MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problem Activation Failure (3270)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that a patient who was suffering from cerebrovascular stenosis underwent a vascular stent placement procedure.During the procedure, the physician tried to release the 4mm x 30mm enterprise 2 stent (encr403012 / 6424218), but the proximal end of the stent was unable to open.The stent was retracted and a new device was used to complete the procedure.There was no report of any patient injury.On (b)(6) 2022, additional information was received.The information indicated that the target location was the m1 segment of the middle cerebral artery (mca).The vessels were reported to be tortuous.The temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.Information related to the brand and size of the microcatheter used could not be obtained; the microcatheter was removed when the stent was replaced, and the microcatheter was also replaced to complete the procedure.The information indicated that ¿although a new microcatheter was used to complete the procedure, the physician thought the complaint issue was not related to the original microcatheter, and the original microcatheter was not involved in this complaint.¿ the replacement was not another 4mm x 30mm enterprise 2 stent (encr403012).There was no clinically significant procedure delay as a result of the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (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 6424218 the history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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 03-jan-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 that a patient who was suffering from cerebrovascular stenosis underwent a vascular stent placement procedure.During the procedure, the physician tried to release the 4mm x 30mm enterprise 2 stent (encr403012 / 6424218), but the proximal end of the stent was unable to open.The stent was retracted and a new device was used to complete the procedure.There was no report of any patient injury.On 01-dec-2022, additional information was received.The information indicated that the target location was the m1 segment of the middle cerebral artery (mca).The vessels were reported to be tortuous.The temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.Information related to the brand and size of the microcatheter used could not be obtained; the microcatheter was removed when the stent was replaced, and the microcatheter was also replaced to complete the procedure.The information indicated that ¿although a new microcatheter was used to complete the procedure, the physician thought the complaint issue was not related to the original microcatheter, and the original microcatheter was not involved in this complaint.¿ the replacement was not another 4mm x 30mm enterprise 2 stent (encr403012).There was no clinically significant procedure delay as a result of the reported issue.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4mm x 30mm enterprise 2 stent was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent component was already detached from the unit and this was not returned to the product analysis lab for inspection; only the delivery wire was returned and it was observed without any damage on it.The delivery wire was inspected under microscopic magnification, and it was observed in good condition, there was no structural damage (i.E., no elongations, kinks, or non-concentric loops were noted).The reported issue documented in the complaint regarding the stent component unable to open at the proximal end was not evaluated as the stent component was not returned.With the limited information available, the root cause of the reported failure remains inconclusive; however, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.The detached condition of the stent was not originally reported in the complaint and is considered secondary to the manipulation required during the stent removal.It is suggested that the stent may have gotten lost during the post-operative handling.This finding is not a contributing factor to the reported issue that the stent component was unable to open at the proximal end during the procedure.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6424218 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.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 5mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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 ¿no findings available (c20)¿ code was used in investigation findings to document that the reported issue related to the stent component unable to open at the proximal end was not evaluated / found as the stent component was not returned; this precluded any testing/evaluation.This code corresponds with the ¿cause not established (d15)¿ code used in the investigation conclusions.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: ENTERPRISE2 4MMX30MM
• 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: 15964918
• MDR Text Key: 308357267
• Report Number: 3008114965-2022-00775
• 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: 01/10/2023

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: 05/28/2024
• Device Catalogue Number: ENCR403012
• Device Lot Number: 6424218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 01/09/2023
• Supplement Dates FDA Received: 01/03/2023; 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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