MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number	ENF403012
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that the 4.0mm dia x 30mm enterprise®2 (enf403012 / 7178222) was pre-deployed out of the dispenser.There was no report of any patient consequence.One (1) photo of the complaint stent component was included in the file.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / 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.The product analysis lab team reviewed the photo included in the complaint file.The review is documented below.[photo review]: the photo included in the complaint showed a stent component already in the detached state from the unit.One of the distal ends of the stent was observed to be not completely flared; however, no damages can be noted that may have contributed to this observation.The other distal end was observed in good condition.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot: 7178222.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The reported issue documented in the complaint that the enterprise ii stent pre-deployed out of the dispenser was confirmed based on the photo included which showed a detached stent component.This investigation was made based only on the photo provided.If when the product is received, an investigation will be performed as per the condition of the returning device.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.
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 the 4.0mm dia x 30mm enterprise®2 (enf403012 / 7178222) was pre-deployed out of the dispenser.There was no report of any patient consequence.One (1) photo of the complaint stent component was included in the file.The product analysis lab team reviewed the photo included in the complaint file.The review is documented below.[photo review]: the photo included in the complaint showed a stent component already in the detached state from the unit.One of the distal ends of the stent was observed to be not completely flared; however, no damages can be noted that may have contributed to this observation.The other distal end was observed in good condition.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7178222.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The reported issue documented in the complaint that the enterprise ii stent pre-deployed out of the dispenser was confirmed based on the photo included which showed a detached stent component.This investigation was made based only on the photo provided.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.0mm dia x 30mm enterprise®2 was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent component was already detached from the unit.This observation is consistent with the photo included in the complaint.The delivery wire and the introducer were found to be in good condition (i.E., no kinks no fractures, and no separation).The stent component was inspected under a microscope and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the distal ends were noted to be completely expanded.The reported issue documented in the complaint regarding the premature deployment of the stent was confirmed due to the detached condition of the stent; however, the exact contributing factors to this issue could not be identified.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.The distance between the delivery wire tip and the reference marker was found to be within specification, manufacturing and design defects are not suspected.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: carefully place the dispenser hoop into the sterile field.Remove the delivery wire from the clip on the dispenser hoop.Grasp the proximal end of the introducer and the delivery wire at the point where it exits the introducer.Hold wire and introducer together to prevent stent movement.Remove the codman enterprise vascular reconstruction device and delivery system from the dispenser hoop.Do not partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during the removal of the codman enterprise vascular reconstruction device and delivery system from the dispenser hoop.Confirm the tip of the delivery wire is entirely within the introducer.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.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 that the product was received in the product analysis lab on 01-feb-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.

• Brand Name: ENTERPRISE2 4MMX30MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16152854
• Report Number: 3008114965-2022-00872
• Device Sequence Number: 7563156
• Product Code: NJE
• UDI-Device Identifier: 10886704075370
• UDI-Public: 10886704075370
• 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): 02/15/2023

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: 04/28/2025
• Device Model Number: ENF403012
• Device Catalogue Number: ENF403012
• Device Lot Number: 7178222
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 02/01/2023; 02/15/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/01/2023; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Patient Sex: Unknown