PulseRider Aneurysm Neck Reconstruction DeviceRecalls & reported problems across all models

We found 8 models of PulseRider Aneurysm Neck Reconstruction Device by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 117 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2017 and Jan 30, 2024 — classified as 3 deaths, 83 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PulseRider Aneurysm Neck Reconstruction Device problems

PulseRider Aneurysm Neck Reconstruction Device models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PulseRider Aneurysm Neck Reconstruction Device 201-D

  Intracranial Neurovascular Stent
  2 deaths74 reports
• PulseRider Aneurysm Neck Reconstruction Device 211-D

  Intracranial Neurovascular Stent
  18 reports
• PulseRider Aneurysm Neck Reconstruction Device 213-D

  Intracranial Neurovascular Stent
  9 reports
• PulseRider Aneurysm Neck Reconstruction Device 313-D

  Intracranial Neurovascular Stent
  5 reports
• PulseRider Aneurysm Neck Reconstruction Device 301-D

  Intracranial Neurovascular Stent
  1 death5 reports
• PulseRider Aneurysm Neck Reconstruction Device 311-D

  Intracranial Neurovascular Stent
  2 reports
• PulseRider Aneurysm Neck Reconstruction Device 303-D

  Intracranial Neurovascular Stent
  2 reports
• PulseRider Aneurysm Neck Reconstruction Device 203-D

  Intracranial Neurovascular Stent
  2 reports

Recent PulseRider Aneurysm Neck Reconstruction Device adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A STENT ASSISTED COIL EMBOLIZATION USING A PULSERIDER T, 3MM, 8MM ARCH ( 201D), TO TREAT A BASILAR ARTERY ANEURYSM. THE PULSERIDER WAS DEPLOYED AT THE TARGET LESION, AND THE ANEURYSM WAS COMPLETELY EMBOLIZED WITH 10 COILS. (PRODUCT NAME UNKNOWN). THE PULSERIDER WAS ATTEMPTED TO BE DETACHED USING THE PULSERIDER'S DETACHMENT SYSTEM AND CONFIRMED THAT THE DETACHMENT SYSTEM INDICATED THAT THE IMPLANT HAD BEEN DETACHED. THEN THE MICROCATHETER WAS ADVANCED, AND THE MICROCATHETER RE-SHEATHED THE PROXIMAL MARKER ON ONE LEG OF THE IMPLANT. ALSO, WHEN THE PULSERIDER DELIVERY WIRE WAS PULLED, THE IMPLANT MOVED SLIGHTLY. REPLACED THE DETACHMENT SYSTEM WITH ANOTHER NEW ONE AND PERFORMED DETACHMENT PROCESS AGAIN, THE DETACHMENT SYSTEM INDICATED A SIGN THAT DETACHMENT WAS COMPLETE, AND THE DETACHMENT PROCESS WAS INTERRUPTED. THE PULSERIDER HAD BEEN DETACHED BY REPEATED PUSHING AND PULLING OF THE DELIVERY WIRE JUST ENOUGH TO KEEP THE PULSERIDER IMPLANT IN PLACE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS TO THE PATIENT. THERE WERE NO COMPLICATIONS TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS PERFORMED. THE PHYSICIAN COMMENTED THAT SUCH INCOMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606196 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, THE PATIENT WITH A HISTORY OF CEREBRAL INFARCTION, VERTEBRAL ARTERY STENOSIS, AND ON SINGLE ANTIPLATELET THERAPY (SAPT) UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION USING A 2.7 TO 3.5 MM, 8 MM, T SHAPE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3077440212) FOR AN UNRUPTURED BIFURCATING CEREBRAL ANEURYSM AT THE BASILAR ARTERY (BA) TOP UNDER GENERAL ANESTHESIA. TO PRESERVE THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA), A HYBRID ORIENTATION IMPLANTATION WAS ATTEMPTED SEVERAL TIMES, BUT THE ORIGIN OF THE LEFT PCA AND THE SUPERIOR CEREBELLAR ARTERY (SCA) WERE CLOSE TO EACH OTHER AND THE RIGHT PCA WAS NARROW. THE INTENDED HYBRID ORIENTATION IMPLANT PLACEMENT WAS RIGHT EXTRA AND LEFT INTRA, BUT IT WAS DIFFICULT TO PLACE THE IMPLANT AND AS A RESULT, THE PULSERIDER WAS IMPLANTED WITH THE INTRA ORIENTATION. COIL EMBOLIZATION WAS PERFORMED WITH SEVERAL AXIUM FRAME (MEDTRONIC) AND AXIUM PRIME 3D (MEDTRONIC) COILS. THE PROCEDURE WAS COMPLETED WITH CONFIRMATION OF BLOOD FLOW INTERRUPTION INTO THE TARGET ANEURYSM. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS WITH CONTINUOUS FLUSH MAINTAINED THROUGH IT. AT A FOLLOW-UP ON

  Patient problems: Ischemia Stroke

  MAUDE report 18145805 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. TITLE: IN-STENT STENOSIS AFTER STENTING THE PULSERIDER FOR A MIDDLE CEREBRAL ARTERY ANEURYSM: A CASE REPORT. AUTHORITY: SAKATA M, TAJIMA Y, KUBOTA M, IWADATE Y. IN-STENT STENOSIS AFTER STENTING THE PULSERIDER FOR A MIDDLE CEREBRAL ARTERY ANEURYSM: A CASE REPORT. RADIOL CASE REP. 2023 JUL 22;18(10):3453-3456. DOI: 10.1016/J.RADCR.2023.07.010. PMID: 37502481; PMCID: PMC10369375. THE 40-YEAR-OLD FEMALE PATIENT WITH AN UNRUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY UNDERWENT A STTENT-ASSISTED COIL EMBOLIZATION WITH PULSED RIDER AND PROWLER SELECT WAS PERFORMED TO TREAT AN UNRUPTURED ANEURYSM IN THE BIFURCATION OF THE LEFT MIDDLE CEREBRAL ARTERY M2. PATIENTS RECEIVED DUAL ANTIPLATELET THERAPY WITH ASPIRIN 100 MG AND PRASUGREL 3.75 MG FOR 10 DAYS BEFORE PROCEDURE. DURING PROCEDURE, SYSTEMIC HEPARINIZATION WAS PROVIDED. ANGIOGRAPHY REVEALED AN ANEURYSM BETWEEN THE SUPERIOR AND INFERIOR TRUNKS OF THE MIDDLE CEREBRAL ARTERY M2. THE SIZE MEASUREMENTS OF THE ANEURYSM WERE AS FOLLOWS: DIAMETER: 5.7 MM, NECK: 4.4 MM, HEIGHT: 5.6 MM, DOME-TO-NECK AND ASPECT RATIO: 1.30 AND 1.27, RESPECTIVELY. A 6-FRENCH FUBUKI INTRODUCER SHEATH (ASAHI INTEC INC.) WA

