PhenomTM 27 Catheter FG15150-0615-1S (UDI 00763000399702)Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00763000399702), received between Jan 18, 2022 and Sep 30, 2026 — classified as 2 deaths, 8 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (98 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 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Retraction Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951805 ↗
• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917640 ↗
• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Medtronic received a report that on (b)(6)2026, a flow diverter stent was planned to be implanted in the patient. When the (Jiushi Shenkang) FD-4.5-15 stent was advanced to the end of the Phenom catheter and was about to be fully delivered, detachment occurred. The stent was immediately replaced with another brand; however, detachment occurred again at the same position. The microcatheter was then replaced, and a new stent was used to complete the procedure successfully. The event cause is identified to the vessel might have had severe calcification, angulation, or significant stenosis, and predilation might not have been sufficient.  The microcatheter might have had insufficient support, preventing effective transmission of the pushing force. No adverse impact occurred to the patient. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this event. *** NOTE "predilution" was corrected to "predilation" in the 2026-Jun-22 CFDA event description narrative*** Additional information received reported that the lesion was located near the ophthalmic artery, measuring 4¿5 mm, a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917618 ↗
• MalfunctionSep 24, 2026Break; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883745 ↗
• MalfunctionSep 23, 2026Difficult to Advance; Unintended Movement

  Medtronic received a report that Xinkainuo 6F105 intermediate catheter + Xinwei 0.014-200 cm neuro guidewire were used. The Phenom27 was advanced under guidance of the neuro guidewire, and an attempt was made to pass through the neck of the giant aneurysm in the posterior communicating segment of the internal carotid artery and advance to the middle cerebral artery. The guidewire passed through the aneurysm neck smoothly, and the Phenom27 microcatheter was continued to be advanced. At this time, the tip end of the Phenom27 microcatheter herniated into the aneurysm sac, increasing tension, and the microcatheter formed a loop within the aneurysm, making smooth advancement impossible. After multiple adjustments and repeated attempts, the tip end of the Phenom27 could not smoothly pass through the aneurysm neck for further advancement. The operator replaced the Phenom27 catheter, and after deployment and adjustment, it advanced smoothly into position, completing Pipeline implantation. The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this even

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869734 ↗
• MalfunctionSep 2, 2026Retraction Problem; Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564380 ↗
• MalfunctionAug 31, 2026Unintended Movement; Physical Resistance/Sticking

  Additional information was received reporting that no causes or contributing factors for the event were identified. It was clarified that the reported issue of unstable was referring to catheter kickback. That high resistance occurred in the proximal section of the device. The catheter was flushed per the IFU during the procedure. The Pipeline did not jump during deployment. Multiple Pipelines were not used in the procedure. The catheter tip was not under stress.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521684 ↗
• MalfunctionAug 11, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213268 ↗
• MalfunctionJul 30, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086710 ↗
• MalfunctionApr 24, 2026Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT CLINOID C5 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.3 MM AND A 3.0 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7.8MM DIAMETER. THE LANDING ZONE WAS 3.1MM DISTALLY AND 4.0MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT AFTER THE OPERATOR ESTABLISHED ACCESS, A PHENOM 27 MICROCATHETER WAS POSITIONED IN PLACE. A SHIELD PED400-18 DEVICE WAS UNPACKED AND HYDRATED. THE DISTAL END OF THE DEVICE WAS ADVANCED THROUGH THE Y-VALVE TO THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. WHILE THE ASSISTANT ADVANCED THE DELIVERY WIRE TO ITS FULL EXTENT, VERY LITTLE RESISTANCE WAS NOTED. THE DISTAL END OF THE DEVICE WAS UNABLE TO ENTER THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. THE OPERATOR THEN WITHDREW THE ENTIRE DEVICE ONTO THE TABLE AND ATTEMPTED TO ADVANCE THE DELIVERY WIRE BACK AND FORTH; HOWEVER, THE STENT REMAINED STATIONARY. IT WAS SUBSEQUENTLY NOTED THAT THE DEVICE HAD BECOME DETACHED (DEVICE DETACHMENT). THE OPERATOR THEN REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982553 ↗
• MalfunctionApr 20, 2026Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING ADVANCEMENT, A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT ENCOUNTERED SEVERE RESISTANCE IN THE PHENOM 27 MICROCATHETER. THE STENT WAS DAMAGED AND FAILED TO OPEN, AND THE MICROCATHETER FRACTURED. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, C6 ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 8 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 8 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED C7 ANEURYSM. THE VESSEL SEGMENT FROM C7 TO C5 WAS TORTUOUS, RESULTING IN SIGNIFICANT RESISTANCE DURING STENT ADVANCEMENT. DURING STENT DEPLOYMENT, ELONGATION AND RELAXATION MANEUVERS WERE PERFORMED TO ADJUST WALL APPOSITION AT THE OUTER CURVE OF C6, THE STENT BECAME FLATTENED AND FAILED TO OPEN. ON THE THIRD ATTEMPT, THE STENT DELIVERY CATHETER FRACTURED, AND THE STENT WAS WITHDRAWN FROM THE BODY TOGETHER WITH THE P27 MICROCATHETER. THE PRODUCTS WERE REPLACED WITH A MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925029 ↗
• MalfunctionApr 11, 2026Difficult to Advance; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT 2 PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS (PED2-425-35, PED2-450-25) FAILED TO OPEN AT THE MIDDLE AND DISTAL SECTIONS WHEN THE PROXIMAL, MIDDLE, AND DISTAL SECTIONS WERE POSITIONED IN A BEND. MORE THAN 50% OF EACH PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, EACH WAS RESHEATHED MORE THAN 2 TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINES. THE PIPELINES WERE RESHEATHED AND REMOVED WITH THE MICROCATHETER. AN ADDITIONAL PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2-425-30) REQUIRED ADJUNCTIVE BALLOON ANGIOPLASTY TO ENHANCE WALL APPOSITION. ADDITIONALLY, RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE PHENOM 27 MICROCATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT CAVERNOUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 4.3 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.9 MM DISTALLY AND 4.3 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. RIGHT INTERNAL CAROTID ARTERY (ICA) ACCESS VESSEL DIAMETER WAS 4.3 MM. DUAL ANTIPLATELET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847475 ↗
• MalfunctionApr 8, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE EXPERIENCED RESISTANCE WITHIN A PHENOM CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE C5 SEGMENT WITH A MAX DIAMETER OF 3.2 MM AND A 2.1 MM NECK DIAMETER. THE PATIENT HAS A DISTAL LANDING ZONE OF 3.78 MM AND A PROXIMAL OF 4.22 MM. IT WAS NOTED THE PATIENT'S ACCESS VESSEL DIAMETER ON THE FEMORAL ARTERY IS 8.9 MM AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER ADVANCING THE MICROCATHETER, THERE WAS RESISTANCE DURING STENT DELIVERY, AND IT COULD NOT BE POSITIONED C ORRECTLY. AFTER REMOVING BOTH THE STENT AND THE MICROCATHETER TOGETHER OUTSIDE THE BODY, IT WAS OBSERVED THAT THE STENT'S TIP END WAS FRAYED AND THE MICROCATHETER'S TIP END ALSO SHOWED ABNORMALITIES. DEVICES WERE FLUSHED AND PREPPED AS INDICATED BY THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE RESISTANCE AND DAMAGE WERE NOT DETERMINED. THERE WAS NO DEVICE JUMP OR CATHETER TIP MOVEMENT DURING DEPLOYMENT. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821348 ↗
• MalfunctionApr 7, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2) DISTAL END FAILED TO OPEN, THEN ENCOUNTERED RESISTANCE IN THE DISTAL SECTION OF A PHENOM 27 MICROCATHETER AND BECAME STUCK IN THE DISTAL SECTION DURING RESHEATHING. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, OPHTHALMIC ANEURYSM. DIMENSIONS OF THE ANEURYSM AND LANDING ZONE WERE UNKNOWN. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. VASCULAR ACCESS WAS OBTAINED VIA THE INTERNAL CAROTID ARTERY (ICA). IT WAS UNKNOWN IF DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED PERFECT STENT PLACEMENT, UPON DEPLOYING THE STENT, IT WAS OBSERVED THAT THE DISTAL END WOULD NOT OPEN. THE TIP COIL WAS RECAPTURED AND TRIED UNSHEATHING AGAIN. THE STENT STILL WOULDN¿T OPEN AFTER DEPLOYING 7-10 MM OF DEVICE. RESHEATHED AND TRIED AGAIN, HOWEVER, STILL WOULDN¿T OPEN DISTAL. THEN WAS UNABLE TO PULL BACK INTO THE PHENOM 27; STATED DEVICE SEEMED STUCK PARTIALLY. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINE AND PHENOM 27 WERE REPLACED WITH A NEW PIPELINE AND P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801346 ↗
• MalfunctionApr 2, 2026Collapse; Retraction Problem; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO CAUSES FOR THE EVENT WERE IDENTIFIED. IT WAS CLARIFIED THAT "CATHETER CRUSHED/KINKED/DAMAGED" IN THE MIDDLE SECTION WAS IN THE SENSE THAT THE STENT WAS STUCK IN THE LUMEN OF THE DEVICE AND COULD NOT BE REMOVED BY THE PHYSICIAN SO THE ENTIRE SYSTEM HAD TO BE REMOVED AND REPLACED. RESISTANCE AT THE DISTAL ZONE OCCURRED, SINCE ONCE ACCESS WAS ALREADY LOST FROM MCA TO ICA, THE PHENOM WAS NOT TRACKING OVER PED AND WE WERE NOT ABLE TO REPOSITION THE SYSTEM. ONCE THE ENTIRE SYSTEM CAME DOWN TO ICA WHILE TRYING TO PUSH PHENOM OVER THE STENT, DISTAL PORTION THE STENT WAS EXPOSED BUT SINCE THE POSITION WAS NOT DESIRED, PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM AND REGAIN ACCESS IN MCA WITH PHENOM AND WIRE. WHILE REMOVING THE STENT FROM PHENOM, THE STENT GOT DEPLOYED IN THE MICROCATHETER LUMEN. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THE PIPELINE DID NOT JUMP DURING DEPLOYMENT; THE STENT FELL DOWN (AKA JUMPED) WHILE GAINING ACCESS IN MCA. IN TOTAL 2 STENTS WERE USED (1 IMPLANTED AND 1 DAMAGED). THE TIP OF THE CATHETER WAS NOT UNDER STRESS AND WAS NOT MOVED DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766160 ↗
• MalfunctionMar 30, 2026Retraction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STENT WAS RESHEATED 0 TIMES. THE PIPELINE WAS PLACED IN A BEND WHEN IT FAILED TO OPEN AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED IN AN ATTEMPT TO OPEN THE PIPELINE. THE CAUSE AND CONTRIBUTING FACTORS FOR THE MOVEMENT DURING DEPLOYMENT WAS IDENTIFIED DURING THE DEPLOYMENT PROCESS. MULTIPLE PIPELINE DEVICES WERE NOT BEING USED WHEN MOVEMENT OCCURRED. THE STENT WAS ABLE TO BE ADVANCED SMOOTHLY DURING DELIVERY AND POSITIONING. ADDITIONALLY, THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION AFTER THE MID SEGMENT FAILED TO OPEN THE ENTIRE SYSTEM WAS RETRIEVED. THE DEVICE DID NOT JUMP DURING DEPLOYMENT AND THE TIP OF THE CATHETER DID NOT MOVE. CAUSES/CONTRIBUTING FACTORS OF THE DAMAGE AND FAILURE TO RESHEATH WERE NOT IDENTIFIED. IT WAS ALSO NOTED THAT THE CATHETER WAS CONTINUOUSLY FLUSHED THROUGHOUT THE PROCESS. IT WAS CLARIFIED THAT THE STATEMENT "EXCHANGED" WAS REFERRING TO THE ECHELON MICROCATHETER BEING USED INITIALLY TO ADVANCE. THERE WAS NO ISSUE WITH THE PHENOM 27 MICROCATHETER, AND THERE WAS NO RESISTANCE DURING RESHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729389 ↗
• MalfunctionMar 30, 2026Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CURRENT PLAN IS TO PROCEED WITH FOLLOW-UP, AS A COMPREHENSIVE ASSESSMENT INDICATED THAT THE ANEURYSM RUPTURE RISK WAS NOT PARTICULARLY HIGH; THEREFORE, THE PROCEDURE WILL NOT BE RESCHEDULED AT THIS TIME. NO CAUSES OR CONTRIBUTING FACTORS WERE IDENTIFIED FOR THE RESISTANCE, MIGRATION, OR PREMATURE DETACHMENT/RELEASE. ONLY ONE PIPELINE DEVICE WAS USED WHEN THE MOVEMENT OCCURRED. THE PIPELINE INITIALLY OPENED AS INTENDED; HOWEVER, IT SLIPPED DURING WITHDRAWAL AND WAS NOT IMPLANTED AT THE INTENDED LOCATION. DEVICE JUMPING WAS OBSERVED DURING WITHDRAWAL POSITIONING. MOVEMENT OF THE MICROCATHETER TIP OCCURRED DURING DEPLOYMENT, WHICH IS EXPECTED BECAUSE THE TIP WILL MOVE WHEN THE STENT IS OPENED DURING CATHETER WITHDRAWAL. THE DEPLOYMENT FOLLOWED A ROUTINE PED PROCEDURE IN WHICH THE DEVICE WAS OPENED IN THE MIDDLE CEREBRAL ARTERY AND THEN PULLED BACK FOR POSITIONING. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE, AS ROTATION IS NOT POSSIBLE AND IS CONSIDERED RISKY AND NOT RECOMMENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714428 ↗
• MalfunctionMar 24, 2026Retraction Problem; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE PHENOM 27 CATHETER. THE PHENOM CATHETER WAS ALSO FOUND DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT C5 SECTION IN THE INTERNAL C AROTID ARTERY WITH A MAX DIAMETER OF 2.4 MM AND A 3.2 MM NECK DIAMETER. LANDING ZONE: DISTAL 3.5 MM AND PROXIMAL: 4 MM. THE ACCESSED VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPL ATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 1. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NORMAL VESSELS WITH CONTRAST AGENT RETENTION IN THE ANEURYSM. IT WAS REPORTED THAT DURING THE FLOW DIVERSION STENT IMPLANTATION PROCEDURE, AFTER PLACEMENT OF AN 8F SHORT SHEATH, A LONG SHEATH WAS PUSHED TO GO UPPER TO THE LEFT MCA C1 SEGMENT, FOLLOWED BY PUSHING A 5F115 NAVIEN TO GO UPPER TO THE C4 SEGMENT. THE PHENOM 27 MICROCATHETER (LOT NUMBER: 230455815) WAS THEN PUSHED TO GO UPPER TO THE DISTAL RIGHT MIDDLE CEREBRAL ARTERY, AND THE PED2-400-18 FLOW DIVERSION STENT (LOT NUMBER: D044346) WAS FULLY HYDRATED IN PREPARATION FOR DELIVERY TO THE LESION SIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674558 ↗
• MalfunctionMar 23, 2026Retraction Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT RELEASE WAS NOT POSSIBLE, AND ONLY THE TIP WAS STORED WITHIN THE MICROCATHETER. SUBSEQUENTLY, EVEN AFTER DEPLOYMENT, THE STENT DID NOT MOVE AND ONLY THE TIP WAS UNSHEATHED, SO THE PHENOM 27 WAS WITHDRAWN AS A UNIT. IT WAS REMOVED FROM THE CATHETER OUTSIDE THE BODY, AND A REPLACEMENT WAS PLACED. IT WAS FURTHER REPORTED THAT THERE WAS BUMPER DISLODGEMENT AT AN EARLY STAGE AND THE SLEEVE APPEARS TO HAVE BECOME DEFORMED. DUAL ANTIPLATELET THERAPY (DAPT) WAS PERFORMED. POSTOPERATIVE BLOOD FLOW IMAGING SHOWED NO CHANGE FROM BEFORE SURGERY. THE PIPELINE DEVICE WAS NOT USED AS OFF-LABEL USE. THE DEVICE WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED IN THE PACKAGE INSERT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY (ICA) WITH A MAX DI AMETER OF 5 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE CONDITION OF THE ANEURYSM SHOWS AN EXAMPLE OF RECANALIZATION AFTER ATLAS SAC. THE BLOOD VESSEL DIAMETER IN THE LANDING ZONE ON THE DISTAL SIDE IS 3.07 MM, AND ON THE PROXIMAL SIDE IT IS 3.85 MM. ANCILLARY DEVICES INCLUDE A 6F SHUTTLE 80 CM, 5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664531 ↗
• MalfunctionMar 23, 2026Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT NO CAUSES OR CONTRIBUTING FACTORS FOR THE STENT COULD NOT BE RETRIEVED OR DAMAGE WERE IDENTIFIED. THE CATHETER RESISTANCE WAS NOTED IN THE DISTAL SECTION. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL. THE STENT DAMAGE OBSERVED WAS, "SLIGHT DEFORMATION OF THE DISTAL TIP, AND FRACTURE OF THE PUSH ROD." NO FRICTION OR DIFFICULTY DURING DELIVERY OR WHEN POSITIONING. THE PIPELINE DID NOT JUMP DURING DEPLOYMENT. ONLY ONE PIPELINE WAS USED DURING THE PROCEDURE. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662640 ↗
• MalfunctionMar 20, 2026Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS CLARIFIED THAT THE STENT WAS STUCK IN THE MIDDLE OF THE CATHETER. THE STENT HAD A "PLEATING DEFORMATION" ON THE MID-SEGMENT. THERE WERE NO CAUSES OR CONTRIBUTING FACTORS IDENTIFIED FOR THE RESISTANCE OR THE STENT DEFORMATION. IT WAS CONFIRMED THE STENT DEFORMATION WAS NOT CAUSED BY THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650013 ↗
• MalfunctionMar 18, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE'S DELIVERY ROD BECAME STUCK AT THE DISTAL END OF THE PHENOM MICROCATHETER AND COULD NOT BE WITHDRAWN. THE PATIENT WAS UNDERGOING ANEURYSM BLOOD FLOW-DIVERTING STENT IMPLANTATION SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 8 MM. IT WAS REPORTED THAT A BLOOD FLOW-DIVERTING STENT IMPLANTATION WAS PERFORMED FOR AN ANEURYSM IN THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY. AFTER THE MICROCATHETER WAS POSITIONED, A PED2-425-25 WAS SUCCESSFULLY DEPLOYED. AFTER STENT DEPLOYMENT, THE DELIVERY ROD WAS RETRIEVED THROUGH THE PHENOM 27 MICROCATHETER; HOWEVER, THE DELIVERY ROD BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT BE WITHDRAWN. THE SYSTEM WAS REMOVED ENTIRELY FROM THE PATIENT, AND ANOTHER MICROCATHETER WAS USED TO CONTINUE THE SUBSEQUENT PROCEDURE. THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626689 ↗
• MalfunctionMar 9, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX THAT FAILED TO OPEN AT THE DISTAL END  AND THEN EXPERIENCED FRICTION AND DEPLOYED PREMATURELY. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY (R-ICA) CAVERNOUS SEGMENT UNRUPTURED AMORPHOUS GIANT THROMBOSED ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 33MM AND THE NECK DIAMETER WAS 30MM. THE DISTAL LANDING ZONE WAS 3.7MM; THE PROXIMAL LANDING ZONE WAS 4.8MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH NORMAL PRU LEVEL NOTED. IT WAS REPORTED THAT AFTER ACCESS WAS ESTABLISHED AND THE PHENOM 27 MICROCATHETER WAS POSITIONED, THE SURGEON MEASURE THE ENTIRE LENGTH OF THE VESSEL TO BE COVERED, WHICH WAS 60MM, WITH THE DISTAL VESSEL BEING EXTREMELY TORTUOUS. IT WAS PLANNED FOR A NON-MEDTRONIC STENT AND PIPELINE FLEX BRIDGING TREATMENT. THE LONG NON-MDT STENT WAS INITIALLY SELECTED, WHICH WAS SUCCESSFULLY DELIVERED AND DEPLOYED. AFTER THAT, CONSIDERING THE TORTUOUS VESSEL, THERE WERE CONCERNS THAT AN OVERLY LONG STENT MIGHT AFFECT PROPER DELIVERY AND POSITIONING, AND THE PROXIMAL VESSEL NEAR THE ANEURYSM NECK WAS NOT SUITABLE FOR EXCESSIVE COV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552001 ↗
• MalfunctionMar 2, 2026Retraction Problem

  ADDITIONAL INFORMATION RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THERE WAS NO OBSERVED DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. REPEATED ATTEMPTS TO RETRIEVE AND REDEPLOY THE DEVICE WERE PERFORMED, BUT THESE EFFORTS STILL FAILED TO OPEN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484077 ↗
• MalfunctionFeb 27, 2026Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN AND TWO PHENOM MICROCATHETERS WERE DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC SEGMENT ANEURYSM WITH A MAX DIAMETER OF 4.78MM AND A 7.98MM NECK DIAMETER. THE LANDING ZONE WAS 2.47MM DISTALLY AND 3.44MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED COIL EMBOLIZATION WAS COMPLETED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE VESSEL WAS HIGHLY TORTUOUS, AND THERE WAS A SHARP THREE-DIMENSIONAL BEND AT THE CAVERNOUS SEGMENT. MULTIPLE ATTEMPTS WERE MADE, BUT THE STENTS COULD NOT FULLY APPOSE TO THE VESSEL WALL OR DEPLOY IN THE CAVERNOUS SEGMENT. THE TIP OF THE MICROCATHETERS WERE ALSO DAMAGED DUE TO FRICTION AND COULD NOT BE USED AGAIN. THE PIPELINES WERE USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETERS WERE FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471677 ↗