PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-350-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000284145), received between Aug 9, 2021 and Mar 4, 2026 — classified as 2 deaths, 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 reports).

12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD THREE PIPELINE VANTAGE STENTS IMPLANTED TO TREAT A 2.8MM UNRUPTURED SACCULAR BASILAR ARTERY ANEURYSM 5 DAYS PRIOR. NO DEVICE MALFUNCTION WAS REPORTED ASSOCIATED WITH THIS EVENT. PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT AROUND 2000, THE PATIENT PRESENTED WITH DYSARTHRIA AND WEAKNESS IN ALL 4 EXTREMITIES. BY THE TIME NEUROLOGY HAD ASSESSED, THE PATIENT'S SYMPTOMS HAD ALMOST RESOLVED EXCEPT FOR SLIGHT DYSARTHRIA AND HAND PARESTHESIA. THE NEXT MORNING AT 0700, THE NEUROLOGICAL EXAM WAS NORMAL. HOWEVER, AROUND 0900, THE PATIENT AGAIN EXPERIENCED RIGHT UPPER EXTREMITY (RUE) WEAKNESS WITH ANARTHRIA AS WELL AS TREMORS IN LEFT UPPER EXTREMITY (LUE) AND JAW. BY 0930, THE PATIENT ALSO HAD MODERATE DYSARTHRIA WITHOUT APHASIA - COMPREHENSION AND NAMING WERE NORMAL. TREMORS DID NOT APPEAR CLONIC IN NATURE AND STOPPED WHEN HOLDING PATIENT'S HAND; SEIZURE SEEMED UNLIKELY. REPEAT COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WITH NO OBSERVATION OF STROKE OR HEMORRHAGE. BASED ON THE AVAILABLE INFORMATION THE CARE TEAM CONSIDERED THE PATIENT'S FLUCTUATING NEUROLOGICAL SYMPTOMS

  Patient problems: Dysphasia; Muscle Weakness/Atrophy; Nervous System Injury; Obstruction/Occlusion; Paresis; Shaking/Tremors

  MAUDE report 24508287 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATENT EXPERIENCED A HEADACHE. THE PATIENT WAS BEING TREATED FOR A RIGHT ICA C4 SIDEWALL ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAXIMUM DIAMETER 2.8 MM, DOME HEIGHT 1.4 MM, DOME WIDTH 1.7 MM, NECK SIZE 2.8 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 2.6 MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM WAS 3.7 MM. NO STASIS WAS NOTED AT THE END OF THE PROCEDURE. COMPLETE NECK COVERAGE WAS NOTED AT THE END OF THE PROCEDURE. POST IMPLANT ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROCEDURE WAS CLASS 3. THE ACCESS VESSEL WAS THE FEMORAL RIGHT. RIST WAS NOT USED. THE PATIENT REPORTED TO EMERGENCY DEPARTMENT WITH A HEADACHE, FACIAL NUMBNESS DIZZINESS RIGHT EYE FLOATERS NAUSEA WITHOUT EMESIS AND PARESTHESIA. THE PATIENT HAD A CT WHICH SHOWED NO ABNORMALITIES. THE PATIENT LEFT AFTER THE CT WITHOUT BEING SEEN. THE PATIENT HAD A MEDICAL HISTORY OF HEADACHES, MIGRAINES, PARESTHESIAS AND IMPAIRED COGNITION. THE PATIENT WAS BEING TREATED WITH ZOFRAN. THE PATIENT WAS ALSO GIVEN 4 MG OF ONDANSETRON ON (B)(6) 2024 SUBCUTANEOUS. THE ADVERSE EVENT (AE) DID NOT RESULT IN THE SUBJECT BEING HOSPITALIZED OR A PROLONGATION OF

  Patient problems: Dizziness; Headache; Nausea; Neuropathy; Numbness; Paresthesia; Suicidal Ideation; Vitreous Floaters

  MAUDE report 21345804 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED A HEADACHE, FATIGUE, WORSENING VISION IN THE RIGHT EYE, AND TINGLING IN FINGERS. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT RECOVERING/RESOLVING. THE ADVERSE EVENT (AE) WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY. THE AE DID NOT RESULT FROM A DEVICE DEFICIENCY. THE SYMPTOMS DID NOT LAST FOR MORE THAN 24 HOURS. THE PATIENT REPORTED TO ER WITH A HEADACHE, FATIGUE, WORSENING VISION IN THE RIGHT EYE, AND TINGLING IN FINGERS. THE PATIENT WAS TREATED WITH A MIGRAINE COCKTAIL AND HEAD CT WAS PERFORMED. THIS INCLUDED INJECTIONS OF DEXAMETHASONE, DIPHENHYDRAMINE, METOCLOPRAMIDE AND MAGNESIUM. NO ABNORMAL FINDINGS WERE REPORTED. THE SYMPTOMS RESOLVED AND THE PATIENT WENT HOME. THE PATIENT WAS BEING TREATED FOR A RIGHT C6 ICA SIDEWALL ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAXIMUM DIAMETER 2 MM, DOME HEIGHT 1.5 MM, DOME WIDTH 2 MM AND NECK SIZE 1.6 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 2.8 MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM WAS 3.3 MM. POST IMPLANT SIGNIFICANT STASIS AND COMPLETE NECK COVERAGE WAS NOTED. POST IMPLANT THE ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROC

  Patient problems: Fatigue; Headache; Neuropathy; Visual Impairment

  MAUDE report 20428995 ↗
• InjuryJul 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED AN ELEVATED WHITE BLOOD CELL COUNT CONCERNING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19807870 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THAT PATIENT EXPERIENCED VISUAL FIELD DEFECT WITH AN ONSET DATE OF (B)(6) . THIS EVENT RESULTED IN NEW HOSPITALIZATION FROM (B)(6) 2023 TO (B)(6) 2023. THIS ADVERSE EVENT (AE) DID NOT RESULT IN ANY TREATMENT, BLOOD TRANSFUSION, PERCUTANEOUS INTERVENTION, OR SURGICAL PROCEDURE. THE OUTCOME STATUS IS RECOVERED/RESOLVED WITH AN OUTCOME DATE OF (B)(6) 2023. AE POSSIBLY RELATED TO THE DISEASE UNDER STUDY. AE DID NOT RESULT IN A NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICIT. AE DID NOT RESULT FROM A DEVICE DEFICIENCY. THE PATIENT REPORTED THAT HER RIGHT UPPER VISION WENT GRAY TEMPORARILY. NORMAL COMPUTERIZED TOMOGRAPHY (CT) HEAD WITHOUT CONTRAST, RESTARTED BRILINTA 60MG, NEUROLOGY CLEARED PATIENT FOR DISCHARGE. THE SITE ASSESSED THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND CAUSALLY RELATED TO THE STUDY DEVICE. ANEURYSM DETAILS:  SIDE (HEMISPHERE): RIGHT SPECIFY SEGMENT OF ICA: C6 LOCATION OF ANEURYSM IN VESSEL: SIDEWALL ANEURYSM MORPHOLOGY: SACCULAR MAXIMUM ANEURYSM DIAMETER: 8.5MM ANEURYSM D

  Patient problems: Visual Disturbances

  MAUDE report 19221809 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE INDEX PROCEDURE DISCHARGE NOTE STATE THAT THE PATIENT DID WELL POST-OP. PATIENT HAD SOME LEFT FACIAL NUMBNESS AND PAIN/HEADACHE TO RIGHT EYE. IMPROVED WITH STEROIDS AND FLUIDS. PAIN WAS CONTROLLED ON PO PAIN MEDICATIONS. IT WAS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT OR ANY MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. IT WAS UNKNOWN IF THERE WAS AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR. THERE WAS NO ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE CLINICAL EVENTS COMMITTEE (CEC).

  Patient problems: Eye Pain; Headache; Numbness

  MAUDE report 18897490 ↗
• MalfunctionNov 2, 2023Structural Problem; Structural Problem

  MEDTRONIC RECEIVED INFORMATION ABOUT A PATIENT WHO UNDERWENT A PROCEDURE ON (B)(6) 2023 IN WHICH 2 PIPELINE STENTS AND A PHENOM MICROCATHETER WAS USED. IT WAS REPORTED THAT DURING THE OPERATION, ONE OF THE PIPELINE STENTS GOT LOST IN THE PHENOM MICROCATHETER DURING AN ATTEMPTED DEPLOYMENT SO THE ENTIRE SYSTEM WAS REMOVED. THE SECOND PIPELINE STENT WAS FOUND TO NOT PROPERLY COVER THE ANEURYSM DOME AND DISTAL LANDING ZONE ON FOLLOW-UP IMAGING. NO MEDICAL INTERVENTION WAS NOTED. THERE WERE NO IMPACTS TO THE PATIENT NOTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THERE WAS DEVICE FORSHORTENING. THE STENT WAS DEPLOYED DISTALLY RIGHT UP TO THE INTERNAL CAROTID ARTERY (ICA) BIFURCATION AND DURING COMPLETE DEPLOYMENT AROUND THE CAVERNOUS BEND THE STENT MOVED PROXIMALLY AND WAS FOUND TO NOT PROPERLY COVER THE ANEURYSM DOME. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE DEVICE COULD NOT BE RESHEATHED DUE TO LOSS OF THE FRICTION PAD WHEN TRYING TO RESHEATH WHEN IT WAS HALFWAY DEPLOYED AND WAS CAPTURED IN THE INTERMEDIATE CATHETER. THERE WERE PUSHWIRE SEPARATION ISSUES. ANEURYSM INFORMATION WAS REPORTED AS: SIDE (HEMISPHERE): RIGHT, SPECIFY SEGMENT OF ICA: C4, LOCATION OF ANEURYSM IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058661 ↗
• MalfunctionNov 2, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION ABOUT A PATIENT WHO UNDERWENT A PROCEDURE ON (B)(6)2023 IN WHICH 2 PIPELINE STENTS AND A PHENOM MICROCATHETER WAS USED. IT WAS REPORTED THAT DURING THE OPERATION, ONE OF THE PIPELINE STENTS GOT LOST IN THE PHENOM MICROCATHETER DURING AN ATTEMPTED DEPLOYMENT SO THE ENTIRE SYSTEM WAS REMOVED. THE SECOND PIPELINE STENT WAS FOUND TO NOT PROPERLY COVER THE ANEURYSM DOME AND DISTAL LANDING ZONE ON FOLLOW-UP IMAGING. NO MEDICAL INTERVENTION WAS NOTED. THERE WERE NO IMPACTS TO THE PATIENT NOTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THERE WAS DEVICE FORSHORTENING. THE STENT WAS DEPLOYED DISTALLY RIGHT UP TO THE INTERNAL CAROTID ARTERY (ICA) BIFURCATION AND DURING COMPLETE DEPLOYMENT AROUND THE CAVERNOUS BEND THE STENT MOVED PROXIMALLY AND WAS FOUND TO NOT PROPERLY COVER THE ANEURYSM DOME. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE DEVICE COULD NOT BE RESHEATHED DUE TO LOSS OF THE FRICTION PAD WHEN TRYING TO RESHEATH WHEN IT WAS HALFWAY DEPLOYED AND WAS CAPTURED IN THE INTERMEDIATE CATHETER. THERE WERE PUSHWIRE SEPARATION ISSUES. ANEURYSM INFORMATION WAS REPORTED AS: SIDE (HEMISPHERE): RIGHT, SPECIFY SEGMENT OF ICA: C4, LOCATION OF ANEURYSM IN V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058650 ↗
• MalfunctionAug 30, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PUSH WIRE BROKE AT THE TIP COIL AS IT WENT INTO THE PHENOM27 TO RETRIEVE THE FIRST PIPELINE USED IN THE PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE WHOLE SYSTEM WITHOUT DAMAGE TO THE PATIENT. THERE WAS MODERATE FRICTION DURING RETRIEVAL. ANOTHER PIPELINE WAS USED TO COMPLETE THE PROCEDURE. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). 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 LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DI AMETER OF 12MM AND A 12MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED THAT THE FIRST PIPELINE WAS RETRACTED WITH NOTHING LEFT IN THE PATIENT AND THE SECOND PIPELINE WAS DEPLOYED SUCCESSFULLY.   ANCILLARY DEVICES INCLUDE A CEREBASE DA SHEATH, AXS CATALYST 5 GUIDE CATHETER, A PHENOM 27 MICROCATHETER, AND AN ARISTOTLE 24 GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650998 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED INTERMITTENT CEREBRAL VASOSPASM POST PROCEDURE. DIAGNOSTIC TESTS AND PROCEDURES WERE PERFORMED. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION AND RESULTED IN AN ADDITIONAL 2 WEEKS OF NIMODIPINE. THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2022. IT WAS REPORTED THAT CEREBRAL ANGIO ON (B)(6) 2022 DEMONSTRATED MODERATE VASOSPASM OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA)/MIDDLE CEREBRAL ARTERY (MCA) AND TREATED WITH VERAPAMIL. CEREBRAL ANGIO ON (B)(6) 2022 DEMONSTRATED MODERATE VASOSPASM LEFT GREATER THAN RIGHT AND WAS TREATED WITH VERAPAMIL. CEREBRAL ANGIO ON (B)(6) 2022 DEMONSTRATED MODERATE VASOSPASM LEFT INTERNAL CAROTID ARTERY (ICA) BRANCHES AND LEFT VERTEBRAL ARTERY (VA), TREATED WITH VERAPAMIL. REPEAT ANGIO WITH IA VERAPAMIL TREATMENTS FOR ANGIO ON (B)(6) 2022. THE (B)(6) 2022 ANGIO DEMONSTRATED COMPLETE ANEURYSM OCCLUSION. THE PATIENT CONTINUED TRANSCRANIAL DOPPLER ULTRASOUND (TCD) MONITORING AND SUBARACHNOID HEMORRHAGE (SAH) PROTOCOL WITH NIMODIPINE AND MAG. TCD ON (B)(6) 2022 SHOWED NO VASOSPASM. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET THERAPY, NON-INDEX STUDY PROCEDURE, STUDY PROCEDURE

  Patient problems: Vasoconstriction

  MAUDE report 17163019 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ANEURYSM WAS LOCATED IN THE VERTEBRAL, POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) AND WAS SACCULAR AND RUPTURED. VESSEL TORTUOSITY WAS NORMAL. THE PATIENT IS RECOVERING WELL. IT WAS NOTED THAT THE PHYSICIAN FEELS THAT THE INTEGRILIN BOLUS MAY HAVE CAUSED THE RUPTURE AFTER THE PIPELINE DEPLOYMENT.

  Patient problems: Rupture

  MAUDE report 16875920 ↗
• DeathMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT PASSED AWAY FOLLOWING A PROCEDURE INVOLVING A PIPELINE, RIST CATHETER, PHENOM PLUS CATHETER, AND PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, BLISTER ANEURYSM LOCATED IN THE COMMUNICATING SEGMENT OF THE DISTAL RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 3.4MM, AND THE NECK DIAMETER WAS 4.5MM. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE WAS 3.05MM DISTAL AND 3.4MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 179. IT WAS REPORTED THAT THE MICROCATHETER SYSTEM WAS NAVIGATED TO THE M2 DIVISION AND THE PIPELINE WAS LOADED INTO THE SYSTEM FOR DEPLOYMENT. DEPLOYMENT WAS UNEVENTFUL, WITH NORMAL OPENING AND PLACEMENT. UTILIZING FOLLOW UP IMAGING, THE PHYSICIAN DETERMINED THAT PROXIMAL AND DISTAL COVERAGE WERE ADEQUATE AND THE PROCEDURE WAS COMPLETED. A SECOND ANGIOGRAPHIC STUDY WAS COMPLETED THE FOLLOWING DAY TO ENSURE PLACEMENT AND PATENCY WERE UNCHANGED. DEVICE PLACEMENT AND PATENCY WERE CONFIRMED WITH THIS ANGIO ON (B)(6) 2023. THE PHYSICIAN NOTIFIED THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT HAD PASSED AWAY DURING THE NIGHT OF (B)(6) 2023 TO (B)(

  Patient problems: Insufficient Information

  MAUDE report 16482359 ↗
• InjuryFeb 22, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2023. THE PATIENT WAS GIVEN ATORVASTATIN WHILE HOSPITALIZED AND CONTINUED DAPT. THE SITE DID NOT AGREE WITH POSSIBLE STROKE. THE PATIENT WAS DISCHARGED WHEN THE ADVERSE EVENT ENDED ON (B)(6) 2023 AND WAS TOLD TO FOLLOW UP WITH NEUROLOGY. THE HOSPITAL DID NOT GIVE A DIRECT DIAGNOSIS AND THE SITE STATED IT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE CAUSE IS UNKNOWN AT THIS TIME. MEDICAL ADVISOR ESCALATION WAS SUBMITTED INTERNALLY AND PENDING EVALUATION.

  Patient problems: Blurred Vision; Headache; Ischemia; Stroke/CVA; Visual Disturbances

  MAUDE report 16422166 ↗
• InjuryNov 4, 2022Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH GRADUAL ONSET 8/10 LEFT-SIDED HEADACHE WITH NAUSEA. THE EVENT WAS DESCRIBED AS SIMILAR TO PREVIOUS MEDICAL HISTORY OF MIGRAINES BUT SLIGHTLY WORSE. PER SITE, THE EVENT STARTED 1 DAY POST PROCEDURE. CT SCAN WAS UNREMARKABLE. THE EVENT RESULTED IN TREATMENT. PER SITE, PROBABLE RELATED TO DISEASE UNDER STUDY. THE OUTCOME STATUS WAS RECOVERED/RESOLVED WITH SEQUELAE.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT ICA C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER.

  Patient problems: Headache; Nausea; Obstruction/Occlusion; Pain

  MAUDE report 15737270 ↗
• DeathOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO PED2 PIPELINES HAD COMPLICATIONS AND DIED. WORSENED MASS EFFECT WITH 6 MM MIDLINE SHIFT ON RIGHT SIDE OF BRAIN. WORSENING OF HYDROCEPHALUS AND SUBARACHNOID HEMORRHAGE (SAH). EXTERNAL VENTRICULAR DRAIN PLACES (E.V.D) DUE TO ADVERSE EVENT (AE). WORSENING OF HYDROCEPHALUS AND SAH. "ECTERNAL" VENTRICULAR DRAIN PLACEMENT DUE TO AE. NEW FOCAL DISSECTION AND ASSOCIATE HIGH-GRADE STENOSIS INVOLVING THE DISTAL CERVICAL RIGHT INTERNAL CAROTID ARTERY JUST BEFORE IT ENTERS THE CAROTID CANAL. MODERATE VASOSPASM OF RIGHT ANTERIOR CIRCULATION AND MILD VASOSPASM OF LEFT ANTERIOR CIRCULATION AND LEFT POSTERIOR CEREBRAL ARTERY. THIS WAS TREATED WITH TRANSCATHETER INTRA-ARTERIAL INFUSION OF VERAPAMIL 20 MG TO RIGHT INTERNAL CAROTID ARTERY AND VERAPAMIL 10 MG TO THE LEFT INTERNAL CAROTID ARTERY (ICA). WORSENING OF LEFT-SIDED WEAKNESS PER PHYSICIAN. WORSENING OF LEFT-SIDED WEAKNESS PER NEUROLOGICAL CHECK BY PHYSICIAN. PATIENT WAS REINTUBATED DUE TO WORSENING OF RESPIRATORY DISTRESS. AS OF SEPT 28, 2022 CT THORAX SCAN: RIGHT UPPER, RIGHT LOWER AND LEFT LOWER LOBE AIRSPACE DISEASE. CONSOLIDATION LIKELY REPRESENTING COMBINATION OF PNEUMONIA AN

  Patient problems: Cerebral Edema; Hydrocephalus; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Respiratory Insufficiency; Stenosis; Stroke/CVA; Swelling/ Edema; Vascular Dissection; Vasoconstriction

