MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 4MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 213-D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: it was reported by a healthcare professional that a patient underwent pulserider- assisted coil embolization of an unruptured basilar tip aneurysm and experienced a cerebral infarction during the post-operative period.The exact timing of the event in relation to the index procedure was not reported.However, it was stated that the event was noted at the time of follow-up.The outcome was favorable, and the patient was discharged from the hospital in good health.The cerebral infarction was classified as mild in severity.It was further reported that the procedure was completed successfully with the implantation of a (b)(6) 10t, 3.5 -4.5mm (213d/3049703304) aneurysm neck reconstruction device (anrd) and unspecified coils.No additional information is available.The pulserider anrd remains implanted therefore, no further investigation can be performed.Initiation.A manufacturing record evaluation was performed for the finished device 3049703304 number, and no non-conformances related to the malfunction were identified.Cerebral infarction is a known complication associated with coil embolization procedures and is listed in the pulserider instructions for use (ifu) as such.With the information provided, it is not possible to determine the root cause of the event.However, there are patient, procedural, and pharmacological factors that may have contributed to the reported event.There were no alleged intraoperative complications or device malfunctions.The cerebral infarction is considered a serious injury and the relationship of the pulserider anrd to the event cannot be excluded.The file will be re-reviewed if additional information is received at a later date.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.

Event Description

It was reported by a healthcare professional that a patient underwent pulserider- assisted coil embolization of an unruptured basilar tip aneurysm and experienced a cerebral infarction during the post-operative period.The exact timing of the event in relation to the index procedure was not reported.However, it was stated that the event was noted at the time of follow-up.The outcome was favorable, and the patient was discharged from the hospital in good health.The cerebral infarction was classified as mild in severity.It was further reported that the procedure was completed successfully with the implantation of a pulserider 10t, 3.5 -4.5mm (213d/3049703304) aneurysm neck reconstruction device (anrd) and unspecified coils.No additional information is available.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received indicated that the mild infarction occurred at the left posterior cerebral artery (pca).Regarding the relationship between the reported cerebral infarction and the pulserider anrd, there was a physician's comment that "it may be related that it took time to deploy the pulse rider".The patient had no clinical symptoms such as paralysis.Hospitalization was not prolonged for treatment.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: PULSERIDER T, 4MM, 10MM ARCH
• 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 & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12953813
• MDR Text Key: 286442791
• Report Number: 3008114965-2021-00634
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005123
• UDI-Public: 00859030005123
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 213-D
• Device Catalogue Number: 213D
• Device Lot Number: 3049703304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/24/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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