PulseRider Aneurysm Neck Reconstruction Device 313-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00859030005086), received between Feb 6, 2018 and Mar 31, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 3, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE FEMALE PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM. THE PATIENT EXPERIENCED PUNCTURE SITE HEMORRHAGE DURING THE PROCEDURE. AN APPROACH WAS MADE FROM THE RIGHT BRACHIAL ARTERY (BA) WITH A 6F GUIDING SHEATH (BRAND UNSPECIFIED). THE SHEATH WAS ADVANCED TOWARD THE RIGHT VERTEBRAL ARTERY. A GUIDEPOST WAS THEN ADVANCED TO THE BASILAR ARTERY. A PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE / LOT NUMBER) WAS DELIVERED TO THE ANEURYSM NECK. A PULSERIDER 10Y, 3.5 ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (313D / W3662-07) WAS DEPLOYED IN A GOOD POSITION AT THE NECK OF THE ANEURYSM AFTER ITS DIRECTION WAS ADJUSTED SEVERAL TIMES. COIL EMBOLIZATION WAS THEN INITIATED. MULTIPLE ATTEMPTS WERE MADE TO POSITION TWO GALAXY G3 COILS (GLY120412 / 30526869 & GLY120308 / 30546473); HOWEVER, THE COILS WERE NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE PHYSICIAN SELECTED A 3MM X 8CM TARGET 360 SOFT COIL (STRYKER) FOR USE, BUT THIS COIL WAS ALSO NOT ABLE TO BE WINDED. THE PHYSICIAN TRIED TO REMOVE THE COIL, BUT IT BECAME ENTANGLED WITH THE PULSERIDER ANRD. THE DELIVERY WIRE WAS PUSHED SEVERAL T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930111 ↗
• InjuryMay 11, 2020Migration; Migration

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CONGESTIVE HEART FAILURE (CHF), CORONARY ARTERY DISEASE (CAD), DIABETES, FOCAL NEUROLOGICAL DEFICITS, HEADACHES, CONTROLLED HYPERLIPIDEMIA, CONTROLLED HYPERTENSION, ISCHEMIC STROKE, PERIPHERAL VASCULAR DISEASE, AND SMOKING (CURRENT) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A GIANT RECURRENT BASILAR ARTERY ANEURYSM ON (B)(6) 2019. THE TARGET ANEURYSM HAD PREVIOUSLY BEEN TREATED WITH COIL EMBOLIZATION ON (B)(6) 2015. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A POSTERIOR CIRCULATION ANEURYSM AT THE BASILAR ARTERY BIFURCATION. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 17.1MM, DOME 17.8MM, MAXIMUM ANEURYSM DIAMETER 24.0MM, NECK SIZE 8.0MM, AND DOME-TO-NECK RATIO 2.2MM. PARENT VESSEL DIAMETER WAS 3.0MM. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF 8 MICRUSFRAME S, 8 GALAXY G3, 3 GALAXY G3 XTRASOFT, AND 12 COMPETITOR COILS VIA A SL-10 (STRYKER) MICROCATHETER. ACCORDING TO THE CASE REPORT FORM (CRF), AN ENTERPRISE STENT AND PULSERIDER Y 4MM 10MM ARCH (313D/W3303-16) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WERE IMPLANTED, BUT A SOLITAIRE PLATINUM (MEDTRONI

  Patient problems: No Code Available

  MAUDE report 10043008 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PATIENT, WITH A HISTORY OF A SMALL MIDBRAIN EMBOLIC STROKE ON (B)(6) 2018, PRESENTED WITH LEFT-SIDED WEAKNESS ON (B)(6) 2018. THE PATIENT WAS ADMITTED FROM INPATIENT REHABILITATION UNIT FOR OBSERVATION AND SOURCE WORKUP. MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN PERFORMED ON (B)(6) 2018 REVEALED A PUNCTATE INFARCT IN THE LEFT TEMPORAL LOBE WITH NO EVIDENCE OF INTRACRANIAL HEMORRHAGE, DILATED LATERAL VENTRICLES, OR HYDROCEPHALUS. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) OF THE HEAD SHOWED NO STENOSIS OR ANEURYSM WITHIN THE VISUALIZED VESSEL. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS NEGATIVE FOR THROMBUS OR VEGETATION. THE PATIENT WAS CONTINUED ON MEDICATIONS AND PROVIDED PHYSICAL AND OCCUPATIONAL THERAPIES. THE LEFT-SIDED WEAKNESS REPORTEDLY RESOLVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. THE PATIENT WAS SEEN IN CLINIC FOR A SCHEDULED FOLLOW-UP VISIT ON (B)(6)2018. IT WAS LAST REPORTED THAT THE PATIENT STILL HAS SOME PERSISTENT MEMORY DEFICITS AND BASELINE GAIT ISSUES, BUT SYMPTOMS HAVE GREATLY IMPROVED. THE PHYSICIAN STATED THAT THE EVENT COULD ¿POSSIBLY BE RELATED TO THE DEVICE OR COILS¿ OR THE PATIENT¿S PRE-EXISTING MIDDLE CERE

  Patient problems: Infarction, Cerebral

  MAUDE report 7445507 ↗
• InjuryFeb 6, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE IMMEDIATELY FOLLOWING AN ELECTIVE COIL EMBOLIZATION OF A 6 MM WITH 5 MM NECK BASILAR TIP ANEURYSM WITH A 3.5-4.5 MM 10 MM Y-SHAPE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (313D/ W2590-12). POST-STROKE NEUROLOGICAL ASSESSMENT REVEALED HOMONYMOUS HEMIANOPSIA. BRAIN MAGNETIC RESONANCE IMAGING (MRI) PERFORMED TWO DAYS AFTER THE PROCEDURE REVEALED POSTERIOR CEREBRAL ARTERY (PCA) ISCHEMIA WITH MULTIPLE SCATTERED FOCI. THE STROKE WAS ¿EXPECTANTLY¿ MANAGED AND THE PATIENT WAS DISCHARGED WITH RESIDUAL STROKE SYMPTOMS. THE PHYSICIAN STATED THAT DUE TO THE ANGLE THE ¿LEFT ARM [WAS] DEPLOYED IN THE ANEURYSM, NOT THE PCA¿. THE GEOMETRIC CONFIGURATION OF THE ANEURYSM PRESENTED A CHALLENGE TO THE PHYSICIAN. ONE OF THE PCAS WAS POINTING SUPERIORLY 30 DEGREES WHILE THE LEFT PCA WAS POINTING INFERIORLY. DUE TO THE PCAS¿ ANGULATION, ONE LEAFLET WAS PLACED INSIDE OF THE ANEURYSM AND THE OTHER WAS PLACED INSIDE OF THE ANEURYSM DOME. THE PHYSICIAN FELT IT WAS DIFFICULT TO PROJECT HOW EFFECTIVELY THE LEAFLET IN THE PCA WAS PROTECTING THE ORIGIN OF THE ARTERY AND PERHAPS SOME OF THE COILS THAT WERE PLACED DUR

  Patient problems: Infarction, Cerebral

  MAUDE report 7243987 ↗