  MAUDE report 15657715 ↗
• MalfunctionSep 8, 2022Retraction Problem; Unintended Movement; Retraction Problem; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE DOCTOR UNSHEATHED THE PIPELINE SHIELD. THE DEVICE OPENED VERY WELL AND WAS FULLY OPEN, HE DRAGGED THE DEVICE BACK TO DISTAL LANDING ZONE AND THEN PUSHED WIRE TO DEPLOY MORE DEVICE. UPON WAGGING AROUND GENU DEVICE FELL BACK AND THE DOCTOR WENT TO RECAPTURE DEVICE USING 80% WIRE PULL, 20% CATHETER PUSH. THERE WAS PARTIAL RECAPTURE, HOWEVER HE WAS UNABLE TO RECAPTURE DEVICE. IT WAS STUCK DURING RETRACTION. THERE WAS AN "ACCORDION" LIKE APPEARANCE WITHIN THE PHENOM PLUS. THEY DECIDED TO PULL OUT THE SYSTEM AND TO USE A NAVIEN 058 IN PLACE OF PHENOM PLUS, USED A NEW PHENOM 27 AND A NEW PIPELINE SHIELD 3.5X12. THERE WAS A SUCCESSFUL DEPLOYMENT AND PLACEMENT OF 2ND DEVICE. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SUCCESSFUL PIPELINE SHIELD PLACEMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. 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 IN THE RIGHT SUPRACLINOID WITH A 5MM NECK DIAMETER. THE LANDING ZONE WAS 2.7MM ON THE DISTAL END AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381130 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE INDEX PROCEDURE NOTES INDICATED POTENTIAL INCOMPLETE WALL APPOSITION. COMPLETION ANGIOGRAPHY OF THE LEFT INTERNAL CAROTID ARTERY DEMONSTRATED THE PRESENCE OF THE PIPELINE DEVICE ACROSS THE NECK OF THE ANEURYSM WITH NO EVIDENCE OF CONTRAST EXTRAVASATION. IT WAS BETTER APPOSED TO THE VESSEL WALL; THERE WAS A SMALL EAR NOT APPOSED AT THE PROXIMAL END. THERE WAS NO EVIDENCE OF ANY MAJOR PARENT VESSEL COMPROMISE. INTRACRANIAL VESSELS WERE SEEN AND ITS BRANCHES WITHOUT EVIDENCE OF A VESSEL DROP OFF, EXTRAVASATION OR EMBOLUS. THE SITE REPORTED THAT MRI IMAGING THE DAY AFTER THE PROCEDURE SHOWED MULTIPLE SMALL FOCI OF DIFFUSION RESTRICTION WITHIN THE LEFT CAUDATE HEAD, BILATERAL FRONTAL LOBES, LEFT PARIETAL LOBE, AND LEFT POSTERIOR TEMPORAL LOBE. CORELAB IMAGING AGREED WITH THE REPORT OF SMALL INFARCTS SEEN IN THE LEFT AND RIGHT FRONTAL AND LEFT HEAD OF THE CAUDATE.

  Patient problems: Stroke/CVA

  MAUDE report 15116835 ↗
• MalfunctionJun 30, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A CASE IN WHICH A PIPELINE FLEX WITH SHIELD WAS USED. NO OTHER INFORMATION WAS PROVIDED AND THUS NO COMPLAINT WAS NOTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE SHIELD WAS BEING DEPLOYED TORTUOUS ANATOMY. THE DEVICE WAS DEPLOYED A BIT TOO PROXIMAL FROM DESIRE LOCATION SO THE PHYSICIAN DECIDED TO RESHEATH AND REPOSITION. DURING THE RE-SHEATHING PROCESS, THE DEVICE BECAME STUCK IN THE MICRO-CATHETER AND WOULD NOT RE-SHEATH. THE MICROCATHETER AND FLOW-DIVERTER WERE REMOVED TOGETHER. BOTH DEVICES WERE REPLACED AND A NEW FLOW DIVERTER WAS SUCCESSFULLY DEPLOYED WITH A NEW MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE PREPARED AS INDICATED IN THE IFU (INSPECTION, HYDRATION, ETC.). IT WAS NOTED THAT A PHENOM 27 CATHETER WAS USED. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED. LESION CHARACTERISTICS (LOCATION, SIZE, TYPE, SIDE, DIMENSION,ETC.): RIGHT PCOM ANEURYSM, 3.5X3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880773 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EDTRONIC RECEIVED A REPORT THAT POST PROCEDURE IMAGE OF RADIOPAQUE ARTIFACT DISTAL TO ANEURYSM. THE PIPELINE WAS USED ON-LABEL AND WAS PREPARED AS INDICATED IN THE IFU.  NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, PRU LEVEL WAS 104.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT PCOM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. LANDING ZONE WAS 3.1MM DISTALLY AND 3.6MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 14023270 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD RE-HEMORRHAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT PARA-OPTHALMIC ARTERY WITH A MAX DI AMETER OF 7MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 2.9MM ON THE DISTAL END AND 3.4MM ON THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE PATIENT HAD PIPELINE SHIELD DEVICE TO TREAT RIGHT PARA-OPHTHALMIC ANEURYSM ON (B)(6) 2021. SURGERY WAS SUCCESSFUL AND POST PROCEDURE ANGIOGRAM SHOWED GOOD RESULT. THE PATIENT SUFFERED AN ICH ON (B)(6) 2021. THE DOCTOR PERFORMED A DECOMPRESSION SURGERY AND CLOT REMOVAL. AFTER THE SURGERY THE PATIENT RE-HEMORRHAGED. PATIENT HAD ISCHEMIC STROKE A FEW DAYS POST PROCEDURE AFTER PIPELINE. PATIENT HAD HEMORRHAGIC CONVERSION THIS PAST WEEKEND. THE PATIENT IS DECEASED. DAPT (DUAL ANTIPLATELET TREATMENT) ADMINISTERED AND PRU LEVEL WAS 130. THE PIPELINE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2021-AUG-24. IT WAS REPORTED THAT THE PATIENT IS NOT DECEASED. SHE DID BLEED AND HAVE DECOMPRESSION SURGERY POST PIPELINE EMBOLIZATION SURGERY. THE DOCTORS IS UNABL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12404315 ↗
• MalfunctionAug 9, 2021Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 2021-AUG-11. IT WAS REPORTED THAT THERE WAS NOT ANY DIFFICULTY OR FRICTION DURING THE INITIAL ATTEMPT TO DELIVER THE DEVICE.  THE DISTAL END OF THE DEVICE OPENED APPROPRIATELY.  IT WAS ONLY AFTER THE DEVICE FELL BACK PAST THE INTENDED LANDING ZONE AND THE ATTEMPTED RESHEATHING THAT THE DEVICE GOT STUCK IN THE PHENOM 027.  THE DEVICE DID JUMP DURING DEPLOYMENT.  IT WAS BELIEVED THIS WAS DUE TO PATIENT ANATOMY AND GUIDE CATHETER POSITION.  BECAUSE THE DEVICE JUMPED BACK BELOW THE INTENDED LANDING ZONE THE RESHEATHING ATTEMPT WAS MADE. THE CATHETER TIP MOVED DURING THE ATTEMPTED DEPLOYMENT.  HOWEVER, THE CATHETER TIP MUST MOVE IN ORDER TO DEPLOY THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294992 ↗
• MalfunctionAug 9, 2021Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 2021-AUG-11. IT WAS REPORTED THAT THERE WAS NOT ANY DIFFICULTY OR FRICTION DURING THE INITIAL ATTEMPT TO DELIVER THE DEVICE.  THE DISTAL END OF THE DEVICE OPENED APPROPRIATELY.  IT WAS ONLY AFTER THE DEVICE FELL BACK PAST THE INTENDED LANDING ZONE AND THE ATTEMPTED RESHEATHING THAT THE DEVICE GOT STUCK IN THE PHENOM 027.  THE DEVICE DID JUMP DURING DEPLOYMENT.  IT WAS BELIEVED THIS WAS DUE TO PATIENT ANATOMY AND GUIDE CATHETER POSITION.  BECAUSE THE DEVICE JUMPED BACK BELOW THE INTENDED LANDING ZONE THE RESHEATHING ATTEMPT WAS MADE. THE CATHETER TIP MOVED DURING THE ATTEMPTED DEPLOYMENT.  HOWEVER, THE CATHETER TIP MUST MOVE IN ORDER TO DEPLOY THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294927 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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-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