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 Restenosis (4576)

Event Type  Injury  

Event Description

It was reported through a personal interaction that a patient of unknown age and sex (no demographic information was provided) underwent a stent-assisted endovascular coil embolization of a middle cerebral artery (mca), aneurysm with a 3mm 8mm arch pulserider t (201d/unknown lot).It was stated, that the coil embolization was completed without problems.It was further mentioned that ¿the patient has been under monitored and stenosis at the mca was confirmed¿.It was referred that ¿post-procedure, there were no symptoms, and the patient has been stable¿.Continuous flush was done.A concomitant device mentioned was a prowler select plus microcatheter.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.The product lot number was not reported.The implantation date was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted.If new facts arise, which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).Section b5: additional information received on 16-may-2023.Summary of additional information provided: it was stated that ¿the event occurred after the procedure/during the follow up, the exact date was unknown.¿ attempts were made to obtain pulserider device lot number and details on the prowler select plus microcatheter, but this information has not been provided by the physician.It is currently unknown what factors might have contributed to the event or how the event was treated.Patient baseline neurological status is unknown.No symptoms were observed on the patient after the event.It was further indicated that the event didn¿t result in a stroke or thrombotic event.It was reiterated that there were no alleged product malfunctions with the pulserider or with the prowler select plus microcatheter.Complaint conclusion: it was reported through a personal interaction that a patient of unknown age and sex (no demographic information was provided) underwent a stent-assisted endovascular coil embolization of a middle cerebral artery (mca) aneurysm with a 3mm 8mm arch pulserider t (201d/unknown lot).It was stated that the coil embolization was completed without problems.It was further mentioned that ¿the patient has been under monitored and stenosis at the mca was confirmed¿.It was referred that ¿post-procedure, there were no symptoms, and the patient has been stable¿.Continuous flush was done.A concomitant device mentioned was a prowler select plus microcatheter.Additional information received on 16-may-2023.Summary of additional information provided: it was stated that ¿the event occurred after the procedure / during the follow up, the exact date was unknown.¿ attempts were made to obtain pulserider device lot number and details on the prowler select plus microcatheter, but this information has not been provided by the physician.It is currently unknown what factors might have contributed to the event or how the event was treated.Patient baseline neurological status is unknown.No symptoms were observed on the patient after the event.It was further indicated that the event didn¿t result in a stroke or thrombotic event.It was reiterated that there were no alleged product malfunctions with the pulserider or with the prowler select plus microcatheter.The device remains implanted; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Stenosis of stented segment is a well-known potential adverse event following stent implantation and is listed in the pulserider instructions for use (ifu) as such.Experience with stent implants indicates that there is a risk of stenosis.Patient, procedural, and pharmacological factors may have contributed, however, based on the available information, no conclusion can be made regarding the reported event.Since the severity of the stenosis is not clear and it seems to have occur peri-procedural use of the device, the relationship of the pulserider to the reported event cannot be excluded.Therefore, this event is usfda reportable under 21 cfr 803 with a 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 to identify statistical signals for consideration of further correction action.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.

• 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 ; 3035526892
• MDR Report Key: 16618817
• MDR Text Key: 312286701
• Report Number: 3008114965-2023-00198
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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: 05/17/2023
• 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: PROWLER SELECT PLUS MICROCATHETER
• Patient Outcome(s): Life Threatening