MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X28MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452812

Device Problem Material Separation (1562)

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

Event Date 06/25/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.E.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7469238.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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.

Event Description

The healthcare professional reported that during a stent-assisted coil embolization procedure in the patient suffering from a middle cerebral artery (mca) aneurysm, the physician released the complaint device, a 4.5mm x 28mm enterprise vascular reconstruction device (vrd) (enc452812 / 7469238) and withdrew the delivery system.It was observed that the delivery wire was fractured and a portion of the delivery wire (from the proximal radiopaque area to the distal tip of the delivery wire) remained in the patient¿s body.It was reported that ¿then the physician completed the surgery.¿ the patient was reported to be in stable condition.There was no report of any negative patient impact.The complaint included three (3) procedure images that are pending independent physician review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 18-jul-2023.[additional information]: on 18-jul-2023, additional information was received.The information indicated that the target was a ruptured aneurysm.There were no vessel factors that may have contributed to the issue encountered when the physician withdrew the delivery system.The microcatheter used was a prowler select plus (catalog/lot# unknown).Continuous flush was maintained through the microcatheter during the procedure.The information indicated that the physician tried to use a microwire to retrieve the partially fractured delivery system but was not successful.¿physician tried to use microwire to retrieve the partially fractured delivery wire but failed.Then physician completed the surgery.¿ information related to whether there was any negative patient impact as a result of the reported issue could not be obtained.There had been no resistance during the advancement of the stent through the microcatheter.It was indicated that the stent had been retracted / recaptured once prior to the physician releasing and then withdrawing the delivery system.It was unknown if the delivery wire was reshaped prior to use.There was no evidence of obstructed blood flow due to the reported event.The reported event did not result in the prolongation of the patient¿s hospitalization.The patient was reportedly discharged.There was no clinically significant delay in the procedure as a result of the reported event.Per the additional information received on 18-jul-2023, the event required an additional surgical intervention since the physician attempted to retrieve the fractured wire remaining in the patient using a microwire.Therefore, this event meets us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ this file will be reassessed if new information becomes available.Updated sections: b.4, e.1, e.3, g.3, g.6, h.1, h.2, h.6, h.10, and concomitant products.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 completed review of the three procedure images that were included in the complaint file.The procedure images included in the complaint underwent independent physician review.The assessment is documented below.¿the event description is clear.The stent is visible in the images and so is the apparent detachment of the pusher wire.The cause of the disconnection/breakage cannot be deducted from the images.Additional analysis of the proximal wire that was removed may render more clarity.¿ physician name and date reviewed: (b)(6) 2023.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: EU 4.5X28MM STENT 12 MM DW TIP
• 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.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17329016
• MDR Text Key: 319124187
• Report Number: 3008114965-2023-00442
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• 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,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452812
• Device Lot Number: 7469238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• 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.