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

Model Number 211-D

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email is not available / reported.The event was reported via the pms pulserider study, the (b)(6) patient underwent successful pulserider-assisted coil embolization of an unruptured left middle cerebral artery (mca) aneurysm on (b)(6) 2021 and experienced a cerebral hemorrhage on (b)(6) 2021.The cerebral hemorrhage during the 30-day follow-up visit.The hemorrhage was in the perfusion area of the pulserider implanted vessel, ipsilateral to the target aneurysm.The nih stroke scale score (nihss) was 0.No additional treatment was performed.On (b)(6) 2021, it was confirmed that the patient had recovered from the event.The physician commented that the relationship of the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / w3320-16) to the cerebral hemorrhage can be ruled out as the event was related to antiplatelet / anticoagulant therapy; the relationship to the index procedure cannot be excluded.The event was not considered serious.The pulserider anrd remains implanted and is thus not available for evaluation.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (w3320-16) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Intracranial or intracerebral hemorrhage is a known potential complication associated with coil embolization procedures and is listed in the pulserider instructions for use (ifu) as such.Dual antiplatelet therapy (dapt) is often required after stent implantation for prevention of thrombosis.This medication increases the risk of bleeding.Per the pulserider ifu: typical antiplatelet and anticoagulation regimen used for interventional intracranial procedures is recommended at the discretion of the treating physician.This typically consists of pre-procedure dapt for three to five days (if possible), intraoperative intravenous anticoagulant therapy, intravenous anticoagulant therapy for 24 hours post-procedure, dapt for at least 90 days post-procedure, and antiplatelet monotherapy for life.With the information provided, it is not possible to determine the root cause of the hemorrhage.However, there are patient, procedural, and pharmacological factors that may have contributed to the event.There were no alleged device malfunctions or defects associated with the pulserider anrd.Since cerebral hemorrhage is a serious injury and occurred on the same side as the implanted pulserider anrd, the event meets mdr reporting criteria.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.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 event was reported via the pms pulserider study, the (b)(6) patient underwent successful pulserider-assisted coil embolization of an unruptured left middle cerebral artery (mca) aneurysm on (b)(6) 2021 and experienced a cerebral hemorrhage on (b)(6) 2021.The cerebral hemorrhage during the 30-day follow-up visit.The hemorrhage was in the perfusion area of the pulserider implanted vessel, ipsilateral to the target aneurysm.The nih stroke scale score (nihss) was 0.No additional treatment was performed.On (b)(6) 2021, it was confirmed that the patient had recovered from the event.The physician commented that the relationship of the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / w3320-16) to the cerebral hemorrhage can be ruled out as the event was related to antiplatelet / anticoagulant therapy; the relationship to the index procedure cannot be excluded.The event was not considered serious.The pulserider and remains implanted and is thus not available for evaluation.

• 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: 12366520
• MDR Text Key: 268115180
• Report Number: 3008114965-2021-00379
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 00859030005130
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2021

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: 04/28/2021
• Device Model Number: 211-D
• Device Catalogue Number: 211D
• Device Lot Number: W3320-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR