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

Catalog Number 213D

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

Patient Problem Ischemia Stroke (4418)

Event Date 01/21/2022

Event Type  Injury  

Event Description

The healthcare professional reported that a (b)(6) female patient underwent pulserider-assisted coil embolization of an internal carotid-posterior communicating artery (ic-pc) aneurysm on (b)(6) 2022 and experienced a cerebral infarction on the following day.The infarct was confirmed in the periphery of the territory supplied by the right middle cerebral artery (mca), the site treated with the pulserider aneurysm neck reconstruction device (anrd).The patient only experienced a slight discomfort in the left foot and was otherwise asymptomatic.There was no treatment nor reoperation performed.The patient recovered and was discharged from the hospital on (b)(6) 2022.The pulserider 10t, 3.5 ¿ 4.5mm anrd (213d / 3050709708) was allegedly used according to the instructions for use (ifu).There was a continuous flush maintained.The pulserider was deployed via a prowler select plus microcatheter (unknown product code / lot number) and coil embolization was performed.The procedure was completed, and the pulserider was detached without incident.The physician commented that the pulserider was moved in and out of the microcatheter multiple times when adjusting the deployment position.At that time.A small thrombus was formed and may have flown to the periphery.It was stated that there were no possible causes other than the device.The complaint device remains implanted in the patient and is thus not available for evaluation.On 07-feb-2022, additional information was received.The information indicated that prolongation of hospitalization was not required due to the event.The patient has been discharged from the hospital and the slight discomfort has resolved.There was no device performance issue associated with the pulserider device during the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that a (b)(6) female patient underwent pulserider-assisted coil embolization of an internal carotid-posterior communicating artery (ic-pc) aneurysm on (b)(6) 2022 and experienced a cerebral infarction on the following day.The infarct was confirmed in the periphery of the territory supplied by the right middle cerebral artery (mca), the site treated with the pulserider aneurysm neck reconstruction device (anrd).The patient only experienced a slight discomfort in the left foot and was otherwise asymptomatic.There was no treatment nor reoperation performed.The patient recovered and was discharged from the hospital on (b)(6) 2022.The pulserider 10t, 3.5 ¿ 4.5mm anrd (213d / 3050709708) was allegedly used according to the instructions for use (ifu).There was a continuous flush maintained.The pulserider was deployed via a prowler select plus microcatheter (unknown product code / lot number) and coil embolization was performed.The procedure was completed, and the pulserider was detached without incident.The physician commented that the pulserider was moved in and out of the microcatheter multiple times when adjusting the deployment position.At that time.A small thrombus was formed and may have flown to the periphery.It was stated that there were no possible causes other than the device.The complaint device remains implanted in the patient and is thus not available for evaluation.On 07-feb-2022, additional information was received.The information indicated that prolongation of hospitalization was not required due to the event.The patient has been discharged from the hospital and the slight discomfort has resolved.There was no device performance issue associated with the pulserider device during the procedure.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3050709708) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Cerebral infarction is a known complication associated with the use of the pulserider anrd in the intracranial arteries and is listed in the 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.Since cerebral infarction is considered a serious injury and the relationship of the pulserider anrd to the event cannot be excluded, the event meets mdr reporting criteria.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: 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 ; 949789-868
• MDR Report Key: 13472690
• MDR Text Key: 289444753
• Report Number: 3008114965-2022-00071
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005123
• UDI-Public: 859030005123
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 213D
• Device Lot Number: 3050709708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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
• Treatment: MICROCATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female