  Patient problems: Perforation of Vessels; Restenosis

  MAUDE report 18135084 ↗
• MalfunctionOct 16, 2023Migration; Migration

  AS REPORTED BY THE FIELD, DURING A COILING PROCEDURE OF BASILAR ARTERY (BA-TOP) ANEURYSM WITH A PULSERIDER T, 4MM, 10MM ARCH (213D, 3077440609) SUCCESSFUL IMPLANTATION ON (B)(6) 2023. DURING THE PROCEDURE, A 5FR FUBUKI DILATOR WAS PLACED AND VECTA71 INTERMEDIATE CATHETER, PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE/LOT NUMBER), HEADWAY17 MICROCATHETER WAS INSERTED. THE PULSERIDER WAS IMPLANTED THROUGH PROWLER SELECT PLUS, THEN COILING WAS CONDUCTED. AFTER THE COILING, DETACHMENT WAS CONFIRMED. NO ABNORMALITIES WERE FOUND ON ONE MONTH FOLLOW UP. ON THE FOLLOW UP ANGIOGRAPHY IN (B)(6), SUSPECTED MINOR MIGRATION OF THE PULSERIDER WAS NOTED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 04-OCT-2023 INDICATED THAT THE PULSERIDER'S LEAFLET SLIPPED FROM THE ANEURYSM NECK, TOWARD THE BASILAR ARTERY. NO ISCHEMIC-HEMORRHAGIC COMPLICATIONS OCCURRED. SLIGHT COMPACTION WAS FOUND ON THE COIL MASS. THE PHYSICIAN IS PLANNING TO SHARE DIAGNOSTIC IMAGES, AND FUTURE PLAN HOW TO TREAT THE ISSUE WILL BE DISCUSSED. ADDITIONAL INFORMATION RECEIVED ON 12-OCT-2023 INDICATED THAT A SLIGHT COMPACTION WAS CONFIRMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940299 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT A RECURRENT BASILAR ARTERY ANEURYSM, AFTER PREPARATION OF THE DEVICES, THE PROCEDURE WAS INITIATED. THE COMPLAINT DEVICE, A PULSERIDER 10T, 3.5 ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (213D / LOT# UNKNOWN) WAS PLACED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND TWO (2) COMPETITOR COILS WERE IMPLANTED. CONTINUOUS FLUSH WAS MAINTAINED. IT WAS REPORTED THAT THROMBUS WAS OBSERVED AND MEDICATION WAS ADMINISTERED. THROMBUS REDUCTION WAS CONFIRMED, AND THE PULSERIDER ANRD WAS WITHDRAWN. IT WAS REPORTED THAT PROCEDURE WAS COMPLETED. PATIENT IMPACT WAS REPORTED AS UNKNOWN AT THE TIME OF THE COMPLAINT INITIATION. ON 03-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, THE LOT NUMBER OF THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) IS 3079596004. THE INFORMATION INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY ADDITIONAL THROMBUS GENERATED.

  Patient problems: Thromboembolism

  MAUDE report 17322396 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FORM A PERSONAL INTERACTION THAT ON (B)(6) 2023 A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF A BASILAR ARTERY (BA) TOP ANEURYSM USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3078569808). PER DETAILS OF THE PROCEDURE, LESION SITE WAS ACCESSED FROM THE RIGHT RADIAL ARTERY VIA THE RIGHT VERTEBRAL ARTERY (VA). THE PULSERIDER WAS IMPLANTED IN THE FIRST ATTEMPT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY (DETAILS ON COILS USED ARE CURRENTLY UNKNOWN). IT WAS STATED THAT, LATER, ON REVIEWING THE POSTOPERATIVE CT SCAN, A PARTIAL INFARCTION IN THE CEREBELLUM WAS FOUND. THE PATIENT IS HOSPITALIZED AS OF ONE WEEK AFTER THE SURGERY. OTHER CONCOMITANT DEVICES USED WERE A 6FR 25CM SHEATH INTRODUCER (UNKNOW MANUFACTURER), 6FR 115CM SOFIA (MICROVENTION) GUIDING CATHETER, CHIKAI 14 (ASAHI INTECC), GUIDEWIRE, PROWLER SELECT PLUS MICROCATHETER. IT WAS MENTIONED THAT CONTINUOUS FLUSH WAS DONE AND THAT THE DEVICE WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS REFERRED THAT ¿THE INFARCT LESION FOUND WAS LIKE LACUNAR INFARCT. THIS MAY NOT BE RELATED TO THE ISSUE, BUT PATIENT HUSBAND WAS FOUND TO BE COVID-POSITIVE AFTER THE SURGERY¿ AND A ¿COVID EPIDEMIC OCCURRED

  Patient problems: Ischemia Stroke

  MAUDE report 17106318 ↗
• MalfunctionJun 5, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION PROCEDURE FOR UNRUPTURED BASILAR TIP ANEURYSM. THE PROCEDURE WAS PERFORMED BY DOUBLE CATHETER TECHNIQUE. A PULSERIDER T, 3MM, 8MM ARCH (201D, 3078569818) WAS USED WITH THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 30883124), WHILE THE PHENOM17 WAS USED FOR THE COIL. AFTER THE PROWLER SELECT PLUS WAS INSERTED TO THE ANEURYSM, THE PULSERIDER WAS ATTEMPTED TO INSERTED, BUT THERE WAS A RESISTANCE, SO THE PULSERIDER WAS WITHDRAWN. THE ISSUE WAS RESOLVED BY REPLACING BOTH THE PULSERIDER AND THE PROWLER SELECT PLUS TO NEW ONES. THE COIL EMBOLIZATION PROCEDURE WAS COMPLETED WITH SUCCESSFUL PULSERIDER IMPLANTATION. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058135 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A BIFURCATING ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA), THE PROCEDURE WAS STARTED USING A PROWLER SELECT PLUS MICROCATHETER AND AN SL-10® MICROCATHETER (STRYKER) WITH A 7FR SHUTTLE® LONG SHEATH (COOK MEDICAL), AND TWO (2) GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL). A CONTINUOUS FLUSH WAS MAINTAINED / CONDUCTED. THE PROWLER SELECT PLUS MICROCATHETER WAS DELIVERED TO THE M1 SEGMENT PROXIMAL TO THE ANEURYSM, AND A PULSERIDER Y SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (301D / LOT# UNKNOWN) WAS USED. AFTER THE PULSERIDER Y SHAPE, 8MM ANRD WAS SUCCESSFULLY DEPLOYED, THE SL-10® MICROCATHETER WAS INSERTED INTO THE ANEURYSM AND COILING WAS ATTEMPTED. THE 2.5MM G3 COIL (CATALOG AND LOT NUMBER UNKNOWN) WAS USED AS THE FIRST COIL; IT COULD NOT DEPLOY PROPERLY AND WAS REMOVED. THE PULSERIDER Y SHAPE, 8MM ANRD WAS ALSO REMOVED AND REPLACED WITH ANOTHER PULSERIDER ANRD OF A DIFFERENT SHAPE. THE PROWLER SELECT PLUS MICROCATHETER WAS INSERTED INTO THE M2 SEGMENT, AND A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3077440202) WAS A

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16840075 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CERENOVUS SALES REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT EMPLOYED THE USE OF A PULSERIDER T SHAPE, 8MM , 3.5MM ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (203D / LOT# UNKNOWN); THE PULSERIDER ANRD WAS IMPLANTED ¿BUT THERE WAS ISSUE.¿ AT THE COMPLAINT INITIATION, THE SALES REPRESENTATIVE REPORTED THAT ¿DETAILS ARE UNKNOWN.¿ ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN SAID, ¿I HAVE BEEN TOLD THAT THERE HAS BEEN A CASE OF THROMBOSIS FOLLOWING THE USE OF PULSERIDER. I HAVE NOT BEEN ABLE TO IDENTIFY THE FACILITY OR THE PATIENT.¿ ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NO FURTHER INFORMATION CAN BE OBTAINED. THE PHYSICIAN WHO REPORTED THIS EVENT DOES NOT KNOW AT WHICH FACILITY THE EVENT OCCURRED AT AND THERE IS NO MEANS TO INVESTIGATE FURTHER. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 30-MAR-2023 AND 17-APR-2023, THE EVENT WILL BE CONSERVATIVELY REPORTED TO THE FDA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16764083 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CONFERENCE PRESENTATION, THE PHYSICIAN REPORTED TREATING A PATIENT WITH A BASILAR ARTERY TIP ANEURYSM USING A 3.5 TO 4.5 MM, 10 MM, Y SHAPE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (313D / LOT# UNKNOWN). THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS WITH CONTINUOUS FLUSH MAINTAINED. IT WAS REPORTED THAT AT THE 8-MONTH FOLLOW-UP, THERE WAS CONFIRMATION OF RECANALIZATION WITHIN THE ANEURYSM. THEREFORE, THE PATIENT UNDERWENT ADDITIONAL EMBOLIZATION VIA STENT-ASSISTED COIL EMBOLIZATION USING AN ENTERPRISE STENT (CATALOG / LOT# UNKNOWN), AND COILS (DEVICE DETAILS UNKNOWN).

