MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKPULSERIDER; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKPULSERIDER

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

Patient Problem Infarction, Cerebral (1771)

Event Date 06/30/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Cerenovus manufacturer's report number: 3008114965-2020-00488.Is related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent treatment of a wide-neck bifurcation aneurysm utilizing the pulserider and suffered dysphasia and hemiparesis that occurred after 1 day.The magnetic resonance imaging showed small multiple ischemic lesions.Intervention was not reported.At 6-months, minimal motor deficit was present.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is the pulserider.Other cnv devices that were also used in this study: prowler select-plus microcatheter non-cnv devices that were also used in this study: unknown brand of introducer sheath, unknown brand guide catheter, unknown brand of coils.Publication details: title: y-stenting versus pulserider-assisted coiling in the treatment of wide-neck bifurcation aneurysms: role of anatomical features on midterm results.Objective: to compare the immediate and 6-mo results of y-stenting vs pr assisted coiling.Methods: a total of 105 consecutive patients were retrospectively divided into 2 groups (73 y-stenting and 32 pr).All underwent angiographic 6-mo follow-up.We evaluated if some anatomical features could influence treatment results.

• Brand Name: UNKPULSERIDER
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): PULSAR VASCULAR; 47709 fremont blvd.; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10773242
• MDR Text Key: 214393852
• Report Number: 3008114965-2020-00489
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 10/16/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR