MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403912

Device Problems Fracture (1260); Premature Activation (1484); Expiration Date Error (2528)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information related to patient is not applicable as the reported issue occurred during a product presentation.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.A photo of the complaint device was included in the file.The product analysis lab reviewed the photo.The review is documented below.[photo review]: a photo was included in the complaint.The photo shows only the stent component.It was noted that the struts are separated / broken almost through the entire length of the stent body.The parylene coating was noted to be coming off the stent in multiple locations.The rest of the device components were not captured in the photo.The issue regarding a stent being damaged and detached from the unit was confirmed based on the conditions observed in the photo.The lot number was noted to have exceeded its expiration date; however, this was not reported as an issue and it cannot be evaluated based on the photo.The delivery wire fracture could not be evaluated.The device said to be involved was reported as discarded, therefore, no further investigation will be performed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 11180144.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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

It was reported that during a product presentation in fluid model, the complaint device, a 4 mm x 39 mm enterprise®2 stent (encr403912 / 11180144) was prematurely released without intention and was found to be damaged.The stent was unable to be retracted to perform the product presentation.The complaint product is not available for return; however, a photo of the stent component was included in the complaint.On 12-jun-2023, additional information was received.The information indicated that the lot number 11180144 is the correct lot number for the device used during the procedure.The damage was reported to be on the delivery wire of the stent, ¿delivery wire of the stent fractured.¿ it was reported that during the process of product presentation in fluid model, the delivery wire of the stent fractured.The microcatheter used was a 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown).Continuous flush had not been maintained through the microcatheter.

• Brand Name: ENTERPRISE2 4MMX39MM
• 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: 17109239
• MDR Text Key: 317919711
• Report Number: 3008114965-2023-00343
• 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
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: ENCR403912
• Device Lot Number: 11180144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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