PulseRider Aneurysm Neck Reconstruction Device 211-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00859030005130), received between Dec 13, 2018 and Feb 13, 2023 — classified as 12 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE GUIDING CATHETER (GC), AN 8F OPTIMO GUIDING CATHETER (TOKAI MEDICAL) WAS GUIDED TO THE RIGHT INTERNAL CAROTID ARTERY (ICA) VIA THE RIGHT FEMORAL ARTERY (FA) APPROACH. THE SOFIA ¿ 5F DISTAL ACCESS CATHETER (MICROVENTION) WAS GUIDED TO THE C1 SEGMENT OF THE ICA, FROM WHICH THE PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT#: UNKNOWN) AND A HEADWAY® 17 MICROCATHETER (MICROVENTION) WERE INSERTED. THE PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED TO THE A1 SEGMENT ¿ ANTERIOR CEREBRAL ARTERY (ACA). A PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / LOT#: UNKNOWN) WAS IMPLANTED IN A HYBRID POSITION. THE HEADWAY® 17 MICROCATHETER MADE THE APPROACH TOWARD THE ANEURYSM VIA TRANS-CELL TECHNIQUE AND COIL EMBOLIZATION WAS INITIATED. THE COMPLAINT COIL, A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30701280) WAS USED, BUT IT BECAME PROTRUDED TO THE NECK SIDE. THE ISSUE WAS NOT RESOLVED DESPITE REWINDING SEVERAL TIMES. THE COIL WAS REMOVED ONCE FROM THE PATIENT¿S BODY. THE POSITION OF THE HEADWAY® 17 MICROCAT

  Patient problems: Thromboembolism

  MAUDE report 16368671 ↗
• MalfunctionDec 14, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANEURYSM AT THE BASILAR TIP, THE COMPLAINT DEVICE, A PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / 3075677410) WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PULSERIDER ANRD WAS DEPLOYED AND IMPLANTED OUTSIDE THE ANEURYSM. A PROWLER SELECT PLUS MICROCATHETER (CATALOG/LOT# UNKNOWN) WAS DELIVERED TO THE ANEURYSM VIA TRANS-CELL TECHNIQUE. COIL EMBOLIZATION WAS INITIATED AND ELEVEN (11) COILS WERE IMPLANTED. THE MICROCATHETER USED FOR THE COIL EMBOLIZATION WAS REMOVED. ATTEMPT TO DETACH THE PULSERIDER AS PER THE IFU WAS MADE. THE GREEN LIGHT FLASHED DURING THE FIRST DETACHMENT CYCLE. THE RED LIGHT FLASHED DURING THE SECOND DETACHMENT CYCLE. THE MICROCATHETER WAS DELIVERED TO THE LEG, BUT THE MICROCATHETER MOVED TOWARD ONE LEG MARKER PART. THE PHYSICIAN THOUGHT THAT ONE SIDE HAD NOT BEEN DETACHED. THE MICROCATHETER WENT DOWN TO THE DETACHMENT MARKER TO ATTEMPT DETACHMENT BUT THE DETACHMENT MARKER OF THE PULSERIDER ANRD DELIVERY WIRE ALSO WENT DOWN. AT THIS POINT, THE PHYSICIAN THOUGHT THAT THE PULSERIDER ANRD WAS DETACHED AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983234 ↗
• MalfunctionSep 6, 2022Migration; Migration

  AS REPORTED BY THE FIELD, THIS WAS AN ENDOVASCULAR EMBOLIZATION TO AN ANEURYSM OF THE VERTEBRAL ARTERY (VA) UNION. A PULSERIDER T, 3MM, 10MM ARCH (211D, 3051697703) WAS DEPLOYED FROM AN INTENDED POSITION OF THE ANEURYSM NECK. THE PULSERIDER WAS INSERTED INTO THE ANEURYSM BY A TRANSCELL WITH AN EXSELSIOR SL10 MICROCATHETER. AT THE END OF THE PROCEDURE, THE COMPLAINT DEVICE WAS DETACHED. THE PHYSICIAN COMMENTED THAT THE DEVICE FELT OFF SLIGHTLY AFTER DETACHMENT. THERE IS NO EFFECT SUCH AS THE COIL MASS COMING OUT TO THE MOTHER VESSEL BUT IF ADDITIONAL TREATMENT SUCH AS RECANALIZATION TREATMENT OCCURS EVENTUALLY, THE DIFFICULTY OF TREATMENT WILL INCREASE. THERE WAS NO PATIENT INJURY. A CONTINUOUS FLUSH WAS DONE. ANOTHER CONCOMITANT DEVICE IS A MICROCATHETER (PROWLER SELECT PLUS). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CORRECT DEVICE SIZE OF THE PULSERIDER WAS SELECTED BASED ON THE INSTRUCTIONS FOR USE (IFU). THE IMPLANT DID NOT MIGRATE INTO ANOTHER VESSEL OR TO A DISTAL PORTION OF THE TARGET VESSEL. NO ADDITIONAL INTERVENTION WAS REQUIRED. THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE EVENT. THERE IS NO INFORMATION AVAILABLE IF THERE WAS ANY ALLEGED PRODUCT MAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15360665 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED BASILAR ARTERY TIP ANEURYSM VIA THE TRANS-CELL TECHNIQUE, AN 8FR SLIM GUIDE® (MEDIKIT CO, LTD) WAS INTRODUCED INTO THE LEFT SUBCLAVIAN ARTERY, AND A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) WAS INTRODUCED FROM THE LEFT VERTEBRAL ARTERY (VA) TO THE PROXIMAL BASILAR ARTERY (BA). THE HEADWAY® DUO MICROCATHETER (MICROVENTION) WAS PLACED NEAR THE LEFT VA UNION, AND THE HEADWAY® 27 MICROCATHETER (MICROVENTION) WAS PLACED UNDER THE ANEURYSM NECK. AFTER THE INTRODUCTION OF THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / 3069219303) VIA THE HEADWAY® 27 MICROCATHETER AND EXTERNALLY EXPANDING THE BILATERAL POSTERIOR CEREBRAL ARTERY (PCA), THE HEADWAY® 27 MICROCATHETER MADE AN APPROACH INTO THE ANEURYSM VIA TRANS-CELL TECHNIQUE. THE COMPLAINT COIL, A 9MM X 25CM GALAXY G3 (GLY120925 / 30715068) WAS INTRODUCED VIA THE HEADWAY® DUO MICROCATHETER AS THE FIRST COIL. WHEN THE COIL WAS INSERTED TO THE DETACHMENT MARKER, IMAGING WAS PERFORMED FOR CONFIRMATION. THERE WAS A GAP IN THE ANEURYSM WALL, AND THE PHYSICIAN ATTEMPTED TO RESHEATH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982065 ↗
• InjuryJun 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A FEMALE UNDERWENT A PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR ARTERY ANEURYSM. THE 3MM, 10MM ARCH PULSERIDER T ANEURYSM NECK RECONSTRUCTION DEVICE WAS IMPLANTED IN THE ANEURYSM NECK WITH ROTATION. THE COIL EMBOLIZATION WAS STARTED BY USING AN UNKNOWN CERENOVUS COIL AND A COMPLETIVE COIL. THE EMBOLIZATION WAS CONTINUED WITHOUT ANY PARTICULAR PROBLEM UP TO THE SEVENTH COIL. WHEN THE 8TH COIL (COMPETITIVE PRODUCT) WAS INSERTED, THE COIL KICKED BACK AND CAME OUT OF THE NECK. THEREFORE, THE COIL'S POSITION WAS ADJUSTED AND PUSHED TO THE NECK. WHEN IMAGING WAS PERFORMED, BILATERAL PCA WAS NOT IMAGED. THEREFORE, THE PHYSICIAN RAISED THE POSITION OF THE PULSERIDER. THE PHENOM, MEDTORNIC MICROCATHETER (MC) WAS REGIONAL CROSSED INTO THE BILATERAL PCA, AN ATLAS STENT WAS INDUCED IN EACH AND PLACED IN THE FORM OF A Y-STENT IN AN OVERLAPPING TO THE PULSERIDER. AFTER THAT, BILATERAL PCA BECAME VISIBLE. THE PROCEDURE WAS COMPLETED. AFTER THE END OF THE PROCEDURE, IT WAS CONFIRMED THAT THE PATIENT WAS CONSCIOUS AND THAT THE LIMBS WERE BEHAVING. THE DEVICE WAS PREPARED PER THE INSTRUCT

  Patient problems: Thromboembolism

  MAUDE report 14601259 ↗
• MalfunctionMay 9, 2022Unstable; Unstable

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION FOR BIFURCATION OF A CEREBRAL ANEURYSM AND WHILE USING A PULSERIDER T, 3MM, 10MM ARCH (211D, 3068658421) ANEURYSM NECK RECONSTRUCTION DEVICE, THERE WAS A CONCERN ABOUT STABILITY. ORIGINALLY, A 3D PRINTER MODEL WAS PREVIOUSLY USED FOR A HANDS-ON. THE PHYSICIAN MEASURED THE SIZE (ANEURYSM, NECK, MATERNAL VESSEL DIAMETER) WITH 3D CT. AT THAT TIME, BECAUSE THE MOTHER VESSEL DIAMETER WAS WITHIN 3.5 MM, THE SALES REPRESENTATIVE TOLD THE PHYSICIAN THAT A DOCTOR THAT A 2.7MM X 3.5MM PULSERIDER T MODEL WOULD BE PREPARED. HOWEVER, THE PRECISE MOTHER VESSEL DIAMETER WAS NOT REMEMBERED, AND THE MEASURED VALUE WAS SMALLER THAN 3.5MM, THEREFORE IT WAS DECIDED TO PREPARE 2.7MM X 3.5MM PULSERIDER. ON THE DAY OF THE PROCEDURE, THE MOTHER VESSEL DIAMETER WAS FOUND TO BE APPROXIMATELY 3.6 MM. THE REASON FOR THIS WAS THAT THE 3D CT IMAGE WAS LESS ACCURATE THAN THE ANGIO IMAGE, RESULTING IN A NUMERICAL VALUE SMALLER THAN THE ACTUAL VESSEL DIAMETER. BECAUSE A 3.5MM X 4.5MM PULSE RIDER WAS NOT PREPARED, THE 10T OF 2.7MM X 3.5MM WAS USED. THE PULSE RIDER WAS PLACED, BUT IT WAS REMOVED BECAUSE THERE WAS A CONCERN ABOUT STABILITY, AND IT WAS REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337461 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT PULSERIDER ASSISTED COIL EMBOLIZATION OF A BASILAR ARTERY TOP ANEURYSM ON (B)(6) 2021 AND EXPERIENCED A CEREBRAL INFARCTION ON THE FOLLOWING DAY. THE INFARCT WAS CONFIRMED IN THE PERIPHERY OF THE TERRITORY SUPPLIED BY THE POSTERIOR CEREBRAL ARTERY (PCA, THE SITE TREATED WITH THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD). THE PATIENT ONLY EXPERIENCED A SLIGHT DISCOMFORT IN THE SENSE OF BALANCE. THERE WAS NO TREATMENT NOR REOPERATION PERFORMED. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANRD (211D / 3057460501) WAS ALLEGEDLY USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS A CONTINUOUS FLUSH MAINTAINED. THE PULSERIDER WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE / LOT NUMBER) AND COIL EMBOLIZATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED, AND THE PULSERIDER WAS DETACHED WITHOUT INCIDENT. THE PHYSICIAN COMMENTED THAT THE PULSERIDER WAS MOVED IN AND OUT OF THE MICROCATHETER MULTIPLE TIMES WHEN ADJUSTING THE DEPLOYMENT POSITION. AT THAT TIME. A SMALL THROMBUS WAS FORMED AND MAY HAVE FLOWN

  Patient problems: Ischemia Stroke

  MAUDE report 13473341 ↗
• MalfunctionJan 28, 2022Break; Positioning Failure; Break; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE, WITH THE TARGET AT THE BIFURCATION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH AN 8FR SHEATH. THE 8FR ROADMASTER GUIDING CATHETER (GOODMAN) APPROACHED THE RIGHT INTERNAL CAROTID ARTERY (ICA). FROM THERE, THE DISTAL ACCESS CATHETER, A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION) APPROACHED TO AROUND THE IC-TOP. THE PROWLER SELECT PLUS MICROCATHETER APPROACHED THE NECK OF THE ANEURYSM AT THE MCA BIFURCATION AND THE COMPLAINT DEVICE, A PULSERIDER T, 3MM, 10 MM ARCH ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / 3060357903) WAS DELIVERED FOR THE PURPOSE OF PLACEMENT. IT WAS DEPLOYED ABOUT 5 TIMES, BUT IT WAS REMOVED ONCE BECAUSE THE LEAFLET DID NOT GO TO THE BRANCH, AND DAMAGE OF THE IMPLANT WAS CONFIRMED. IT WAS REPORTED THAT, ¿SINCE THERE SEEMED TO BE NO PARTICULAR PROBLEM, THE LEAFLET WAS INSERTED AGAIN AND DEPLOYED, BUT IT WAS RETRIEVED BECAUSE THE LEAFLET DID NOT GO TO THE BRANCH.¿ THE TIP SHAPE OF THE MICROCATHETER WAS CHANGED FROM STR TO 45° AND ANOTHER ATTEMPT WAS MADE. ALTHOUGH 5 ATTEMPTS WERE MADE TO DEPLOY THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389000 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/ 3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APP

