MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402300

Device Problem Activation Failure (3270)

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

Event Date 03/22/2024

Event Type  Injury  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, when the physician started to release the 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300 / 8314212), three (3) distal markers of the stent were converged and could not expand as intended.The physician released the stent and used micro delivery wire to massage the distal markers, but the markers still did not open.It was reported the procedure was prolonged by approximately 40 minutes.There was no report of any negative patient impact.On 27-mar-2024, additional information was received.Per the information, the target vessel was the internal carotid artery (ica).The location of the aneurysm being treated during the procedure was on the ocular segment of the ica.The aneurysm was a wide necked unruptured aneurysm.There were no vessel nor aneurysm factors that may have contributed to the incomplete expansion of the stent.The information indicated that there was evidence of obstructed blood flow due to the reported incomplete expansion of the stent, the distal end converges resulting in poor blood flow.The temperature indicator label on the inner pouch had been checked and confirmed to be within acceptable criteria.The concomitant microcatheter used was a prowler select plus microcatheter; there was no resistance during the advancement of the stent.The same microcatheter was used to complete the procedure.Per the information, the stent was not replaced, it was implanted.The procedure was completed with the remedial process which used a microwire to massage the stent.The information indicated that there was no negative patient consequence as a result of the reported issue; the physician did consider the 40-minute procedure extension to be clinically significant.The 40 minutes was used to ¿make to make the stent expand more completely.¿.

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 remains implanted and is thus not available for evaluation.(b)(4) performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8314212.The history record indicates this product was final inspection tested at (b)(4) 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.The incomplete expansion of the enterprise2 stent could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.In this case, the event required the surgical intervention/remedial process of using a microwire to ¿massage the stent.¿ additionally, the event resulted in a 40-minute surgery prolongation, which the treating physician felt was clinically significant and presented high risk to the patient.Due to the surgical intervention required to preclude patient harm and the clinically significant 40-minute surgery prolongation, this event meets us fda reporting criteria under 21 crf 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.

• Brand Name: ENTERPRISE2 4MMX23MM NO 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: 19047697
• MDR Text Key: 339434358
• Report Number: 3008114965-2024-00342
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402300
• Device Lot Number: 8314212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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: MICRO GUIDEWIRE (UNSPECIFIED BRAND); PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Required Intervention