  Patient problems: Aneurysm

  MAUDE report 16660598 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A PERSONAL INTERACTION THAT A PATIENT OF UNKNOWN AGE AND SEX (NO DEMOGRAPHIC INFORMATION WAS PROVIDED) UNDERWENT A STENT-ASSISTED ENDOVASCULAR COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA), ANEURYSM WITH A 3MM 8MM ARCH PULSERIDER T (201D/UNKNOWN LOT). IT WAS STATED, THAT THE COIL EMBOLIZATION WAS COMPLETED WITHOUT PROBLEMS. IT WAS FURTHER MENTIONED THAT ¿THE PATIENT HAS BEEN UNDER MONITORED AND STENOSIS AT THE MCA WAS CONFIRMED¿. IT WAS REFERRED THAT ¿POST-PROCEDURE, THERE WERE NO SYMPTOMS, AND THE PATIENT HAS BEEN STABLE¿. CONTINUOUS FLUSH WAS DONE. A CONCOMITANT DEVICE MENTIONED WAS A PROWLER SELECT PLUS MICROCATHETER. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Restenosis

  MAUDE report 16618817 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET AT THE BASILAR ARTERY (BA) TIP, THE COMPLAINT DEVICE, A PULSERIDER, 3.5-4.5MM, 10MM, T SHAPE (213D / LOT#: UNKNOWN) WAS IMPLANTED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT#: UNKNOWN) WITH CONTINUOUS FLUSH MAINTAINED. THE PROCEDURE WAS COMPLETED. IT WAS THEN REPORTED THAT ¿AFTER HEPARIN WAS CUT, THROMBOSIS WAS CONFIRMED PAST 3 TO 4 DAYS AFTER THE PROCEDURE. THE PATIENT WAS BEING MONITORED WITH MEDICAL TREATMENT, BUT AROUND ON (B)(6) 2023, IT WAS FOUND OUT THAT IT WOULD BE BETTER TO PERFORM AN ADDITIONAL PROCEDURE, AND AN ATLAS STENT WAS ADDITIONALLY PLACED. THE PATIENT HAS BEEN STABLE AFTER IMPLANTATION OF THE ATLAS STENT.¿ THE PATIENT WAS REPORTED TO HAVE BEEN HOSPITALIZED; THE THROMBOSIS HAS BEEN STABLE. NO ADDITIONAL MEDICAL TREATMENT WILL BE PERFORMED. ON 27-FEB-2023, THE JAPAN TEAM TRANSLATED THE MEMO THAT WAS INCLUDED IN THE COMPLAINT. A SUMMARY OF THE MEMOS IS BELOW: THE FIRST MEMO (MEMO 1). IN THE ANTERIOR CIRCULATION, A FLEXOR® SHUTTLE® 7FR GUIDING SHEATH (COOK MEDICAL), TWO (2) TACTICS MICROCATHETERS (TECHNOCRAT CORPORATION), AND DISTAL ACCES

  Patient problems: Thromboembolism

  MAUDE report 16537793 ↗
• InjuryMar 3, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY A PERSONAL INTERACTION THAT A 79-YEAR-OLD FEMALE PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION USING A PULSERIDER T, 3MM, 8MM ARCH AT THE MIDDLE CEREBRAL ARTERY (MCA). PER THE EVENT DESCRIPTION, THE COMPLAINT PULSERIDER WAS USED AS A ¿TORQUE¿ PRIOR TO THE PHYSICIAN DECIDING THE POSITION FOR THE IMPLANT. HOWEVER, THERE WAS RESISTANCE. THE COMPLIANT DEVICE WAS IMPLANTED AS ¿EXTRA¿, AND CONTRAST WAS INJECTED TO CONFIRM THERE WAS A RUPTURE. A CATHETER FOR THE COIL (PHENOM) WAS INSERTED AND COILING WAS PERFORMED. THERE WAS NO BLEEDING CONFIRMED BY FINAL ANGIOGRAPHY AND THE PROCEDURE WAS COMPLETED. OTHER CONCOMITANT DEVICES USED WERE A SYNCHRO 2 GUIDEWIRE (STRYKER), AN 80CM FUBUKI 6FR GS GUIDING CATHETER (ASAHI INTECC), A PROWLER SELECT PLUS MICROCATHETER AND A VECTA71 INTERMEDIATE CATHETER (STRYKER). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023. SUMMARY OF ADDITIONAL INFORMATION PROVIDED: THE PATIENT DID NOT FULLY RETURN TO CONSCIOUSNESS BUT WAS ABLE TO RAISE THEIR HANDS. THE PATIENT GRADUALLY RECOVERED. INITIALLY, DEPLOYMENT IN ANTEGRADE WAS ASSUMED, BUT IT WAS CHANGED TO DEPLOYMENT IN RETROGRADE ACCORDING TO THE BEHAVIOR OF THE COMPLAINT PULSERIDER. IT WAS AN

