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

Catalog Number ENC402300

Device Problem Defective Device (2588)

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

Event Date 07/01/2023

Event Type  Injury  

Event Description

The healthcare professional reported that in an intracranial atherosclerotic disease (icad) stenting procedure, during the vascular stent placement, the physician deployed the complaint stent, a 4.0mm x 23mm no distal tip enterprise® 2 vascular reconstruction device (vrd) (enc402300 / 7057094) in the patient, after deployment, the physician found that the stent had foreshortened to 14.5mm.The physician deployed a second enterprise stent, a 4mm x 30mm enterprise stent and successfully completed the procedure.There was no report of any negative patient impact or complication.A procedure image was included in the complaint.The one (1) procedure image is pending independent physician review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, age, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone and email address are not available / reported.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 7057094.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Per the instructions for use (ifu), the enterprise 4mmx23mm no tip stent may foreshorten by 7.7% or 2.0mm, resulting in an expected total length of 21.0mm.Per the event description, the stent foreshortened to a length of 14.5mm.The adverse event of ¿incorrect stent length: too short¿ could potentially result in patient harm due to treatment failure or prolonged surgery.In this case, the event required the additional surgical intervention of placing a second stent to the target location.Therefore, this event meets us fda reporting criteria under 21 cfr 803.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.

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 01-sep-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 include the completed review of the one procedure image that was included in the complaint file.The procedure image included in the complaint underwent independent physician review.The assessment is documented below.¿the description of the case and complaint are clear.The most distal stent seems shorter than the proximal stent and the measurement done by the physician adds up to 14,5 mm instead of 23.From this 2d image (without a second plain or rotation) it cannot be assured that the measurement is the central luminal line and this non-3d rendering should be taken into account.If the measurement is indeed accurate there seems to be an under sizing of the stent compared to the listed size.¿ physician name and date reviewed:(b)(6), (b)(6) 2023.Updated sections: b.4, g.3, g.6, h.2, h.6, and h.10.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 that the product that was received in the product analysis lab is not a cerenovus product.A delivery wire component was returned to cerenovus for evaluation; however, it was confirmed that is not an enterprise delivery wire.Based on the following differences observed: 1.The tip coil of the enterprise delivery wire is welded, while the tip coil of the received sample is glued.2.Enterprise features a stent positioning marker; this was not observed on the received sample.3.Enterprise retraction bump has a tapered distal end, not square as the received sample.The actual complaint device was not returned for analysis, and product analysis cannot be conducted.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.A device history record (dhr) was performed for the reported lot number of the complaint device (7057094) and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.As part of 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 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 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.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: 17492526
• MDR Text Key: 320750595
• Report Number: 3008114965-2023-00527
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC402300
• Device Lot Number: 7057094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female