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

Catalog Number 201D

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

Patient Problem Ischemia Stroke (4418)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3077440212) 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.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 a result, the investigation will be closed.Cerebral infarction is a known potential complication associated with the use of the pulserider® aneurysm neck reconstruction device and is listed in the instructions for use (ifu) as such.Additionally, per the ifu, the device is not intended for use in patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the device or the use of adjunctive devices.There were no alleged quality issues/malfunctions related to the device, as the device performed as intended.However, the treating physician attributed the event to either the original stenosis of the area or to the pulserider device.The event required the additional surgical intervention of a mechanical thrombectomy as an attempt at recanalization but was unsuccessful.Intravenous medication had to be administered instead.The severity and outcome of the event is unknown.Since a cerebral infarction is considered a serious injury and the relationship of the pulserider device to the reported event cannot be excluded, the event meets us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ 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 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 803.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) 2023, the patient with a history of cerebral infarction, vertebral artery stenosis, and on single antiplatelet therapy (sapt) underwent a stent-assisted coil embolization using a 2.7 to 3.5 mm, 8 mm, t shape pulserider aneurysm neck reconstruction device (anrd) (201d / 3077440212) for an unruptured bifurcating cerebral aneurysm at the basilar artery (ba) top under general anesthesia.To preserve the right posterior cerebral artery (pca), a hybrid orientation implantation was attempted several times, but the origin of the left pca and the superior cerebellar artery (sca) were close to each other and the right pca was narrow.The intended hybrid orientation implant placement was right extra and left intra, but it was difficult to place the implant and as a result, the pulserider was implanted with the intra orientation.Coil embolization was performed with several axium frame (medtronic) and axium prime 3d (medtronic) coils.The procedure was completed with confirmation of blood flow interruption into the target aneurysm.The microcatheter used was a prowler select plus with continuous flush maintained through it.At a follow-up on an unspecified date in september, there was no problem with the blood flow, ¿although neck evaluation was difficult due to artifacts.¿ the physician also commented that ¿there were no worsening of the stenosis of the [parent] vessel, and the prognosis was good.¿ due to a history of cerebral infarction, the patient was on a prophylactic single antiplatelet therapy (sapt) prior to undergoing the stent-assisted coil embolization procedure.After undergoing the pulserider anrd implantation procedure, the patient was on a dual antiplatelet therapy (dapt) and was returned back to sapt in september.It was reported that there was originally a stenosis in the area where the pulserider leg is prior to the implantation of the pulserider anrd, and the physician was informed of the indicated vessel diameters described in the instructions for use (ifu).The pulserider anrd was used based on the physician¿s decision.On (b)(6) 2023, the patient presented to the emergency room with symptoms of cerebral infarction.Infarction was confirmed at the leg of the pulserider anrd implant.Mechanical thrombectomy was performed using an axs vecta 46 intermediate catheter (stryker) but recanalization could not be achieved ¿as smooth approach by devices was difficult.Since the stent retriever could not be used to possible interference with the pulserider, the procedure was terminated with [intravenous administration] of urokinase.¿ the patient is currently still being hospitalized.It was reported that the possible cause other than the devices is ¿there was originally a stenosis in the vertebral artery (va), and the physician decided to perform the procedure after a preliminary discussion about interference with neck and whether it would affect the stenosis.At 6 months follow-up, there was no worsening of the stenosis, no symptoms of stroke, and no recanalization of the aneurysm, so the patient was continued on monitoring with the antiplatelet drug sapt.¿ on 13-nov-2023, limited additional information was received.Per the additional information, related to the symptoms the patient experienced since the procedure on 13- oct-2023 was terminated, ¿the physician commented that ¿there was no worsening of the stenosis of the [parent] vessel, and the prognosis was good.¿ regarding whether the physician think the patient¿s history of cerebral infarction is a contributing factor to the stroke presentation on (b)(6) 2023, the information indicated the following: ¿it is unclear whether the original stenosis or the pulserider caused the delayed infarction.Both may be related.¿ the information indicated that ¿the pulserider was used based on the physician¿s decision based on the ifu.It is unclear whether the original stenosis or the pulserider caused the delayed infarction.Both may be related.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 30-nov-2023, which includes a correction to the patient¿s gender.[additional information]: on 30-nov-2023, additional information was received.Per the information, the patient is female in her 70s.The physician who performed the original procedure on (b)(6) 2023 was the same physician who treated the patient on (b)(6) 2023.As of 15-nov-2023, the patient was still in the hospital.There are no issues with the patient¿s progress.It is unknown as of (b)(6) 2023 if the patient has been discharged from the hospital.There is no future procedure planned.The information indicated that the patient is responsive to urokinase; recanalization was obtained with urokinase.Pre-pulserider procedure, the patient was on a single-antiplatelet therapy (sapt) with cilostazol.Post-pulserider procedure, the patient was put on a dual-antiplatelet therapy (dapt) with aspirin and cilistazol, then changed to aspirin-only at the 6-month follow-up examination.The information indicated that in the future, the patient will be on sapt with effient (dosage unknown).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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18145805
• MDR Text Key: 328224726
• Report Number: 3008114965-2023-00806
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Device Lot Number: 3077440212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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): Required Intervention; Life Threatening
• Patient Sex: Female