PIPELINE PED-500-35 (UDI 00847536016903)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00847536016903), received between Jun 21, 2018 and Apr 26, 2022 — classified as 1 death, 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (22 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE CATHETER REACHED THE DISTAL TIP OF THE ANEURYSM AND THEY WERE READY TO DEPLOY THE PIPELINE. AFTER REPEATED ATTEMPTS, THE STENT COULD NOT BE PUSHED OUT OF THE CATHETER AND WAS REPLACED WITH A SHAPEABLE MICROCATHETER, PHENOM27. THE PED-4.75-30 WAS IMPLANTED TO BRIDGE THE PED4.75-35 AND THE EFFECT WAS GOOD. THE OPERATION WAS SUCCESSFULLY COMPLETED. THE STENT WAS STUCK AT THE DISTAL END OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PHYSICIAN RELEASED THE LOAD IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE CATHETER WAS NOT DAMAGED NOR WAS THE PUSHWIRE DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A AMORPHOUS, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 18MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC POST PROCEDURE SHOWED CONTRAST AGENT RETENTION WAS OBVIOUS, THE DENSE NET STENT STUCK TO THE WALL WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210916 ↗
• MalfunctionMar 21, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DUE TO THE TORTUOSITY OF THE BLOOD VESSELS, THE DISTAL END OF THE TUMOR NECK WAS UNKNOWN AND SPECIAL. AFTER THE CATHETER AND STENT REACHED THE LESION THROUGH THE MIDDLE, THE STENT WAS WITHDRAWN, AND IT WAS DIFFICULT TO OPEN THE CATHETER TIP. IT WAS ADJUSTED FOR OPERATION AND IT WAS FOUND THAT THE TIP IMAGE WAS ABNORMAL. IT WAS WITHDRAWN FROM THE BODY, AND THE TIP DAMAGE WAS FOUND. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED GOOD RESULT. THE PIPELINE WAS USED FOR AN INDICATION WAS APPROVED AND THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PIPELINE WAS NOT POSITIONED IN A BEND AND IT WAS RESHEATHED "LESS THAN OR EQUAL TO 2 TIMES." NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE, IT WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN C4 WITH A MAX DIAMETER OF 13.3MM AND A 7MM NECK DIAMETER. THE LANDING ZONE WAS 4.31MM IN THE DISTAL END AND 3.93MM IN THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13843225 ↗
• MalfunctionFeb 23, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINES FAILED TO OPEN AND THERE WAS RESISTANCE IN THE CATHETER. THE FIRST PIPELINE THAT WAS USED COULD NOT BE PUSHED OUT AT THE TIP AND THE DISTAL END FAILED TO OPEN. IT WAS UNKNOWN IF IT WAS POSITIONED IN A BEND AND IT WAS UNKNOWN HOW MUCH OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT WAS UNKNOWN HOW MANY TIMES THE PIPELINE WAS RESHEATHED AND IF THERE WERE ANY ADDITIONAL STEPS REQUIRED TO OPEN THE PIPELINE. IT WAS UNKNOWN IF THE PIPELINE WAS REMOVED FROM THE PATIENT. THE SECOND PIPELINE WAS STUCK IN THE CATHETER AT THE DISTAL END. IT WAS UNKNOWN IF THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. IT WAS UNKNOWN IF THE PIPELINE BECAME STUCK. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. IT WAS UNKNOWN IF THE PUSHWIRE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586835 ↗
• MalfunctionJun 21, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE DEVICES FAILED TO OPEN IN THE MIDDLE AND PROXIMAL SECTIONS. THE PATIENT WAS UNDERGOING TREATMENT FOR AN AMORPHOUS, DIRECT CAROTID-CAVERNOUS FISTULA IN THE LEFT ICA DUE TO BLUNT FORCE TRAUMA. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 7MM DISTAL AND 10MM PROXIMAL. THE ACCESS VESSEL WAS THE ICA, WHICH WAS 5MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT PIPELINE HAD TROUBLE COMING THROUGH THE ACUTE TURN OF THE ANTERIOR GENU. THEY CONTINUED TRYING TO DEPLOY, HOPING THAT WITH WAGGING, LOADING, AND CENTERING THE DEVICE MIGHT START TO OPEN MORE. AT ONE POINT IT LOOKED LIKE IT WAS OPENING, BUT WAS RIBBONING/FLATTENING TOO. THE PIPELINE WAS NOT POSITIONED IN A BEND WHEN IT FAILED TO OPEN, AND MORE THAN 50% HAD BEEN DEPLOYED AT THE TIME. THE PHYSICIAN RESHEATHED THE PIPELINE TWO OR LESS TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PHYSICIAN REPLACED THE PIPELINE, BUT TO THE SAME THING HAPPENED WITH THE NEW DEVICE. THE PHYSICIAN REMOVED THIS PIPELINE AND TRIED WITH TWO STRYKER EVOLVE DEVICES, BUT SIMILAR DEPLOYMENT ISSUES OCCURRED. THEY DECIDED TO COMPLETE DEPLOYMENT AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036297 ↗
• MalfunctionJun 21, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE DEVICES FAILED TO OPEN IN THE MIDDLE AND PROXIMAL SECTIONS. THE PATIENT WAS UNDERGOING TREATMENT FOR AN AMORPHOUS, DIRECT CAROTID-CAVERNOUS FISTULA IN THE LEFT ICA DUE TO BLUNT FORCE TRAUMA. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 7MM DISTAL AND 10MM PROXIMAL. THE ACCESS VESSEL WAS THE ICA, WHICH WAS 5MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT PIPELINE HAD TROUBLE COMING THROUGH THE ACUTE TURN OF THE ANTERIOR GENU. THEY CONTINUED TRYING TO DEPLOY, HOPING THAT WITH WAGGING, LOADING, AND CENTERING THE DEVICE MIGHT START TO OPEN MORE. AT ONE POINT IT LOOKED LIKE IT WAS OPENING, BUT WAS RIBBONING/FLATTENING TOO. THE PIPELINE WAS NOT POSITIONED IN A BEND WHEN IT FAILED TO OPEN, AND MORE THAN 50% HAD BEEN DEPLOYED AT THE TIME. THE PHYSICIAN RESHEATHED THE PIPELINE TWO OR LESS TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PHYSICIAN REPLACED THE PIPELINE, BUT TO THE SAME THING HAPPENED WITH THE NEW DEVICE. THE PHYSICIAN REMOVED THIS PIPELINE AND TRIED WITH TWO STRYKER EVOLVE DEVICES, BUT SIMILAR DEPLOYMENT ISSUES OCCURRED. THEY DECIDED TO COMPLETE DEPLOYMENT AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036212 ↗
• MalfunctionMay 19, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO DIFFERENT PIPELINES THAT FAILED TO OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT TANDEM UNRUPTURED SACCULAR ANEURYSMS OF AN INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT. THE MAX DIAMETER WAS 3.74MM AND THE NECK DIAMETER WAS 5.36MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A CATHETER WAS ROUTINELY PLACED AND THE PIPELINE (MODEL: PED-500-35) WAS PREPARED. THE PIPELINE WAS DELIVERED THROUGH THE CATHETER AND DEPLOYMENT BEGAN. THE DISTAL SEGMENT OF THE PIPELINE OPENED NORMALLY BUT THE PROXIMAL END FAILED TO OPEN EVEN AFTER MULTIPLE ATTEMPTS. IT WAS DISCUSSED AND DECIDED TO REMOVE THE STENT TO CHECK OUTSIDE THE PATIENT'S BODY. AFTER TAKING IT OUT, THE CATHETER WAS FOUND TO BE DAMAGED AND THE PIPELINE COULD NOT BE PUSHED OUT OF THE CATHETER NORMALLY. A CATHETER WAS THEN REPLACED WITH A PHENOM 27 SHAPEABLE CATHETER WAS THEN USED AND ANOTHER PIPELINE (MODEL: PED-500-30) WAS DELIVERED NORMALLY. THE DISTAL SEGMENT OF THE PIPELINE OPENED NORMALLY BUT THE MIDDLE SECTION OF THE PIPELINE COULD NOT BE OPENED EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850513 ↗
• MalfunctionMay 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MICROCATHETER WAS KINKED, AND THE PIPELINE STENT COULD NOT BE PUSHED. THE PIPELINE WAS ADVANCED COMPLETELY THROUGH THE CATHETER BUT DIDN'T COME OUT OF THE SHEATH. THE PHYSICIAN WAS UNABLE TO CONTINUE DELIVERY, AND UPON REMOVAL THE CATHETER KINK WAS FOUND IN THE MIDDLE SECTION OF THE CATHETER. REPLACEMENT PRODUCTS 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 ANGIOGRAPHY SHOWED SLOW BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 14.7 MM AND A 11.3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS NOT ADMINISTERED. ANCILLARY DEVICES INCLUDE A COOK6 SHEATH, NAVIEN 5F 115 CM GUIDECATHETER, MARKSMAN MICROCATHETER, SYNCHRO2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845066 ↗
• MalfunctionMar 8, 2021Unintended Ejection; Activation Failure; Physical Resistance/Sticking; Activation Problem; Unintended Ejection; Activation Failure; Physical Resistance/Sticking; Activation Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER REMOVING THE PHENOM 27 AND PIPELINE STENT FROM THE BODY, IT WAS FOUND THAT THE STENT HAD FALLEN OFF IN THE MICROCATHETER. THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE OBSERVED. WHEN ASKED IF THE PUSHWIRE HAD BEEN ROTATED OR PULLED BACK DURING THE PROCEDURE, IT WAS REPORTED THE PUSHWIRE WAS PUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11437085 ↗
• MalfunctionFeb 18, 2021Material Deformation; Unintended Movement; Activation Failure; Material Deformation; Unintended Movement; Activation Failure

  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 11343746 ↗
• MalfunctionJan 29, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE TO IMPLANT A FLOW DIVERSION STENT TO TREAT A PREVIOUS TRAUMATIC DISSECTION OF THE INTERNAL CAROTID ARTERY THAT WAS HEALED BUT WITH RESULTING/REMAINING ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS 4.2MM AND THE PROXIMAL LANDING ZONE WAS 5MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER AND GUIDEWIRE WERE ADVANCE TO THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE GUIDEWIRE WAS REMOVED AND THE PIPELINE WAS ADVANCED WITHOUT C OMPLICATION. DEVICE DEPLOYMENT WAS INITIATED BUT THE PIPELINE DISTAL END DID NOT OPEN. THE DISTAL END HAD A CONICAL OR BULLET SHAPE. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN THE FAILURE TO OPEN WAS OBSERVED. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PHYSICIAN SQUEEZED THE PIPELINE JUST PROXIMAL TO THE UNOPENED END AND THE PIPELINE DID OPEN PARTIALLY BUT NEVER OPENED COMPLETELY. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251685 ↗
• MalfunctionJan 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHILE ADVANCING THE PIPELINE INTO THE PHENOM 027 MICROCATHETER, THE PHYSICIAN FELT RESISTANCE IN THE PROXIMAL SEGMENT. THE SLACK WAS RELEASED IN THE SYSTEM, BUT WAS UNSUCCESSFUL AT RESOLVING THE ISSUE. A CONTINUOUS FLUSH HAD BEEN USED. THE CATHETER AND PIPELINE WERE REMOVED, AND THE PIPELINE NEVER ADVANCE FURTHER THAN THE TIP OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR THE CATHETER. AFTER REMOVING THE SYSTEM, A PIPELINE OF THE SAME SIZE WAS SUCCESSFULLY IMPLANTED WITH A NEW PHENOM MICROCATHETER. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206225 ↗
• MalfunctionOct 12, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT IT WAS DIFFICULT TO OPEN THE DISTAL SEGMENT OF THE PIPELINE, AND IT APPEARED BURRS. THE PIPELINE WAS NOT POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, RE-SHEATHING WAS PERFORMED MORE THAN TWICE, AND NO ADDITIONAL STEPS WERE DONE TO TRY AND OPEN THE PIPELINE. 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 ANGIOGRAPHY SHOWED SLOWED BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SERIES CONNECTION, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS REPORTED AS UP TO STANDARD.

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

  MAUDE report 10667572 ↗
• MalfunctionSep 15, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DISTAL SEGMENT OF THE PIPELINE (PLI-10) FAILED TO OPEN. THE PIPELINE WAS REMOVED FROM THE PATIENT, AND A SECOND PIPELINE (PLI-20) WAS USED. THE SECOND PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE DEVICES WERE NOT POSITIONED IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED, IT WAS UNKNOWN HOW MANY RESHEATHING ATTEMPTS WERE PERFORMED, AND NO ADDITIONAL STEPS WERE DONE TO OPEN THE DEVICES. THE SECOND PIPELINE WAS REMOVED FROM THE PATIENT, AND THE THIRD AND FOURTH PIPELINE WERE DEPLOYED SUCCESSFULLY. 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 THE ANEURYSM WAS COVERED. ANCILLARY DEVICES INCLUDE A NEURONMAX, PHENOM PLUS, PHENOM27. REFER TO MANUFACTURER REPORT 2029214-2020-00930 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10536817 ↗
• MalfunctionSep 1, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THE PIPELINE 5.00MM X 35MM WOULD NOT OPEN COMPLETELY IN AN EXTREMELY ACUTE ANGLE ANTERIOR GENU DISTAL TO THE ANEURYSM. IT WAS NOTED THAT THE DEVICE FAILED TO OPEN 6-8MM FROM THE DISTAL END IN THE ANTERIOR GENU. NOT HAPPY WITH APPOSITION IN THE ANTERIOR GENU, THE PHYSICIAN REMOVED THE PIPELINE 5.00MM X 35MM FROM THE PATIENT AND ATTEMPTED WITH THE PIPLELINE 4.75MM X 30MM: HOWEVER, THE PIPELINE 4.75MM X 30MM BEHAVED THE SAME IN THE EXTREMELY TORTUOUS GENU. THE PIPELINE 4.75MM X 30MM WAS REMOVED FROM THE PATIENT, AND THEN THE PHYSICIAN SUCCESSFULLY DEPLOYED THE SHORTER PIPELINE 4.50MM X 20MM LANDING JUST PROXIMAL TO THE ANTERIOR GENU. IT WAS STATED THAT THE DISTAL SECTION OF THE PIPELINES WERE POSITIONED IN A BEND, AND LESS THAN 50% OF BOTH PIPELINES HAD BEEN DEPLOY WHEN IT FAILED TO OPEN. BOTH PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINES. BOTH PIPELINES WERE RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE RIGHT CAVERNOUS WITH A MAX DIAMETER OF 16MM AND A NECK DIAMETER OF 4-5MM. THE DISTAL L ANDING ZONE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10479789 ↗
• MalfunctionJul 31, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE BRAID DISTAL TIP KINKED AND COULD NOT BE OPENED. THE DEVICE WAS REMOVED FROM THE TREATING VESSEL. THE DEVICE FINALLY WAS ABLE TO BE OPENED WHEN FORCE WAS APPLIED. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. MORE THAN 2 RESHEATHING ATTEMPTS WERE MADE. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT, UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 12.1 MM AND THE NECK WAS 2.3 MM. THE DISTAL LANDING ZONE WAS 3.24 MM AND THE PROXIMAL WAS 4.98 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). PARTIAL RESISTANCE, WITHIN NORMAL RANGE, WAS FELT WHEN THE PED WAS ADVANCED. A CONTINUOUS FLUSH WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10350678 ↗
• MalfunctionJun 16, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. IT WAS REPORTED THAT THE STENT WAS PUSHED OUT OF THE MICROCATHETER IN A KINKED STATE AND THE MIDDLE SECTION COULD NOT BE OPENED. THE PIPELINE HAD NOT BEEN POSITIONED IN A BEND AND WAS MORE THAN 50% DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES AND WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED IN THE VERTEBRAL ARTERY. THE NECK DIAMETER WAS 13.4 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10156291 ↗
• DeathApr 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM IN THE LEFT INTRACRANIAL TERMINUS IT WAS REPORTED THAT THE PIPELINE WAS USED WITH NO ISSUES REPORTED INTRA-OP, AND THE PATIENT DID WELL POST-OP. HOWEVER, THE ANEURYSM BLED TWO DAYS LATER AND THE PATIENT PASSED AWAY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Death; Therapeutic Response, Decreased

