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

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported by a healthcare professional that the patient underwent pulserider-assisted coil embolization of a right middle cerebral artery (mca) aneurysm and experienced a subarachnoid hemorrhage (sah) during the procedure.The patient initially presented with two distal anterior cerebral artery (aca) aneurysms and one right mca aneurysm.The two distal aca aneurysms were treated via the left internal carotid (ic).The pulserider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d/3053092711) was allegedly used as per the instructions for use (ifu) to embolize the mca aneurysm.Concomitant devices included a 6f fubuki guide sheath (asahi intecc), 6f sofia distal access catheter (microvention), prowler select plus microcatheter (product code & lot number unknown), and headway 21 microcatheter (microvention).The distal aca treatment was via the left ic, so the physician re-accessed from the right ic.The prowler select plus microcatheter could not go over the carotid siphon, so the prowler select plus was replaced with a headway 21.The physician advanced the headway 21 microcatheter to the region near the aneurysm and deployed the pulserider anrd.After that, cone beam computed tomography (ct) showed a sah.It was stated that ¿because the bleeding point was not found even when the contrast agent was flowed vigorously, and the physician was worried about the procedure would be continued with the complaint device.¿ the pulserider anrd was replaced with an atlas neuroform stent (stryker) and the procedure was completed successfully.It was reported that there were two potential contributing factors: the physician did not notice the perforation caused by the guidewire.The physician pulled out the thin perforator while pulling out the complaint device.The event was considered not serious.It was last reported that the patient remains hospitalized.No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #
=
>(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received on 04-nov-2021 indicated that the world federation of neurological surgeons (wfns) subarachnoid hemorrhage (sah) grade was i (gcs score of 15 without focal deficit).There was no report of a device malfunction or performance issue.Anonymized procedural films/imaging are not available for review.Section e1 - initial reporter phone: 0(b)(6).

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b4, g3, g6, h2, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that the patient underwent pulserider-assisted coil embolization of a right middle cerebral artery (mca) aneurysm and experienced a subarachnoid hemorrhage (sah) during the procedure.The patient initially presented with two distal anterior cerebral artery (aca) aneurysms and one right mca aneurysm.The two distal aca aneurysms were treated via the left internal carotid (ic).The pulserider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d/3053092711) was allegedly used as per the instructions for use (ifu) to embolize the mca aneurysm.Concomitant devices included a 6f fubuki guide sheath (asahi intecc), 6f sofia distal access catheter (microvention), prowler select plus microcatheter (product code & lot number unknown), and headway 21 microcatheter (microvention).The distal aca treatment was via the left ic, so the physician re-accessed from the right ic.The prowler select plus microcatheter could not go over the carotid siphon, so the prowler select plus was replaced with a headway 21.The physician advanced the headway 21 microcatheter to the region near the aneurysm and deployed the pulserider anrd.After that, cone beam computed tomography (ct) showed a sah.It was stated that ¿because the bleeding point was not found even when the contrast agent was flowed vigorously, and the physician was worried about the procedure would be continued with the complaint device.¿ the pulserider anrd was replaced with an atlas neuroform stent (stryker) and the procedure was completed successfully.It was reported that there were two potential contributing factors: 1) the physician did not notice the perforation caused by the guidewire 2) the physician pulled out the thin perforator while pulling out the complaint device.The event was not considered serious.It was last reported that the patient remains hospitalized.Additional information received indicated that the world federation of neurological surgeons (wfns) subarachnoid hemorrhage (sah) grade was i (gcs score of 15 without focal deficit).There was no report of a device malfunction or performance issue.Anonymized procedural films/imaging are not available for review.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 3053092711 number, and no non-conformances related to the malfunction were identified.Hemorrhage secondary to vessel perforation is a known potential adverse event that may be associated with the use of the pulserider in the intracranial arteries and is listed in the 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 clinical and procedural factors including aneurysm/vessel characteristics, device selection, device interaction, operator technique, and mechanical manipulation of devices within the artery that may have contributed with no indication of a device defect or quality issue.The sah secondary to vessel perforation is a serious injury and the relationship of the device 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: 12672566
• MDR Text Key: 282097103
• Report Number: 3008114965-2021-00535
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 859030005154
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 201D
• Device Lot Number: 3053092711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/04/2021; 12/10/2021
• Supplement Dates FDA Received: 11/16/2021; 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 6F FUBUKI GUIDE SHEATH (ASAHI INTECC),; 6F SOFIA DISTAL ACCESS CATHETER (MICROVENTION); HEADWAY 21 MICROCATHETER (MICROVENTION).; PULSERIDER T, 3MM, 8MM ARCH; UNKPROWLERSELECT