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 Ruptured Aneurysm (4436)

Event Date 02/10/2023

Event Type  Injury  

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.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077900504 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 from a personal interaction that a patient underwent an endovascular embolization procedure of a right middle cerebral artery (mca) aneurysm using a pulserider t, 3mm, 8mm arch (201d/3077900504) aneurysm neck reconstruction device (anrd) on (b)(6) 2023 and experienced an intra-operative aneurysm rupture.Details of the procedure: the physician punctured the right femoral artery and guided a 6f shuttle gs 80cm sheath into the right internal carotid artery (ica).A 3d image was taken and a 6f benchmark (penumbrainc) catheter was delivered to the front of carotid siphon under a shouryu balloon catheter guidance.Next a sl-10 45o (strykerneurovascular) microcatheter (for coil deliver) was delivered to near the terminus segment of the ica and a prowler select plus microcatheter was delivered to the m1 segment of the right mca.The complaint pulse rider was inserted into the prowler select plus microcatheter and deployed close to the aneurysm.It was mentioned that the complaint device was used as per the instructions for use (ifu).When the arch part was about half protruded, the inferior branch was located outside the aneurysm, and the opposite side was located inside the aneurysm.The system was pulled back.As the extrusion on the superior side was also removed, the entire system was pushed slightly, and the device was then deployed.At this moment new images were taken to check the opening of the complaint device, and aneurysm rupture was confirmed.The physician immediately removed the complaint device and the prowler select plus and introduced a shouryu 4x10 (kaneka-med) dilation balloon catheter to the m1 segment of the mca and inflated the device.Simultaneously, heparin reversal agent was given to the patient.The balloon catheter was deflated sightly, the sl-10 microcatheter was approached into the aneurysm through the space between the balloon and the vessel wall, and coil embolization was performed in the aneurysm.The physician confirmed by imaging that the bleeding gradually decreased, and eventually complete hemostasis was achieved approximately 30 minutes after initial aneurysm rupture.After confirmation of hemostasis, cone beam computed tomography was performed and the procedure was completed.Concomitant devices additionally used: a traxcess (microvention) guidewire, a galaxy g3mini 3×6 coil, a galaxy g3mini 2×4coil and an ied 2×3 coil (kaneka-med).The physician judged the adverse event as serious because bleeding occurred due to the ruptured aneurysm.He further stated that the adverse event cannot be ruled out being related to the procedure because at the time of aneurysm rupture, only the complaint device and the prowler select plus were found near the aneurysm.Therefore, it was probably that the complaint device touched the aneurysm wall when one arch was in the aneurysm during deployment of the complaint device.Physician also commented that it was highly possible that the aneurysm itself was fragile and was likely to be torn because of its distorted shape.Continuous flush was done.

Manufacturer Narrative

Product complaint#: (b)(4).Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a patient underwent an endovascular embolization procedure of a right middle cerebral artery (mca) aneurysm using a pulserider t, 3mm, 8mm arch (201d/3077900504) aneurysm neck reconstruction device (anrd) on (b)(6) 2023 and experienced an intra-operative aneurysm rupture.Details of the procedure: the physician punctured the right femoral artery and guided a 6f shuttle gs 80cm sheath into the right internal carotid artery (ica).A 3d image was taken and a 6f benchmark (penumbrainc) catheter was delivered to the front of carotid siphon under a shouryu balloon catheter guidance.Next a sl-10 45o (strykerneurovascular) microcatheter (for coil deliver) was delivered to near the terminus segment of the ica and a prowler select plus microcatheter was delivered to the m1 segment of the right mca.The complaint pulse rider was inserted into the prowler select plus microcatheter and deployed close to the aneurysm.It was mentioned that the complaint device was used as per the instructions for use (ifu).When the arch part was about half protruded, the inferior branch was located outside the aneurysm, and the opposite side was located inside the aneurysm.The system was pulled back.As the extrusion on the superior side was also removed, the entire system was pushed slightly, and the device was then deployed.At this moment new images were taken to check the opening of the complaint device, and aneurysm rupture was confirmed.The physician immediately removed the complaint device and the prowler select plus and introduced a shouryu 4x10 (kaneka-med) dilation balloon catheter to the m1 segment of the mca and inflated the device.Simultaneously, heparin reversal agent was given to the patient.The balloon catheter was deflated sightly, the sl-10 microcatheter was approached into the aneurysm through the space between the balloon and the vessel wall, and coil embolization was performed in the aneurysm.The physician confirmed by imaging that the bleeding gradually decreased, and eventually complete hemostasis was achieved approximately 30 minutes after initial aneurysm rupture.After confirmation of hemostasis, cone beam computed tomography was performed and the procedure was completed.Concomitant devices additionally used: a traxcess (microvention) guidewire, a galaxy g3mini 3×6 coil, a galaxy g3mini 2×4coil and an ied 2×3 coil (kaneka-med).The physician judged the adverse event as serious because bleeding occurred due to the ruptured aneurysm.He further stated that the adverse event cannot be ruled out being related to the procedure because at the time of aneurysm rupture, only the complaint device and the prowler select plus were found near the aneurysm.Therefore, it was probably that the complaint device touched the aneurysm wall when one arch was in the aneurysm during deployment of the complaint device.Physician also commented that it was highly possible that the aneurysm itself was fragile and was likely to be torn because of its distorted shape.Continuous flush was done.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077900504 number, and no non-conformances related to the malfunction were identified.Positioning difficulty and aneurysm perforation are known potential procedural complications associated with endovascular coil embolization of intracranial aneurysms and are listed in the pulserider anrd ifu as such.There are clinical and procedural factors, including aneurysm/vessel characteristics, device selection, device interaction, and operator technique, that may have contributed to the reported event rather than the design or manufacture of the device.However, the treating physician could not rule out the reported adverse event of ¿aneurysm ruptured¿ to be related to the procedure and the complaint device.Since the relationship of the device to the reported event cannot be clearly established, the fact that the adverse event was considered to be serious, the patient required additional medication and implied a modified surgical procedure, the event meets mdr reporting criteria 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 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.

• 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: 16452706
• MDR Text Key: 310345367
• Report Number: 3008114965-2023-00137
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: 3077900504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: 6F BENCHMARK (PENUMBRAINC) CATHETER.; 6F SHUTTLE GS 80CM SHEATH.; GALAXY G3MINI 2×4 COIL.; GALAXY G3MINI 3×6 COIL.; IED 2×3 COIL (KANEKA-MED).; PROWLER SELECT PLUS MICROCATHETER.; SHOURYU 4X10 (KANEKA-MED) BALLOON CATHETER.; SHOURYU BALLOON CATHETER GUIDANCE.; SL-10 45O (STRYKERNEUROVASCULAR) MICROCATHETER.; TRAXCESS (MICROVENTION) GUIDEWIRE.
• Patient Outcome(s): Required Intervention