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

Model Number	ENF403012
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2022
Type of Reportable Event	Malfunction
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, and email address of the initial reporter are not available / reported.The initial reporter phone: (b)(6).[conclusion]: the healthcare professional reported that during an endovascular embolization procedure with the target at the internal carotid artery (ica), when the 4.0m dia x 30mm enterprise®2 stent (enf403012 / 6451023) was advancing through a prowler select plus 45 degree microcatheter, strong resistance was encountered at the microcatheter hub.The stent was fully retracted and removed without removing the microcatheter.The stent was replaced with another 30mm enterprise the device was reported to be without damage.On (b)(6) 2022, clarifying information was received.The information indicated that there was no report of any patient adverse event or patient complication as a result of the reported issue.The reported issue did not result in any clinically significant delay in the procedure.The procedure was successfully completed.The complaint device was returned for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4.0m dia x 30mm enterprise®2 stent was received contained in a pouch.Visual inspection was performed.It was observed that the stent component was separated from the delivery wire inside the introducer.Also, the delivery wire was noted to be broken in two inside the introducer.The introducer was found in good normal conditions (i.E., no kinked or peeling conditions were observed on it).The stent was tried to be removed from the introducer, however, it could not be pushed or pulled due to the separated condition.The tip of the delivery wire was displacing the marker bands of the stent component.These conditions precluded proper functional testing, and no further inspection could be conducted on the stent component.The stent separation and delivery wire breakage as observed on the returned device could be secondary to the manipulation required to recapture the stent into the introducer.The stent and delivery wire components were returned inside the introducer, and the complaint documented that the stent was being advanced through the microcatheter.Although the exact timing of when the delivery wire breakage and separation from the stent could not be determined, it is most likely that these damages occurred during the post-operative handling/shipping of the device.The delivery wire separation from the stent would have caused the stent component to expand, which may have precluded the recapture into the introducer.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6451023.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The condition of the returned complaint device did not provide supportive evidence for the reported resistance issue encountered during the procedure, and functional test could not be performed due to the condition of the returned device, the reported issue documented in the complaint cannot be confirmed.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.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.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 an endovascular embolization procedure with the target at the internal carotid artery (ica), when the 4.0m dia x 30mm enterprise®2 stent (enf403012 / 6451023) was advancing through a prowler select plus 45 degree microcatheter, strong resistance was encountered at the microcatheter hub.The stent was fully retracted and removed without removing the microcatheter.The stent was replaced with another 30mm enterprise.The device was reported to be without damage.Based on the result of the product analysis completed on (b)(6) 2022, the stent was returned separated from the delivery wire.The event has been deemed reportable as a "malfunction." on (b)(6) 2022, clarifying information was received.The information indicated that there was no report of any patient adverse event or patient complication as a result of the reported issue.The reported issue did not result in any clinically significant delay in the procedure.The procedure was successfully completed.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14830341
• Report Number: 3008114965-2022-00456
• Device Sequence Number: 20032190
• 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
• Report Date (Section B): 06/27/2022

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: 05/28/2024
• Device Model Number: ENF403012
• Device Catalogue Number: ENF403012
• Device Lot Number: 6451023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• 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
• Patient Sex: Unknown