS. THE STENT AND TUBE WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14211777 ↗
• MalfunctionMar 31, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE PHENOM CATHETER WAS FOUND TO BE DAMAGED/ACCORDIONED BEFORE THE OPERATION. THE CATHETER WAS REPLACED, AND THERE WERE NO ABNORMALITIES DURING THE OPERATION. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 5MM IN DIAMETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WEREN¿T ANY ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. HYDRATION WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN. IT WAS ALSO NOTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13969637 ↗
• InjuryMar 15, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN AND BECAME STUCK IN THE MIDDLE OF THE PHENOM MICROCATHETER DURING REMOVAL. THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM TREATMENT. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT THE FIRST PIPELINE PHENOM FULLY OPEN PROXIMALLY. AFTER SEVERAL MANEUVERS TO OPEN THE DEVICE, IT WAS PHENOM AND GOT STUCK IN THE CATHETER IN THE ATTEMPT TO BE REMOVED. A SECOND PIPELINE PHENOM FULLY OPEN DISTALLY, AFTER SEVERAL MANEUVERS TO OPEN THE DEVICE IT WAS PHENOM AND GOT STUCK IN THE CATHETER IN THE ATTEMPT TO BE REMOVED. THE MICROCATHETER WAS ENTRAPPED IN THE GUIDE CATHETER. NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT EXPERIENCED THROMBOEMBOLISM CAUSING HEMIPLEGIA AND NEGLECT. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THE DESIRED RESULT WITH THE REPLACEMENT DEVICE. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Neuropathy; Paralysis; Thromboembolism

  MAUDE report 13764979 ↗
• MalfunctionMar 10, 2022Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PHENOM CATHETER WAS TORN IN THE PACKAGE DURING IMPLANT. THE PATIENT WAS UNDERGOING FLOW DIVERTER TREATMENT. VESSEL TORTUOSITY WAS MODERATED. THE ACCESS VESSEL DIAMETER WAS 4MM. THE CATHETER WAS FLUSHED INDICATED IN THE INSTRUCTION FOR USE (IFU). THE DAMAGE WAS IN THE DISTAL LOCATION. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: NEURON MAX LONG SHEALTH 80/4 MP SHEATH, AXS CATALYST 0.058IN X 115 CM GUIDE CATHETER, PHENOM 27 CATHETER ,150 CM MICROCATHETER, TRANSEND 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727318 ↗
• MalfunctionMar 9, 2022Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE END OF THE CATHETER WAS FLAT. THE PATIENT WAS UNDERGOING SURGERY FOR ANEURYSM PIPELINE BLOOD FLOW GUIDED THERAPY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE STENT COULD NOT BE PUSHED IN THE CATHETER. AFTER THE WHOLE WAS WITHDRAWN, IT WAS FOUND THAT THE DISTAL END OF THE CATHETER WAS FLAT, THE LUMEN WAS DEFORMED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715996 ↗
• MalfunctionFeb 22, 2022Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking; Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PHENOM CATHETER HAD RESISTANCE IN THE DISTAL PORTION CAUSING THE PIPELINE FLEX STENT TO MIGRATE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED FUSIFORM ANEURYSM IN THE LEFT CEREBELLAR LOCATION. IT WAS A BRAIN ANEURYSM EMBOLIZATION. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZINE WAS 2.25MM AND THE PROXIMAL LANDING ZONE WAS 3.20MM. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE VAINA SHUTTLE AND THE DIAMETER WAS 3.5MM THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  THE STENT WAS POSITIONED CORRECTLY, WITH OPTIMAL DISTAL OPENING AT A 2.25MM SEGMENT, AND OPTIMAL PROXIMAL OPENING. AT THE TIME OF PERFORMING THE RECAPTURE MANEUVER OF THE DISTAL TIP, THE PHENOM MICROCATHETER WAS ADVANCED TO THE DISTAL AREA AND IT WAS OBSERVED THAT THE PTFE WINGS WERE NOT COMPLETELY RECAPTURED AND WHEN THE PHENOM MICROCATHETER WAS RETRACTED IT WAS NOTED THAT IT PUSHED THE DEVICE TO THE NECK OF THE ANEURYSM THAT HERNIATED IN IT, AT THAT MOMENT THE SYSTEM WAS WITHDRAWN AND ANOTHER PHENOM MICROCATHETER WAS USED THAT WAS ADVANCED INSIDE THE PIPELINE INSIDE THE ANEURYSM UNTIL IT CROSSED DISTAL TO THE M1 SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582004 ↗
• MalfunctionDec 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE PHENOM 27 CATHETER. THE CATHETER WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS 7MM IN DIAMETER. ADDITIONAL INFORMATION WAS RECEIVED. THE PROXIMAL END OF THE PED PUSH ROD (40-50 FROM THE EXTREME END) WAS KINKED, BUT THE DEGREE OF KINK WAS MODERATE. THE SURGEON SAID THAT THE STENT WAS NOT DAMAGED AND WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965200 ↗
• MalfunctionDec 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD THAT FAILED TO OPEN IN THE MIDDLE AND THEN BECAME STUCK AND DEPLOYED IN THE HUB OF THE PHENOM MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) CAVERNOUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 11MM AND THE NECK DIAMETER WAS 7MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT, THE MIDDLE SECTION OF THE PIPELINE WAS NOT OPENING. RESHEATHING WAS TRIED BUT THE PIPELINE STILL DID NOT OPEN. IT WAS NOTED THE MIDDLE OF THE PIPELINE WAS POSITIONED IN THE VESSEL CAVERNOUS BEND. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. WHEN RESHEATHING INTO THE DELIVERY SHEATH, THE PIPELINE GOT STUCK IN THE PHENOM CATHETER HUB AND DEPLOYED IN THE CATHETER HUB. THE DEVICE WAS REMOVED AND A COMPETITOR'S DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. POST-PROCEDURE ANGIOGRAPHY WAS UNEVENTFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964621 ↗
• MalfunctionNov 15, 2021Difficult to Remove; Difficult to Remove

  MEDTRONIC RECEIVED A REPORT THAT THEY DID NOT RECAPTURE THE FLO-DIVERTER STENT. THERE WAS CATHETER ENTRAPMENT IN THE VESSEL. THE TIP OF THE CATHETER WAS STUCK. THERE WAS NO VASOSPASM AND THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE CATHETER HAD BEEN FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR RIGHT VERTEBRAL ARTERY ANEURYSM REPAIR. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816531 ↗
• MalfunctionJun 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END AND THEN BECAME STUCK IN THE PHENOM-27 MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM OF AN INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 16MM AND THE NECK DIAMETER WAS 8MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). WHEN THE PIPELINE WAS LESS THAN 50% D EPLOYED, THE DISTAL END FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES BUT OPENING FAILED. NO OTHER ADDITIONAL STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINE. FINALLY, THE PHYSICIAN RESHEATHED THE PIPELINE TO REMOVE THE SYSTEM WITH THE MICROCATHETER BUT WHEN THE DELIVERY SYSTEM WAS RETRIEVED, IT WAS FOUND THAT THE PIPELINE HAD DISLODGED. THE PHENOM CATHETER WAS CUT OPEN TO MAKE SURE THE PIPELINE HADN'T BEEN LEFT IN THE PATIENT AND IT WAS CONFIRMED THAT THE PIPELINE WAS WITHIN THE PHENOM MICROCATHETER. A COMPETITOR'S PRODUCT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033398 ↗