MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 201-D

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

Patient Problem Ischemia Stroke (4418)

Event Date 12/02/2021

Event Type  Injury  

Event Description

It was reported by a healthcare professional that a (b)(6) female patient underwent pulserider-assisted coil embolization of a middle cerebral artery (mca) aneurysm and experienced a slight infarction after the procedure.There was reportedly no change in the patient¿s condition; she was stable.No additional treatment was provided.The patient was discharged from the hospital as scheduled.The relationship between the pulse rider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d/3064200019) is unclear.Additional information received on 10-dec-2021 indicated that the physician commented that there was no relationship between the cerebral infarction and the pulserider.The cause of the event was unknown.The patient did not experience any clinical symptoms as a result of the cerebral infarction.There was no additional treatment provided.Additional information received on 23-dec-2021 indicated that the date of the procedure was (b)(6) 2021.There were no device malfunctions or performance issues associated with the pulserider.

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 (b)(6) female patient underwent pulserider-assisted coil embolization of a middle cerebral artery (mca) aneurysm and experienced a slight infarction after the procedure.There was reportedly no change in the patient¿s condition; she was stable.No additional treatment was provided.The patient was discharged from the hospital as scheduled.Additional information received indicated that the physician commented that there was no relationship between the cerebral infarction and the pulse rider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d/3064200019).The cause of the event was unknown.The patient did not experience any clinical symptoms as a result of the cerebral infarction.There was no additional treatment provided.Additional information received on 23-dec-2021 indicated that the date of the procedure was 28-jul-2021.There were no device malfunctions or performance issues associated with the pulserider.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3064200019 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.

• Brand Name: PULSERIDER T, 3MM, 8MM 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: 13151721
• MDR Text Key: 288484579
• Report Number: 3008114965-2022-00001
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

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 Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3064200019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Sex: Female