MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number 201D

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

Patient Problems Perforation of Vessels (2135); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.Title: in-stent stenosis after stenting the pulserider for a middle cerebral artery aneurysm: a case report.Authority: sakata m, tajima y, kubota m, iwadate y.In-stent stenosis after stenting the pulserider for a middle cerebral artery aneurysm: a case report.Radiol case rep.2023 jul 22;18(10):3453-3456.Doi: 10.1016/j.Radcr.2023.07.010.Pmid: 37502481; pmcid: pmc10369375.Section b.3: date of event: the date of the event is not known.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section d.6.A: the implantation date, month, and year is not known.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Arterial stenosis and vascular injury are both known potential complications associated with the use of the pulserider aneurysm neck reconstruction device and are mentioned in the instructions for use (ifu) as such.There were no alleged quality issues related to the device, as the device performed as intended.The physician attributed the event to arterial wall damage caused by the metal markers of the pulserider device during deployment, which induced intimal hyperplasia and in-stent stenosis.Damage to the vessel leading to stenosis, a flow altering condition to a vital organ, is considered a serious injury.Since the correlation of the event to the used device cannot be ruled out, this event meets us fda reporting criteria under 21 cfr 803 with a classification of a ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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

This complaint is from a literature source.Title: in-stent stenosis after stenting the pulserider for a middle cerebral artery aneurysm: a case report.Authority: sakata m, tajima y, kubota m, iwadate y.In-stent stenosis after stenting the pulserider for a middle cerebral artery aneurysm: a case report.Radiol case rep.2023 jul 22;18(10):3453-3456.Doi: 10.1016/j.Radcr.2023.07.010.Pmid: 37502481; pmcid: pmc10369375.The 40-year-old female patient with an unruptured aneurysm in the middle cerebral artery underwent a sttent-assisted coil embolization with pulsed rider and prowler select was performed to treat an unruptured aneurysm in the bifurcation of the left middle cerebral artery m2.Patients received dual antiplatelet therapy with aspirin 100 mg and prasugrel 3.75 mg for 10 days before procedure.During procedure, systemic heparinization was provided.Angiography revealed an aneurysm between the superior and inferior trunks of the middle cerebral artery m2.The size measurements of the aneurysm were as follows: diameter: 5.7 mm, neck: 4.4 mm, height: 5.6 mm, dome-to-neck and aspect ratio: 1.30 and 1.27, respectively.A 6-french fubuki introducer sheath (asahi intec inc.) was placed in the left carotid artery.A prowler select plus microcatheter was placed centrally to the aneurysm.A pulserider (2.7-3.5 mm 8t) was deployed by extra.A headway17 (microvention inc.) microcatheter was crossed between the leaflets of the pulserider and placed within the aneurysm.Coil embolization of the aneurysm was performed using three embolic coils.No complications occurred during the procedure, and postoperative angiography confirmed the filling of the aneurysm with contrast medium.The patient was discharged on the third postoperative day.An angiography was performed 6 months after the procedure, which confirmed complete occlusion of the aneurysm but also showed in-stent stenosis near the inner marker of the pulserider.Aspirin was continued, and no delayed neurologic complications were reported.Patient's condition: discharged from hospital.Physician's opinion regarding the relationship between this event and the product: although pulserider is characterized by low metal volume, we believe that the marker may damage the arterial wall during pulsed rider deployment and induce intimal hyperplasia.Possible causes other than the product: in the present case, the patient was 40 years old and thus prone to intimal hyperplasia, which may have induced in-stent stenosis.In this case, careful antiplatelet therapy was necessary.¿ no further information was made available at the time of this review.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18135084
• MDR Text Key: 328109957
• Report Number: 3008114965-2023-00836
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• 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
• Treatment: 6FR FUBUKI INTRODUCER SHEATH (ASAHI INTECC); HEADWAY® 17 MICROCATHETER (MICROVENTION); MICROCATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female