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

Catalog Number 201D

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported by the field, this was a stent assisted coil embolization using a pulserider t, 3mm, 8mm arch ( 201d), to treat a basilar artery aneurysm.The pulserider was deployed at the target lesion, and the aneurysm was completely embolized with 10 coils.(product name unknown).The pulserider was attempted to be detached using the pulserider's detachment system and confirmed that the detachment system indicated that the implant had been detached.Then the microcatheter was advanced, and the microcatheter re-sheathed the proximal marker on one leg of the implant.Also, when the pulserider delivery wire was pulled, the implant moved slightly.Replaced the detachment system with another new one and performed detachment process again, the detachment system indicated a sign that detachment was complete, and the detachment process was interrupted.The pulserider had been detached by repeated pushing and pulling of the delivery wire just enough to keep the pulserider implant in place.The procedure was completed without complications to the patient.There were no complications to the patient.It is unknown if a continuous flush was performed.The physician commented that such incomplete implant detachment was very rare, but if the incomplete detachment was not noticed, there was a risk that the already implanted coil would protrude into the parent vessel and cause thromboembolism.The reason for the incomplete detachment in this procedure was unknown.Additional event information received on (b)(6) 2024, confirmed that there was no migration of the device.There was no delay clinically significant.

Manufacturer Narrative

Product complaint # : (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section b3: date of event: the date of the event was not reported.D.4: the product lot number is not available/ not reported.The expiration date of the device is not known.Section e1: initial reporter: the customer contact information, including name and occupation was not reported.H.4: the device manufacture date is not known as the device lot number is not available not reported.The device remains implanted & therefore, is not available for analysis.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Per the pulserider instructions for use (ifu): do not fully deploy and retrieve the implant more than 3 times.Excessive deployment cycles of the anchor section of the pulserider may reduce the radial force of the device which could impact the implant stability.Increased detachment time may occur when the delivery wire and microcatheter markers are not properly positioned, there is improper setup of continuous flush, embolic coils are present, or connections between detachment power supply and delivery wire or patien¿s groin (return electrode) are poor.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 followup report will be filed as appropriate.

• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18606196
• MDR Text Key: 334850770
• Report Number: 3008114965-2024-00150
• 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: Other
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• 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: EMBOLIC COILS (UNSPECIFIED BRAND); MICROCATHETER (UNSPECIFIED BRAND); PULSERIDER'S DETACHMENT SYSTEM
• Patient Age: 50 YR
• Patient Sex: Male