MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 14MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CF2505
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.(b)(6) the initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported during a non-acute recanalization of intracranial large vessel occlusion, angiography confirmed severe stenosis in the m1 segment of the right middle cerebral artery.After balloon dilation, stent-assisted angioplasty was performed using the 4.5mm x 14mm no distal tip enterprise® vascular reconstruction device (enc451400 / 6216426).It was reported that the stent could not advance within the prowler select microcatheter (catalog and lot number unknown) when it arrived at the proximal end of the microcatheter.The physician attempted to adjust but was not successful.The stent and the microcatheter were withdrawn from the patient and another device was used to complete the procedure.There was no report of any patient injury or complication as a result of the reported issue.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.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4.5mm x 14mm no distal tip enterprise® vascular reconstruction device was received contained in a pouch.Visual inspection was performed.It was noted that only the delivery wire and the introducer were returned for evaluation.The stent component was not returned with the rest of the device.The delivery wire and the introducer were inspected and found in normal, good condition.Functional test could not be performed without the stent component.(b)(4) performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6216426.The history record indicates this product was final inspection tested at (b)(4) and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The reported issue related to the stent being impeded in the microcatheter could not be confirmed through functional test.Functional evaluation requires the stent to still be inside the introducer tube.The stent component of the complaint device was not returned.The exact time when the stent became detached from the rest of the device cannot be determined.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) contains the following directions: 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.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 2 products involved with the reported complaint.The associated manufacturer report numbers are: "3008114965-2021-00454 and 3008114965-2021-00454." 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 during a non-acute recanalization of intracranial large vessel occlusion, angiography confirmed severe stenosis in the m1 segment of the right middle cerebral artery.After balloon dilation, stent-assisted angioplasty was performed using the 4.5mm x 14mm no distal tip enterprise® vascular reconstruction device (enc451400 / 6216426).It was reported that the stent could not advance within the microcatheter when it arrived at the proximal end of the microcatheter.The physician attempted to adjust but was not successful.The stent was withdrawn from the patient and another device was used to complete the procedure.There was no report of any patient injury or complication as a result of the reported issue.The complaint device was returned with a prowler select microcatheter (catalog and lot number unknown).Based on the follow-up response from the affiliate received on (b)(6) 2021, the microcatheter was used in the same procedure; it was used with the 4.5mm x 14mm no distal tip enterprise® vascular reconstruction device.When the stent was impeded in the microcatheter during the procedure, the physician removed it together with the stent resulting a loss of the target position.Based on the response received, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: EU ENT4.5MMD 14MML WNO DSTL TP
• 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: 12457470
• Report Number: 3008114965-2021-00454
• Device Sequence Number: 3964212
• Product Code: NJE
• UDI-Device Identifier: 10878528009457
• UDI-Public: 10878528009457
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2021

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: 12/28/2022
• Device Model Number: 641CF2505
• Device Catalogue Number: ENC451400
• Device Lot Number: 6216426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKPROWLERSELECT