MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Activation Failure (3270)

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

Event Date 12/09/2022

Event Type  malfunction  

Event Description

The healthcare professional reported the patient presented with a ruptured aneurysm on the anterior communicating artery (acom) underwent an endovascular embolization procedure.During the procedure, the complaint device, a 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 / 7258220) was placed in the target position, then the physician attempted to release the stent, but the stent could not be completely opened.The physician retracted the stent and switched to the second stent, a 4mm x 30mm enterprise 2 stent (encr403012 / 7115179) but encountered the same issue with the stent unable to be opened completely.A third stent (competitor brand) was used and the procedure was successfully completed.The concomitant microcatheter was not replaced.There was no report of any negative patient impact.Four (4) photos were included in the complaint file.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The 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.The product analysis lab reviewed the four (4) photos that were included in the complaint.[photo review]: the photos were reviewed.In one of the photos, it was noted that the enterprise inside the hoop of the dispenser and only the proximal section of the delivery wire was shown.No damages were noted.The rest of the device was not able to be evaluated.The rest of the pictures provided only show the outer packages.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7258220.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The issue documented in the complaint could not be evaluated because the stent component was not shown in the photos.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00822 and 3008114965-2022-00823.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.

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 (b)(6) 2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: (b)(4) and (b)(4).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 investigational finding of the returned device.[conclusion]: the healthcare professional reported the patient presented with a ruptured aneurysm on the anterior communicating artery (acom) underwent an endovascular embolization procedure.During the procedure, the complaint device, a 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 / 7258220) was placed in the target position, then the physician attempted to release the stent, but the stent could not be completely opened.The physician retracted the stent and switched to the second stent, a 4mm x 30mm enterprise 2 stent (encr403012 / 7115179) but encountered the same issue with the stent unable to be opened completely.A third stent (competitor brand) was used and the procedure was successfully completed.The concomitant microcatheter was not replaced.There was no report of any negative patient impact.Four (4) photos were included in the complaint file.The product analysis lab reviewed the four (4) photos that were included in the complaint.[photo review]: the photos were reviewed.In one of the photos, it was noted that the enterprise inside the hoop of the dispenser and only the proximal section of the delivery wire was shown.No damages were noted.The rest of the device was not able to be evaluated.The rest of the pictures provided only show the outer packages.The issue documented in the complaint could not be evaluated because the stent component was not shown in the photos.This investigation was performed based only on the photo provided.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 complaint file will be updated accordingly.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5mm x 22mm enterprise® vrd was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent component was already detached from the unit.The delivery wire and the introducer were returned for evaluation; both were found to be in good condition (i.E., no kinks, no fractures, and no separations).The stent component was inspected under a microscope.No abnormalities were observed on it (i.E., no broken struts, and no kinks).Both of the distal ends were noted to be completely expanded.The reported issue documented in the complaint that the stent was unable to be opened completely was not confirmed as the stent component was noted to be fully expanded during the analysis.It is possible that the marker bands may have converged together but apposed to the vessel wall.The stent detachment was not originally reported in the complaint and the exact time when the stent component became detached cannot be determined based on the information available.However, this finding is not a contributing factor to the reported stent¿s inability to open that was experienced during the procedure.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7258220.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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: ¿ maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage 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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00822 and 3008114965-2022-00823.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 4.5X22MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16087700
• MDR Text Key: 308613825
• Report Number: 3008114965-2022-00822
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: ENC452212
• Device Lot Number: 7258220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/17/2023; 01/18/2023
• Supplement Dates FDA Received: 01/17/2023; 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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