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

Model Number	641CF3509
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a stent assist coil embolization, an eu ent4.5mmd 22mml wno dstl tip stent (enc452200, 7014926) arrived at the target position and the physician started to release the stent, but the stent could not be opened.Then doctor retracted the stent and switched a new one to complete the surgery.There was no patient injury report.Additional information received indicated that the temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.There had been no resistance during the advancement of the device.The stent did not appear damaged.It is unknown if there were vessel or aneurysm factors that may have contributed to the incomplete expansion.The physician tried to open the stent again, but still failed to open.There was no blood flow restriction.There were no procedural delays due to the event.
Additional Manufacturer Narrative
(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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a stent assist coil embolization, an eu ent4.5mmd 22mml wno dstl tip stent (enc452200, 7014926) arrived at the target position and the physician started to release the stent, but the stent could not be opened.Then doctor retracted the stent and switched to a new one to complete the surgery.There was no patient injury report.Additional information received indicated that the temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.There had been no resistance during the advancement of the device.The stent did not appear damaged.It is unknown if there were vessel or aneurysm factors that may have contributed to the incomplete expansion.The physician tried to open the stent again, but still failed to open.There was no blood flow restriction.There were no procedural delays due to the event.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 noted that only the delivery wire and the introducer were returned for evaluation; they were found in good condition (i.E., no kinks, no bents, fractures, or elongations).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 issue documented that the stent could not be opened cannot be evaluated since the stent was not returned to the laboratory for evaluation.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.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.A device history record (dhr) of lot number 7014926 was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do 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 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EU ENT4.5MMD 22MML WNO DSTL TP
• Common Device Name: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15454423
• Report Number: 3008114965-2022-00603
• Device Sequence Number: 15206624
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 7014926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown