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

Model Number 201-D

Device Problem Positioning Failure (1158)

Patient Problem Aneurysm (1708)

Event Date 11/17/2022

Event Type  Injury  

Event Description

1.Overview of the procedure.This procedure was a coil embolization for cerebral aneurysm using the complaint pulse rider.2.Details of the procedure.The complaint pulse rider was used for ba-top aneurysm.Another device (10t) was used but deployment was difficult.The 10 t device was replaced with the complaint pulse rider (8t).When the devices were aligned antegrade against blood vessel, the microcatheter jumped and entered the aneurysm and perforated with the tip of the complaint pulse rider protruding.After that, the complaint pulse rider was re-sheathed once and one coil was winded.The complaint pulse rider was deployed.The microcatheter was reinserted by trans-cell technique and the coil was embolized inside aneurysm and stopped blood flow.Because the balloon was unable to be used as the system, embolization was immediately performed and the procedure was terminated.3.Post-procedure changes in the patient.Postoperative drainage was performed.The current condition is unknown after drainage.The patient has been hospitalized.Continuous flush was done.The lesion was the ba.Other concomitant devices are a microcatheter (prowler select plus) and an intermediate catheter (sofia 6fr).When additional information is reported, it will be input as aei.

Manufacturer Narrative

Product complaint #: (b)(4).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.

Manufacturer Narrative

Product complaint # (b)(4).The device is not available for further investigation.A manufacturing record evaluation was performed for the finished device 3077440303 number, and no non-conformances related to the malfunction were identified.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).Section b5: additional information received on 23-dec-2022 indicated that at first, a 10t pl was deployed but deployment was difficult and then, 8t pl was used for the procedure instead of the 10t pl.The second pl was 8t and no malfunction was reported.There was no alleged product malfunction with the prowler select.There was no information available on whether the patient had a craniotomy.There was no information available on whether the pulserider was implanted in the desired location.The current status of the patient is unknown.There was no information available regarding the anatomical information including vessel characteristics.Complaint conclusion: it was reported through a personal interaction that a 50-year-old female patient underwent a stent-assisted endovascular coil embolization of a top basilar artery (ba) aneurysm with a 3mm 8mm arch pulserider t (201d/3077440303).It was stated that when the devices were aligned antegrade against the blood vessels, the microcatheter jumped and entered and perforated the aneurysm with the tip of the complaint pulse rider protruding.After that, it was described that the complaint pulse rider was re-sheathed once and one coil was ¿winded¿.The complaint pulse rider was deployed.The microcatheter was reinserted by trans-cell technique and the coil was embolized inside the aneurysm and stopped blood flow.It was said that because a balloon was unable to be used as part of the system, embolization was immediately performed, and the procedure was terminated.It was stated that ¿postoperative drainage was performed.The current condition is unknown after drainage.¿ the patient has been hospitalized.Other concomitant devices are a microcatheter (prowler select plus) and an intermediate catheter (sofia 6fr).It was also mentioned that ¿another device (10t)¿ has been used but it was reported that deployment was difficult.The ¿10t¿ device was replaced with the complaint pulse rider.Additional information received on 23-dec-2022 was reviewed.Summary of the information provided: at first, 10t pl was deployed but deployment was difficult and then, 8t pl was used for the procedure instead of the 10t pl.The second pl was 8t and no malfunction was reported.There was no alleged product malfunction with the prowler select.There was no information available on whether the patient had a craniotomy.There was no information available on whether the pulserider was implanted in the desired location.The current status of the patient is unknown.There was no information available regarding the anatomical information including vessel characteristics.The device is not available for further investigation.A manufacturing record evaluation was performed for the finished device 3077440303 number, and no non-conformances related to the malfunction were identified.Positioning difficulty and aneurysm perforation are known potential procedural complications associated with the pulserider anrd.Manipulation of devices in or near the intracranial aneurysm increases the risk of rupturing the fragile aneurysm wall.With the amount of information available and without procedural films, it is not possible to draw a clinical conclusion between the device and the aneurysm perforation.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device manipulation, device interaction, device selection, and operator technique that may have contributed rather than the design or manufacture of the devices.Since aneurysm perforation is considered a serious injury and the relationship of the devices to the aneurysm perforation cannot be clearly established, 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15950186
• MDR Text Key: 305180157
• Report Number: 3008114965-2022-00816
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3077440303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/09/2022; 12/23/2022
• Supplement Dates FDA Received: 12/12/2022; 01/06/2023
• 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: PROWLER SELECT PLUS; SOFIA 6FR INTERMEDIATE CATHETER
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female