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

Model Number	ENF403912
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).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: 6678684.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 4.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 or Problem Description
The healthcare professional reported that during the procedure, when a 4.0mm dia x 39mm enterprise® 2 stent (enf403912 / 6678684) was 50% deployed and the physician attempted to retrieve the stent, the retrieval was not successful.The physician felt strong resistance during the retrieval of the stent into the prowler select plus microcatheter.The physician removed all devices from the patient¿s body and used a ¿same-like¿ product.The procedure was successfully completed.There was no report of any negative impact to the patient.
Additional 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 20-oct-2022.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the procedure, when a 4.0mm dia x 39mm enterprise® 2 stent (enf403912 / 6678684) was 50% deployed and the physician attempted to retrieve the stent, the retrieval was not successful.The physician felt strong resistance during the retrieval of the stent into the prowler select plus microcatheter.The physician removed all devices from the patient¿s body and used a ¿same-like¿ product.The procedure was successfully completed.There was no report of any negative impact to the patient.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this complaint file will be updated accordingly.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.0mm dia x 39mm enterprise® 2 stent was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.All components were received in good condition.A microscopic inspection was performed.The delivery wire was inspected along its entire length.No damages were observed.The stent component was still inside the introducer.Functional test was performed.A lab sample prowler select plus microcatheter was flushed using a lab sample syringe.After flushing, the 4.0mm dia x 39mm enterprise® 2 stent was introduced into the prowler select plus microcatheter.The stent component exited out from the distal tip of the microcatheter; when 50% of the stent was outside, it was retrieved back inside the microcatheter without any resistance / friction felt.The functional test was performed without issues, the strong resistance reported during the stent retrieval into the prowler select plus microcatheter could not be confirmed.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.It is possible that a continuous flush had not been done; without an adequate flush, issues such as resistance between the stent and the microcatheter can arise; however, this cannot be conclusively determined.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the laboratory setting.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6678684.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: ¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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.Updated sections: b.4, g.3, g.6.H.2, h.3, 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.

• Brand Name: ENTERPRISE2 4MMX39MM
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15547688
• Report Number: 3008114965-2022-00619
• Device Sequence Number: 1919304
• Product Code: NJE
• UDI-Device Identifier: 10886704075394
• UDI-Public: 10886704075394
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Model Number: ENF403912
• Device Catalogue Number: ENF403912
• Device Lot Number: 6678684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 10/31/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/20/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER.
• Patient Sex: Unknown