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 Hemorrhage, Cerebral (1889); No Patient Involvement (2645)

Event Date 06/30/2018

Event Type  Injury  

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. .

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿use of the pulserider device in the treatment of ruptured intracranial aneurysms: a case series.¿ a (b)(6) male patient with ruptured wide-necked basilar artery aneurysm who underwent pulserider-assisted coil embolization has developed small hemorrhage along the tract of external ventricular drains (evds) in 6 days after initiation of dapt (dual antiplatelet therapy) , evd was placed 22 hours prior to initiation of dapt.Goal of this study to report a small but promising series of successful use the pulserider in the acute treatment of wide-necked, ruptured basilar artery aneurysms.Method: between march and june 2018, 4 consecutive cases of ruptured wide-necked basilar bifurcation aneurysms at the university of (b)(6) hospital, (b)(6), with pulse rider assisted coil embolization have been treated.All aneurysms were initially diagnosed on head computed tomography angiogram and underwent formal digital subtraction angiography.

Manufacturer Narrative

The article was re-reviewed.The following statements: "patient 2 (33-year-old male) had small hemorrhage along the tract of external ventricular drains (evds) which developed 6 days after initiation of dapt" (p.3) has been interpreted as a typo.The clinical presentation mentioned in the article (evd associated hemorrhage 6 days post-dapt initiation) relates to patient 1( (b)(4)).Patient 2 had a small evdassociated hemorrhage, prior to antiplatelet administration which was seen on a computed tomography scan prior to embolization).Since a small evdassociated hemorrhage was seen on a computed tomography scan prior to embolization the coding has been updated to no adverse event.

• Brand Name: UNKPULSERIDER
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA 95032
• MDR Report Key: 8692865
• MDR Text Key: 147780961
• Report Number: 3008680601-2019-00567
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR