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

Catalog Number ENCR403912

Device Problem Activation Failure (3270)

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

Event Date 11/13/2023

Event Type  malfunction  

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.Section e.1: initial reporter facility: (b)(6) school.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device 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 7660536.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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 endovascular embolization procedure, the complaint stent, a 4 mm x 39 mm enterprise®2 stent (encr403912 / 7660536) was placed in the target site and an attempt to release the stent was made.The two distal markers on the stent did not fully open or expand as intended.The physician retracted the stent and switched to a new stent to complete the procedure using the original concomitant microcatheter (unspecified brand).There was no report of any negative patient impact.On 20-nov-2023, additional information was received.Per the information, the target was an unruptured aneurysm.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.There was no evidence of obstructed blood flow due to the reported issue.The microcatheter used was a prowler select plus microcatheter.The replacement stent was not another 4 mm x 39 mm enterprise®2 stent (encr403912).The additional information also confirmed there was no negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 13-dec-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 report the investigation finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4 mm x 39 mm enterprise®2 stent was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the stent was already detached from the unit and this was not returned to the laboratory for inspection.Only the delivery wire was returned and no damages were noted on it.The delivery wire was inspected under the microscope.It was observed in good condition, there was no structural damage (i.E., no elongations, kinks, nor non-concentric loops were noted) only residues of dried blood were noted on the distal portion of the wire.The reported issue documented in the complaint regarding the stent not being able to open or expand was not able to be evaluated since the stent was not returned for inspection.With the limited information available, the root cause of the reported failure remains inconclusive; however, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.The detached condition of the stent was not originally reported in the complaint and is considered secondary to the manipulation required during the stent removal.It is suggested that the stent may have gotten lost during the post-operative handling.This finding is not a contributing factor to the stent's inability to open experienced during the procedure.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7660536.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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: maintain adequate stent length (approximately 5mm) on each side of the aneurysm neck to ensure appropriate neck coverage.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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 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: 18207787
• MDR Text Key: 328968267
• Report Number: 3008114965-2023-00846
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403912
• Device Lot Number: 7660536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/26/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 01/04/2024
• Supplement Dates FDA Received: 12/13/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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