MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	211D
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Device manufacture date: not available at time of report.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.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.
Event or Problem Description
As reported by the field, during a stent-assisted embolization for bifurcation of a cerebral aneurysm and while using a pulserider t, 3mm, 10mm arch (211d, 3068658421) aneurysm neck reconstruction device, there was a concern about stability.Originally, a 3d printer model was previously used for a hands-on.The physician measured the size (aneurysm, neck, maternal vessel diameter) with 3d ct.At that time, because the mother vessel diameter was within 3.5 mm, the sales representative told the physician that a doctor that a 2.7mm x 3.5mm pulserider t model would be prepared.However, the precise mother vessel diameter was not remembered, and the measured value was smaller than 3.5mm, therefore it was decided to prepare 2.7mm x 3.5mm pulserider.On the day of the procedure, the mother vessel diameter was found to be approximately 3.6 mm.The reason for this was that the 3d ct image was less accurate than the angio image, resulting in a numerical value smaller than the actual vessel diameter.Because a 3.5mm x 4.5mm pulse rider was not prepared, the 10t of 2.7mm x 3.5mm was used.The pulse rider was placed, but it was removed because there was a concern about stability, and it was replaced with another stent (lvis stent).There was no effect on the patient, and the procedure completed.Although the stent was different from the one originally planned, the procedure was completed without any problem, and there was no impact on the patient.A continuous flush was done.A prowler select plus microcatheter was used.
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.Section b5: additional information received indicated that the complaint device is the pulserider t, 3mm, 10mm arch.There were no procedural delays due to the event.Complaint conclusion: as reported by the field, during a stent-assisted embolization for bifurcation of a cerebral aneurysm and while using a pulserider t, 3mm, 10mm arch (211d, 3068658421) aneurysm neck reconstruction device, there was a concern about stability.Originally, a 3d printer model was previously used for a hands-on.The physician measured the size (aneurysm, neck, maternal vessel diameter) with 3d ct.At that time, because the mother vessel diameter was within 3.5 mm, the sales representative told the physician that a 2.7mm x 3.5mm pulserider t model would be prepared.However, the precise mother vessel diameter was not remembered, and the measured value was smaller than 3.5mm, therefore it was decided to prepare 2.7mm x 3.5mm pulserider.On the day of the procedure, the mother vessel diameter was found to be approximately 3.6 mm.The reason for this was that the 3d ct image was less accurate than the angio image, resulting in a numerical value smaller than the actual vessel diameter.Because a 3.5mm x 4.5mm pulse rider was not prepared, the 10t of 2.7mm x 3.5mm was used.The pulse rider was placed, but it was removed because there was a concern about stability, and it was replaced with another stent (lvis stent).There was no effect on the patient, and the procedure completed.Although the stent was different from the one originally planned, the procedure was completed without any problem, and there was no impact on the patient.A continuous flush was done.A prowler select plus microcatheter was used.Additional information received indicated that the complaint device is the pulserider t, 3mm, 10mm arch.There were no procedural delays due to the event.The device was not returned for analysis; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3068658421 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿device instability - prior to detachment¿ could not be confirmed.Based on the device history record 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 devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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: PULSERIDER T, 3MM, 10MM ARCH
• 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 & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14337461
• Report Number: 3008114965-2022-00328
• Device Sequence Number: 20397396
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 859030005130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H160002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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: 10/31/2024
• Device Catalogue Number: 211D
• Device Lot Number: 3068658421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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