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 Intracranial Hemorrhage (1891)

Event Date 04/12/2023

Event Type  Injury  

Event Description

The healthcare professional reported that during a coil embolization procedure targeting a bifurcating aneurysm on the middle cerebral artery (mca), the procedure was started using a prowler select plus microcatheter and an sl-10® microcatheter (stryker) with a 7fr shuttle® long sheath (cook medical), and two (2) guidepost® distal access catheter (tokai medical).A continuous flush was maintained / conducted.The prowler select plus microcatheter was delivered to the m1 segment proximal to the aneurysm, and a pulserider y shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (301d / lot# unknown) was used.After the pulserider y shape, 8mm anrd was successfully deployed, the sl-10® microcatheter was inserted into the aneurysm and coiling was attempted.The 2.5mm g3 coil (catalog and lot number unknown) was used as the first coil; it could not deploy properly and was removed.The pulserider y shape, 8mm anrd was also removed and replaced with another pulserider anrd of a different shape.The prowler select plus microcatheter was inserted into the m2 segment, and a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3077440202) was advanced to the tip of the microcatheter.The pulserider anrd was deployed at the origin of the m2, not inside the aneurysm.As the pulserider anrd did not cover the neck of the aneurysm, it was retracted into the microcatheter for adjustment of angle and position.It was reported that during the retrieval of the pulserider t shape anrd, the patient¿s body movements became intense.On imaging test, bleeding was confirmed around the origin of the m2 segment.The whole system was withdrawn and a balloon catheter (unspecified brand) was used to attempt to stop the bleeding.Emergency treatment was initiated; it included drug administration (medication name and dosage not reported at the time of complaint initiation).After several minutes, the imaging test showed no bleeding and blood flow returned to normal.The need for emergency surgery was discussed and the patient was taken to the operating room.It was reported that the patient¿s vital signs became unstable due to the severe physical movement after bleeding, but hemostasis was achieved by ¿emergency hemostasis using a balloon.¿ it was reported that at the time of the complaint initiation, the patient¿s post-operative condition is unknown.It was reported that at around 12:00 on (b)(6) 2023, the bleeding occurred.The bleeding was stopped via emergency hemostasis approximately 30 minutes later, and the patient¿s condition stabilized.The patient was then transferred to the operating room, and the details of subsequent procedures and re-operations were unknown.The drug administered, the use of anesthesia, the incision wound size, and the length of the patient¿s hospitalization were also unknown.On 20-apr-2023, additional information was received.The information indicated that the source of the reported bleed was at the beginning of the m2 segment.Both pulserider devices (201d and 301d) have the same target maximum neck diameter, parent vasculature, and arch width.The difference in geometrical shape was selected based on the physician¿s clinical decision.There was no device performance issue / malfunction associated with the pulserider 8y anrd.There was no device performance issue / malfunction associated with the pulserider t anrd.The information confirmed that the synchro guide wire was one of the concomitant products used.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone and email address are not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (3077440202) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.Hemorrhage secondary to the vessel or aneurysm perforation are known potential procedural complications associated with the pulserider anrd.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event as the etiology of the bleed is currently unknown.The event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.However, since there was the need for additional surgical intervention (balloon hemostasis) coiling and medication (¿emergency treatment, including drug administration¿), the event meets us fda mdr reporting criteria under 21 cfr 803 with the 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 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.

Manufacturer Narrative

Manufacturer¿s ref no: (b)(4).The purpose of this mdr submission is to include the additional event information received on 01-jun-2023.[additional information]: on 01-jun-2023, additional information was received.The information indicated that the patient is a 62-year-old male.The patient was moved to the operating room and hemostasis was achieved by the clipping procedure.The patient is reported to be in an improved condition.The patient experienced a subarachnoid hemorrhage and the source of the bleed was at the beginning of the m2 segment.Per the physician¿s opinion, the etiology / cause of the bleed was a vessel perforation ¿by leaflet of the pulserider.¿ the bleeding might have occurred during deployment of the pulserider.Further information related to this could not be obtained.The physician attributed the retrieval of the 201d pulserider caused the patient¿s body movement and ultimately resulted in the bleeding on imaging.The patient¿s ¿violent body movement¿ was not a seizure, ¿it was thought because of pain by bleeding.¿ the information indicated that the pulserider 8y (301d) was reportedly successfully deployed but then removed because it did not cover the neck appropriately and was thought not to be implanted.Both devices, 201d pulserider and 301d pulserider have the same target maximum neck diameter, parent vasculature, and arch width.The difference in geometry was selected based on the physician¿s clinical decision.There were no problems (performance issue / device malfunction) associated with the pulserider 8y.The information indicated that the leaflet of the 201d pulserider ¿was deployed at the neck, but the first frame coil was dislodged to the parent vessel several times and considered the pulserider did not cover well.¿ there were no problems (performance issue / device malfunction) associated with the 201d pulserider.The physician did not suspect the involvement of the prowler select plus microcatheter (606s255x / 30541509) to the reported event.The information indicated that the 2.5mm g3 coil used with the pulserider 8y (301d) that did not deploy properly and was removed was a 2.5mm x 3.5cm galaxy g3 xsft (glx122535 / 30399446).It was not known if the coil was replaced.The balloon catheter that was used to attempt to stop the bleeding was a transform® balloon catheter (stryker); it was used during the emergency treatment for the bleeding.The information also confirmed that a synchro guidewire was one of the concomitant products used.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, 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.; 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16840075
• MDR Text Key: 314269166
• Report Number: 3008114965-2023-00256
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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: 3077440202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• 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: 7FR SHUTTLE® LONG SHEATH (COOK MEDICAL).; GALAXY G3 XSFT 2.5MM X 3.5CM.; GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL).; GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL).; MICROCATHETER.; PROWLER SELECT PLUS 150/5CM.; PULSERIDER Y 3MM, 8MM ARCH.; SL-10® MICROCATHETER (STRYKER).; SYNCHRO2¿ GUIDEWIRE (STRYKER).; TRANSFORM® BALLOON CATHETER (STRYKER).
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male