MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X37MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problems Retraction Problem (1536); Activation Failure (3270); Migration (4003)

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

Event Date 07/12/2023

Event Type  Injury  

Event Description

The healthcare professional reported that during a stent-assisted aneurysm embolization procedure, the physician released a 4.5mm x 37mm enterprise® vascular reconstruction device (enc453712 / 7412878) in the target position and found that two (2) proximal markers on the stent did not open as intended after deployment.The physician retracted the delivery wire and suddenly encountered resistance; the physician then withdrew the delivery system.It was found that the position of the stent had migrated which resulted in the proximal section of the stent just covering the aneurysm neck.The physician implanted a second stent (competitor brand) inside the first stent to complete the procedure.There was no report of any negative impact to the patient.On 25-jul-2023, additional information was received.The target aneurysm was a 4mm x 2.7mm unruptured regular aneurysm.There were no vessel nor aneurysm factors that may have contributed to the incomplete expansion.There was no evidence of any obstructed blood flow due to the reported event.The temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.The concomitant microcatheter used was a 150cm x 5cm prowler select plus microcatheter (606s255x / 30909766).Adequate continuous flush was maintained through the microcatheter.There was no resistance during the advancement of the stent; the same microcatheter was used to deliver the second stent.There was no allegation of patient injury / negative patient impact as a result of the reported issue.There was no clinically significant delay in the procedure due to the reported issue.

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 was 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: 7412878.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 documented in the complaint cannot be confirmed through functional evaluation and product 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 sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.Incomplete stent expansion and stent migration are known complications associated with the enterprise vascular reconstruction device and are listed in the instructions for use (ifu) as such.However, in this case, the additional surgical intervention of a second stent placement was required to fully cover the target lesion and preclude patient injury.Thus, the event is considered us fda reportable under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.

• Brand Name: EU 4.5X37MM 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: 17431332
• MDR Text Key: 320119070
• Report Number: 3008114965-2023-00515
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC453712
• Device Lot Number: 7412878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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: PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Required Intervention