UNKPULSERIDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-04 for UNKPULSERIDER manufactured by Pulsar Vascular.

Event Text Entries

[177653552] (b)(4). Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. Device history record (dhr) review cannot be conducted because no lot number was provided by the customer. Information regarding patient weight, height, medical history, race, and ethnicity was not reported. Cerenovus manufacturer's report numbers: 3008680601-2020-00002, 3008680601-2020-00003, 3008680601-2020-00004, 3008680601-2020-00005, 3008680601-2020-00007, 3008680601-2020-00008. Are related to the same incident.
Patient Sequence No: 1, Text Type: N, H10


[177653553] This complaint is from a literature source. As reported in the literature publication entitled,? Early postmarket results with pulserider for treatment of wide-necked intracranial aneurysms: a multicenter experience? (pmid:31703202). 1 patient with intracranial aneurysm who was treated with pulserider experienced intraprocedural aneurysm rupture leading to death. The complication resulted from the perforation of the left pca by the pulserider arch during deployment. Objective: traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. Pulserider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the pulserider device. Methods: this study was a prospective registry of patients treated with pulserider at 13 american neurointerventional centers following fda approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications. Cerenovus devices were used in this study. No device specific information (including catalog and lot number) were provided in the article.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008680601-2020-00006
MDR Report Key9666953
Report SourceLITERATURE
Date Received2020-02-04
Date of Report2020-01-15
Date Mfgr Received2020-01-15
Date Added to Maude2020-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone949789-868
Manufacturer G1PULSAR VASCULAR
Manufacturer Street130 KNOWLES DR SUITE E
Manufacturer CityLOS GATOS CA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKPULSERIDER
Generic NameINTRACRANIAL NEUROVASCULAR STENT
Product CodeNJE
Date Received2020-02-04
Catalog NumberUNKPULSERIDER
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPULSAR VASCULAR
Manufacturer Address130 KNOWLES DR SUITE E LOS GATOS CA 95032 US 95032


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-04

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