MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 211-D

Device Problem Separation Failure (2547)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an unruptured aneurysm at the basilar tip, the complaint device, a pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3075677410) was prepped as per the instructions for use (ifu).The pulserider anrd was deployed and implanted outside the aneurysm.A prowler select plus microcatheter (catalog/lot# unknown) was delivered to the aneurysm via trans-cell technique.Coil embolization was initiated and eleven (11) coils were implanted.The microcatheter used for the coil embolization was removed.Attempt to detach the pulserider as per the ifu was made.The green light flashed during the first detachment cycle.The red light flashed during the second detachment cycle.The microcatheter was delivered to the leg, but the microcatheter moved toward one leg marker part.The physician thought that one side had not been detached.The microcatheter went down to the detachment marker to attempt detachment but the detachment marker of the pulserider anrd delivery wire also went down.At this point, the physician thought that the pulserider anrd was detached and withdrew the remainder of the pulserider anrd and the procedure was reported to be completed.There was no report of any patient adverse event.On 05-dec-2022, the cerenovus sales representative provided the lot number 3075677410 for the complaint pulserider anrd.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Initial reporter name and address: initial reporter facility name: (b)(6).The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an unruptured aneurysm at the basilar tip, the complaint device, a pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3075677410) was prepped as per the instructions for use (ifu).The pulserider anrd was deployed and implanted outside the aneurysm.A prowler select plus microcatheter (catalog/lot# unknown) was delivered to the aneurysm via trans-cell technique.Coil embolization was initiated and eleven (11) coils were implanted.The microcatheter used for the coil embolization was removed.Attempt to detach the pulserider as per the ifu was made.The green light flashed during the first detachment cycle.The red light flashed during the second detachment cycle.The microcatheter was delivered to the leg, but the microcatheter moved toward one leg marker part.The physician thought that one side had not been detached.The microcatheter went down to the detachment marker to attempt detachment but the detachment marker of the pulserider anrd delivery wire also went down.At this point, the physician thought that the pulserider anrd was detached and withdrew the remainder of the pulserider anrd and the procedure was reported to be completed.There was no report of any patient adverse event.On 05-dec-2022, the cerenovus sales representative provided the lot number 3075677410 for the complaint pulserider anrd.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (3075677410) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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 in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on (b)(6) 2022.[additional information]: on (b)(6) 2022, additional information was received.The information confirmed the lot number of the pulserider anrd was 3075677410.The prowler select plus microcatheter (catalog / lot# unknown) was used to deliver the pulserider anrd.The physician did not suspect any involvement related to the prowler select plus microcatheter.The information indicated that the complaint pulserider anrd was detached and successfully implanted at the end.There was no blood flow restriction / reduction as a result of the reported issue.There was no allegation of patient injury, prolongation of patient¿s hospitalization.The reported issue did not result in any clinically significant delay in the procedure.E.1: initial reporter phone: (b)(6).Updated sections: b.4, d.6.A., e.1, e.3, g.3, g.6, h.2, h.6, and h.10.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.

• Brand Name: PULSERIDER T, 3MM, 10MM 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 ; 303552-689
• MDR Report Key: 15983234
• MDR Text Key: 306454865
• Report Number: 3008114965-2022-00800
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 00859030005130
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 211-D
• Device Catalogue Number: 211D
• Device Lot Number: 3075677410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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