MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	ENF403000
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
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, ethnicity, and medical history were not provided.The initial reporter phone and email address are not available / reported.[conclusion]: the healthcare professional reported that the 4.0mm dia x 30mm with no tip enterprise®2 stent (enf403000 / 11089436) was impeded in the concomitant 150cm x 5cm prowler select plus microcatheter (606s255fx / 30333005).There was no report of any patient adverse event or complication.The complaint device was returned for evaluation.The investigation is documented below.Investigation summary: the non-sterile 4.0mm dia x 30mm with no tip enterprise®2 stent was received with the 150cm x 5cm prowler select plus microcatheter.The microcatheter was contained in a pouch with the enterprise 2 stent stuck inside the microcatheter.The stent could not be removed from the microcatheter, as a result, visual inspection and functional testing could not be performed on the enterprise 2 stent.The prowler select plus microcatheter was flushed with warm water in attempt to remove the enterprise 2 stent.However, the stent could not be removed.The microcatheter was inspected under x-ray to determine if there is any damages on the braided mesh can be discerned or if the enterprise 2 stent was stuck at the compressed section.There was no damage observed on the braided mesh of the microcatheter under x-ray.The enterprise 2 stent was observed stuck at the compressed section.Based on this observation, the reported issue that the enterprise 2 stent was impeded in the microcatheter was confirmed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 11089436.The history record indicates 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.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event, the instructions for use (ifu) contains the following precautions: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance 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.With the limited information, the exact cause of the enterprise 2 stent becoming stuck at the compressed area of the concomitant microcatheter cannot be conclusively determined.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.This is one of two (2) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00235.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 the 4.0mm dia x 30mm with no tip enterprise®2 stent (enf403000 / 11089436) was impeded in the concomitant 150cm x 5cm prowler select plus microcatheter (606s255fx / 30333005).There was no report of any patient adverse event or complication.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 file will be updated accordingly.

• Brand Name: ENTERPRISE2 4MMX30MM NO TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11926034
• Report Number: 3008114965-2021-00234
• Device Sequence Number: 4345218
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: 10886704075387
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 10/28/2021
• Device Model Number: ENF403000
• Device Catalogue Number: ENF403000
• Device Lot Number: 11089436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1