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

Model Number	201-D
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Based on complaint information, the device remains implanted and is thus not available for evaluation.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.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 or contributed 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.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 or Problem Description
The event was reported via a post-market study (pms), the 49-year-old patient underwent a pulserider-assisted endovascular coil embolization procedure to treat an unruptured aneurysm located in the middle portion of the anterior communicating artery (acoma) using a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / lot# unknown) on (b)(6) 2022.The dimensions of the target aneurysm are as follows: height 11.3mm, maximum aneurysm diameter 13.1mm, dome width 12.9mm, neck diameter 6.4mm, dome to neck ratio 2.The parent vessel diameter was 2.7mm, the (2) branching vessel diameter was 2.2mm and (3) branching vessel diameter was 1.8mm.The pulserider anrd was delivered via a prowler select plus microcatheter (catalog / lot# unknown) and successfully implanted in a hybrid orientation with one of the wings inside the aneurysm.The coil mass was successfully maintained and the procedure was completed.It was not known if a continuous flush was maintained through the microcatheter.On 31-jan-2023, a ¿migration / deviation / insufficient embolization of embolic coils occurred.¿ there was a recurrence of aneurysm due to coil compaction.There was no negative impact on the patient.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 08-mar-2023.[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 lot number of the pulserider is not known.Physician name address and phone number was provided.E.1: 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
• Common Device Name: 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 ; 303552-6892
• MDR Report Key: 16419657
• Report Number: 3008114965-2023-00119
• Device Sequence Number: 20255366
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H160002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 49 YR
• Patient Sex: Unknown