MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452800

Device Problems Activation Failure (3270); Activation Problem (4042)

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

Event Date 04/05/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted endovascular embolization procedure, the microcatheter and the complaint stent, a 4.5mm x 28mm no distal tip enterprise vascular reconstruction device (enc452800 / 6610132) were placed in the target position and the physician started to release the stent.The distal markers of the stent were unable to open.After approximately three (3) minutes, the position of the stent migrated and the stent partially deployed (only one (1) of the stent markers opened).The physician retracted the stent and replaced it to complete the procedure.The microcatheter was not replaced.There was no report of any negative patient impact.On (b)(6) 2023, per the cerenovus sales representative, the product is not available to be returned for evaluation and analysis.On 20-apr-2023, additional information was received.The information indicated that the procedure was targeting an unruptured regular aneurysm with the following dimensions: 4mm x 2.9mm on the ophthalmic artery segment.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion of the stent.There was no evidence of obstructed blood flow due to the reported issue.The microcatheter used was 150cm x 5cm prowler select plus (606s255x / 30909766).An adequate continuous flush was maintained through the microcatheter.The stent component was still on the delivery wire when it was removed from the patient.The stent / stent delivery system did not appear damaged.Nothing unusual was noted about the system prior to use.The replacement stent was another 4.5mm x 28mm no distal tip enterprise (enc452800).There was no allegation of any patient injury or negative patient impact due to the reported issue.No clinically significant delay in the procedure was reported.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity 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 6610132.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.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 make a correction to the expiration date of the device.The expiration correct device expiration date is 12-oct-2023.Corrected section d.4: expiration date.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.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.The expiration date of the device was incorrectly documented as 28-oct-2023.The correct expiration date is 12-oct-2023.

• Brand Name: EU ENT4.5MMD 28MML WNO DSTL TP
• 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 AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16781467
• MDR Text Key: 313848515
• Report Number: 3008114965-2023-00232
• 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,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Catalogue Number: ENC452800
• Device Lot Number: 6610132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: PROWLER SELECT PLUS 150/5CM