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

Catalog Number ENC452212

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).The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Initial reporter address line 2: (b)(6).Device evaluated by mfr: 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 6920540.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: 3008114965-2022-00714.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 a patient suffering from an aneurysm on the a1 segment of the left anterior cerebral artery underwent an endovascular embolization procedure, a 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 /6920540) was advanced within the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / 30679785) and arrived at the target position.The physician withdrew the microcatheter to release the stent but felt much resistance.After several adjustments, the stent was still impeded in the microcatheter.The physician retracted the stent with the microcatheter together and replaced both devices to complete the procedure.There was no report of any negative patient impact.On (b)(6) 2022, additional information was received.The information indicated that continuous flush had been maintained through the microcatheter.The stent component was reported as still being on the delivery wire when it was removed from the patient.The stent / stent delivery system did not appear damaged.There were not visible kinks nor other damages observed on the microcatheter.Nothing unusual was noted about the system prior to use.The stent was replaced by another 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212) and the microcatheter was replaced with another 150cm x 5cm prowler select plus microcatheter of the same product code (606s255x).The reported issue did not result in any clinically significant delay in the procedure.

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 29-nov-2022.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: 3008114965-2022-00714 and 3008114965-2022-00715.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 a patient suffering from an aneurysm on the a1 segment of the left anterior cerebral artery underwent an endovascular embolization procedure, a 4.5mm x 22mm enterprise® vascular reconstruction device (vrd) (enc452212 /6920540) was advanced within the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / 30679785) and arrived at the target position.The physician withdrew the microcatheter to release the stent but felt much resistance.After several adjustments, the stent was still impeded in the microcatheter.The physician retracted the stent with the microcatheter together and replaced both devices to complete the procedure.There was no report of any negative patient impact.On 07-nov-2022, additional information was received.The information indicated that continuous flush had been maintained through the microcatheter.The stent component was reported as still being on the delivery wire when it was removed from the patient.The stent / stent delivery system did not appear damaged.There were not visible kinks nor other damages observed on the microcatheter.Nothing unusual was noted about the system prior to use.The stent was replaced by another 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212) and the microcatheter was replaced with another 150cm x 5cm prowler select plus microcatheter of the same product code (606s255x).The reported issue did not result in any clinically significant delay in the procedure.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® vascular reconstruction device (vrd) was received contained in the decontamination pouch.Visual inspection was performed.The stent component of the complaint device was observed detached inside the luer hub of the prowler select plus microcatheter.The stent component was removed and was observed to be in good condition (i.E., no broken struts, no broken marker bands, and no kinks were observed).The length of the stent was confirmed to be 22mm.The reported issue in the complaint that the stent was impeded in the microcatheter could not be confirmed through functional evaluation; the stent component was received in a detached condition.The detached state of the stent was not originally reported in the complaint, and the exact time when the stent became detached could not be determined as the complaint detailed that the stent component was still attached to the delivery wire; however, when the devices arrived at the lab, the stent component was already deployed inside the luer hub of the microcatheter.Based on the appearance of the stent, there is no evidence to suggest that it was subjected to excessive manipulation due to the reported resistance encountered and it being impeded in the microcatheter during the procedure.With the information available and the evidence obtained from the returned devices, the issue documented that the stent was impeded in the microcatheter could not be evaluated; it is possible that other factors not described within the information provided may have contributed to the issue encountered during the procedure that could not be replicated in the laboratory setting.(b)(6) performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6920540.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.H.6: the code ¿device migration (c0701)¿ was used in the investigation findings to capture the condition of the returned stent in a detached state.This code corresponds with the ¿cause not established (d15)¿ in the investigation conclusion as the stent was not originally reported as detached and the exact time it became detached could not be determined.The code ¿no findings available (c20)¿ was used in the investigation findings to document that the reported issue in the complaint that the stent was impeded in the microcatheter could not be confirmed through functional analysis.This code corresponds with the ¿cause not established (d15)¿ in the investigation conclusion.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00714 and 3008114965-2022-00715.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: 15811129
• MDR Text Key: 308068633
• Report Number: 3008114965-2022-00715
• 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: 12/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: ENC452212
• Device Lot Number: 6920540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 12/05/2022
• Supplement Dates FDA Received: 11/29/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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