MAUDE Adverse Event Report: PULSAR VASCULAR PULSERIDER Y 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number 301D

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the event was reported through the (b)(6)study that the (b)(6)-year-old female patient with a history of hypertension, hyperlipidaemia, peripheral artery disease, peripheral vascular disease (two stenting surgeries for pvd), headaches, smoking, left leg numbness, guillain-barré syndrome, and renal insufficiency presented with a midline anterior communicating artery (acom) aneurysm with the following characteristics and dimensions: 2.3mm parent vessel diameter, maximum aneurysm diameter was 8.9mm, 5.7mm dome, 4.3mm neck size, and a dome to neck ratio of 1.3mm underwent the stent-assisted embolization index procedure on (b)(6) 2019.One of the pulserider aneurysm neck reconstruction devices (anrd) that was chosen was the pulserider y, 3mm, 8mm arch (301d / w3274-13).The pulserider device was deployed at the target site and prior to detachment, the device moved away from its intended position of placement.Due to the tortuosity of the patient¿s vasculature, the pulserider device was not implanted.There was no report of any patient adverse event.It was reported that the device was discarded and is not available to return for evaluation.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (w3274-13) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product and available for analysis, the reported customer complaint could not be confirmed.In addition, the spontaneous movement of the device away from its intended position as reported in the complaint is related to and dependent on the characteristics of the target aneurysm and on the tortuosity of the parent vessel.The decision made that was made by the physician to not implant the pulserider device due to the tortuosity of the patient vasculature has congruence with the fact that the product analysis lab is not able to replicate a similar environment with vessel tortuosity and other characteristics related to the target aneurysm to conduct testing related to spontaneous device movement or placement accuracy of the device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, the patient vasculature and aneurysm characteristics may have been the contributing factors to the reported event.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008680601-2019-00571.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The event was reported through the (b)(6) study that the (b)(6)-year-old female patient with a history of hypertension, hyperlipidaemia, peripheral artery disease, peripheral vascular disease (two stenting surgeries for pvd), headaches, smoking, left leg numbness, guillain-barré syndrome, and renal insufficiency presented with a midline anterior communicating artery (acom) aneurysm with the following characteristics and dimensions: 2.3mm parent vessel diameter, maximum aneurysm diameter was 8.9mm, 5.7mm dome, 4.3mm neck size, and a dome to neck ratio of 1.3mm underwent the stent-assisted embolization index procedure on (b)(6) 2019.One of the pulserider aneurysm neck reconstruction devices (anrd) that was chosen was the pulserider y, 3mm, 8mm arch (301d / w3274-13).The pulserider device was deployed at the target site and prior to detachment, the device moved away from its intended position of placement.Due to the tortuosity of the patient¿s vasculature, the pulserider device was not implanted.There was no report of any patient adverse event.It was reported that the device was discarded and is not available to return for evaluation.

• Brand Name: PULSERIDER Y 3MM, 8MM ARCH
• 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: 8742185
• MDR Text Key: 215270622
• Report Number: 3008680601-2019-00572
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005116
• UDI-Public: 00859030005116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 301D
• Device Lot Number: W3274-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR