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 Problem Ischemia Stroke (4418)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3078569808 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported form a personal interaction that on (b)(6) 2023 a patient underwent endovascular embolization of a basilar artery (ba) top aneurysm using a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3078569808).Per details of the procedure, lesion site was accessed from the right radial artery via the right vertebral artery (va).The pulserider was implanted in the first attempt and the procedure was completed successfully (details on coils used are currently unknown).It was stated that, later, on reviewing the postoperative ct scan, a partial infarction in the cerebellum was found.The patient is hospitalized as of one week after the surgery.Other concomitant devices used were a 6fr 25cm sheath introducer (unknow manufacturer), 6fr 115cm sofia (microvention) guiding catheter, chikai 14 (asahi intecc), guidewire, prowler select plus microcatheter.It was mentioned that continuous flush was done and that the device was used according to the instructions for use (ifu).It was referred that ¿the infarct lesion found was like lacunar infarct.This may not be related to the issue, but patient husband was found to be covid-positive after the surgery¿ and a ¿covid epidemic occurred in the hospital after the surgery.¿ it was also stated that ¿no treatment or reoperation is being performed at this time.The physician commented that the patient could be return to her daily life with rehabilitation¿.In the physician's opinion, this was a non-serious (moderate/minor) adverse event.Physician further commented that ¿the patient could not be treated without the pulserider, so it may have been inevitable.¿ he also stated that he has experienced similar issue in the past.The physician communicated also that ¿the pulserider was implanted in the first attempt and that the coiling was also smoothly completed.The issue might be due to covid epidemic after the surgery, or there might be a relationship with the pulserider.

Manufacturer Narrative

Product complaint #: (b)(4).Section b5: additional information was received on 07-jul-2023.Summary of relevant information provided: the physician does not feel that the cerenovus coils were the cause of the event.There were no problems related to the prowler select.Additional intervention was not performed, rehabilitation was scheduled.Complaint conclusion: it was reported from a personal interaction that on (b)(6) 2023 a patient underwent endovascular embolization of a basilar artery (ba) top aneurysm using a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3078569808).Per details of the procedure, the lesion site was accessed from the right radial artery via the right vertebral artery (va).The pulserider was implanted in the first attempt and the procedure was completed successfully (details on coils used are currently unknown).It was stated that, later, on reviewing the postoperative ct scan, a partial infarction in the cerebellum was found.The patient is hospitalized as of one week after the surgery.Other concomitant devices used were a 6fr 25cm sheath introducer (unknow manufacturer), 6fr 115cm sofia (microvention) guiding catheter, chikai 14 (asahi intecc), guidewire, prowler select plus microcatheter.It was mentioned that continuous flush was done and that the device was used according to the instructions for use (ifu).It was referred that ¿the infarct lesion found was like lacunar infarct.This may not be related to the issue, but patient husband was found to be covid-positive after the surgery¿ and a ¿covid epidemic occurred in the hospital after the surgery.¿ it was also stated that ¿no treatment or reoperation is being performed at this time.The physician commented that the patient could be return to her daily life with rehabilitation¿.In the physician's opinion, this was a non-serious (moderate/minor) adverse event.Physician further commented that ¿the patient could not be treated without the pulserider, so it may have been inevitable.¿ he also stated that he has experienced similar issue in the past.The physician communicated also that ¿the pulserider was implanted in the first attempt and that the coiling was also smoothly completed.The issue might be due to covid epidemic after the surgery, or there might be a relationship with the pulserider.Additional information was received on 07-jul-2023.Summary of relevant information provided: the physician does not feel that the cerenovus coils were the cause of the event.There were no problems related to the prowler select.Additional intervention was not performed, rehabilitation was scheduled.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3078569808 number, and no non-conformances related to the malfunction were identified.Cerebral infarction is a known potential complication associated with the use of the pulserider aneurysm neck reconstruction device (anrd) and is listed in the instructions for use (ifu) as such.If the pulserider anrd does not hold the embolic coils within the aneurysm sack, there could be thrombosis formation, which could lead to cerebral ischemia.There was no alleged device defect or quality issue reported during the procedure.However, per information received from the treating physician, there might be a relationship between the pulserider anrd and the reported event.Therefore, this event is usfda reportable 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 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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 ; 3035526892
• MDR Report Key: 17106318
• MDR Text Key: 316951656
• Report Number: 3008114965-2023-00373
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 3078569808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 6FR 115CM SOFIA (MICROVENTION) GUIDING CATHETER; 6FR 25CM SHEATH INTRODUCER; CHIKAI 14 (ASAHI INTECC); PROWLER SELECT PLUS
• Patient Outcome(s): Hospitalization
• Patient Sex: Female