PIPELINE PED-500-25 (UDI 00847536019751)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00847536019751), received between Jun 29, 2018 and Jul 14, 2021 — classified as 1 death, 22 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (19 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS DELIVERED TO THE DISTAL END OF THE MARKSMAN MICROCATHETER. WHEN THE TIP OF THE CATHETER WAS WITHDRAWN, THE DISTAL END OF THE PIPELINE COULD NOT OPEN NORMALLY. THE STENT WAS RE-SHEATHED AND RE-DEPLOYED BUT STILL FAILED TO OPEN. THE PIPELINE WAS REPLACED, AND THE SECOND PIPELINE DEPLOYED SMOOTHLY. POST-PROCEDURE ANGIOGRAPHY SHOWED GOOD WALL APPOSITION AND STENT OPENING. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 10.0 MM AND A 6.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166372 ↗
• MalfunctionMar 17, 2021Activation Failure; Activation Failure

  ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505569 ↗
• MalfunctionFeb 18, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT IMPLANTATION WAS UNSUCCESSFUL TWICE. THE FIRST TIME WAS BECAUSE THE PIPELINE DELIVERY GUIDEWIRE WAS BROKEN. THE SECOND TIME, THE DISTAL WAS ENLARGED DURING THE OPERATION AND THE ANCHORING WAS UNSTABLE. IT WAS FLATTENING AT THE BENT SITE AND REQUIRED REPEATED SWINGING TO RELEASE, BUT THE DISTAL FELL DOWN DURING SWINGING. THE CASE ITSELF WAS RATHER DIFFICULT, SO IT FAILED AGAIN. REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURE. 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 ANGIOGRAPHIC RESULTS SHOWED NORMAL EMBOLISM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT C4 INTERNAL CAROTID ARTERY (ICA) AND LEFT C5 ICA WITH A MAX DIAMETER OF 15.54 MM AND A 11.63 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. PIPELINE LOT #: B032587 WAS USED WITH CATHETER LOT #: NV19-035; PIPELINE LOT #: B118889 WAS USED WITH CATHETER LOT #: NV19-048. ADDITIONAL INFORMATION RECEIVED CLARIFIED THE DAMAGE TO THE PUSHWIRE, IT WAS STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343682 ↗
• MalfunctionFeb 5, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS SUCCESSFULLY PLACED IN THE MIDDLE CEREBRAL ARTERY (MCA) IN THE PHENOM MICROCATHETER, AND THEN IT WAS PREPARED TO DEPLOY THE TIP AT THE M1 SEGMENT. THE DISTAL TIP OF THE PIPELINE COULD NOT BE OPENED AFTER SEVERAL ATTEMPTS, AND IT COULD NOT BE OPENED AFTER WITHDRAWN FROM THE INTERNAL CAROTID ARTERY (ICA). AFTER SEVERAL MORE ATTEMPTS, IT STILL FAILED. IN VITRO, THE STENT WAS PUSHED OUT AND THE TIP OF THE PIPELINE WAS SHAPED LIKE A FISH MOUTH. IT WAS NOTED THE PIPELINE WAS NOT POSITIONED IN A BEND AT THE TIME OF DEPLOYMENT, LESS THAN 50% HAD BEEN DEPLOYED, AND RESHEATHING WAS PERFORMED LESS THAN THREE TIMES. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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 ANGIOGRAPHIC RESULTS SHOWED BLOOD ENTERING THE ANEURYSM IMMEDIATELY SLOWED DOWN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC AND CLINOID SEGMENTS WITH A MAX DIAMETER OF 13 MM AND A 7.7 MM NECK DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11286043 ↗
• MalfunctionDec 21, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING FOUR PIPELINE DEVICES THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING A FLOW DIVERSION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE CAVERNOUS SEGMENT OF AN INTERNAL CAROTID ARTERY (ICU). THE ANEURYSM MAX DIAMETER WAS 14MM AND THE NECK DIAMETER WAS 8MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH NOTED PRU LEVEL OF 160. IT WAS REPORTED THAT THE SECOND ATTEMPT TO IMPLANT FLOW DIVERTER WAS MADE WITH A 5 X 25MM PIPELINE (MODEL: PED-500-25, LOT: B067560). AS HAD OCCURRED WITH THE FIRST DEVICE, THERE WAS FAILURE OF THE DISTAL END TO OPEN AND A NOTED "CIGAR" SHAPE WITH MORE THAN 50% OF THE DEVICE DEPLOYED WHEN IT FAILED TO OPEN. THE MIDDLE SECTION OF THIS PIPELINE WAS PLACED IN A VESSEL BEND. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES AND REDEPLOYED BUT STILL DID NOT OPEN. NO OTHER ADDITIONAL STEPS OR DEVICES WERE TRIED TO OPEN THIS PIPELINE. IT WAS RESHEATHED AND REMOVED WITH THE PHENOM MICROCATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED RELATED TO THE EVENT. POST-PROCEDURE ANGIOGRAPHY REVEALED NO ISSUE. THE ANEURYSM REMAINED UNRUPTURED AND THERE WAS NO EV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047496 ↗
• MalfunctionNov 9, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THE PIPELINE WAS NOT PLACED IN A BEND WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED AND REDEPLOYED, WITH THE WINGS PUSHED, IN AN ATTEMPT TO GET THE DEVICE TO OPEN.

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

  MAUDE report 10812419 ↗
• MalfunctionOct 30, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WHICH FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED AMORPHOUS ANEURYSM OF THE HORIZONTAL POTION OF THE CAVERNOUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 7.24MM AND THE NECK DIAMETER WAS 3.35MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS IN PLACE AT THE ANEURYSM LOCATION THE PIPELINE FLEX STENT WAS DELIVERED. THE MICROC ATHETER WAS RETRIEVED TO DEPLOY THE PIPELINE. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED, OVER 15MM, BUT BOTH THE MIDDLE AND DISTAL SECTIONS FAILED TO OPEN EVEN AFTER WAITING FOR MORE THAN 10 MINUTES. THE PIPELINE WAS RETRIEVED INTO THE MICROCATHETER AND THEN DEPLOYED AGAIN, AGAIN MORE THAN 15MM, BUT STILL THERE WAS NO SIGN OF OPENING AFTER WAITING FOR MORE THAN 10 MINUTES. A THIRD ATTEMPT WAS ALSO MADE TO RETRIEVE AND REDEPLOY WITHOUT SUCCESS. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND. THE PIPELINE WAS RETRIEVED FROM THE PATIENT WITH A SNARE RETRIEVAL DEVICE AND REPLACED TO COMPLETE THE PROCEDURE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: MA

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

  MAUDE report 10762615 ↗
• MalfunctionOct 28, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS DELIVERED TO THE M2 SEGMENT, AND THE PIPELINE WAS DELIVERED. AN ATTEMPT WAS MADE TO OPEN THE STENT AT THE M1 SECTION, BUT THE DISTAL TIP COULD NOT BE OPENED WHEN THE MICROCATHETER WAS RETRIEVED 10 MM. MORE THAN TWO ATTEMPTS WERE MADE, THE WHOLE SET UP WAS RETRIEVED TO THE INTERNAL CAROTID ARTERY, BUT THE TIP STILL COULD NOT BE OPENED. IT WAS NOTED LESS THAN 50% OF THE STENT HAD BEEN DEPLOYED, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE STENT. AFTER THIS, THE ENTIRE SET UP WAS WITHDRAWN, AND A NEW MICROCATHETER AND STENT WAS USED TO COMPLETE THE SURGERY WITH NO REPORTED 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT COMMUNICATING ARTERY SEGMENT WITH A MAX DIAMETER OF 14 MM AND A 8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

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

  MAUDE report 10751642 ↗
• MalfunctionSep 3, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE STENT WOULD NOT OPEN IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE CATHETER HAD BEEN WITHDRAWN FROM THE END OF M1 TO THE BIFURCATION, AND THE PIPELINE STILL COULD NOT BE OPENED.

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

  MAUDE report 10486607 ↗
• MalfunctionAug 26, 2020Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE DEVICE HAD NOT BEEN PLACED IN A VESSEL BEND AT THE TIME, AND THERE WAS NOT ANY FRICTION/DIFFICULTY DURING DELIVERY OR POSITIONING. THE DEVICE DID NOT JUMP DURING DEPLOYMENT, NOR WAS THE TIP OF THE CATHETER MOVED DURING DEPLOYMENT. NO ADDITIONAL STEPS WERE ATTEMPTED TO OPEN THE PIPELINE.

