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

Model Number	641CF3509
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a stent assist coil embolization, an enterprise 4.5mmd 22mml intracranial neurovascular stent (enc452200, 6259376) became impeded in an unspecified microcatheter (mc) and could not advance any more.The physician retracted the stent and found stent body was not connected to the delivery wire.The stent was found to be released in microcatheter, after flushed microcatheter with saline, doctor observed the delivery wire broke.A new stent was used to complete the surgery.There was no patient injury reported.Pictures were received with the complaint file.No additional information is available.
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¿ 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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h10.Three photos were received with the compliant file.Based on the visual analysis, the stent could be noted detached from the unit and only one section of the delivery wire were shown in the pictures.No damages could be noted in the device, even though the stent could be noted deployed it cannot be determined how this condition appears.Further investigation will be performed once the device arrives for analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6259376.Indicating this product was final inspection tested at lake region medical and was determined to be acceptable.The customer complaint was not able to be confirmed.This investigation was performed based only on the photos provided.No further investigation will be conducted since the device said to be involved will not be returned for evaluation since was reported as discarded.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, d9, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a stent assist coil embolization, an enterprise 4.5mmd 22mml intracranial neurovascular stent (enc452200, 6259376) became impeded in an unspecified microcatheter (mc) and could not advance any more.The physician retracted the stent and found stent body was not connected to the delivery wire.The stent was found to be released in microcatheter, after flushed microcatheter with saline, doctor observed the delivery wire broke.A new stent was used to complete the surgery.There was no patient injury reported.No additional information is available.Photo investigation was performed, and according to the pictures provided, the stent is detached from the rest of the device.The marked bands on one end seem to be not fully opened (flared).The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A non-sterile eu ent4.5mmd 22mml wno dstl tp was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed on the device components (i.E., delivery wire, stent and introducer) and they were found to be in good conditions (i.E., no kinks, no fractures).The stent was separated from the delivery wire, but the delivery wire was not broken into separate fragments.The stent component was inspected under magnification, and no structural damages were noted, the struts were not broken nor deformed.None of the marker bands are bent neither, however, it was noted that the marker bands are flared on one end whereas the marker bands on the other end seem to be converging.The delivery wire showed no evidence of damage.The stent was submerged in lukewarm water, and the stent was noted to be damaged as it did not fully expand, one of the ends was not flared.The issue documented that the stent became impeded in the microcatheter could not be tested for since the stent component became detached during the procedure.The stent must be still inside the introducer tube to perform the functional analysis.The most likely cause of the stent damage is that it could be the result of the manipulation required to advance it through the microcatheter, it is possible that the microcatheter became kinked or compressed which resulted in the stent damage; however, since the microcatheter was not submitted to the lab, no further evaluation could be conducted.The customer complaint regarding a premature deployment (detachment) of the stent in the microcatheter was confirmed due to the detached condition noted on the stent.The stent detachment could be secondary to the impeded condition encountered during the procedure; it is possible that in an attempt to advance the stent through the microcatheter, force may have been inadvertently applied, which resulted in the stent detachment and damage.Factors not described such as device manipulation, vessel tortuosity, or concomitant devices may have contributed to the issues encountered during the procedure, rather than the manufacturing of the device.With the limited information available, a root cause cannot be assigned; however, there is no indication that the issues reported in the complaint are a result of a defect inherently related to the device.A device history record evaluation was performed, and no non-conformances were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ 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.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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
• 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: 14655369
• Report Number: 3008114965-2022-00414
• Device Sequence Number: 17373167
• 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): 09/02/2022

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: 02/28/2023
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 6259376
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 08/25/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 06/16/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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