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

Catalog Number ENC452812

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 12/26/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not reported / available.The product was received by cerenovus product analysis lab on (b)(6) 2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Lake region medical did review the device history records relative to the manufacturing, inspection, and packaging of the lot 5708444.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a procedure with the patient who was suffering from an anterior communicating artery (acom) aneurysm, the microcatheter was placed at the target position.When the reference marker on the delivery wire of the 4.5mm x 28mm enterprise® vascular reconstruction device (vrd) (enc452812 / 5708444) was approaching the y connector, the stent could not be advanced further.After several unsuccessful attempts, the physician retracted the stent and tried to push it to the microcatheter again.The guidewire of the stent tip was observed to be damaged at the y connector.A new device was used as replacement to complete the procedure.There was no report of any patient adverse event or complication.On 25-jan-2022, additional information was received.The information indicated that the microcatheter used was a 150cm x 5cm prowler select plus (606s255x / 30517676); the microcatheter was used with the replacement device to complete the procedure.There was no damage on the microcatheter; nothing was obstructing the microcatheter.A continuous flush was maintained through it and excessive force was not applied.The information indicated that the damage observed on the delivery wire of the stent device was that it separated into two or more pieces and the separated part was discarded.Based on the additional information, the event has been deemed reportable as a ¿malfunction.¿.

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 a procedure with the patient who was suffering from an anterior communicating artery (acom) aneurysm, the microcatheter was placed at the target position.When the reference marker on the delivery wire of the 4.5mm x 28mm enterprise® vascular reconstruction device (vrd) (enc452812 / 5708444) was approaching the y connector, the stent could not be advanced further.After several unsuccessful attempts, the physician retracted the stent and tried to push it to the microcatheter again.The guidewire of the stent tip was observed to be damaged at the y connector.A new device was used as replacement to complete the procedure.There was no report of any patient adverse event or complication.On 25-jan-2022, additional information was received.The information indicated that the microcatheter used was a 150cm x 5cm prowler select plus (606s255x / 30517676); the microcatheter was used with the replacement device to complete the procedure.There was no damage on the microcatheter; nothing was obstructing the microcatheter.A continuous flush was maintained through it and excessive force was not applied.The information indicated that the damage observed on the delivery wire of the stent device was that it separated into two or more pieces and the separated part was discarded.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4.5mm x 28mm enterprise® vascular reconstruction device was received contained in a pouch.Visual inspection was performed.It was noted that the stent component was inside the introducer.There were no kinks nor any damage noted on the delivery wire or introducer.Microscopic inspection was performed.Under magnification, the delivery wire was observed damaged inside the introducer; the coil wire that wraps around the nitinol core wire was stretched inside the introducer, near the proximal end of the stent.This damage could have been the result of several attempts made to advance the stent.Additionally, it was noted that the tip of the delivery wire was missing.Functional evaluation: a lab sample microcatheter was flushed and the stent was advanced through the microcatheter without any resistance or friction.However, when the stent was advanced out of the microcatheter and deployed, the delivery wire was noted to be broken off.The deployed stent was observed in good condition.Based on the condition of the delivery wire after the functional evaluation, the reported issue documented in the complaint that the delivery wire was separated into two or more pieces with the separated part discarded was confirmed.The functional test was conducted and completed without issues; the reported impeded condition encountered during the procedure could not be confirmed.It is likely factors related to the procedure or other factors related to device handling that may have been the contributing factors to the issue.Lake region medical did review the device history records relative to the manufacturing, inspection, and packaging of the lot 5708444.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of 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) contains the following recommendations: 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.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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13419379
• MDR Text Key: 285348685
• Report Number: 3008114965-2022-00058
• 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
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: ENC452812
• Device Lot Number: 5708444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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 Sex: Male