PipelineTM Flex Embolization Device with Shield TechnologyTMRecalls & reported problems across all models

We found 79 models of PipelineTM Flex Embolization Device with Shield TechnologyTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 1,020 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2020 and Sep 28, 2026 — classified as 29 deaths, 170 injuries, 821 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (707 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PipelineTM Flex Embolization Device with Shield TechnologyTM problems

PipelineTM Flex Embolization Device with Shield TechnologyTM models

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

• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-12

  Intracranial aneurysm flow diverter
  67 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-14

  Intracranial aneurysm flow diverter
  3 deaths56 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-16

  Intracranial aneurysm flow diverter
  4 deaths53 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-25

  Intracranial aneurysm flow diverter
  52 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-20

  Intracranial aneurysm flow diverter
  50 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-35

  Intracranial aneurysm flow diverter
  47 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-18

  Intracranial aneurysm flow diverter
  38 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-20

  Intracranial aneurysm flow diverter
  35 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-20

  Intracranial aneurysm flow diverter
  1 death34 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-14

  Intracranial aneurysm flow diverter
  1 death31 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-16

  Intracranial aneurysm flow diverter
  27 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-30

  Intracranial aneurysm flow diverter
  26 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-12

  Intracranial aneurysm flow diverter
  25 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-14

  Intracranial aneurysm flow diverter
  24 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-12

  Intracranial aneurysm flow diverter
  2 deaths22 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-12

  Intracranial aneurysm flow diverter
  1 death21 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-14

  Intracranial aneurysm flow diverter
  21 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-14

  Intracranial aneurysm flow diverter
  2 deaths19 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-16

  Intracranial aneurysm flow diverter
  1 death19 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-18

  Intracranial aneurysm flow diverter
  1 death18 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-25

  Intracranial aneurysm flow diverter
  16 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-12

  Intracranial aneurysm flow diverter
  16 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-10

  Intracranial aneurysm flow diverter
  15 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-16

  Intracranial aneurysm flow diverter
  14 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-12

  Intracranial aneurysm flow diverter
  14 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-20

  Intracranial aneurysm flow diverter
  14 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-20

  Intracranial aneurysm flow diverter
  13 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-16

  Intracranial aneurysm flow diverter
  12 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-25

  Intracranial aneurysm flow diverter
  12 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-30

  Intracranial aneurysm flow diverter
  12 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-12

  Intracranial aneurysm flow diverter
  11 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-35

  Intracranial aneurysm flow diverter
  11 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-18

  Intracranial aneurysm flow diverter
  10 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-16

  Intracranial aneurysm flow diverter
  2 deaths9 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-10

  Intracranial aneurysm flow diverter
  9 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-20

  Intracranial aneurysm flow diverter
  5 deaths8 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-14

  Intracranial aneurysm flow diverter
  8 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-18

  Intracranial aneurysm flow diverter
  8 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-12

  Intracranial aneurysm flow diverter
  7 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-14

  Intracranial aneurysm flow diverter
  7 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-25

  Intracranial aneurysm flow diverter
  7 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-25

  Intracranial aneurysm flow diverter
  7 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-14

  Intracranial aneurysm flow diverter
  1 death6 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-20

  Intracranial aneurysm flow diverter
  6 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-30

  Intracranial aneurysm flow diverter
  6 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-20

  Intracranial aneurysm flow diverter
  5 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-16

  Intracranial aneurysm flow diverter
  1 death5 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-35

  Intracranial aneurysm flow diverter
  5 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-25

  Intracranial aneurysm flow diverter
  1 death4 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-18

  Intracranial aneurysm flow diverter
  4 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-25

  Intracranial aneurysm flow diverter
  4 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-18

  Intracranial aneurysm flow diverter
  1 death3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-20

  Intracranial aneurysm flow diverter
  3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-25

  Intracranial aneurysm flow diverter
  1 death3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-16

  Intracranial aneurysm flow diverter
  3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-20

  Intracranial aneurysm flow diverter
  3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-30

  Intracranial aneurysm flow diverter
  1 death3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-18

  Intracranial aneurysm flow diverter
  3 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-10

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-14

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-20

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-16

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-10

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-16

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-10

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-35

  Intracranial aneurysm flow diverter
  2 reports
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-12

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-10

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-12

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-14

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-12

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-14

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-18

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-35

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-10

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-25

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-10

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-10

  Intracranial aneurysm flow diverter
  1 report
• PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-35

  Intracranial aneurysm flow diverter
  1 report

Recent PipelineTM Flex Embolization Device with Shield TechnologyTM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922188 ↗
• MalfunctionSep 25, 2026Retraction Problem

  Medtronic received a report that there was difficulty recapturing the pusher wire into the microcatheter. Pushwire stuck during retraction at the PTFE Sleeves was reported. The pushwire was not rotated during removal. The catheter and pushwire were not damaged. The Pipeline was used for an indication that is approved (on-label). 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. The patient was undergoing surgery for treatment of a saccular, unruptured left paraopthalmic aneurysm with a max diameter of 3mm and a 3mm neck diameter. Landing zone: Distal: 2.8mm and Proximal: 3.7mm. It was noted the patient's vessel tortuosity was normal. DAPT (Dual antiplatelet treatment) was administered. PRU (Platelet Reaction Unit) level was 60. The angiographic result post procedure showed the stent deployed in the desired location. Ancillary devices include a Phenom 27 FG15150-0615-1S Microcatheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898168 ↗
• MalfunctionSep 23, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Activation Failure; Physical Resistance/Sticking

  Medtronic received a report of Pipeline failure to open and a Navien kink. The patient was undergoing flow-diverting mesh stent implantation surgery for treatment of a fusiform, unruptured, left clinoid segment aneurysm with a max diameter of 9 mm and a 4.9 mm neck diameter. The landing zone was 3.9 mm distally and 4.2 mm proximally. The access vessel was the femoral artery with a diameter of 20 mm. It was noted the patient's vessel tortuosity was severe. The angiographic result post procedure showed a clinoid segment aneurysm. It was reported that the patient was approached via the femoral artery, and the vessel was severely tortuous. The stent catheter was delivered into position, and the flow-diverting mesh Pipeline stent was advanced to the straight segment. When deployment was performed, the distal end could not open. Repeated adjustments were unsuccessful. It was removed and then replaced. During delivery of the intermediate Navien catheter, there was significant resistance at the tip end. It could not be positioned. After withdrawal, a kink was found at the tip end of the Navien, and it was replaced. The kink was the distal end. The Pipeline was not used for an indication th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869251 ↗
• MalfunctionSep 11, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735144 ↗
• MalfunctionSep 9, 2026Structural Problem; Activation Failure

  Patient problems: Cognitive Changes; Failure of Implant; Headache; Ischemia

  MAUDE report 50694256 ↗
• MalfunctionAug 31, 2026Structural Problem

  Patient problems: Aneurysm

  MAUDE report 50531779 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  Medtronic received a report of a post-procedure adverse event (AE) of Pneumonia that is procedure related. It was reported that on 2024 (b)(6) new hospitalization occurred for the patient that encountered the AE of Pneumonia until 2024 (b)(6) with the outcome status of recovered/resolved. The AE resulted in treatment given Zyvox and Zosyn. The AE did was not treated with a blood transfusion, percutaneous intervention, or surgical procedure. No diagnostic tests or procedures were performed. The relative time from the index procedure was post-procedure. The AE was not related to the disease under study. It did not result in new or worsening of existing neurological deficits. The AE did not result from a device deficiency. The patient came in with right sided chest pain; troponins negative, increased white blood cell count and febrile. The patient was admitted with concern for Pneumonia. Infectious disease following on Zyvox and Zosyn for suspected HAP (hospital-acquired pneumonia). The blood cultures were negative. The site seriousness assessment concluded that there was no congenital anomaly, death, disability, life threatening, medical intervention present, however, hospitalization

  Patient problems: Bronchopneumonia; Chest Pain

  MAUDE report 50477567 ↗
• MalfunctionJun 2, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM AT LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 4 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4 MM DISTALLY AND 4.75 MM PROXIMALLY. IT WAS UNKNOWN IF A DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE PED2 DISTAL END OF THE DEVICE CAME OUT ¿CIGARED¿ AND WOULD NOT OPEN FULLY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361439 ↗
• MalfunctionApr 29, 2026Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE THAT FAILED TO OPEN IN THE MID-SEGMENT OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6MM AND A 6MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 3.5MM DISTAL AND 3.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT WAS POST PROCEDURE, "FOLLOWING STENT REPLACEMENT, SIGNIFICANT CONTRAST STAGNATION WAS OBSERVED IN THE ANEURYSM, WITH NO VASCULAR LOSS DETECTED. NO IMAGES ARE AVAILABLE FOR REVIEW. IT WAS REPORTED THAT STENT DELIVERY WAS STARTED, THE PHENOM27 (P27) MICROCATHETER WAS POSITIONED AT THE M1 SEGMENT, AND STENT DELIVERY WAS STARTED. AS THE PATIENT¿S M1 SEGMENT WAS NOT STRAIGHT, THE CUSTOMER DECIDED TO DEPLOY THE STENT IN SITU. THE P27 MICROCATHETER WAS RETRACTED, AND DEPLOYMENT OF THE TIP OF THE STENT WAS INITIATED. THE STENT TIP GRADUALLY OPENED BUT INITIALLY APPEARED SOMEWHAT ROD-SHAPED. WITH ADVANCEMENT OF THE STENT, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033278 ↗
• MalfunctionApr 28, 2026Positioning Failure; Retraction Problem; Malposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT HAD DIFFICULT DELIVERY, FAILURE TO RECAPTURE, AND DEPLOYED IN THE WRONG PLACE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE (ARTERY SIZE) WAS 3.25MM DISTAL AND 3.73MM PROXIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH THE PLATELET REACTIVITY UNITS (PRU) LEVEL OF, "THERAPEUTIC." NO IMAGES ARE AVAILABLE FOR REVIEW. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS, "PIPELINE WAS DEPLOYED, BUT IT WAS DEPLOYED FROM THE M1 DOWN INTO THE INTERNAL CAROTID ARTERY. THE PHYSICIANS PLAN WAS TO BRING THE DEVICE DOWN INTO THE ICA, BUT HE ENDED UP DEPLOYING IT FROM THE M1 DUE TO LOSING HIS ABILITY TO MANIPULATE THE ADVICE. BUT HIS SECOND OPTION IF HE WAS NOT ABLE TO GET A DEVICE TO SIT IN THE ICA APPROPRIATELY WAS TO START FROM THE ONE SO THIS WAS ACTUALLY HIS BACKUP PLAN. I THINK THE ONLY REASON WHY THIS INCIDENT DID NOT CREATE AN ISSUE FOR THE PATIENT." IT WAS REPORTED THAT "THE PIPELINE DEVICE WAS DEPLOYED, PARTIALLY AN M1,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021527 ↗
• MalfunctionApr 27, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT COULD NOT BE OPENED. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, CAVERNOUS SEGMENT ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.5 MM AND A 8 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 4.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED CAVERNOUS SEGMENT ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY. AFTER OPENING THE PACKAGE AND HYDRATING THE STENT, THE STENT WAS DELIVERED. HOWEVER, THE TIP END OF THE STENT COULD NOT BE OPENED DURING DEPLOYMENT, AND MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. THE STENT WAS REPLACED WITH A MEDTRONIC PRODUCT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THE PIPELINE WAS USED FOR AN APPROVED INDICATION (O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999977 ↗
• MalfunctionApr 24, 2026Unintended Ejection; Detachment of Device or Device Component; 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 24982534 ↗
• MalfunctionApr 23, 2026Use of Device Problem; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT PIPELINE FAILED TO OPEN DISTALITY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE R OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE WAS 4.3MM DISTALLY AND 4,9 PROXIMALLY. IT WAS NOTED THE PATIENT'S BLOOD VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PHYSICIAN STARTED TO DEPLOY PIPELINE IN M1 BY UNSHEATHING THE TIP COIL AND PUSHING OUT THE DEVICE. HE WAS UNSATISFIED WITH THE OPENING SO HE DECIDED TO RESHEATH. PHYSICIAN SUBSEQUENTLY DEPLOYED AND RESHEATHED THE DEVICE 3 MORE TIMES. ON THE 4TH DEVICE DEPLOYMENT, THE DISTAL END OF THE PIPELINE WAS SIGNIFICANTLY FRAYED UPON OPENING. IT WAS MENTIONED TO THE PHYSICIAN AND WE DECIDED TO REMOVE THE DEVICE AND TRY WITH A NEW DEVICE. THE PIPELINE FAILED TO OPEN AT THE DISTAL SECTION, AND MORE THAT 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS ALSO RESHEATED MORE THAT 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. BOTH THE PIPELINE AND THE CATHETER WERE RESHEATHED AND REMOVED FROM THE PATIENT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT WAS NOT APPROVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968333 ↗
• MalfunctionApr 20, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS ENCOUNTERED DIFFICULTIES WITH OPENING AND WERE KINKED. ADDITIONALLY, A PHENOM 27 MICROCATHETER WAS BENT. THE PATIENT WAS UNDERGOING STENT ASSISTED COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM IN THE SUPERIOR HYPOPHYSEAL SECTION WITH A MAX DIAMETER OF 3 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.4 MM DISTALLY AND 4.0 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ICA ACCESS VESSEL DIAMETER WAS 4.08 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS GOOD. IT WAS REPORTED THAT ACCESS CATHETERS WERE ADVANCED TO THE TARGET LESION. A PHENOM 27 WAS ADVANCED TO THE M2 SEGMENT, AND A 4.5×10 MM PIPELINE DEVICE WAS DEPLOYED TO INITIATE BRAID OPENING. THE DEVICE WAS OPENED IN A STRAIGHT SEGMENT AND DID NOT APPEAR TO BE DEPLOYED ACROSS A BEND; HOWEVER, THE BRAID WAS DIFFICULT TO OPEN AND DID NOT FULLY EXPAND. PARTIAL OPENING REVEALED A SIGNIFICANT KINK AT THE DISTAL END OF THE BRAID, APPROACHING A 90 DEGREE ANGULATION. THE DEVICE WAS THEREFORE REMOVED. A SECOND 4.5×10MM PIPELINE DEVICE (LOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931645 ↗
• MalfunctionApr 15, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT WITH A MAX DIA METER OF 10MM AND A 7MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 4.3MM DISTAL AND 5.1MM PROXIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH A NORMAL LEVEL OF PLATELET REACTIVITY UNITS (PRU). THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS AN, "OPHTHALMIC SEGMENT ANEURYSM." NO IMAGES ARE AVAILABLE FOR REVIEW. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT AFTER ROUTINE ACCESS WAS ESTABLISHED, THE STENT WAS ADVANCED, WITH THE PLAN TO OPEN THE TIP END OF THE STENT IN THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY. FOLLOWING STANDARD TECHNIQUE, THE OPERATOR RETRACTED THE MARKSMAN MICROCATHETER TO EXPOSE APPROXIMATELY 10 MM OF THE TIP END OF THE STENT. THE TIP END OF THE STENT FAILED TO OPEN AUTOMATICALLY. THE OPERATOR ADVANCED THE SYSTEM TO APPLY TENSION, BUT THE STENT STILL FAILED TO OPEN. REPEATED MANEUVERS WERE UNSUCCESSFUL. IT WAS NOTED THAT THE FAILURE TO OPEN WAS IN THE DISTAL SECTION OF THE DEVICE. THE PIPELINE WAS NOT POSITIONED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884865 ↗

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