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

Catalog Number ENC452200

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

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, an eu ent4.5mmd 22mml wno dstl tp intracranial neurovascular stent (enc452200, 6998479) became impeded in a prowler select plus 150/5cm microcatheter (606s255x, 30772065) and could not advance anymore.The physician retracted the stent and observed delivery wire of the stent broke.The stent body remained in microcatheter (mc).The doctor switched new stent and microcatheter to complete the surgery.There was no patient injury reported.No additional information is available.

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¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00694.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint#: (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization, an eu ent4.5mmd 22mml wno dstl tp intracranial neurovascular stent (enc452200, 6998479) became impeded in a prowler select plus 150/5cm microcatheter (606s255x, 30772065) and could not advance anymore.The physician retracted the stent and observed delivery wire of the stent broke.The stent body remained in microcatheter (mc).The doctor switched new stent and microcatheter to complete the surgery.There was no patient injury reported.No additional information is available.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, and it was observed that the stent was returned detached from the delivery wire.The stent component was inspected under microscopic magnification, and it was observed to be undamaged.The distal section of the delivery wire was noted to be in a kinked condition, and also non-concentric loops were noted.The delivery wire was returned in one piece.A device history record (dhr) was performed and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.The impeded condition, as reported, could not be tested in the lab due to the stent detachment and delivery wire damage; however, the kink noted on the delivery wire section suggests excessive manipulation as a result of the impeded condition.The complaint event documented that the stent became impeded in the microcatheter (mc) and could not advance anymore; it is possible that excessive force may have inadvertently been exerted on the enterprise system to make the stent pass through the microcatheter, bending the delivery wire to accommodate the stent which ultimately got detached.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure; as such, the customer complaint in relation to the stent becoming impeded in the microcatheter was confirmed.However, with the amount of information available, there is no indication that the issues reported in the complaint result from a defect inherently related to the enterprise device.The customer's complaint that the delivery wire of the stent broke could not be confirmed since the delivery wire was confirmed to be in one piece.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.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
• 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 ; 3035526892
• MDR Report Key: 15708313
• MDR Text Key: 303826326
• Report Number: 3008114965-2022-00693
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: ENC452200
• Device Lot Number: 6998479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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.