  MAUDE report 9952010 ↗
• MalfunctionDec 5, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE (PED) WAS DELIVERED VIA THE MICROCATHETER. THE PED WAS DEPLOYED, HOWEVER, THE DISTAL TIP DID NOT OPEN AND WAITED. THE PED DID FINALLY OPEN BUT OPENED POORLY. THE PED WAS THE RETRIEVED (RESHEATHED) AND ATTEMPTED TO BE RE-DEPLOYED. HOWEVER, PED WAS UNABLE TO MOVE. THE MICROCATHETER AND THE PED HAD TO BE REMOVED AS A SYSTEM. THE MICROCATHETER WAS NOTICED TO BE DAMAGED IN THE DISTAL SECTION. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER FLUSHED AS INDICATED IN THE IFU. THE DEVICE WAS NOT PLACED IN A BEND IN THE ANATOMY. LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN THE EVENT OCCURRED. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THIS EVENT OCCURRED DURING THE TREATMENT OF A LATERAL CAVERNOUS SEGMENT ANEURYSM. THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 33MM AND THE NECK WAS 11MM. THE DISTAL LANDING ZONE WAS 4.04MM AND THE PROXIMAL WAS 5.14MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415976 ↗
• MalfunctionMay 1, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING PIPELINE FLEX EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT INTERNAL CAROTID ARTERY. MEASURING 15MMX8MM, LANDING ZONE DISTAL 4.2MM PROXIMAL 5.1MM. THE VESSEL WAS MODERATELY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS DEPLOYED AND DID NOT OPEN. LESS THAN 50% THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE RE-SHEATHED AND REMOVED WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY PLACING A NEW DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569601 ↗
• MalfunctionApr 29, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX FAILURE TO OPEN DURING A PROCEDURE. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT OF A RUPTURED BLISTER ANEURYSM IN OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM WAS REPORTED TO HAVE A MAX DIAMETER AND A NECK DIAMETER OF 2MM. THE LANDING ZONE WAS 3.8MM DISTALLY AND 4.3MM PROXIMALLY. THE ANATOMY WAS REPORTED TO HAVE BEEN NORMAL IN TORTUOSITY. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS USED DURING THE DELIVERY OF THE DEVICES. USING STANDARD INTERVENTION TECHNIQUES, ACCESS WAS GAINED TO THE ANEURYSM. ONE FLOW DIVERSION DEVICE WAS PLACED. NEXT, A PED-500-35 WAS SELECTED. WHILE DEPLOYING THE SECOND DEVICE, THE DISTAL END WAS OBSERVED NOT TO BE OPENING WELL, SO IT WAS RE-SHEATHED AND DEPLOY 2-3 TIME. UNDER FLUOROSCOPY THE DISTAL STRUTS OF PED ENTANGLED AND LOOKING LIKE IT IS CRIMPED SO IT WAS REMOVED FROM THE PATIENT. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8559718 ↗
• MalfunctionMar 7, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX DEVICE DID NOT EXPAND AT THE DISTAL PART OF THE DEVICE. THE DEVICE WAS REMOVED AND DISCARDED. THE UNRUPTURED, SACCULAR ANEURYSM WAS IN THE IC-CAVERNOUS SINUS. MAXIMUM DIAMETER OF THE ANEURYSM WAS MORE THAN 30 MM. NECK WIDTH OF THE ANEURYSM AND VASCULAR DIAMETER OF THE LANDING ZONE ARE UNKNOWN. NUMBER OF RESHEATHING DURING THE OPERATION ARE UNKNOWN. VESSEL ANATOMY IS UNKNOWN. VESSEL DIAMETER WAS REPORTED TO HAVE BEEN MEDIUM. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. IN ADDITION, OPERATION WAS PERFORMED AS USUALLY PERFORMED IN A PROCEDURE SUCH AS TURNING OVER THE PROTECTIVE SLEEVE, ETC. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401952 ↗
• MalfunctionFeb 25, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DISTAL TIP OF THE PIPELINE COULD NOT BE OPENED AFTER THE PIPELINE WAS DELIVERED TO THE INTENDED LOCATION THROUGH THE MARKSMAN MICROCATHETER. THEY TRIED TO RESHEATH AND RELEASE TWICE BUT THE TIP OF THE PIPELINE STILL COULD NOT BE OPENED AT ALL. THE SURGEON WITHDREW THE ENTIRE SYSTEM AND REPLACED THE IT WITH A NEW PIPELINE AND MARKSMAN WHICH RELEASED WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DISTAL SEGMENT OF THE MICROCATHETER WAS FOUND TO BE KINKED. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 23.41 MM BY 21.89 MM LOCATED IN THE C AVERNOUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 4.1 MM AND 3.9 MM. THE PATIENT¿S VASCULATURE WAS SEVERE IN TORTUOSITY. ACCESS WAS BY THE FEMORAL ARTERY WITH DIAMETER OF 8.6. THE PATIENT WAS ON DUAL ANTIPLATE LET THERAPY AND THE PRU LEVEL WAS STANDARD. THE REPORTED DEVICE AND ANCILLARY DEVICES WERE FLUSHED PER INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS FLUSHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8365278 ↗
• MalfunctionJan 29, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING THE PIPELINE FLEX (PED) EMBOLIZATION, THERE WAS RESISTANCE WHEN THE PIPELINE WAS PUSHED OUT OF THE CATHETER. THE PIPELINE THEN FAILED TO OPEN AT THE DISTAL END. THE PED WAS THE RESHEATHED AND REMOVED FROM THE PATIENT. THE DEVICES WERE REPORTED TO HAVE BEEN PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT INJURY OCCURRED. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ANEURYSM IN SUPERIOR SEGMENT OF RIGHT INTERNAL CAROTID ARTERY. THE ANEURYSM WAS UNRUPTURED, SACCULAR WITH A MAX DIAMETER OF 22.8MM AND A NECK OF 20.9MM. THE DISTAL LANDING ZONE WAS 4.8MM AND THE PROXIMAL WAS 3.7MM. THE ANATOMY WAS SEVERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8287450 ↗
• MalfunctionJan 28, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DURING THE DEPLOYMENT OF THE PIPELINE, THE DEVICE NARROWED IN THE MIDDLE SEGMENT THAT COULD NOT BE RESOLVED. THE PIPELINE WAS REMOVED WITH THE CATHETER, AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. THE DEVICE WAS DEPLOYED IN A BEND, WHICH IS WHEN THE MIDDLE SECTION DID NOT EXPAND. MORE THAN 50% OF THE DEVICE HAS BEEN DEPLOYED WHEN THE EVENT OCCURRED. THE DEVICE WAS RESHEATHED 2 TIMES. NO PATIENT INJURY OCCURRED. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RIGHT ICA ANEURYSM. THE ANEURYSM WAS SACCULAR, WITH A MAX DIAMETER OF 8MM AND A NECK OF 4MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL WAS 4.75MM. THE ANATOMY WAS MODERATE IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282527 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT POST THE UNEVENTFUL PIPELINE EMBOLIZATION PROCEDURE OF AN UNRUPTURED 24MM ANEURYSM, THE PATIENT WAS REPORTED TO HAVE NEUROLOGICAL DETERIORATION THAT CONSISTED OF ¿MASS EFFECT DETERIORATION¿ (4TH DAY POST TX.), OCULAR MOVEMENT DISORDER. APPROXIMATELY, ONE MONTH LATER THE PATIENT WAS REPORTED TO HAVE MASS EFFECT DETERIORATION, HEADACHE, VOMITING, NAUSEA AND OCULAR MOVEMENT DISORDER. 2 YEARS POST THE INITIAL TREATMENT THE SYMPTOMS OF OPTIC NERVE WERE NONE. THE MASS EFFECT WAS UNCHANGED. MRS TWO YEARS AFTER THE PROCEDURE: 2 THE ANEURYSM WAS IN THE LEFT INTERNAL CAROTID ARTERY - CAVERNOUS / UNRUPTURED SACCULAR ANEURYSM IN THE CAVERNOUS SINUS (MAXIMUM DIAMETER: 23.9 MM, NECK WIDTH: 16.2 MM). PAST HISTORY: SMOKING IN THE PAST, MASS EFFECT

  Patient problems: Neurological Deficit/Dysfunction; Visual Impairment

  MAUDE report 8173879 ↗

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-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-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-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