Marksman FA-55150-1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00836462014077), received between May 15, 2019 and Sep 30, 2026 — classified as 1 death, 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (23 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Altered State of Consciousness; Embolism/Embolus; Headache; Intracranial Hemorrhage; Nervous System Injury; Respiratory Failure; Vasoconstriction

  MAUDE report 50952190 ↗
• MalfunctionSep 23, 2026Retraction Problem

  Medtronic received a report that the Pipeline tip failed to open and became stuck in the marksman and could not be withdrawn. The patient was undergoing surgery for treatment of a saccular, unruptured right internal carotid artery aneurysm with a max diameter of 4.75 mm and a 5 mm neck diameter. The distal landing zone was 4.75 mm and the poximal landing zone was 4.31 mm. The access vessel was the femoral artery with a diameter of 7 mm. It was noted the patient's vessel tortuosity was moderate/normal. Dual antiplatelet therapy (DAPT) was administered and platelet reactivity units (PRU) level was in the ideal range. The angiographic result post procedure was immediate aneurysm stasis. It was reported that the patient was diagnosed with a right internal carotid artery aneurysm and was scheduled to undergo transcatheter embolization of intracranial aneurysm. Intraoperative angiography showed that the patient was suitable for use of a flow-diverting mesh stent. Preoperatively, the flow-diverting mesh stent (model PED-475-16) was hydrated. Following routine operations, the stent was delivered to the target lesion vessel location. During the procedure, deployment of the tip end was not s

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872136 ↗
• MalfunctionApr 11, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM LOCATED LEFT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 4.3 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT AFTER THE CATHETER WAS POSITIONED, THE STENT WAS HYDRATED AND DELIVERED THROUGH THE CATHETER TO THE M1 SEGMENT. ABOUT 15 MM OF THE STENT¿S TIP WAS DEPLOYED, BUT REPEATED ADJUSTMENTS FAILED TO DEPLOY THE STENT. AFTER FULLY RETRIEVING THE STENT AND ATTEMPTING TO DEPLOY IT AGAIN, IT STILL COULD NOT BE OPENED. AFTER ABOUT 20 MINUTES OF ADJUSTMENTS, IT WAS DECIDED TO REPLACE IT WITH A 4.75×20 STENT. THE NEW STENT OPENED WELL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. 2026-FEB-23 E1 (REP, HCP, FOR): ADDITIONAL INFORMATION WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847665 ↗
• MalfunctionJan 30, 2026Retraction Problem; Difficult to Advance; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MARKSMAN CATHETER WAS IN PLACE, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS DELIVERED, AND THE STENT DEPLOYMENT PROCESS WAS SMOOTH. HOWEVER, AFTER DEPLOYING THE STENT AND WHEN RETRACTING THE STENT DELIVERY ROD, THE DISTAL END OF THE DELIVERY ROD COULD NOT BE RETRACTED INTO THE DISTAL CATHETER, RESULTING IN THE DISTAL RADIOPAQUE MARKER AND PROTECTIVE SLEEVE BEING OUTSIDE THE CATHETER. AT THIS POINT, THE SURGEON COULD ONLY WITHDRAW BOTH THE CATHETER AND THE DELIVERY ROD TOGETHER. UPON REMOVAL FROM THE BODY, IT WAS FOUND THAT THE CATHETER WAS SEVERELY DEFORMED, AND THE STENT DELIVERY ROD WAS OUTSIDE THE CATHETER, AFFECTING INTRAOPERATIVE MANIPULATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTRACRANIAL ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. RIGHT FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7.2 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223810 ↗
