MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CF3509
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during an intracranial large vessel occlusion and recanalization in the non-acute stage, a 4.5mmd 22mml enterprise vascular reconstruction device with no distal tip (enc452200, 5852763) became impeded.The stent couldn¿t advance within the unspecified microcatheter (mc) when it arrived at the middle of the mc.It couldn¿t advance or move back.Therefore, the physician removed the stent system and microcatheter together outside of the patient.The procedure was completed by another new stent system and microcatheter (same code as them).There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during an intracranial large vessel occlusion and recanalization in a non-acute stage, a 4.5mmd 22mml enterprise vascular reconstruction device with no distal tip (enc452200, 5852763) became impeded.The stent couldn¿t advance within the unspecified microcatheter (mc) when it arrived at the middle of the mc.It couldn¿t advance or move back.Therefore, the physician removed the stent system and microcatheter together outside of the patient.The procedure was completed by another new stent system and microcatheter (same code).There was no patient injury reported.Additional information received indicated that a prowler select plus (606s255x, 30413519) was used with the enterprise.The introducer was fully seated and secured in the hub.The user was not able to torque the device.There was no evidence of physical material within the device.The resistance was felt in the body/shaft.The replacement stent was 4.5mmd 22mml.The event prolonged the procedure by 20 minutes.It was noted that the prolonging of the operation time of patients brings certain risks.Adequate flush was maintained through the devices.No excessive force was applied to the device.A non-sterile prowler select plus 150/5cm was received coiled inside of a pouch with an eu ent4.5mmd 22mml wno dstl tp inside it.The prowler select plus 150/5cm was flushed with warm water, and it was attempted to be removed from the eu ent4.5mmd 22mml wno dstl tp.The eu ent4.5mmd 22mml wno dstl tp was removed without a problem.Only the delivery wire for the eu ent4.5mmd 22mml wno dstl tp was returned for evaluation.The delivery wire was inspected, and no damages or anomalies were observed on it.The functional test analysis could not be performed due to only the delivery wire was returned for evaluation.It is s necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative (dhr) to the manufacturing, inspecting and packaging of the lot 5852763.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The reported customer complaint of ¿delivery wire - impeded in microcatheter¿ was not confirmed as only the wire of the eu ent4.5mmd 22mml wno dstl tp was returned to cerenovus for evaluation.Also, based on the visual analysis, no damages or anomalies were observed.However, the kinked and compress condition observed on the device could be related to the customer experience regarding impeded in microcatheter condition.A device history review was performed, and no non-conformances related to the reported complaint condition were identified.The instructions for use (ifu) do contain the following recommendations and warnings: 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.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Concomitant products updated: prowler select plus (606s255x, 30413519) section b5: additional information received indicated that a prowler select plus (606s255x, 30413519) was used with the enterprise.The introducer was fully seated and secured in the hub.The user was not able to torque the device.There was no evidence of physical material within the device.The resistance was felt in the body/shaft.The replacement stent was 4.5mmd 22mml.The event prolonged the procedure by 20 minutes.It was noted that the prolonging of the operation time of patients brings certain risks.Adequate flush was maintained through the devices.No excessive force was applied to the device.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00162 and 3008114965-2021-00192.

• Brand Name: EU ENT4.5MMD 22MML 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: 11699730
• Report Number: 3008114965-2021-00162
• Device Sequence Number: 17055542
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2021

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: 05/28/2022
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 5852763
• 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: 03/31/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 05/24/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/10/2021; 06/10/2021
• 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: PROWLER SELECT PLUS 150/5CM; UNSPECIFIED MICROCATHETER