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

Model Number	201-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	12/05/2022
Type of Reportable Event	Death
Additional 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.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 or Problem Description
It was reported from a personal interaction that during an endovascular embolization of an anterior communicating artery (acom) aneurysm on a female patient performed on (b)(6) 2022, while deploying a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3077900503) aneurysm neck reconstruction device (anrd), a perforation of acom branch vessels and subarachnoid hemorrhage has occurred.It was described that a phenom 21 microcatheter was delivered to the vicinity of the aneurysm neck, and the complaint pulse rider was deployed.At first, hybrid placement was planned, but when the complaint device was repeatedly taken in and out between the anterior cerebral artery (aca) a2 segment and the acom, the procedure was changed to proceed with an extra-aneurysm placement.When contrast imaging was done, it was confirmed that bleeding occurred from around the pulse rider leaflet of the acom.After that, reversal of the heparin was performed and waited for 5 minutes.It was stated that both aneurysm and acom bleeding point were embolized by introducing a microcatheter (unknown device details) for coil (unknown device details) deployment.It was referred that coil embolization for the aneurysm and the bleeding point was completed.Subsequently, the complaint pulse rider was detached, and procedure was deemed completed.It was stated that there was no change in the patient's condition during procedure.A control magnetic resonance angiography (mra) performed on (b)(6) 2022 and an additional mra is scheduled to happen in the future.No additional details or reports were provided.The physician considered the adverse events reported to be related to the complaint device with the following rationale: ¿as a factor causing this event, when extra was placed for a2 and a-com (thinner than usual), the leaflet developed to a2 without any problem, and the other leaflet might have been slightly caught by a-com.Under the circumstances, since the complaint pulse rider was brought close to the neck, when the entire pulse rider¿s system was pressed, force was applied to the a-com, possibly causing bleeding.¿ continuous flush was done.It was stated that the anrd device was prepped and used as per the instructions for use (ifu).It was reported that the patient has been hospitalized.Her current health status is not known.No further information was provided at the time of complaint initiation.Other concomitant devices used during the procedure: a chikai guidewire (unknown device details) and a prdsacd detachment device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information was received indicating that a microcatheter (headway duo/0000154663) and a coil (hydrosoft 3d 2×8 / 2001205x6) were used.There was no alleged product malfunction with the pulserider.Complaint conclusion: it was reported from a personal interaction that during an endovascular embolization of an anterior communicating artery (acom) aneurysm on a female patient performed on (b)(6) 2022, while deploying a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3077900503) aneurysm neck reconstruction device (anrd), a perforation of acom branch vessels and subarachnoid hemorrhage has occurred.It was described that a phenom 21 microcatheter was delivered to the vicinity of the aneurysm neck, and the complaint pulse rider was deployed.At first, hybrid placement was planned, but when the complaint device was repeatedly taken in and out between the anterior cerebral artery (aca) a2 segment and the acom, the procedure was changed to proceed with an extra-aneurysm placement.When contrast imaging was done, it was confirmed that bleeding occurred from around the pulse rider leaflet of the acom.After that, a reversal of the heparin was performed, and waited for 5 minutes.It was stated that both aneurysm and acom bleeding points were embolized by introducing a microcatheter (unknown device details) for coil (unknown device details) deployment.It was referred that coil embolization for the aneurysm and the bleeding point was completed.Subsequently, the complaint pulse rider was detached, and the procedure was deemed completed.It was stated that there was no change in the patient's condition during the procedure.A control magnetic resonance angiography (mra) was performed on (b)(6) 2022 and an additional mra is scheduled to happen in the future.No additional details or reports were provided.The physician considered the adverse events reported to be related to the complaint device with the following rationale: ¿as a factor causing this event, when extra was placed for a2 and a-com (thinner than usual), the leaflet developed to a2 without any problem, and the other leaflet might have been slightly caught by a-com.Under the circumstances, since the complaint pulse rider was brought close to the neck when the entire pulse rider¿s system was pressed, the force was applied to the a-com, possibly causing bleeding.¿ continuous flush was done.It was stated that the anrd device was prepped and used as per the instructions for use (ifu).It was reported that the patient has been hospitalized.Her current health status is not known.No further information was provided at the time of complaint initiation.Other concomitant devices used during the procedure: a chikai guidewire (unknown device details) and a prdsacd detachment device.A microcatheter (headway duo/0000154663) and a coil (hydrosoft 3d 2×8 / 2001205x6) were used.There was no alleged product malfunction with the pulserider.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077900503 number, and no non-conformances related to the malfunction were identified.Subarachnoid hemorrhage and 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.However, 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.Since there was the need for additional surgical intervention (additional acom) coiling and medication (heparin antagonism) and the physician considered the reported event to be related to the complaint device, 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b2, b4, b5, g3, g4, g6, h1, h2, h6 and h10.Section b5: additional information was received on 23-jan-2023.Summary of additional information provided: there was a re-bleeding and the patient died at the end of the last year.This is considered mdr reportable as a ¿death¿.The file will be re-reviewed if additional information is received at a later date.
Additional Manufacturer Narrative
Product complaint (b)(4).Section e1.Initial reporter phone: (b)(6).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077900503 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.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• Common Device Name: 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: 16003821
• Report Number: 3008114965-2022-00859
• Device Sequence Number: 5620439
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H160002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3077900503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 01/11/2023; 01/24/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/10/2023; 01/18/2023; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHIKAI GUIDEWIRE; HEADWAY DUO/0000154663 MICROCATHETER; HYDROSOFT 3D 2×8 / 2001205X6; PHENOM 21 MICROCATHETER; PRDSACD DETACHMENT DEVICE; UNSPECIFIED COIL; UNSPECIFIED MICROCATHETER
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Female