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 04/18/2022

Event Type  Injury  

Event Description

The event was reported via a post-market study (pms); on (b)(6) 2021, a 57-year-old patient underwent a pulserider-assisted endovascular embolization procedure to treat an unruptured middle cerebral artery (mca) aneurysm with the following dimensions: height 8.9mm, maximum aneurysm diameter 9.5mm, dome width 9.2mm, neck diameter 4.5mm, dome to neck ratio 2.The parent vessel diameter was 3.1mm, the (2) branching vessel diameter was 2.9mm and (3) branching vessel diameter was 2.1mm.A pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 30480552) was successfully implanted at the target position in a partial intraaneurysmal position with one ¿wing¿ inside the aneurysm.The coil mass was successfully maintained and the procedure was completed.There was no product malfunction reported.On 18-apr-2022, it was reported that a ¿migration/deviation/insufficient embolization of embolic coils occurred.Coil compaction increased aneurysmal blood flow.¿ there was no report of any negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30480552) 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.Coil migration or compaction are known potential adverse events associated stent-assisted endovascular coil embolization with the use of the pulserider anrd in the intracranial arteries and are listed in the ifu as such.Aneurysm recanalization is a condition potentially requiring additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization.Currently there is no medical evidence to indicate that the reported event was related to the pulserider aneurysm neck reconstruction device.There was no alleged device defect or quality issue reported during the procedure.However, with the information presently available we cannot exclude that the pulserider anrd failed to maintain the coils within the confines of the target aneurysm which could ultimately have led to the aneurysm recanalization.Since the actual severity of the event is not clear from the information provided, and the relationship of the pulserider to the reported event cannot be excluded, 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.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).[additional information]: on 08-mar-2023, limited responses to additional information request as related to this adverse event was received.The information indicated that there is no specific study name for this post-market study (pms), ¿because this is for good post-marketing study practice, which is regulatory requirement of shonin process.¿ the correct size of the pulserider device was selected based on the instructions for use (ifu).The physician name address and phone number was provided.E1: initial reporter phone: (b)(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.

• 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 ; 303552-689
• MDR Report Key: 16419035
• MDR Text Key: 310000630
• Report Number: 3008114965-2023-00116
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 30480552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR