MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 4MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 213-D

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

Patient Problem Ischemia Stroke (4418)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.Cerebral infarction is a known potential adverse events associated stent-assisted endovascular coil embolization with the use of the pulserider anrd in the intracranial arteries and are listed in the ifu as such.Per the information provided, the device performed as intended.There was no alleged device defect or quality issue reported during the procedure.However, the principal investigator assessed the that a causal relationship between the reported adverse event of ¿cerebral infarction¿ and the complaint device or the procedure could not be ruled out.In addition, the patient required additional medication.Therefore, this event does meet mdr reporting criteria as a ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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 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

The event was reported via a post-market study (pms), the 46-year-old patient underwent a pulserider-assisted endovascular coil embolization procedure targeting a ruptured (non-acute) aneurysm at the basilar artery (ba) bifurcation using a pulserider t shape, 10mm, 3.5 ¿ 4.5mm aneurysm neck reconstruction device (anrd) (213d / lot# unknown) on (b)(6) 2022.The dimensions of the target aneurysm are as follows: height 4.6mm, maximum aneurysm diameter 5.9mm, dome width 4.7mm, neck diameter 5.5mm, dome to neck ratio 0.9.The parent vessel diameter was 3.2mm, the (2) branching vessel diameter was 3.0mm and (3) branching vessel diameter was 2.5mm.The pulserider anrd was delivered via a prowler select plus microcatheter (catalog / lot# unknown) and successfully implanted outside the aneurysm.The coil mass was successfully maintained and the procedure was completed.It was not known if a continuous flush was maintained through the microcatheter.On the same day, it was reported that the patient suffered a cerebral infarction ipsilateral to the target aneurysm.Edaravone was administered.On 12-mar-2022, it was reported that the patient was confirmed to be recovering.The treating physician commented that, ¿the causal relationship with the complaint pulserider or the procedure cannot be ruled out.¿ the event was considered non-serious.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 08-mar-2023.[additional information]: on 08-mar-2023, limited responses to additional information request as related to this adverse event was received.The information indicated that there is no specific study name for this post-market study (pms), ¿because this is for good post-marketing study practice, which is regulatory requirement of shonin process.¿ the lot number of the pulserider is not known.Physician name address and phone number was provided.E.1: initial reporter phone: (b)(6).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.

• Brand Name: PULSERIDER T, 4MM, 10MM 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16419167
• MDR Text Key: 309998422
• Report Number: 3008114965-2023-00117
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005123
• UDI-Public: 00859030005123
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 213-D
• Device Catalogue Number: 213D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• 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: MICROCATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR