MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 211-D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thromboembolism (2654)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization of an unruptured aneurysm on the anterior communicating artery (acom), the guiding catheter (gc), an 8f optimo guiding catheter (tokai medical) was guided to the right internal carotid artery (ica) via the right femoral artery (fa) approach.The sofia ¿ 5f distal access catheter (microvention) was guided to the c1 segment of the ica, from which the prowler select plus microcatheter (catalog / lot#: unknown) and a headway® 17 microcatheter (microvention) were inserted.The prowler select plus microcatheter was advanced to the a1 segment ¿ anterior cerebral artery (aca).A pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / lot#: unknown) was implanted in a hybrid position.The headway® 17 microcatheter made the approach toward the aneurysm via trans-cell technique and coil embolization was initiated.The complaint coil, a 4mm x 8cm galaxy g3 xsft (glx120408 / 30701280) was used, but it became protruded to the neck side.The issue was not resolved despite rewinding several times.The coil was removed once from the patient¿s body.The position of the headway® 17 microcatheter i the aneurysm was changed.It was reported that the complaint coil could not be used and be re-sheathed because the introducer sheath had been damaged during the first attempt.A new 4mm x 8cm galaxy g3 xsft (glx120408) was opened and implanted in the aneurysm.After that, additional coils were added, a total of 19 coils (g3, g3 xsft, and g3 mini) were implanted and coil embolization was completed.The pulserider anrd was detached and final contrast imaging was performed.It was at that time that a slight thrombus was confirmed at the a2 segment of the aca.After activating clotting time (act) was measured and confirmed, antiplatelet agent ozagrel was administered intravenously.The physician waited for 15 minutes and confirmed that the thrombus had disappeared, the procedure was deemed completed.It was reported that continuous flush was maintained.There was no post-operative issue / problem detected in the patient.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.Cerebral thrombosis is a known potential adverse event associated with coil embolization procedures.This is a known potential complication associated with the use of the pulserider anrd, embolization coils and endovascular microcatheters and is listed in the instructions for use (ifu) as such.If the anrd does not hold the embolic coils within the aneurysm sac, there could be thrombosis formation, which could then lead to cerebral ischemia.Even though the devices performed as intended, the relationship of these devices to the reported event cannot be excluded.Therefore, 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 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 is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00090 and 3008114965-2023-00092.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.

Event Description

The healthcare professional reported that during a pulserider-assisted coil embolization of an unruptured aneurysm on the anterior communicating artery (acom), the guiding catheter (gc), an 8f optimo guiding catheter (tokai medical) was guided to the right internal carotid artery (ica) via the right femoral artery (fa) approach.The sofia ¿ 5f distal access catheter (microvention) was guided to the c1 segment of the ica, from which the prowler select plus microcatheter (catalog / lot#: unknown) and a headway® 17 microcatheter (microvention) were inserted.The prowler select plus microcatheter was advanced to the a1 segment ¿ anterior cerebral artery (aca).A pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / lot#: unknown) was implanted in a hybrid position.The headway® 17 microcatheter made the approach toward the aneurysm via trans-cell technique and coil embolization was initiated.The complaint coil, a 4mm x 8cm galaxy g3 xsft (glx120408 / 30701280) was used, but it became protruded to the neck side.The issue was not resolved despite rewinding several times.The coil was removed once from the patient¿s body.The position of the headway® 17 microcatheter i the aneurysm was changed.It was reported that the complaint coil could not be used and be re-sheathed because the introducer sheath had been damaged during the first attempt.A new 4mm x 8cm galaxy g3 xsft (glx120408) was opened and implanted in the aneurysm.After that, additional coils were added, a total of 19 coils (g3, g3 xsft, and g3 mini) were implanted and coil embolization was completed.The pulserider anrd was detached and final contrast imaging was performed.It was at that time that a slight thrombus was confirmed at the a2 segment of the aca.After activating clotting time (act) was measured and confirmed, antiplatelet agent ozagrel was administered intravenously.The physician waited for 15 minutes and confirmed that the thrombus had disappeared, the procedure was deemed completed.It was reported that continuous flush was maintained.There was no post-operative issue / problem detected in the patient.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 10-mar-2023.[additional information]: on 10-mar-2023, limited additional information was received.The information indicated that the lot number of the pulserider and could not be obtained; the catalog and lot numbers of the other 18 coils used could not be obtained.There were no issues with the 18 coils.Anonymized images / angiographs of the procedure are not available.The information indicated that the procedure had been completed with the complaint device detached when angiography was taken and the physician noticed the thrombus in the a2 segment.Information related to what the physician thought may have caused the thrombus could not be obtained.E.1: initial reporter phone: (b)(6).This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00090, 3008114965-2023-00091, and 3008114965-2023-00092.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 10-mar-2023.[additional information]: on 10-mar-2023, limited additional information was received.The information indicated that the lot number of the pulserider anrd could not be obtained; the catalog and lot numbers of the other 18 coils used could not be obtained.There were no issues with the 18 coils.Anonymized images / angiographs of the procedure are not available.The information indicated that the procedure had been completed with the complaint device detached when angiography was taken and the physician noticed the thrombus in the a2 segment.Information related to what the physician thought may have caused the thrombus could not be obtained.E.1: initial reporter phone: (b)(6).This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00090, 3008114965-2023-00091, and 3008114965-2023-00092.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.This follow-up report is documented as follow-up number 2 because the follow-up number 1 was not accepted due to a duplicate report.Follow-up number 1 did not pass acknowledgement 1 on 13-mar-2023.The medwatch was reopened for re-submission on 14-mar-2023.A data error was received for duplicate report.

• Brand Name: PULSERIDER T, 3MM, 10MM 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 ; 303552-689
• MDR Report Key: 16368671
• MDR Text Key: 309482953
• Report Number: 3008114965-2023-00091
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 00859030005130
• 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,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 211-D
• Device Catalogue Number: 211D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8F OPTIMO GUIDING CATHETER (TOKAI MEDICAL); HEADWAY® 17 MICROCATHETER (MICROVENTION); MICROCATHETER; SOFIA ¿ 5F DISTAL ACCESS CATHETER (MICROVENTION); SYNCHRO SELECT¿ 14 GUIDEWIRE (STRYKER)
• Patient Outcome(s): Required Intervention