• MalfunctionDec 10, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. RESISTANCE OCCURRED IN THE PROXIMAL SECTION OF THE CATHETER. SLIGHT DEFORMATION WAS OBSERVED IN THE DISTAL FLEXIBLE SEGMENT OF THE MARKSMAN DEVICE. THERE WAS NO DEVICE JUMPING OR CATHETER TIP MOVEMENT DURING DEPLOYMENT. THE PIPELINE DID NOT OPEN IN THE PROXIMAL AND MIDDLE SECTIONS. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. RESHEATHING WAS ATTEMPTED AS AN ADDITIONAL STEP TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767214 ↗
• MalfunctionNov 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT RELEASED AS EXPECTED, BUT WHEN SLOWLY ADVANCING THE MICROCATHETER TO RETRIEVE THE PTFE FINS (DISTAL PROTECTIVE SLEEVES), THE DPS MOVED THE STENT. THE STENT MIGRATED TO THE NECK OF THE ANEURYSM AND FELL INTO THE ANEURYSM AND IT WAS NOT POSSIBLE TO RECOVER WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, FUSIFORM, SEGMENT C5 TO C6 ANEURYSM WITH A MAX DIAMETER OF 15 MM AND A 10 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 4.71 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED IMAGE WITHOUT INJURY, HOWEVER, THE DEVICE STOPPED FULFILLING ITS FUNCTION OF RETAINING THE FLOW UPON MIGRATION INTO THE ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL) AND WAS IMPLANTED AT THE INTENDED LOCATION WITH FULL WALL APPOSITION. NO SIDE BRANCHES WERE COVERED BY THE PIPELINE. MEDICAL OR SURG

  Patient problems: Aneurysm

  MAUDE report 23633429 ↗
• MalfunctionNov 3, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. ONLY ONE MARKSMAN CATHETER (PLI20) WAS USED WITH THE SAME STENT, WITH THE SAME COMPLAINT REPORTED FOR BOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452229 ↗
• MalfunctionNov 3, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. VESSEL TORTUOSITY WAS CONFIRMED AS MODERATE BENDING. BOTH THE STENT AND MARKSMAN CATHETERS WERE REMOVED FROM THE PATIENT; ONLY ONE MARKSMAN CATHETER (PLI20) WAS USED WITH THE SAME STENT, WITH THE SAME COMPLAINT REPORTED FOR BOTH. THE CAUSES OF THE STENT FAILURE TO OPEN AND THE INABILITY TO DEPLOY OR RETRIEVE THE STENT WERE NOT DETERMINED. SUSPECTED BLOOD VESSEL TORTUOSITY AND DAMAGE CAUSED BY RETRIEVAL WERE CONSIDERED AS POSSIBLE CAUSES FOR THE SUSPECTED MARKSMAN CATHETER DAMAGE. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN, AND THE DEVICE HAD NOT BEEN PLACED IN A VESSEL BEND AT THE TIME OF FAILURE. RESHEATHING WAS ATTEMPTED, AND HIGH RESISTANCE WAS ENCOUNTERED DURING DELIVERY, SPECIFICALLY IN THE DISTAL SECTION OF THE CATHETER. THE CATHETER WAS FLUSHED ACCORDING TO THE IFU DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452205 ↗
• MalfunctionMar 27, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE STENT COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO DETACH THE STENT WITH THE DETACHMENT BOX 3 TIMES. EACH ATTEMPT WAS 2. THE CONDITION OF THE DETACHMENT BOX AND DETACHMENT CABLES WAS BRAND-NEW OUT OF BOX. THERE WAS NO DAMAGE TO THE DETACHMENT BOX. THE CATHETER TIP WAS LOCATED STANDARD OPERATION FROM THE DETACHMENT ZONE DURING THE DETACHMENT ATTEMPT. THE DETACHMENT ZONE WAS NOT UP AGAINST THE VESSEL WALL. A STEEL NEEDLE WAS USED DURING THE DETACHMENT. THE NEEDLE WAS PLACED IN MUSCLE LAYER. THE PHYSICIAN USED A NEW BATTERY DURING THE DETACHMENT. THE DETACHMENT BOX DISPLAY AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE BLACK CABLE WAS CONNECTED TO THE NEEDLE. THE RED CABLE WAS CONNECTED TO THE PUSHER WIRE. THE PUSHWIRE WAS ON A DRY, CLEAN SURFACE. ADDITIONALLY, THE CATHETER TIP WAS DAMAGED (KINKED) AND UNABLE TO DELIVER. THE DAMAGE WAS THE DISTAL SECTION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING LARGE ARTERY OCCLUSION EMBOLECTOMY SURGERY FOR TREATMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707899 ↗
• MalfunctionFeb 6, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A LARGE PROGRESSIVE DISSECTING ANEURYSM IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY, WHICH WAS FIRST MEASURED AT 13*15MM (B)(6) AND MEASURED 18*23MM DURING SURGERY (B)(6). DURING THE PLANNED OPERATION, THE DENSE MESH STENT WAS ANCHORED IN THE MIDDLE AND DISTAL PART OF THE ANTERIOR A2 TO THE BIFURCATION OF A1 AND CAROTID ARTERY. AFTER THE MICROCATHETER WAS IN PLACE DURING THE OPERATION, THE STENT WAS OPENED AND ANCHORED, AND LAID TO THE ANEURYSM NECK. THE POSITION WAS NOT IDEAL, TRIED TO RETRIEVE IT. AFTER THE MICROCATHETER WAS RETRIEVED 20%, THE STENT WAS COMPLETELY IMMOBILE AND COULD NOT BE PUSHED FORWARD OR RETRIEVED. THEY PUSHED THE INTERMEDIATE CATHETER TO GO UPPER TO A1 TO PROVIDE EXTERNAL SUPPORT. THE STENT AND MICROCATHETER WERE LOCKED AND COULD NOT BE PUSHED. AFTER REPEATED ATTEMPTS TO RETRIEVE THE ENTIRE SYSTEM, IT WAS FINALLY REMOVED FROM THE BODY AND THE MICROCATHETER WAS FOUND TO BE SEVERELY DEFORMED (MULTI-SEGMENT FOLDS) IN THE DISTAL SECTION AND THE STENT WAS LOCKED IN THE DISTAL SECTION OF THE CATHETER AND COULD NOT BE REMOVED. THE PHYSICIAN RELEASED THE LOAD IN THE SYSTEM AND IT DID NOT RESOLVE THE ISSUE. THE PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329446 ↗
• MalfunctionJan 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS DETERMINED TO BE STENT DISLODGEMENT. RESISTANCE OCCURRED IN THE TIP END OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED. THERE WERE NOT MULTIPLE PIPELINE DEVICES BEING USED WHEN MOVEMENT OCCURRED. FRICTION OR DIFFICULTY OCCURRED DURING DELIVERY OR POSITIONING AND THE DEVICE JUMPED DURING DEPLOYMENT. THE TIP OF THE CATHETER MOVED DURING DEPLOYMENT. PREMATURE DEPLOYMENT OCCURRED WHEN THE STENT PASSED THROUGH THE TUMOR NECK. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THERE WAS RESISTANCE DURING RESHEATHING INTO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095776 ↗
• MalfunctionDec 27, 2024Difficult to Remove; Stretched; Physical Resistance/Sticking; Difficult to Remove; Stretched; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT FOR A LEFT INTERNAL CAROTID ARTERY GIANT ANEURYSM USING A PIPELINE EMBOLIZATION DEVICE, SEVERAL COMPLICATIONS OCCURRED. THE STENT BECAME STUCK IN THE MARKSMAN MICROCATHETER DURING DEPLOYMENT. AFTER MULTIPLE ATTEMPTS TO RE-SHEATH AND RELEASE THE STUCK PORTION, THE STENT FELL INSIDE THE ANEURYSM FROM ITS PROXIMAL PART AND SUBSEQUENTLY SHRANK. ANOTHER FLOW DIVERTER, SURPASS 5X30, WAS SUCCESSFULLY DEPLOYED INSIDE THE PIPELINE. THE CATHETER TIP BECAME ENTRAPPED, AND CATHETER STRETCH OCCURRED DURING REMOVAL, RESULTING IN DAMAGE TO THE DISTAL SECTION. THE PIPELINE BECAME STUCK IN THE MIDDLE SECTION OF THE CATHETER DURING DEPLOYMENT, MISSED THE LANDING ZONE, AND WAS NOT IMPLANTED AT THE INTENDED LOCATION. MIGRATION OF THE PIPELINE AFTER DEPLOYMENT WAS NOTED DUE TO MULTIPLE ATTEMPTS TO RELEASE THE STENT FROM THE MICROCATHETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS NORMAL. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES: GUIDE CATHETER GUIDER SOFTIP 8F, GUIDEWIRE SYNCHRO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029397 ↗
• MalfunctionNov 18, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN/RESISTANCE WAS NOT DETERMINED. RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707754 ↗
• MalfunctionJul 11, 2024Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE'S FAILED TO OPEN AND A MARKSMAN CATHETER ENCOUNTERED CATHETER KICKBACK. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE C7 WITH A MAX DIAMETER OF 4 MM AND A 3.58 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.6 MM AND PROXIMAL 5.03 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE BLOOD VESSELS UNOBSTRUCTED, BUT THE DISTAL END OF THE PIPELINE HAS NOT OPENED AT ALL. IT WAS REPORTED THAT DURING THE TAE (TRANSCATHETER ARTERIAL EMBOLIZATION) PROCEDURE, THE DOCTOR USED PED2-500-20 FOR DEPLOYMENT. THE RELEASE STARTED FROM THE M1 LOCATION OF THE BLOOD VESSELS. UPON FLUOROSCOPIC EXAMINATION, IT WAS OBSERVED THAT THE DISTAL END DID NOT OPEN. AFTER A BRIEF WAITING PERIOD WITH NO CHANGE, THE DOCTOR DECIDED TO RETRACT THE PIPELINE INTO THE CATHETER AND REPEAT THE PR PROCEDURE. DURING THE SECOND ATTEMPT TO RELEASE THE PIPELINE, THERE WAS AN OPENING IN THE MIDDLE SEGMENT, BUT THE DISTAL END REMAINED UNOPENED. THE DOCTOR THEN PULLED THE PIPELINE BACK TO THE T-ZONE TO ATTEMPT TO OPEN THE DISTAL END. HOWEVER, DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725821 ↗
• MalfunctionJul 31, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE GOT STUCK IN THE DISTAL PART OF THE MARKSMAN CATHETER DURING DELIVERY AND COULDN'T BE RELEASED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN A1 SEGMENT. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3MM DISTAL AND 4MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 7500. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS ADMINISTERED. THE PHYSICIAN HAD TRIED TO RELEASE THE LOAD/SLACK IN THE SYSTEM, BUT THIS DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE DISTAL PART OF THE CATHETER WAS DAMAGED, BUT THERE WAS NO DAMAGE TO THE PUSHWIRE. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE PERFECT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS, AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTIONS OR EXTENDED HOSPITALIZATION WERE NEEDED. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN AVIGO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426782 ↗
• MalfunctionNov 9, 2021Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT SUBMITTED TO EMBOLIZATION OF THE OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. SELECTIVE CATHETERIZATION WAS PERFORMED USING NAVIEN'S ADVANCED INTRACRANIAL SUPPORT CATHETER. THE MICROGUIDE WAS ADVANCED DISTALLY TO THE DILATION AND POSTERIORLY THE MARKSMAN MICROCATHETER DISTALLY. IRRIGATION OF THE PIPELINE STENT IN THE Y CONNECTOR WAS INITIATED. THE SYSTEM WAS ADVANCED IN A DELICATE MANNER AND IT'S DISCONNECTION WAS OBSERVED AT THE INLET OF THE MICROCATHETER. THREE ATTEMPTS WERE MADE TO CHANGE THE SYSTEM, HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THE PROCEDURE WAS ABORTED FOR SURGICAL TIME AND RESCHEDULED. THE PIPELINE WAS NOT USED FOR AN INDICATED THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN IF A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.8MM AND A 4

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778246 ↗
• MalfunctionJul 22, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED MATERIALS ARE AVAILABLE FOR COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215032 ↗
• MalfunctionFeb 12, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO KINK OR DAMAGE OBSERVED TO THE SOLITAIRE PUSHWIRE, AND THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325736 ↗
• MalfunctionDec 21, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE COULD NOT BE DELIVERED THROUGH THE MARKSMAN, AND THE DISTAL SEGMENT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSELTORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED: PRASUGREL. IT WAS REPORTED THAT THE MARKSMAN MICROCATHETER WAS POSITIONED IN SECTOR M1/M2, AND AN ATTEMPT WAS MADE TO DEPLOY THE PIPELINE. HOWEVER, FORCE WAS EXERTED, BUT IT WAS NOT POSSIBLE TO ADVANCE THE PIPELINE. THE STENT DID NOT COME OUT OF THE MARKSMAN, AND THE ENTIRE SET WAS REMOVED. IT WAS ALSO STATED THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE STENT WAS NOT POSITIONED IN A BEND, LESS THAN 50% WAS DEPLOYED, AND RESHEATHING WAS PERFORMED LESS THAN THREE TIMES. A REPLACEMENT PIPELINE 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 SATISFACTORY RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047997 ↗
• MalfunctionDec 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE MARKSMAN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY CAVERNOUS S EGMENT WITH A MAX DIAMETER OF 25MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE MARKSMAN MICROCATHETER WAS IN PLACE, AND THEN THE PIPELINE STENT WAS PUSHED. HOWEVER, IT WAS DIFFICULT TO PUSH THE PIPELINE THROUGH THE MIDDLE AND DISTAL SEGMENTS, AND IT COULD NOT BE DEPLOYED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE OR THE CATHETER. AFTER REPLACING THE PIPELINE, THE SURGERY WAS COMPLETED SMOOTHLY. 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 FLOW IN THE PARENT ARTERY WAS SMOOTH, AND THE BLOOD FLOW IN THE ANEURYSM WAS SLOWLY DEPOSITED. ANCILLARY DEVICES INCLUDE A 6FNAVIEN 115, MARKSMAN 150.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015960 ↗
• MalfunctionOct 29, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO DAMAGE TO THE MICROSNARE. THE PRODUCT WAS ONLY SEGREGATED BECAUSE IT WAS COMPOSING THE SYSTEM THAT WAS REMOVED FROM THE PATIENT: FRACTURED MARKSMAN DISTAL TIP AND PIPELINE.

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

  MAUDE report 10759643 ↗
• MalfunctionOct 29, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FIRST MARKSMAN CATHETER USED BROKE INTO 4 PARTS AT THE DISTAL SECTION DURING THE DELIVERY OF THE FIRST PIPELINE. IT WAS STATED THAT SEVERE RESISTANCE WAS ENCOUNTERED IN THE DISTAL SECTION OF THE FIRST CATHETER DURING THE DELIVERY. IT WAS FOUND THAT THE FIRST PIPELINE'S HYPOTUBE AND PUSHWIRE HAD A KINK ON THE PROXIMAL SECTION. THE REBAR CATHETER WAS USED TO TO DELIVER THE MICRO SNARE, AND WAS ABLE TO REMOVE THE ENTIRE SYSTEM AND BROKEN DISTAL CATHETER TIP FROM THE PATIENT. ANOTHER MARKSMAN CATHETER AND PIPELINE WERE USED; HOWEVER, THE CATHETER'S DISTAL TIP BROKE AGAIN DURING DELIVERY. THROUGH THE SOFIA CATHETER, THE DISTAL TIP OF THE CATHETER AND PIPELINE SYSTEM, WHICH WAS TRAPPED INSIDE, WAS RESCUED. THERE WAS NO OTHER DAMAGE TO THE CATHETERS ASIDE FROM THE RUPTURE. IT WAS NOTED THAT THE CATHETERS WAS CONTINUOUSLY PERFUSED IN A PRESSURE BAG. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION AS WELL AS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE FIRST CATHETER WAS ENTRAPPED/STUCK; HOWEVER, IT WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO VASOSPASM. IMPLANTATION OF THE THIRD PIPELI

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

  MAUDE report 10759591 ↗
• MalfunctionOct 9, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE WHICH HAD RESISTANCE AND BECAME STUCK IN A MARKSMAN MICROCATHETER. THE PATIENT WAS BEING TREATED FOR A RUPTURED SACCULAR ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 5MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT FIRST A PHENOM27 MICROCATHETER WAS GOING TO BE USED BUT DURING PREPARATION THE CATHETER WAS OBSERVED TO BE KINKED SO IT WAS REPLACED WITH A MARKSMAN CATHETER. THE DEVICES WERE PREPARED AND USED PER INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER IFU. THE INTRACRANIAL SUPPORT CATHETER WAS TO THE ANEURYSM SITE. THE MARKSMAN WAS THEN ADVANCED INTO THE M1 SEGMENT. THE PIPELINE WAS ADVANCING THROUGH THE MARKSMAN BUT BEGAN HAVING RESISTANCE IN THE MIDDLE SECTION AND COULD NOT TRACK TO THE DEPLOYMENT LOCATION AND THE PIPELINE BECAME STUCK IN THE DISTAL END. MULTIPLE ATTEMPTS WERE MADE TO ADJUST PLACEMENT OF THE SUPPORT CATHETER AND MICROCATHETER AS WELL AS RELEASE THE SLACK IN THE SYSTEM BUT THE PIPELINE STILL COULD NOT BE MOVED. THE SURGEON THEN REMOVED THE PIPELINE AND MARKSMAN TOGETHER AND IT APPEARED THEY MAY HAVE BEEN STRETCHED AND THE PIPELINE PUSHWI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10659776 ↗
• MalfunctionAug 12, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT NO PIECES OF THE DEVICE WERE LEFT WITHIN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10396600 ↗
• MalfunctionJun 2, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST MARKSMAN WAS ACCORDIONED, RESULTING IN THE PIPELINE BEING STUCK IN IT; THE SECOND MARKSMAN WAS BROKEN, RESULTING IN PED STUCK IN IT. FINALLY, A PHENOM27 AND A THIRD PIPELINE WAS USED AND EVEN WITH RESISTANCE, THE TREATMENT WAS COMPLETED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT CAVERNOUS SINUS WITH A MAX DIAMETER OF 25MM AND A 21MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THE MICROCATHETER (PLI30) ENTERED AS FAR AS THE END OF THE INTERNAL CAROTID ARTERY, 5F NAVIEN WAS PUSHED UP TO THE HORIZONTAL SEGMENT OF THE CAVERNOUS SINUS. THEN THE FIRST PIPELINE (PLI10) WAS PUSHED INTO THE MICROCATHETER. SINCE THE INTERNAL CAROTID ARTERY C1 WAS VERY TORTUOUS, THE RESISTANCE WAS EXTREMELY LARGE AT THE DISTAL END OF THE MICROCATHETER. REPEATED ATTEMPTS, SUCH AS WITHDRAWING THE MICROCATHETER AND PUSHING THE STENT, ALL FAILED TO PUSH THE STENT OUT OF THE MICROCATHETER. THE SURGEON PUSHED 5F-NAVIEN UP TO THE END OF THE INTERNAL CAROTID ARTERY AND INCREASED THE SUPPORT FORCE, BUT STILL UNABLE TO PUSH OUT THE STENT. THE SURGEON CONSIDERED IT WAS THE QUALITY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10112446 ↗