MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 12/09/2022

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.(b)(6).The initial reporter email address was not available / reported.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 7107407.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: 3008114965-2022-00825 and 3008114965-2022-00826.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.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 the patient presented with a dissecting aneurysm underwent an endovascular embolization procedure, during the procedure, the 4.5mm x 14mm enterprise® vascular reconstruction device (vrd) (enc451412 / 7107407) became impeded in the concomitant microcatheter, a 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x / 30743231) and could not advance nor be withdrawn.The physician retracted the stent and microcatheter and observed that the microcatheter had become kinked / bent and the stent was released in the microcatheter.The physician switched to a new microcatheter and released two stents (unspecified brand(s)) in the target aneurysm and the procedure was successfully completed.There was no negative impact to the patient.Additional information was received on 12-dec-2022.Based on the additional information, the 150cm x 5cm, 2 markers prowler select plus microcatheter was discarded and is no longer available for return.On 14-dec-2022, additional information was received.The information indicated that the procedure was targeting a dissecting aneurysm on the m1 segment of the left middle cerebral artery (mca).There was continuous flush maintained through the microcatheter.The stent / stent delivery system did not appear damaged when it was removed.Nothing unusual was noted about the system prior to use.The microcatheter was replaced with another 150cm x 5cm prowler select plus microcatheter of the same product code (606s255x).The two stents replaced and placed in the aneurysm were 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212).There was no clinically significant delay as a result of the reported event.

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 05-jan-2023.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: 3008114965-2022-00825 and 3008114965-2022-00826.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 include the additional event information received on 13-feb-2023.[additional information]: on 13-feb-2023, confirmation was received from the cerenovus sales representative indicating that the product originally returned and received on 05-jan-2023 was not the product associated with this complaint; the 4.5mm x 14mm enterprise® vrd (enc451412 / 7107407) reported in this complaint is not available for return.Based on the additional information received, the complaint device is not available to be returned for analysis.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7107407.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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: 3008114965-2022-00825 and 3008114965-2022-00826.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 4.5X14MM 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: 16035799
• MDR Text Key: 308546163
• Report Number: 3008114965-2022-00825
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: ENC451412
• Device Lot Number: 7107407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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