MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF401600

Device Problem Premature Activation (1484)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, during a stent assist coil embolization, an enterprise2 4mmx16mm no tip intracranial stent was pre-maturely deployed in a prowler select plus microcatheter (product/lot unknown).The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization, an enterprise2 4mmx16mm no tip intracranial stent was pre-maturely deployed in a prowler select plus microcatheter (product/lot unknow).The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.A non-sterile enterprise2 4mmx16mm no tip was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that only the delivery wire and the introducer were returned for evaluation.These were found in good condition (i.E., no kinks, fractures, or separations).The received components were inspected under magnification, and no structural damages were found.Even though the stent was not returned for evaluation, it was noted that was already released from the unit, and based on this condition, the customer complaint regarding a premature detachment of the stent in the microcatheter was confirmed.However, the exact contributing factors to this failure cannot be identified without the stent.It is suggested that the stent remains inside of the involved microcatheter since the event states that it got prematurely detached inside of it; since the microcatheter was not returned for evaluation this remains only speculative and no further investigation can be conducted.At this time, there is no indication that the reported complaint issue results from a defect inherently related to the device.(b)(6) medical reviewed the device history records relative to the manufacturing, inspection, and packaging of lot 6272788.The historical 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) do contain the following recommendations: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.Confirm the tip of the delivery wire is entirely within the introducer.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX16MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15728285
• MDR Text Key: 306995638
• Report Number: 3008114965-2022-00717
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: 10886704075349
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: ENF401600
• Device Catalogue Number: ENF401600
• Device Lot Number: 6272788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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 MICROCATHETER