  Patient problems: Ischemia Stroke; Thromboembolism

  MAUDE report 13204785 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE FEMALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE OF A RECANALIZED, PREVIOUSLY CLIPPED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2021 AND SUFFERED FROM A CEREBRAL INFARCTION DURING THE POST-OPERATIVE COURSE. THE TIMING OF THE STROKE RELATIVE TO THE PROCEDURE WAS NOT REPORTED. DURING THE PROCEDURE, A PROWLER SELECT PLUS MICROCATHETER (PRODUCT CODE AND LOT NUMBER UNKNOWN) WAS USED WITH THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / LOT# UNKNOWN). IT WAS NOT CLEAR IF CONTINUOUS FLUSH HAD BEEN MAINTAINED. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. ON 08-OCT-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ON WEDNESDAY, (B)(6) 2021, BETWEEN 1PM AND 4PM, THE PULSERIDER ANRD WAS SUCCESSFULLY IMPLANTED AFTER SEVERAL ATTEMPTS AT A RECANALIZED, PREVIOUSLY CLIPPED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE PULSERIDER WAS ALLEGEDLY USED AS PER THE IFU. THE LOT NUMBER OF THE PULSERIDER DEVICE WAS 3056488801. COIL EMBOLIZATION BEGAN WITH THREE COILS: 8MM X 30CM COMPLEX EXTRASOFT (KANEKA MEDIX), 3MM X 8CM GALAXY G3 (GLY120308 / LOT UNK

  Patient problems: Ischemia Stroke

  MAUDE report 12677781 ↗
• MalfunctionSep 1, 2021Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A BIFURCATION ANEURYSM, A HEADWAY, TERUMO MICROCATHETER (MC) WAS INITIALLY USED TO DELIVER A PULSERIDER T, 3MM, 10MM ARCH (211D, 3051697712) BUT THE DEVICE WAS NOT ABLE TO BE ADVANCE THROUGH THE HUB OF THE MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH A PROWLER SELECT PLUS (PRODUCT/LOT NUMBER UNKNOWN) BUT THERE WAS A RESISTANCE FELT WHEN THE COMPLAINT DEVICE WAS ADVANCING THROUGH THE MICROCATHETER. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE REPLACED COIL WAS ABLE TO BE DELIVERED AND IMPLANTED. THE COIL EMBOLIZATION WAS SUCCESSFUL, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406531 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE PMS PULSERIDER STUDY, THE (B)(6) PATIENT UNDERWENT SUCCESSFUL PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2021 AND EXPERIENCED A CEREBRAL HEMORRHAGE ON (B)(6) 2021. THE CEREBRAL HEMORRHAGE DURING THE 30-DAY FOLLOW-UP VISIT. THE HEMORRHAGE WAS IN THE PERFUSION AREA OF THE PULSERIDER IMPLANTED VESSEL, IPSILATERAL TO THE TARGET ANEURYSM. THE NIH STROKE SCALE SCORE (NIHSS) WAS 0. NO ADDITIONAL TREATMENT WAS PERFORMED. ON (B)(6) 2021, IT WAS CONFIRMED THAT THE PATIENT HAD RECOVERED FROM THE EVENT. THE PHYSICIAN COMMENTED THAT THE RELATIONSHIP OF THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / W3320-16) TO THE CEREBRAL HEMORRHAGE CAN BE RULED OUT AS THE EVENT WAS RELATED TO ANTIPLATELET / ANTICOAGULANT THERAPY; THE RELATIONSHIP TO THE INDEX PROCEDURE CANNOT BE EXCLUDED. THE EVENT WAS NOT CONSIDERED SERIOUS. THE PULSERIDER AND REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 12366520 ↗
• MalfunctionAug 13, 2021Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PULSERIDER-ASSISTED PROCEDURE WITH THE TARGET LESION BEING A BIFURCATING ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH SEVERE VESSEL TORTUOSITY AT THE PROXIMAL REGION, THE PULSERIDER T, 3MM, 10 MM ARCH ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / 3051697717) DID NOT ORIENTATE / POSITION AS THE PHYSICIAN INTENDED. TORQUE WAS APPLIED AND THE PULSERIDER ANRD WAS RETRACTED MANY TIMES, BUT IT DID NOT POSITION WELL. IT WAS REPORTED THAT THE PULSERIDER ANRD FULLY DEPLOYED OUTSIDE THE LESION TWICE. IT APPEARED TO BE TWISTED AT THE BODY AND LEG PART WHEN IT DEPLOYED THE SECOND TIME. THE PHYSICIAN STOPPED USING THE PULSERIDER ANRD. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED ¿BY MAKING Y-STENT¿ WITH TWO 21MM NEUROFORM ATLAS STENTS (STRYKER). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT / COMPLICATION. THE COMPLAINT DEVICE IS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321023 ↗
• InjuryJul 22, 2021Malposition of Device; Difficult or Delayed Separation; Malposition of Device; Difficult or Delayed Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A MALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM AND EXPERIENCED INTRAOPERATIVE ANEURYSM RUPTURE. THE PULSERIDER T 10MM ARCH, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (211D / 3051697708) WAS DEPLOYED AT THE TARGET ANEURYSM, AND COIL EMBOLIZATION WAS STARTED. A 5MM X 15CM GALAXY G3 COIL WAS USED TO FRAME THE ANEURYSM AND TWO GALAXY G3 XSFT (4MM X 10CM & 4MM X 6CM) WERE USED AS FILLING COILS. A 3MM X 4CM GALAXY G3 MINI (GLM930040 / L13708) WAS ALLEGEDLY USED AS PER THE INSTRUCTIONS FOR USE (IFU) AS THE FOURTH COIL, BUT BLEEDING WAS CONFIRMED FROM A BLEB ABOVE THE ANEURYSM. A TOTAL OF NINE GALAXY G3 MINI COILS WERE SUBSEQUENTLY IMPLANTED FOR HEMOSTASIS. ANGIOGRAPHY SHOWED NO FURTHER BLEEDING FROM THE BLEB. AFTER COILING WAS COMPLETED, THE PHYSICIAN ATTEMPTED TO DETACH THE PULSERIDER ANRD IMPLANT, BUT THE ANCILLARY DETACHMENT CONTROLLER (PRODUCT CODE & LOT NUMBER UNKNOWN) DISPLAYED AN ERROR. THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE DEVICE, BUT A FLASHING RED LIGHT DISPLAYED ON THE CONTROLLER. THE PULSERIDER ACCESSORY CABLE (PRDSACD / 30393940) WAS REPLACED, BUT THE SAME ISSUE CON

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 12212267 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE FIELD THAT AFTER A PULSERIDER (211D/W3320-02) ASSISTED COIL EMBOLIZATION PROCEDURE, AN ASYMPTOMATIC BRAINSTEM INFARCTION WAS OBSERVED. THE PULSERIDER DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). ACCORDING TO THE DOCTOR, THIS IS COMMON AFTER AN ENDOVASCULAR TREATMENT HOWEVER THE DOCTOR NOTATED THAT THE RELATIONSHIP OF THE EVENT AND DEVICE IS UNKNOWN. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Ischemia Stroke

  MAUDE report 11294388 ↗
• InjuryDec 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  A REPORT FROM THE FIELD INDICATED THAT THE FEMALE PATIENT UNDERWENT PULSE-RIDER ASSISTED COIL EMBOLIZATION OF AN UNSPECIFIED ANEURYSM ON (B)(6) 2020. A 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L14568) WAS INSERTED AS THE LAST COIL BUT MIGRATED TO THE PERIPHERAL POSTERIOR CEREBRAL ARTERY (PCA) RESULTING IN ARTERIAL OBSTRUCTION. CONSEQUENTLY, THE PATIENT DEVELOPED ANOPSIA (LEFT OCCIPITAL LOBE SYMPTOM). ANTICOAGULANT AND ANTIPLATELET THERAPY WAS ADMINISTERED AS TREATMENT. THE EXACT TIMING OF THE COIL MIGRATION IN RELATION TO THE INDEX PROCEDURE WAS NOT REPORTED. THE PATIENT MADE GOOD PROGRESS AND WAS SCHEDULED TO BE DISCHARGED ON (B)(6) 2020. HOWEVER, DURING THE MORNING OF (B)(6) 2020, SHE DEVELOPED CONSCIOUSNESS DISORDER AND RIGHT HEMIPLEGIA. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVEALED THROMBUS IN THE P1 SEGMENT OF THE LEFT PCA. THROMBOLYTIC DRUG TREATMENT WAS SUBSEQUENTLY PERFORMED, AND RECANALIZATION OF THE VESSEL WAS ACHIEVED. THE PATIENT REPORTEDLY RECOVERED FROM THE SYMPTOMS. REPEAT DSA REVEALED THAT THE P1 THROMBUS WAS ¿SHRINKING¿ AND THE COIL HAD FURTHER MIGRATED. IT WAS LAST REPORTED THAT THE PATIENT REMAINS HOSPITALIZED AND ¿THE CLINICAL COURSE HAS RECOVERED SOMEHOW¿. THEREF

  Patient problems: Ischemia Stroke

  MAUDE report 10929077 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE (B)(6) STUDY THAT A (B)(6)-YEAR FEMALE PATIENT WITH A HISTORY OF SMOKING (PREVIOUS), CARDIAC ARRHYTHMIA, CONTROLLED HYPERTENSION, HEADACHE, AND BLACKOUT SPELLS WITH RIGHT HAND NUMBNESS UNDERWENT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AT THE 180-DAY FOLLOW-UP VISIT ON (B)(6) 2019, WHICH IDENTIFIED A GREATER THAN 50% VESSEL STENOSIS IN DAUGHTER VESSEL. NO INTERVENTION WAS PERFORMED. THE PATIENT DID NOT HAVE ANY ASSOCIATED CLINICAL SYMPTOMS. THE VESSEL STENOSIS DID NOT RESULT IN A STROKE OR THROMBOTIC EVENT. THE CAUSE OF THE STENOSIS IS CURRENTLY UNKNOWN. THE PATIENT INITIALLY UNDERWENT A SUCCESSFUL EXTRA-ANEURYSMAL IMPLANTATION OF A PULSERIDER T 3MM 10MM ARCH (211DCT / W2579-36) DEVICE AT A MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2018. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. ANTI-PLATELET FUNCTION TESTING RESULTS WERE PRU 66 AND ARU 396. THE ANEURYSM DIAMETER WAS 6.4MM, DOME HEIGHT WAS 6.9MM, 8MM, NECK SIZE WAS 5.2MM, AND DOME-TO-NECK RATIO WAS 1.3MM. THE PARENT VESSEL DIAMETER WAS 2.9MM. THE PULSERIDER DEVICE WAS IMPLANTED WITH ONE LEAFLET IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCA) AND THE OTHER LEAFLET IN THE RIGHT

  Patient problems: Stenosis

  MAUDE report 9683850 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE (B)(6) STUDY (PATIENT (B)(6)), A (B)(6) FEMALE WITH A FAMILY HISTORY OF ANEURYSMS, A HISTORY OF HYPERTENSION, ¿BLACKOUT SPELLS¿ AND RIGHT-HAND NUMBNESS EXPERIENCED VASOSPASM DURING THE INDEX PROCEDURE AND HEADACHE ON THE DAY OF THE PROCEDURE, (B)(6) 2018. THE PATIENT PRESENTED WITH A MIDLINE BASILAR ARTERY ANEURYSM WITH MAXIMUM DIAMETER OF 6.4 MM. THE DOME HEIGHT WAS 6.92 MM; ANEURYSM NECK SIZE OF 5.2 MM. THE PARENT VESSEL DIAMETER WAS 2.9MM. THE PATIENT UNDERWENT ANTI-PLATELET FUNCTION TESTING WITH THE FOLLOWING RESULTS: PRU 66 AND ARU 396. PRE-PROCEDURE MODIFIED RANKIN SCORE (MRS) WAS 1. THE INDEX PROCEDURE ON (B)(6) 2018, INVOLVED THE SUCCESSFULLY EXTRA-ANEURYSMAL IMPLANTATION OF THE PULSERIDER T, 3 MM, 10 MM ARCH (211DCT / W2579-36) THROUGH THE PROWLER SELECT PLUS MICROCATHETER. TEN COILS WERE IMPLANTED IN THE ANEURYSM WITH PACKING VOLUME USING ANGIOCALC OF 137.26% WITH RAYMOND SCALE CLASS III. IT WAS REPORTED THAT THE VASOSPASM OCCURRED DURING THE PROCEDURE. THE MILD HEADACHE OCCURRED FOLLOWING THE PROCEDURE AND WAS CONSIDERED TO BE POSSIBLY RELATED TO THE STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICE. HOWEVER, CAUSALITY OF TH

  Patient problems: Headache; Vasoconstriction

  MAUDE report 8160631 ↗