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

Model Number 201-D

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Aneurysm (1708)

Event Date 09/26/2022

Event Type  Injury  

Event 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 3053092710).Coil embolization was after performed (unknow number and device details).It was mentioned that one wing of the pulserider was successfully placed at the cerebral artery.Coil mass was maintained, and the procedure completed.There was no abnormality on the devices.Reported aneurysm dimensions were: diameter (height) 9.5, aneurysm diameter (largest diameter) 10.2mm, aneurysm diameter (dome width) 7.5mm, aneurysm neck diameter 5.2mm, dome/neck ratio 1.4.Parental vessel diameter was 3.2mm.It is unknown if continuous flush was done.Details on concomitant devices are unknown.On (b)(6) 2022 the patient experienced an aneurysm recurrence due to coil compaction within the aneurysm.It was mentioned ¿embolic coil migration/extrusion/ insufficient embolism occurred.There was no patient injury.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3053092710 number, and no non-conformances related to the malfunction were identified.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.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, g3, g6, h2 and h10.Section b5: additional information was received on 05-jan-2023.Summary of additional information provided: the following cerenovus coils were implanted during the initial aneurysm treatment, a 7 mm x 21 cm galaxy g3 coil (gly120721), two 5 mm x 10 cm galaxy g3 coils (gly120510), two 4 mm x 8 cm galaxy g3 xsft coils (glx120408), four galaxy g3 coils size 3 mm x 6 cm (gly120306) and one 2 mm x 3 cm galaxy g3 mini coil (glm920030).No further information is available as to what coil compacted.At the time of the procedure, the physician felt that the aneurysm was adequately treated.The patient was not symptomatic as a result of recanalization.No follow-up interventions are required.Section e1.Initial reporter phone:(b)(6).Complaint conclusion: 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 3053092710).Coil embolization was performed (unknown number and device details).It was mentioned that one wing of the pulserider was successfully placed at the cerebral artery.Coil mass was maintained, and the procedure was completed.There was no abnormality on the devices.Reported aneurysm dimensions were diameter (height) 9.5, aneurysm diameter (largest diameter) 10.2mm, aneurysm diameter (dome width) 7.5mm, aneurysm neck diameter 5.2mm, dome/neck ratio 1.4.The parental vessel diameter was 3.2mm.It is unknown if a continuous flush was done.Details on concomitant devices are unknown.On (b)(6) 2022 the patient experienced an aneurysm recurrence due to coil compaction within the aneurysm.It was mentioned ¿embolic coil igration/extrusion/ insufficient embolism occurred.There was no patient injury.Additional information received indicated that the following cerenovus coils were implanted during the initial aneurysm treatment, a 7 mm x 21 cm galaxy g3 coil (gly120721), two 5 mm x 10 cm galaxy g3 coils (gly120510), two 4 mm x 8 cm galaxy g3 xsft coils (glx120408), four galaxy g3 coils size 3 mm x 6 cm (gly120306) and one 2 mm x 3 cm galaxy g3 mini coil (glm920030).No further information is available as to what coil compacted.At the time of the procedure, the physician felt that the aneurysm was adequately treated.The patient was not symptomatic as a result of recanalization.No follow-up interventions are required.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.Aneurysm recanalization 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.Furthermore, the relationship of the pulserider anrd to the reported event cannot be excluded.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 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of eleven products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00782, 3008114965-2023-00029, 3008114965-2023-00030, 3008114965-2023-00031, 3008114965-2023-00032, 3008114965-2023-00033, 3008114965-2023-00034, 3008114965-2023-00035, 3008114965-2023-00036, 3008114965-2023-00037 and 3008114965-2023-00038.

• 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: 15876696
• MDR Text Key: 304425575
• Report Number: 3008114965-2022-00782
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3053092710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: GALAXY G3 3MM X 6CM; GALAXY G3 3MM X 6CM; GALAXY G3 3MM X 6CM; GALAXY G3 5MM X 10CM; GALAXY G3 5MM X 10CM; GALAXY G3 7MM X 21CM; GALAXY G3 MINI 2MM X 3CM; GALAXY G3 MINI 2MM X 3CM; GALAXY G3 XSFT 4MM X 8CM; GALAXY G3 XSFT 4MM X 8CM; UNKNOWN COILS
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR