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

Model Number	201-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	11/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter phone: (b)(6).The device remains implanted, therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3076329114 number, and no non-conformances related to the malfunction were identified.Infarction is a known potential complication associated with the use of the pulserider anrd and is listed in the instructions for use (ifu) as such.If the anrd does not hold the embolic coils within the aneurysm sack, there could be thrombosis formation, which could lead to cerebral ischemia.Since the relationship between the pulserider anrd and the reported event cannot be excluded, specially taken into consideration the timeline between the procedure and the reported adverse event, the event will be conservatively reported to the fda 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.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.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.
Event or Problem Description
It was reported via post market studies that on (b)(6) 2022 a patient underwent endovascular embolization of an unruptured aneurysm on the right middle cerebral artery (mca) using a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3076329114).Coil embolization was performed after (unknown number and device details).It was mentioned that the pulserider was successfully implanted in the intracranial aneurysm.Coil mass was maintained, and the procedure completed.There was no abnormality on the devices.Reported aneurysm dimensions were: diameter (height) 5.6mm, aneurysm diameter (maximum diameter) 7.7mm, aneurysm diameter (dome width) 6.5mm, aneurysm neck diameter 7mm, dome/neck ratio 0.9.Parental vessel diameter was 2.8mm.The concomitant device used was a phenom (medtronic) microcatheter.It is unknown if continuous flush was done.On (b)(6) 2022 the patient experienced a cerebral infarction on the region of the target cerebral aneurysm and also at the contralateral side.It was mentioned that ¿a selective thrombolysis procedure was performed.Confirmed recovery of outcome¿.The physician assessed the event as non-serious and it was communicated that ¿a causal relationship with the complaint pulse rider can be denied because the physician judged this event occurred by accidental.On the other hand, a causal relationship with the procedure cannot be denied.¿.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• Common Device Name: 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: 15870542
• Report Number: 3008114965-2022-00772
• Device Sequence Number: 6707712
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H160002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3076329114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown