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

Model Number	641CF3509
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6441600.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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.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 during an endovascular embolization procedure, the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452200 / 6441600) arrived at the target position and the physician attempt to release it, but the stent could not be opened.The physician retracted the stent and switched to a new stent to complete the procedure.There was no report of any negative patient impact or patient complication.On 29-aug-2022, additional information was received.The information indicated that the target was a 4mm x 8mm unruptured aneurysm.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.There was no evidence of obstructed blood flow due to the event.The temperature indicator on the inner pouch was checked and found to be within acceptable criteria.The concomitant microcatheter used was a 150cm x 5cm prowler select plus (606s255x / lot# unknown).The information indicated that there had been resistance during advancement of the stent, the stent could not be deployed in the microcatheter.There was no damage observed on the microcatheter.The replacement stent was another 4.5mm x 22mm no distal tip enterprise vascular reconstruction device of the same catalog number (enc452200).There was no clinically significant delay in the procedure as a result of the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (vrd) (enc452200 / 6441600) arrived at the target position and the physician attempt to release it, but the stent could not be opened.The physician retracted the stent and switched to a new stent to complete the procedure.There was no report of any negative patient impact or patient complication.On 29-aug-2022, additional information was received.The information indicated that the target was a 4mm x 8mm unruptured aneurysm.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.There was no evidence of obstructed blood flow due to the event.The temperature indicator on the inner pouch was checked and found to be within acceptable criteria.The concomitant microcatheter used was a 150cm x 5cm prowler select plus (606s255x / lot# unknown).The information indicated that there had been resistance during advancement of the stent, the stent could not be deployed in the microcatheter.There was no damage observed on the microcatheter.The replacement stent was another 4.5mm x 22mm no distal tip enterprise vascular reconstruction device of the same catalog number (enc452200).There was no clinically significant delay in the procedure as a result of the reported issue.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5mm x 22mm no distal tip enterprise® vascular reconstruction device (vrd) was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.All the components were received in good condition.Further inspection was performed under a microscope.Under magnification, the delivery wire was inspected along its entire length.No damages were observed on the delivery wire.The stent component was found still inside the introducer.Functional test was performed.A lab sample prowler select plus microcatheter was flushed using a lab sample syringe.After the microcatheter was flushed, the returned 4.5mm x 22mm no distal tip enterprise® vrd was introduced into the microcatheter and it was advanced.No resistance / friction was felt.The stent component exited out of the distal tip of the microcatheter.Additionally, the deployed stent component was observed in good condition, without any structural damage (i.E., no broken structs, no kinks).The functional test was performed without issues and the deployed stent was found without abnormalities, the customer complaint regarding a stent incomplete expansion could not be confirmed.However, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6441600.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 19-sep-2022.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• 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: 15364528
• Report Number: 3008114965-2022-00553
• Device Sequence Number: 17761986
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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: 07/28/2023
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 6441600
• 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: 08/21/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 09/26/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 09/19/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS 150/5CM
• Patient Sex: Unknown