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

Model Number 201-D

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

Patient Problem Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Date of event: the date of the event is not known.The expiration date of the device is not known as the device lot number is not available / not reported.Initial reporter the name, phone and email address of the initial reporter are not available / reported.Initial reporter address line 2: (b)(6).The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that a patient underwent an endovascular embolization procedure; a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / lot# unknown) was used.It was reported that the patient experienced ischemia.The location of the target lesion is unknown.It was also not known if a continuous flush was maintained.It was documented in the event description of the complaint, ¿confirmed by materials of the complaint pulse rider which was requested to physician.¿ limited information was available at the time of the complaint initiation.Based on complaint information, the device is not available to be returned for analysis.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 ischemia is a known potential procedural complication associated with the pulserider anrd.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.Since the relationship of the device to the reported event cannot be clearly established, the event does meet mdr reporting criteria with the classification of ¿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 healthcare professional reported that a patient underwent an endovascular embolization procedure; a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / lot# unknown) was used.It was reported that the patient experienced ischemia.The location of the target lesion is unknown.It was also not known if a continuous flush was maintained.It was documented in the event description of the complaint, ¿confirmed by materials of the complaint pulse rider which was requested to physician.¿ limited information was available at the time of the complaint initiation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 28-feb-2023.[additional information]: on 28-feb-2023, additional information was received.It was noted that this complaint contained materials that were provided by the surgeon as promotional materials, thus, making further additional research difficult.The information indicated that the lot number of the pulserider and cannot be confirmed as the complaint was ¿obtained by someone other than the sales representative.¿ the information indicated that the statement ¿confirmed by materials of the complaint pulse rider which was requested to physician.¿ meant that ¿this complaint was contained in materials provided by the surgeon for the promotional materials.¿ e.1: initial reporter phone: 0562-93-2111.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, 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): 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: 16131849
• MDR Text Key: 307015112
• Report Number: 3008114965-2023-00023
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• 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
• Patient Outcome(s): Life Threatening