MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problem Failure to Advance (2524)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, and weight were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7345836.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 product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.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 device; 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 is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00338, and 3008114965-2024-00339.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 an angioplasty procedure, after balloon dilation of the target site, it became restenosed.The physician intended to implant the stent, a 4mm x 23mm enterprise 2 (encr402312 / 7345836) via a 150cm x 5cm prowler select plus microcatheter (606s255x / 31028210), but the stent was impeded at the distal end of the microcatheter and could not pass through.The physician removed the stent and the microcatheter from the patient and replaced the microcatheter with another 150cm x 5cm prowler select plus microcatheter (606s255x / 31028210) to deliver the same stent; the same issue occurred.The physician removed the stent and the second microcatheter and delivered the stent into the second microcatheter in vitro; the stent still could not pass through the tip of the microcatheter.The physician completed the procedure with balloon dilation.The procedure was prolonged by approximately 40 minutes.The patient was admitted to the intensive care unit (icu) after the procedure.A short video of the procedure image was included in the complaint.The video will undergo independent physician review.On 27-mar-2024, additional information was received.Per the information, the target was the v4 segment of the vertebral artery.The balloon catheter used was a competitor brand.A clarification was received related to the statement ¿lesion site began to deflate,¿ indicating that the vessel became stenotic again after balloon dilation.Adequate continuous flush was maintained through the microcatheter; flush was maintained when the stent wad delivered into the second microcatheter in vitro.There was no damage to the stent / stent delivery system.There were no damage (i.E., kink) identified on the microcatheters.The information confirmed that the stent and the two microcatheters were not replaced; the procedure was completed via balloon dilation with the original balloon catheter.The information confirmed there was no negative patient impact.The reason for the patient being admitted to the icu post-procedure was ¿routine to icu monitoring treatment after general anesthesia.¿ the patient is still in the icu with a light coma.The physician did not consider the 40-minute procedure delay to be clinically significant.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the medical review of the mp4 video clip completed on 16-may-2024.The mp4 video clip of the procedure included in the complaint underwent independent physician review.The assessment is documented below.¿the description of the case details the treatment of an intracranial stenosis.The stent (enterprise) did not exit the microcatheter (prowler) which can be a failure of either device or a result of the anatomy/pathology.If the exit route of the device was at an angle, or if the microcatheter was clogged with stenotic material, this could explain the findings.The possibility of a mechanical failure of either device can only be excluded by investigating the devices upon returning.The footage provided doesn¿t give additional information leading to a clear cause.¿ review: (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: ENTERPRISE2 4MMX23MM
• 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: 19045193
• MDR Text Key: 340121054
• Report Number: 3008114965-2024-00337
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 7345836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: BALLOON GUIDE CATHETER (UNSPECIFIED BRAND); PROWLER SELECT PLUS 150/5CM; PROWLER SELECT PLUS 150/5CM
• Patient Age: 82 YR
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian