MAUDE Adverse Event Report: PULSAR VASCULAR UNKPULSERIDER; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKPULSERIDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Type  Death  

Manufacturer Narrative

Product complaint # (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 the no lot number was provided by the customer.Cerenovus manufacturer's report numbers: 3008680601-2020-00002, 3008680601-2020-00003, 3008680601-2020-00004, 3008680601-2020-00005, 3008680601-2020-00006, 3008680601-2020-00008 are related to the same incident.

Event Description

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 delayed device thrombosis leading to death.Mechanical thrombectomy was performed, which was technically challenging due to the presence of the pulserider device 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.

• Brand Name: UNKPULSERIDER
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA 95032
• Manufacturer (Section G): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9666984
• MDR Text Key: 177674749
• Report Number: 3008680601-2020-00007
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKPULSERIDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR