MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X28MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452812

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: 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 7002191.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00899.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 Description

The healthcare professional reported that during an endovascular embolization procedure, the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812 / 7002191) was impeded in the proximal section of the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / 30734775) and could not be further advanced.The physician removed the microcatheter and the stent from the patient and switched to new devices to complete the procedure.It was reported that the procedure was prolonged by approximately 30 minutes.There was no report of any negative patient impact.On (b)(6) 2023, additional information was received.The information indicated that the target of the procedure was a middle cerebral artery (mca) aneurysm in a 48-year-old male patient.A continuous flush was maintained through the microcatheter.When the stent was removed from the patient, it was still on the delivery wire.The stent was impeded in the proximal section of the microcatheter.The replacement stent was another 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812) and the replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).The information confirmed that there was no negative patient impact.Regarding the 30-minute procedure extension being considered clinically significant, the information could not be obtained.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 26-dec-2023.The information is a correction of the device lot number.[additional information]: on (b)(6) 2023, additional information was received.Per the information, the lot number of the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812) was corrected from 7002191 to 7158894.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7158894.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Corrected section: d.4.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00898 and 3008114965-2023-00899.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.The lot number of the 4.5mm x 28mm enterprise® vascular reconstruction device was updated / corrected from 7002191 to 7158894.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5mm x 28mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was detached from the delivery system and it remain inside of the concomitant microcatheter hub.The introducer was in good condition (i.E., no kinks, bents, or elongations).The delivery wire was not returned for evaluation.The stent was removed from the microcatheter hub and then inspected, and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the stent ends were noted to be completely expanded.No other damages were found.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7158894.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.The issue documented in the complaint regarding the stent being impeded in the proximal section of the microcatheter could not be evaluated through functional test since the stent was returned already separated from the unit, and the stent must still be attached to the delivery system and inside the introducer in order to perform a functional test.The exact time of detachment of the stent cannot be determined; however, it was stated that the stent was still attached to the delivery system, therefore, this condition could be related to the post-operative handling/inspection of the device, and it is not related to the issue encountered during the procedure.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.Based on this, the reported issue in the complaint was confirmed.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 could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.If resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.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: 3008114965-2023-00898 and 3008114965-2023-00899.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.The supplemental report #3 has the manufacturing documentation review of the originally reported lot number of the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812), which was 7002191.On 26-dec-2023, additional information was received.Per the information, the lot number of the 4.5mm x 28mm enterprise® vascular reconstruction device (enc452812) was corrected from 7002191 to 7158894.This is to add the correct manufacturing documentation review for lot 7158894.

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 09-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00898 and 3008114965-2023-00899.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5mm x 28mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was detached from the delivery system and it remain inside of the concomitant microcatheter hub.The introducer was in good condition (i.E., no kinks, bents, or elongations).The delivery wire was not returned for evaluation.The stent was removed from the microcatheter hub and then inspected, and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the stent ends were noted to be completely expanded.No other damages were found.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7002191.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.The issue documented in the complaint regarding the stent being impeded in the proximal section of the microcatheter could not be evaluated through functional test since the stent was returned already separated from the unit, and the stent must still be attached to the delivery system and inside the introducer in order to perform a functional test.The exact time of detachment of the stent cannot be determined; however, it was stated that the stent was still attached to the delivery system, therefore, this condition could be related to the post-operative handling/inspection of the device, and it is not related to the issue encountered during the procedure.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.Based on this, the reported issue in the complaint was confirmed.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 could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.If resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.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: 3008114965-2023-00898 and 3008114965-2023-00899.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 4.5X28MM STENT 12 MM DW TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18307630
• MDR Text Key: 330255653
• Report Number: 3008114965-2023-00898
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: ENC452812
• Device Lot Number: 7158894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM
• Patient Age: 48 YR
• Patient Sex: Male