PIPELINE PED-450-25 (UDI 00847536016507)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00847536016507), received between Oct 9, 2018 and Aug 12, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Jul 13, 2021Open, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2021Break; Material Deformation; Activation Failure; Break; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. DURING THE RETRIEVAL PROCESS OF THE WHOLE SYSTEM, THE PUSH WIRE WAS NOT DETACHED. AFTER THE PUSH ROD AND THE MICRO CATHETER WERE ALL WITHDRAWN TOGETHER, IT DETACHED WHEN PULLING THE PUSH WIRE FROM THE PROXIMAL END OF PHENOM27 MICROCATHETER IN VITRO, AND THE STENT REMAINED AT THE HUB OF PHENOM27 PROXIMAL END. THERE WAS FRICTION/RESISTANCE, BUT NOT VERY HIGH RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313350 ↗
• MalfunctionApr 30, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FIRST PIPELINE WAS DEPLOYED SUCCESSFULLY; HOWEVER WITH THE SAME MICROCATHETER, THE SECOND PIPELINE COULD NOT BE OPENED WELL AT THE CONTRALATERAL ANEURYSM, BUT IT WAS STILL USED. IT WAS STATED THAT THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION OF THE MICROCATHETER. IT WAS INDICATED THAT THERE WAS PATIENT INJURY DETAILS OF AN ANEURYSM; HOWEVER, THE PATIENT WAS BEING TREATED FOR A CEREBRAL VASCULAR ANEURYSM. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY SEGMENT, AND ITS VESSEL DIAMETER WAS 4.24MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANXILLARY DEVICE: 6F 115CM NAVIEN GUIDE CATHETER, MARKSMAN MICROCATHETER.

  Patient problems: Insufficient Information

  MAUDE report 11755684 ↗
• MalfunctionApr 6, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT PLACED IN A VESSEL BEND. IT WAS CONFIRMED THE FAILURE TO OPEN OCCURRED AT THE DISTAL TEND OF THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618690 ↗
• MalfunctionMar 4, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS NOT POSITIONED IN A VESSEL BEND; IT WAS LOCATED IN THE STRAIGHT SECTION OF THE M1 SEGMENT AND COULD NOT BE OPENED EVEN WHEN PULLED BACK INTO THE CAROTID ARTERY. IT WAS THE TIP OF THE PIPELINE WHICH FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413897 ↗
• MalfunctionDec 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST PIPELINE REACHED THE TARGET LOCATION WITH THE MARKSMAN MICROCATHETER. HOWEVER, DURING THE DEPLOYMENT PROCESS, THE PIPELINE FAILED TO OPEN IN THE DISTAL SEGMENT. THE SURGEON FOLLOWED THE INSTRUCTIONS, RESHEATHED, AND REDEPLOYED THE STENT MORE THAN TWICE AND WAITED FOR MORE THAN 10 MINUTES EACH TIME. THE SLACK IN THE SYSTEM WAS RELEASED AS WELL, BUT THE STENT STILL WOULD NOT OPEN. MORE THAN 50% HAD BEEN DEPLOYED, THE STENT WAS NOT IN A BEND, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. IT WAS ALSO STATED THE STENT BECAME LOCKED UP IN THE DISTAL SEGMENT OF THE MARKSMAN EVEN THOUGH A CONTINUOUS FLUSH WAS USED. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. THE DEVICES WERE REMOVED FROM THE PATIENT. A NEW PIPELINE AND MARKSMAN OF THE SAME MODEL/LOT# WERE USED, BUT THE SECOND PIPELINE BECAME STUCK AT THE DISTAL END OF THE MARKSMAN DURING DELIVERY. THE SLACK WAS RELEASED IN THE SYSTEM, BUT THE ISSUE DID NOT RESOLVE. THE DISTAL SEGMENT OF THE SECOND MARKSMAN BECAME ACCORDIONED, AND THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. REPLACEMENT PRODUCTS WERE USED AGAIN, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS INDICATED THAT ALL DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024584 ↗
• MalfunctionDec 9, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE SECTION OF TWO PIPELINES WOULD NOT OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE CAVERNOUS SINUS SEGMENT. THE PATIENT¿S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.89 MM DISTAL AND 4.21 MM PROXIMAL. DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED AT STANDARD PRU LEVELS. PATIENT MEDICAL HISTORY INCLUDES HYPERTENSION AND CORONARY HEART DISEASE. IT WAS REPORTED THAT TWO STENTS TWISTED AND COULDN¿T BE OPENED. MORE THAN 50% HAD BEEN DEPLOYED WHEN THE PIPELINE FAILED TO OPEN. THE PHYSICIAN RESHEATHED MORE THAN TWO TIMES AND REPEATEDLY PUMPED THE DEVICE TO TRY TO GET IT TO OPEN. THE PIPELINE WAS NOT PLACED IN A BEND. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976557 ↗
• MalfunctionNov 23, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FAILURE TO OPEN. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL ARTERY POSTERIOR COMMUNICATING SEGMENT. THE ANEURYSM MAX DIAMETER WAS 15.6MM AND THE NECK DIAMETER WAS 6.8MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED AND PRU LEVEL WAS 40. IT WAS REPORTED THAT THE MARKSMAN WAS USED TO DELIVER A PIPELINE STENT DEVICE. THE DISTAL TIP WOULD NOT OPEN EVEN WITH REPEATED ATTEMPTS. THE PIPELINE WAS ACCIDENTALLY DEPLOYED SO IT WAS WITHDRAWN FROM THE BODY. WHEN REMOVED FROM THE CATHETER, IT WAS NOTED THAT THE TIP OF THE PIPELINE WAS DEFORMED. A NEW MICROCATHETER AND DIFFERENT STENT WERE THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886460 ↗
• MalfunctionOct 26, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHILE UNSHEATHING THE PIPELINE, THE MIDDLE SECTION COULD NOT BE OPENED SUCCESSFULLY. IT WAS SUSPECTED THE PIPELINE HAD BEEN TWISTED, WHICH CAUSED FOR THE DIFFICULTY OF DEPLOYMENT. IT WAS NOTED THE STENT WAS POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS PERFORMED MORE THAN TWICE, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE PIPELINE. A REPLACEMENT PIPELINE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHY SHOWED THE STENT COVERED THE ANEURYSM AND ATTACHED TO THE WALL PERFECTLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY C4 WITH A MAX DIA METER OF 14 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN. ANCILLARY DEVICES INCLUDE A NEURON 088 80CM, NAVIEN 058 115CM, MARKSMAN 150CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10734458 ↗
• MalfunctionSep 21, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST PIPELINE REACHED THE TARGET LOCATION WITH THE MARKSMAN MICROCATHETER. HOWEVER, DURING THE DEPLOYMENT PROCESS, THE PIPELINE FAILED TO OPEN IN THE DISTAL SEGMENT. THE SURGEON FOLLOWED THE INSTRUCTIONS, RE-SHEATHED, AND REDEPLOYED THE STENT MORE THAN TWICE, THEN WAITED FOR MORE THAN 10 MINUTES EACH TIME. THE SLACK IN THE SYSTEM WAS RELEASED AS WELL, BUT THE STENT STILL WOULD NOT OPEN. MORE THAN 50% HAD BEEN DEPLOYED, THE STENT WAS NOT IN A BEND, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. IT WAS ALSO STATED THE STENT BECAME LOCKED UP IN THE DISTAL SEGMENT OF THE MARKSMAN EVEN THOUGH A CONTINUOUS FLUSH WAS USED. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. THE DEVICES WERE REMOVED FROM THE PATIENT. A NEW PIPELINE, AND MARKSMAN OF THE SAME MODEL/LOT# WERE USED, BUT THE SECOND PIPELINE BECAME STUCK AT THE DISTAL END OF THE MARKSMAN DURING DELIVERY. THE SLACK WAS RELEASED IN THE SYSTEM, BUT THE ISSUE DID NOT RESOLVE. THE DISTAL SEGMENT OF THE SECOND MARKSMAN BECAME ACCORDIONED, AND THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. REPLACEMENT PRODUCTS WERE USED AGAIN, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS INDICATED THAT AL

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10564460 ↗
• MalfunctionAug 14, 2020Retraction Problem; Migration; Retraction Problem; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE FIRST PIPELINE THAT SLIPPED INTO THE ANEURYSM SACK WAS NOT REMOVED AS IT WAS COMPLETED DEPLOYED AND COULD NOT BE REMOVED. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10407523 ↗
• MalfunctionJun 18, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE PUSHWIRE BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT CAVERNOUS INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 20MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE WAS DEPLOYED WITH NO ISSUES. UPON RETRIEVING THE DELIVERY SYSTEM, THE WIRE BROKE ABOUT FIVE INCHES FROM THE DISTAL TIP. PER THE PHYSICIAN, NOT MUCH FORCE WAS DELIVERED. THE BROKEN PART OF THE PUSHWIRE WAS INSIDE OF THE PHENOM MICROCATHETER ENOUGH THAT IT WAS ABLE TO BE EASILY RETRIEVED AND REMOVED FROM THE PATIENT. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A BENCHMARK GUIDECATHETER, PHENOM27 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10172294 ↗
• MalfunctionMay 4, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE DEVICE PUSHWIRE THAT BROKE DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AND UNRUPTURED SACCULAR ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICE AND ACCESSORIES WERE PREPARED AS INDICATED IN THE MANUFACTURER INSTRUCTIONS FOR USE. THOUGH NOT SEVER, THE PATIENT'S ANATOMY WAS STILL RATHER TORTUOUS AND THE PHYSICIAN MENTIONED THIS MULTIPLE TIMES DURING THE PROCEDURE. IT WAS NOTED THAT THE SURGICAL SYSTEM SET-UP WAS NOT IDEAL AS THE SUPPORT CATHETER WAS TOO PROXIMAL TO THE ANEURYSM. THE PHYSICIAN STARTED TO DEPLOY THE PIPELINE TO THE TIP OF THE CATHETER AND HAD TO YOU STRONG FORCE DURING THE DEPLOYMENT. DURING THIS PROCESS, THE PHYSICIAN NOTED THAT THE PIPELINE PUSHWIRE BROKE AND IMMEDIATELY REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. NO PRODUCT WAS LEFT BEHIND. THE SURGEON THEN REPLACED THE PIPELINE AND SELECTED A DIFFERENT CATHETER MODEL AND WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10022106 ↗
• MalfunctionJan 6, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX WAS COMPLETELY RELEASED. DURING THE PROCESS OF RETRIEVING THE GUIDEWIRE, THE GUIDEWIRE WAS BROKEN WHEN THE MICROCATHETER AND THE GUIDEWIRE PASSED THROUGH THE MIDDLE PART OF THE STENT, LEAVING THE PROTECTION COIL INSIDE THE BODY. THEN THE OPERATOR CAPTURED THE GUIDE WIRE AND THE PROTECTION COIL WITH SOLITAIRE AND TOOK IT OUT. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). NO FRICTION OR DIFFICULTY WAS EXPERIENCED. THIS EVENT OCCURRED DURING THE TREATMENT OF A CAVERNOUS SINUS, UNRUPTURED ANEURYSM. THE MAX DIAMETER WAS 9MM AND THE NECK WAS 4MM. THE DISTAL LANDING ZONE WAS 4.1MM AND THE PROXIMAL WAS 4.5MM. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9553269 ↗
• MalfunctionSep 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL SECTION OF THE PIPELINE FLEX FAILED TO OPEN. THE DEVICE WAS NOT PLACED IN A BEND. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT OPHTHALMICARTERY. THE ANEURYSM WAS SACCULAR, UNRUPTURED, WITH A MAX DIAMETER OF 20MM. THE DISTAL LANDING ZONE WAS 3.95MM AND THE PROXIMAL WAS 4.09MM. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8960356 ↗
• MalfunctionAug 16, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE MIDDLE SECTION OF THE PIPELINE FLEX DEVICE WAS FLAT AROUND THE PROXIMAL TURN AND FAILED TO OPEN AFTER BOTH THE DISTAL AND PROXIMAL END OF THE DEVICE OPENED AND OPPOSED THE VESSEL WALL. VISIBILITY OF THE MIDDLE OF THE DEVICE WAS CHALLENGING DUE TO BONY STRUCTURES. IN ORDER TO ADDRESS THE KINK IN THE PIPELINE A SCEPTER BALLOON (4MMX15MM) WAS USED TO POST DILATE THE PIPELINE. IT DID HELP OPEN THE PIPELINE LESS THAN MODERATELY AT THE SITE OF THE KINK. THE POST INTERVENTION ANGIOGRAM SHOWED NORMAL FLOW THROUGH INTERNAL CAROTID WITH MODERATE FLOW INTO THE ANEURYSM. ANGIOGRAM ALSO HIGHLIGHTED KINKED PIPELINE FLOW-DIVERTING DEVICE THROUGH THE PROXIMAL GENU. THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT DISTAL INTERNAL CAROTID ARTERY ANEURYSM THAT WAS UNRUPTURED. THE ANEURYSM WAS AMORPHOUS WITH A MAX DIAMETER OF 9MM AND A NECK OF 4MM. THE DISTAL LANDING ZONE WAS 3.5MM AND A PROXIMAL ZONE OF 4.25MM. THE ANATOMY WAS MODERATE IN VESSEL TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8902516 ↗
• MalfunctionApr 24, 2019Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DEVICE DID NOT OPEN DURING THE PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT WITH FLOW DIVERSION FOR A SMALL UNRUPTURED SACCULAR RIGHT OPHTHALMIC ARTERY ANEURYSM, MEASURING 9.33MMX4.27MM. LANDING ZONE DISTAL 2.59MM PROXIMAL 4.51MM. THE VESSEL WAS MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. IT WAS REPORTED THE TIP OF THIS PIPELINE STENT CANNOT BE OPENED. DURING PROCEDURE, THE PHYSICIAN TRIED TO OPEN THE TIP OF THE PIPELINE IN THE MIDDLE SEGMENT OF THE MIDDLE CEREBRAL ARTERY OF A STRAIGHT BLOOD VESSEL, BUT IT WAS UNSUCCESSFUL. THE PIPELINE RE-SHEATHED, AND THE TIP WAS RELEASED AGAIN. THEN TRIED TO PULL THE END OF THE STENT TO THE END OF THE INTERNAL CAROTID ARTERY, AND THE SYSTEM GAVE TENSION. AFTER MANY ATTEMPTS, IT STILL CANNOT BE OPENED. THE TIP OF THE PIPELINE BRAID FRAYED. THERE WAS NO WAY TO WITHDRAW THE STENT. THE PIPELINE FLEX COULD NOT BE RESHEATH AS THE PIPELINE FLEX BRAID WAS STUCK ON THE DPS SLEEVES. THE PIPELINE RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8547691 ↗
• MalfunctionApr 23, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL TIP OF THE PIPELINE DEVICE POORLY OPENED, THE DEVICE WAS UNABLE TO BE RESHEATHED. DURING THESE MANEUVERS, THE PIPELINE AND THE CATHETER FELL INTO THE ANEURYSM SAC. THE SYSTEM WAS WITHDRAWN FROM THE BODY AND THE CATHETER WAS FOUND TO BE DEFORMED DUE TO THE PATIENT'S BLOOD VESSEL BEING DISTORTED (TORTUOUS). THE CATHETER¿S DISTAL SECTION WAS NOTED TO BE DAMAGED WHEN ASSESSED. A NEW CATHETER AND STENT WERE USED TO COMPLETE THE SURGERY. THE ANATOMY WAS SEVERE IN TORTUOSITY. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8542073 ↗
• MalfunctionApr 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. THE PIPELINE (4.75X25) HAD BEEN POSITIONED ON A BEND AND DEPLOYED LESS THAN 50% AND IT WOULD NOT OPEN IN THE MIDDLE. IT WAS RE-SHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE DEVICE WAS REMOVED. EVENTUALLY, A NEW PIPELINE (4.25X25) WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 4MM X 3MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 3.7MM X 4.6MM. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY AND PRU WAS 289.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485667 ↗
• MalfunctionMar 26, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX WITH SHIELD DEVICE DID NOT OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED AMORPHOUS OPHTHALMIC ARTERY ANEURYSM, MEASURING 10MM X 8MM, LANDING ZONE DISTAL 3.2MM, PROXIMAL 4.4MM. THE VESSEL WAS MODERATELY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. IT WAS REPORTED THAT AFTER THE MICROCATHETER AND PIPELINE WERE IN PLACE, THE MICROCATHETER WAS RETRACTED, THE STENT WAS RELEASED, AND THE TIP END OF THE STENT COULD NOT BE OPENED. THE IMAGE INDICATED THAT THE TIP END WAS IN THE SHAPE OF A BAR. AFTER STANDARD OPERATION, THE TIP END CANNOT BE OPENED, AND THE SURGEON FELT THAT THE STENT DELIVERING RESISTANCE WAS VERY LARGE. THE MICROCATHETER AND STENT WERE SIMULTANEOUSLY WITHDRAWN FROM THE BODY FOR INVESTIGATION. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454525 ↗
• MalfunctionOct 9, 2018Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX DEVICES GOT DAMAGED AND WOULD NOT TRACK INTO THE TARGET AREA FOR PLACEMENT. IT WAS STATED THAT WHILE PUSHING THE FIRST PIPELINE THERE WAS HUGE RESISTANCE IN THE DISTAL END CAUSING IN INABILITY TO TRACK/DEPLOY TO THE POINT THAT THE PHYSICIAN COULDN'T MOVE IT EVEN AFTER USING VARIOUS STANDARD RESCUE TECHNIQUES LIKE REMOVING SLACK, AND PUSHING THE CATHETERS FURTHER FOR BETTER PROXIMAL SUPPORT. THE DEVICE WAS THEN TAKEN OUT OF THE PATIENT'S BODY WHICH SHOWED THAT THE DISTAL PART OF THE PIPELINE WAS CRAMPED. AS A RESULT ANOTHER PIPELINE WAS USED BUT THE ISSUE PERSISTED, SO IT WAS REMOVED AGAIN AND THE PATIENT TREATED WITH BALLOON ASSISTED COILING. IT WAS NOTED THAT THERE WAS STRETCH DAMAGE ON THE DISTAL END OF THE PIPELINE. PRIOR TO THE ISSUE 4 COILS HAD BEEN SUCCESSFULLY DEPLOYED. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A SACCULAR, RUPTURED, OPTHALMIC ANEURYSM WITH A MAX DIAMETER OF 19MM AND A NECK DIAMETER OF 6MM. THE DEVICES WERE PREPARED/FLUSHED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A NEURON MAX GUIDE CATHETER, SCEPTER-C AND ECHELON 10, AND SYNCRO/AXIUM COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949068 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-0309-2017 · Oct 5, 2016 · Terminated
  Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
• Z-0307-2017 · Oct 5, 2016 · Terminated
  Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
• Z-0308-2017 · Oct 5, 2016 · Terminated
  Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
• Z-0120-2016 · Sep 4, 2015 · Terminated
  -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
• Z-1453-2014 · Apr 1, 2014 · Terminated
  Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
• Z-2045-2013 · Jul 19, 2013 · Terminated
  Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-neck