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

  MAUDE report 10458051 ↗
• MalfunctionAug 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MARKSMAN MICROCATHETER WAS POSITIONED, THE PIPELINE BECAME STUCK AND EXPERIENCED RESISTANCE AT THE DISTAL END DURING DELIVERY. AS A RESULT, THE ENTIRE SYSTEM WAS WITHDRAWN AND THE DISTAL SEGMENT OF CATHETER WAS ACCORDIONED. THERE WAS NO PUSHWIRE DAMAGE, AND THE PHYSICIAN DID NOT ATTEMPT TO RELEASE THE SLACK IN THE SYSTEM. A NEW MARKSMAN AND PIPELINE WERE USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. ANGIOGRAPHIC RESULTS POST-PROCEDURE SHOWED SLOWED BLOOD FLOW IN THE ANEURYSM. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE C4 WITH A MAX DIAMETER OF 5MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER, COOK LONG SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446508 ↗
• MalfunctionJul 24, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING THE PROCEDURE THE PIPELINES WERE BEING PLACED IN A VESSEL BEND WHEN THEY FAILED TO OPEN. ATTEMPTS TO OPEN THE DEVICES WERE MADE WITH RESHEATHING AND ATTEMPTING TO OPEN IN OTHER VESSELS BUT ATTEMPTS WERE STILL UNSUCCESSFUL. THE PROCEDURE COULD NOT BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10320032 ↗
• MalfunctionApr 2, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX (PED) PUSHWIRE SEPARATED DURING THE INTERVENTION. THE DEVICE AND THE SEPARATED PIECE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT INJURY OCCURRED. THE DISTAL ACCESS CATHETER (DAC) WAS PLACED HIGH INTO THE PETROUS INTERNAL CAROTID ARTERY (ICA) BEFORE BRINGING THE MICROCATHETER UP INTO THE M2 SEGMENT. AFTER PREPPING THE PED PER THE INSTRUCTIONS FOR USE, THE PED WAS LOADED INTO THE MICROCATHETER. ONCE IT REACHED THE ICA RESISTANCE WAS FELT. THE PED WAS ABLE TO ADVANCE ALL THE WAY TO THE END OF THE MICROCATHETER BUT WITH GREAT FORCE. WHEN ATTEMPTED TO UNSHEATH AND POSITION THE PED, IT WAS NOTICED THAT THE DEVICE WAS NOT RESPONDING TO THE WIRE ANYMORE. IT WAS THEN SUSPECTED THAT THE PUSHWIRE FRACTURED. THE MICROCATHETER, PED (PARTIALLY OPENED) AND THE WIRE WERE REMOVED AS A UNIT BACK THROUGH THE DAC DEVICE AND OUT OF THE PATIENT. NO ILL EFFECTS ON THE PATIENT WERE NOTED FROM THESE MANEUVERS. NEW DEVICES WERE USED TO TREAT THE PATIENT. THE COMPLIANT PED WAS REPORTED TO HAVE LOCKED UP IN THE DISTAL SECTION OF THE MICROCATHETER. THE PHYSICIAN DID RELEASE THE LOAD (SLACK) IN THE SYSTEM TO RESOLVE THE ISSUE BUT FAILED. THE CATHETER W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916773 ↗
• MalfunctionJan 6, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX (PED) FAILED TO OPEN IN THE MIDDLE SECTION. LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE PED. THE PED WAS RESHEATHED WITH THE CATHETER AND REMOVED. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES: PHENOM PLUS, PHENOM .027, SYNCHRO SOFT. THIS EVENT OCCURRED DURING THE TREATMENT OF A PCOMM, UNRUPTURED, AMORPHOUS ANEURYSM. THE MAX DIAMETER WAS 16MM AND THE NECK WAS 6MM. THE DISTAL LANDING ZONE WAS 3.5MM AND THE PROXIMAL WAS 5.1MM. THE VESSEL ANATOMY WAS SEVERE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9553975 ↗
• MalfunctionNov 27, 2019Activation Failure; Migration; Physical Resistance/Sticking; Activation Failure; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FELL INTO THE ANEURYSM WHILE ATTEMPTING TO RETRIEVE THE DELIVERY SYSTEM BACK INTO THE MICROCATHETER. PRIOR TO THE EVENT, THE MICROCATHETER WAS USED TO DELIVER THE PIPELINE TO THE ANEURYSM. THE PIPELINE WAS THEN RELEASED, BUT COULD NOT BE RETRIEVED CAUSING IT TO FALL INTO THE ANEURYSM. THE MICROCATHETER WAS REMOVED AND THE DISTAL PART WAS OBSERVED TO BE STRETCHED AND ACCORDIONED. ANOTHER PIPELINE WAS IMPLANTED TO BRIDGE THE CONNECTION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE ANEURYSM DIAMETERS WERE 24.1MM/19.8MM. THE ANEURYSM WAS NOT RUPTURED AND SACCULAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9387257 ↗
• MalfunctionAug 29, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT OPEN IN THE DISTAL END DESPITE MULTIPLE ATTEMPTS. AS A RESULT THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED. LESS THAN HALF OF THE DEVICE DEPLOYED WHEN IT FAILED TO OPEN. MORE THAN 2 RESHEATHING ATTEMPTS WERE MADE, AND NO ADDITIONAL STEPS WERE MADE TO ATTEMPT TO OPEN THE DEVICE. THE PHYSICIAN ALSO ATTEMPTED TO OPEN THE DEVICE OUTSIDE OF THE BODY WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM THAT COVERED A WIDE NECK. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED BUT THE PRU LEVEL WAS UNKNOWN. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946711 ↗
• MalfunctionAug 19, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE STENT COULD NOT BE OPENED IN THE DISTAL END, EVEN AFTER TWO ATTEMPTS. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. RESHEATHING AND PUSHING/PULLING OF THE DEVICE DID NOT RESOLVE THE ISSUE. AS A RESULT THE DEVICE WAS REMOVED WITH THE MICROCATHETER. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED ANEURYSM RETENTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 7.56MM AND A NECK DIAMETER OF 6.74MM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER, MARKSMAN MICROCATHETER, SYNCHRO GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908812 ↗
• MalfunctionJun 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY BECAUSE IT WAS STRETCHED. IT WAS NOTED THAT LESS THAN HALF OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, IT WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES, THERE WERE NO ADDITIONAL STEPS TAKEN TO OPEN THE DEVICE. AS A RESULT THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR AN UNRUPTURED, AMORPHOUS ICA ANEURYSM WITH A MAX DIAMETER OF 8MM AND A NECK DIAMETER OF 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED WHICH SHOWED A PRU LEVEL AS PER THE RECOMMENDATION. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8669135 ↗
• MalfunctionMay 14, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX WOULD NOT OPEN AND ATTACH TO THE WALL PROPERLY (FULL WALL APPOSITION WAS NOT ACHIEVED). REPEATED ATTEMPTS TO OPEN THE DISTAL PART OF THE PIPELINE WERE MADE BUT WITHOUT SUCCESS. THERE WAS ALSO MENTION OF PIPELINE RESISTANCE INSIDE THE DISTAL SEGMENT OF THE MICROCATHETER. THE OPERATION WAS COMPLETED BY REPLACING THE PIPELINE AND MICROCATHETER WITH NEW PIPELINE AND MICROCATHETER. THE PIPELINE AS NOT PLACED ON A BEND. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED BEFORE IT OPENED AND THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM PATIENT BY RESHEATHING. POST PROCEDURAL ANGIOGRAPHY WAS MODERATELY DISTORTED (IMAGES ATTACHED). NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. SECOND PIPELINE IMPLANTED PROPERLY AND FULLY OPENED. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED FUSIFORM ANEURYSM MEASURING 5.25MM X 14.66MM LOCATED IN THE V3-V4 SEGMENT OF THE RIGHT VERTEBRAL ARTERY. THE DISTAL AND PROXIMAL LANDING ZONE WAS 3.22M X 3.42MM. THE VASCULATURE WAS MODERATE IN TORTUOSITY. ACCESS WAS BY FEMORAL ARTERY. IT WAS UNKN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8607692 ↗
• MalfunctionFeb 8, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF FIVE DIAMETER PIPELINE WITH NEVER FULLY OPEN. DESPITE OF SEVERAL ATTEMPTS, THE PHYSICIAN RE-SHEATHED AND TAKE THE FULL SYSTEM OUT WITH THE CATHETER. ANOTHER SIZE OF THE PIPELINE REPLACED AND COMPLETED THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT WITH FLOW DIVERSION OF A MEDIUM UNRUPTURED FUSIFORM OPHTHALMIC ANEURYSM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323246 ↗
• DeathJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT POST PROCEDURE PATIENT EXPERIENCED RIGHT EYE EDEMA AND IT WAS DISCOVERED THAT CAROTID CAVERNOUS FISTULA (CCF) OCCURRED DUE TO ANEURYSM RUPTURED. THE PATIENT WAS REPORTED A BRAIN DEATH. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT WITH FLOW DIVERSION FOR A MEDIUM SIZE SACCULAR ANEURYSM LOCATED IN INTERNAL CAROTID ARTERY IN CAVERNOUS SEGMENT. MAXIMUM DIAMETER OF ANEURYSM: 18.0 MM, NECK WIDTH OF ANEURYSM: 8.0 MM, BLOOD VESSEL DIAMETER IN LANDING ZONE: (DISTAL SIDE ) 4.22 MM, (PROXIMAL SIDE) 3.77 MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. VESSEL DIAMETER WAS MEDIUM. IT WAS REPORTED THAT STENOSIS OF THE BLOOD VESSELS IN THE NECK PROXIMAL PART AND THE DISTAL PART WAS FOUND BUT PIPELINE WAS SAFELY PLACED. ECLIPSE SIGN AFTER PLACEMENT WAS ALSO SEEN, AND THE PTA WAS ALSO APPLIED TO THE STENOSIS PART, ALTHOUGH IT WAS IN A SITUATION SLIGHTLY FLOATING BUT ENDED. ONE WEEK LATER, PATIENT'S RIGHT EYE EDEMA WAS FOUND, AND AS A RESULT OF ANGIO PERFORMED ON THE (B)(6), IT WAS DISCOVERED THAT CCF OCCURRED DUE TO AN BURST. SINCE A LARGE AMOUNT OF BACKFLOW TO SOV ETC. WAS SEEN FROM CAVERNOUS, PAO TREATMENT WAS DONE. AS THE FLOW WAS FOUND TO BE REDUCED, THE PROCEDU

  Patient problems: Death; Edema; Fistula; Intracranial Hemorrhage

  MAUDE report 8223351 ↗
• MalfunctionAug 13, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT A PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT OF AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE RIGHT, CAVERNOUS INTERNAL CAROTID ARTERY (ICA). VESSEL TORTUOSITY WAS DESCRIBED AS SEVERE. THE ANEURYSM MAX. DIAMETER WAS 20MM AND NECK DIAMETER WAS 11MM. THE LANDING ZONE WAS 3MM DISTAL AND 4.9MM PROXIMAL. THE PATIENT HAD BEEN ADMINISTERED DUAL ANTIPLATELETS AND WAS WITHIN THE THERAPEUTIC RANGE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE CATHETER AND CATHETER WERE PLACED IN THE RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY. A PIPELINE FLEX 5X25MM WAS ADVANCED THROUGH THE CATHETER. AT DEPLOYMENT, THE PIPELINE FLEX WAS UNSHEATHED BY PULLING BACK THE CATHETER AND PUSHING THE DEVICE OUT; IT WAS REPORTED THAT THE TIP WIRE BECAME "STUCK" ON A SIDE BRANCH IN THE PCOM ARTERY. THE CATHETER AND PIPELINE FLEX WERE PULLED BACK TO THE ICA AND DEPLOYMENT CONTINUED. THE TIP WIRE REPORTEDLY BECAME STUCK ON THE DISTAL ICA STENOSIS; BEING UNABLE TO REPOSITION, DEPLOYMENT CONTINUED. IT WAS REPORTED THAT THE DISTAL END OF THE PIPELINE FLEX DID NOT COMPLETELY OPEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7779516 ↗
• MalfunctionJun 29, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE STENT COULDN'T BE OPENED WHEN PUSHED FROM THE MICROCATHETER, AFFECTING THE SHAPE OF THE STENT. IT WAS NOTED THAT THERE WAS A DIFFICULTY IN NAVIGATION AND FRICTION DURING DELIVERY OF THE CATHETER, AND THAT LESS THAN 50% OF THE PIPELINE HAD DEPLOYED WHEN IT FAILED TO OPEN. THE PATIENT WAS UNDERGOING ANEURYSM INTERVENTIONAL THERAPY FOR AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 4MM. THE VESSEL TORTUOSITY WAS MODERATE WITH AN ACCESS DIAMETER OF 6MM. THE DEVICES WERE PREPARED AS INDICATED AND FLUSHED PER THE IFU WITH THE PIPELINE RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED COMPLETE EMBOLIZATION. THERE WERE NO PATIENT SYMPTOMS ALLEGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651171 ↗

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-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-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-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