MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number 211D

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

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that a female patient underwent a pulserider-assisted coil embolization of an 8mm weak right middle cerebral artery (mca) aneurysm with wide neck (6mm) on (b)(6) 2022 and experienced a hemorrhage during the procedure.The pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3057460515) was allegedly used as per the instructions for use (ifu).The pulserider anrd was placed partially intraaneurysmal (i.E., hybrid).The inferior side was placed extraaneurysmally, and the superior was placed intraaneurysmally.Concomitant devices included an 8fr radifocus® introducer sheath (terumo), a good tec y-connector (goodman), a 7f launcher ¿ guide catheter (medtronic), a chikai guidewire (asahi-intecc), prowler select plus microcatheter (unknown product code / lot number), an sl-10® microcatheter (stryker), and a 4.2f fubuki intermediate catheter (asahi intecc).A continuous flush was maintained through the devices.Seven coils (brand / manufacturer not specified) were implanted.Final imaging showed leakage of contrast medium, which had not been seen before, and slight bleeding was confirmed.20 minutes later, imaging demonstrated that the hemorrhage had decreased.Therefore, the patient was managed postoperatively in the intensive care unit (icu).It was unknown because the patient was under general anesthesia.The physician commented that the bleeding could not be confirmed when the last coil was placed, but bleeding was confirmed after the complaint pulserider anrd was energized (i.E., detached).¿this might be because the delivery wires, which were divided into two, were pushed by the complaint device, resulting in penetration of perforators, resulting in bleeding¿.¿after that, the complaint device was pushed up slightly to confirm the contrast, and the complaint device was transected.Hemorrhage was confirmed at the final imaging after transection.¿ the physician judged the event as non-serious because about 20 minutes later, the bleeding was decreasing, and the ¿postoperative complication could not be determined under the current condition.¿ computed tomography (ct) and magnetic resonance angiography (mra) were taken on the day after the procedure.Angio was also performed which showed no hemorrhage.Thus, dual antiplatelet therapy (dapt) was started.Physician¿s comment on the day after the procedure: hemorrhage was probably the m1 bifurcation point.Since the pulserider leg itself is located proximal to m1, the pulserider's delivery wire is unlikely to be the direct cause.The patient was extubated and is conscious.The patient exhibited left hand paralysis, and her left leg was barely able to ¿stand on the knees¿.The patient was speaking from the left side, but there was no response.There was some language disorder/impairment.There were no issues with the right side.It was further reported that the hospitalization was prolonged due to the hemorrhage.The physician said that ¿it would depend on the patient¿s future rehabilitation in the icu¿.The pulseron ider anrd remains implanted in the patient and is thus not available for evaluation.On 01-feb-2022, additional information was received.The patient has been extubated.The information indicated that the patient is conscious and clear.The prolongation of hospitalization will be dependent on the rehabilitation progress; the patient has not been discharged.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 (3057460515) 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.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.Hemorrhage secondary to vascular injury is a known potential adverse event associated with the use of the pulserider anrd in the intracranial arteries.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including vessel/aneurysm characteristics, device selection, device interaction, operator technique, and mechanical manipulation of devices within the artery that may have contributed to the reported event.Based on the available information, there is no indication of any device malfunctions or manufacturing issues related to the reported event.Since the intracranial hemorrhage caused neurological deficit and required prolonged hospitalization and the relationship of the pulserider anrd to the reported event cannot be disassociated, it is considered serious and mdr reportable.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.

Event Description

The healthcare professional reported that a female patient underwent a pulserider-assisted coil embolization of an 8mm weak right middle cerebral artery (mca) aneurysm with wide neck (6mm) on (b)(6) 2022 and experienced a hemorrhage during the procedure.The pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / 3057460515) was allegedly used as per the instructions for use (ifu).The pulserider anrd was placed partially intraaneurysmal (i.E., hybrid).The inferior side was placed extraaneurysmally, and the superior was placed intraaneurysmally.Concomitant devices included an 8fr radifocus® introducer sheath (terumo), a good tec y-connector (goodman), a 7f launcher ¿ guide catheter (medtronic), a chikai guidewire (asahi-intecc), prowler select plus microcatheter (unknown product code / lot number), an sl-10® microcatheter (stryker), and a 4.2f fubuki intermediate catheter (asahi intecc).A continuous flush was maintained through the devices.Seven coils (brand / manufacturer not specified) were implanted.Final imaging showed leakage of contrast medium, which had not been seen before, and slight bleeding was confirmed.20 minutes later, imaging demonstrated that the hemorrhage had decreased.Therefore, the patient was managed postoperatively in the intensive care unit (icu).It was unknown because the patient was under general anesthesia.The physician commented that the bleeding could not be confirmed when the last coil was placed, but bleeding was confirmed after the complaint pulserider anrd was energized (i.E., detached).¿this might be because the delivery wires, which were divided into two, were pushed by the complaint device, resulting in penetration of perforators, resulting in bleeding¿.¿after that, the complaint device was pushed up slightly to confirm the contrast, and the complaint device was transected.Hemorrhage was confirmed at the final imaging after transection.¿ the physician judged the event as non-serious because about 20 minutes later, the bleeding was decreasing, and the ¿postoperative complication could not be determined under the current condition.¿ computed tomography (ct) and magnetic resonance angiography (mra) were taken on the day after the procedure.Angio was also performed which showed no hemorrhage.Thus, dual antiplatelet therapy (dapt) was started.Physician¿s comment on the day after the procedure: hemorrhage was probably the m1 bifurcation point.Since the pulserider leg itself is located proximal to m1, the pulserider's delivery wire is unlikely to be the direct cause.The patient was extubated and is conscious.The patient exhibited left hand paralysis, and her left leg was barely able to ¿stand on the knees¿.The patient was speaking from the left side, but there was no response.There was some language disorder/impairment.There were no issues with the right side.It was further reported that the hospitalization was prolonged due to the hemorrhage.The physician said that ¿it would depend on the patient¿s future rehabilitation in the icu¿.The pulserider anrd remains implanted in the patient and is thus not available for evaluation.On 01-feb-2022, additional information was received.The patient has been extubated.The information indicated that the patient is conscious and clear.The prolongation of hospitalization will be dependent on the rehabilitation progress; the patient has not been discharged.There was no device performance issue associated with the pulserider device during the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 10-feb-2022 and 14-feb-2022.[additional information]: additional information was provided on 10-feb-2022 and on 14-feb-2022.The information confirmed that the procedure date is (b)(6) 2022.The patient¿s condition has markedly improved compared to after the procedure.Per the treating physician who has been monitoring the patient¿s course of treatment, the patient¿s status is ¿very good, and all symptoms that occurred immediately after the procedure were improving.¿ per the attending physician: "bleeding could not be confirmed when the last coil was placed, but bleeding could be confirmed after the complaint pulserider was placed after being energized.This might be because the delivery wires, which were divided into two, were pushed by the complaint device, resulting in penetration of perforators, resulting in bleeding." the physician further commented that the point of the bleeding may have been the m1 bifurcation.Since the legs of the pulserider were at the proximal m1, it may be that the cause of the bleeding was not due to the pulserider¿s delivery wire.There was a possibility that the microcatheter scratched the vessel wall.However, the exact cause of the bleeding is unknown.Hemorrhage secondary to vascular injury is a known potential adverse event associated with the use of the pulserider anrd and prowler select plus microcatheter in the intracranial arteries.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including vessel/aneurysm characteristics, device selection, device interaction, operator technique, and mechanical manipulation of devices within the artery that may have contributed to the reported event.Based on the available information, there is no indication of any device malfunctions or manufacturing issues related to the reported event.Since the intracranial hemorrhage caused neurological deficit and required prolonged hospitalization and the relationship of the pulserider anrd and prowler select plus microcatheter to the reported event cannot be disassociated, it is considered serious and mdr reportable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00066 and 3008114965-2022-00110.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, 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: 13425606
• MDR Text Key: 285348820
• Report Number: 3008114965-2022-00066
• Device Sequence Number: 1
• Product Code: NJE
• 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,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 211D
• Device Lot Number: 3057460515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4.2F FUBUKI INTERMEDIATE CATHETER (ASAHI INTECC).; 8FR RADIFOCUS® INTRODUCER SHEATH (TERUMO).; CHIKAI GUIDEWIRE (ASAHI-INTECC).; GOOD TEC Y- CONNECTOR (GOODMAN).; LAUNCHER ¿ GUIDE CATHETER (MEDTRONIC).; MICROCATHETER.; SL-10® MICROCATHETER (STRYKER).
• Patient Outcome(s): Disability; Hospitalization
• Patient Sex: Female