MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKPULSERIDER; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKPULSERIDER

Device Problems Patient-Device Incompatibility (2682); Lack of Effect (4065)

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

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e.1: initial reporter phone: (b)(6).The initial reporter email address is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device was 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.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 during a coil embolization of a middle cerebral artery (mca) aneurysm using the pulserider aneurysm neck reconstruction device (anrd), after inserting the prowler select plus microcatheter (catalog / lot# unknown), a 2.7 to 3.5 mm, 10 mm, t shape pulserider anrd (211d / 3075677414) was used.It was reported that ¿as the angle was not correct, the pulserider was repeatedly pulled back into the [microcatheter] and the torquer was turned, but the angle did not change at all.After many attempts to change the angle, the angel did not change at all, so the pulserider was determined to be malfunctioned.¿ it was replaced with another pulserider device, an 8t pulserider (catalog / lot# unknown), which could be deployed, ¿but the coil could not be supported at all, so all devices were retrieved, and the procedure was terminated.¿ it was reported that continuous flush was maintained during the procedure.There was no negative patient impact reported.On 07-aug-2023, additional information was received.The information indicated that the prowler select plus microcatheter was used with both pulserider devices.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 13-sep-2023.This report also includes a correction to the medical device problem code.[additional information]: on 13-sep-2023, limited additional information was received.The information indicated that the endovascular procedure was terminated.Craniotomy was scheduled at a later date (not specified).No other information is available.Updated sections: b.4, g.3, g.6, h.2, h.6, h.10, and h.11.Corrected section: h.6.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.The medical device problem code was incorrectly reported as ¿patient-device incompatibility (a0101)¿ in the 3500a initial report.The correct medical device problem code is ¿lack of effect (a0105).¿.

• Brand Name: UNKPULSERIDER
• 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 ; 303552-689
• MDR Report Key: 17544434
• MDR Text Key: 321945971
• Report Number: 3008114965-2023-00539
• Device Sequence Number: 1
• Product Code: NJE
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKPULSERIDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• 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: MICROCATHETER