  Patient problems: Ruptured Aneurysm

  MAUDE report 16478984 ↗
• InjuryFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM USING A PULSERIDER T, 3MM, 8MM ARCH (201D/3077900504) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) ON (B)(6) 2023 AND EXPERIENCED AN INTRA-OPERATIVE ANEURYSM RUPTURE. DETAILS OF THE PROCEDURE: THE PHYSICIAN PUNCTURED THE RIGHT FEMORAL ARTERY AND GUIDED A 6F SHUTTLE GS 80CM SHEATH INTO THE RIGHT INTERNAL CAROTID ARTERY (ICA). A 3D IMAGE WAS TAKEN AND A 6F BENCHMARK (PENUMBRAINC) CATHETER WAS DELIVERED TO THE FRONT OF CAROTID SIPHON UNDER A SHOURYU BALLOON CATHETER GUIDANCE. NEXT A SL-10 45O (STRYKERNEUROVASCULAR) MICROCATHETER (FOR COIL DELIVER) WAS DELIVERED TO NEAR THE TERMINUS SEGMENT OF THE ICA AND A PROWLER SELECT PLUS MICROCATHETER WAS DELIVERED TO THE M1 SEGMENT OF THE RIGHT MCA. THE COMPLAINT PULSE RIDER WAS INSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER AND DEPLOYED CLOSE TO THE ANEURYSM. IT WAS MENTIONED THAT THE COMPLAINT DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). WHEN THE ARCH PART WAS ABOUT HALF PROTRUDED, THE INFERIOR BRANCH WAS LOCATED OUTSIDE THE ANEURYSM, AND THE OPPOSITE SIDE WAS LOCATED INSIDE T

  Patient problems: Ruptured Aneurysm

  MAUDE report 16452706 ↗
• InjuryFeb 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE EVENT WAS REPORTED VIA A POST-MARKET STUDY (PMS), THE 49-YEAR-OLD PATIENT UNDERWENT A PULSERIDER-ASSISTED ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM LOCATED IN THE MIDDLE PORTION OF THE ANTERIOR COMMUNICATING ARTERY (ACOMA) USING A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) ON (B)(6) 2022. THE DIMENSIONS OF THE TARGET ANEURYSM ARE AS FOLLOWS: HEIGHT 11.3MM, MAXIMUM ANEURYSM DIAMETER 13.1MM, DOME WIDTH 12.9MM, NECK DIAMETER 6.4MM, DOME TO NECK RATIO 2. THE PARENT VESSEL DIAMETER WAS 2.7MM, THE (2) BRANCHING VESSEL DIAMETER WAS 2.2MM AND (3) BRANCHING VESSEL DIAMETER WAS 1.8MM. THE PULSERIDER ANRD WAS DELIVERED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND SUCCESSFULLY IMPLANTED IN A HYBRID ORIENTATION WITH ONE OF THE WINGS INSIDE THE ANEURYSM. THE COIL MASS WAS SUCCESSFULLY MAINTAINED AND THE PROCEDURE WAS COMPLETED. IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ON 31-JAN-2023, A ¿MIGRATION / DEVIATION / INSUFFICIENT EMBOLIZATION OF EMBOLIC COILS OCCURRED.¿ THERE WAS A RECURRENCE OF ANEURYSM DUE TO COIL COMPACTION. THERE WAS NO NEGAT

  Patient problems: Aneurysm

  MAUDE report 16419657 ↗

Other Medos International Sàrl products

• TRUESPAN ORTHOCORD6 models · 4,109 reports
• FMS39 models · 3,588 reports
• EXPEDIUM291 models · 3,312 reports
• EXPEDIUM VERSE90 models · 2,686 reports
• EXPRESSEW6 models · 2,459 reports
• OMNISPAN ORTHOCORD3 models · 1,581 reports
• HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
• PROWLER SELECT9 models · 1,066 reports