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 Problems Paralysis (1997); Visual Disturbances (2140); Vomiting (2144); Ischemia Stroke (4418); Decreased Appetite (4569)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter phone: (b)(6).The initial reporter email address is not available.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that on (b)(6) 2022 during a pulserider-assisted coil embolization procedure targeting a basilar apex aneurysm in the 72-year-old female patient.Radial access was gained and a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / lot# unknown) was placed in the apical aneurysm via a sofia¿ 6f intermediate catheter (microvention) and a prowler select plus with continuous flush maintained.After placement of one (1) cerenovus coil and four (4) competitor coils, the pulserider anrd was detached.The procedure was completed.There were no problems with the pulserider placement or the coil embolization.The patient was reported to be in stable condition.On (b)(6) 2022 infarction findings were confirmed by computed tomography (ct).The patient did not have any symptoms at this time.On (b)(6) 2022 the patient experienced mild paralysis and was vomiting.On 16-jun-2022, the cerenovus representative was made aware of the event during a follow-up visit.The patient presented with symptoms of oculomotor nerve palsy and could not open her eyes.The patient also had no appetite.The perforator may be occluded at the marker site inside the leaflet that affects the right posterior cerebral artery.In the physician¿s opinion, the efficacy of antiplatelet agents bayaspirin and clopidogrel may also be involved and there is a possibility that the issue is related to the device.The complaint device was used in accordance with the instructions for use (ifu).It was reported that no additional treatment was provided.The event was considered serious because the patient hospitalization was prolonged due to the symptoms of the oculomotor nerve palsy.On 29-jun-2022, additional information was received.The information indicated that the physician commented that the perforating branch may be occluded by the marker site inside the leaflet but accurate occlusion site was unknown.The patient is still in the hospital.The mild paralysis and vomiting have not resolved.The dosage of bayaspirin and clopidogrel were not provided.Anonymized images / angiographs are not available.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Cerebral infarction is a known complication associated with coil embolization procedures and is listed in the pulserider ifu as such.There are patient, procedural, and pharmacological factors that may have contributed to the reported events.There were no alleged intraoperative complications or device malfunctions or performance issues furthermore, the relationship of the pulserider to the reported event cannot be excluded.Therefore, this event is considered serious and mdr reportable.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.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.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 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.

Event Description

The healthcare professional reported that on (b)(6) 2022, during a pulserider-assisted coil embolization procedure targeting a basilar apex aneurysm in the 72-year-old female patient.Radial access was gained and a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / lot# unknown) was placed in the apical aneurysm via a sofia¿ 6f intermediate catheter (microvention) and a prowler select plus with continuous flush maintained.After placement of one (1) cerenovus coil and four (4) competitor coils, the pulserider anrd was detached.The procedure was completed.There were no problems with the pulserider placement or the coil embolization.The patient was reported to be in stable condition.On (b)(6) 2022, infarction findings were confirmed by computed tomography (ct).The patient did not have any symptoms at this time.On (b)(6) 2022, the patient experienced mild paralysis and was vomiting.On 16-jun-2022, the cerenovus representative was made aware of the event during a follow-up visit.The patient presented with symptoms of oculomotor nerve palsy and could not open her eyes.The patient also had no appetite.The perforator may be occluded at the marker site inside the leaflet that affects the right posterior cerebral artery.In the physician¿s opinion, the efficacy of antiplatelet agents bayaspirin and clopidogrel may also be involved and there is a possibility that the issue is related to the device.The complaint device was used in accordance with the instructions for use (ifu).It was reported that no additional treatment was provided.The event was considered serious because the patient hospitalization was prolonged due to the symptoms of the oculomotor nerve palsy.On 29-jun-2022, additional information was received.The information indicated that the physician commented that the perforating branch may be occluded by the marker site inside the leaflet but accurate occlusion site was unknown.The patient is still in the hospital.The mild paralysis and vomiting have not resolved.The dosage of bayaspirin and clopidogrel were not provided.Anonymized images / angiographs are not available.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 19-jul-2022.[additional information]: on 19-jul-2022, the cerenvous sales representative provided the lot number of the pulserider aneurysm neck reconstruction device.The device lot number is 3070988602.A review of manufacturing documentation associated with this lot (3070988602) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Updated sections: b.4, d.4, g.3, g.6, h.2, h.4, h.6, and h.10.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, 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14894121
• MDR Text Key: 295231080
• Report Number: 3008114965-2022-00449
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• 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: 3070988602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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.; SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION).
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female