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

Model Number 201-D

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problems Aneurysm (1708); Intracranial Hemorrhage (1891)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that the 50-year-old female patient underwent a stent-assisted coil embolization procedure targeting an aneurysm on the middle cerebral artery (mca), a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3077440213) was used.After delivery of an 8fr asahi fubuki guide catheter (asahi intecc) to the origin of the internal carotid artery, a sofia¿ 6f intermediate catheter (microvention), a phenom¿ 21 microcatheter (medtronic) for the delivery of the pulserider anrd, and an sl-10® microcatheter (stryker) for coil embolization were delivered to the m1 segment of the mca.Information related to the aneurysm dimensions and characteristics were not provided.To deploy the pulserider anrd, the phenom 21 microcatheter was delivered to the proximal aneurysm and the pulserider anrd was retrogradely deployed.As the pulserider anrd faced improper orientation, adjustment with the torque device was repeated three times.It was reported that because the pulserider anrd faced proper orientation on the fourth time, the pulserider anrd was deployed.Angiography was performed to confirm whether the pulserider anrd was implanted outside the aneurysm on the m2 segment; it was found that both arches of the pulserider anrd had penetrated the aneurysm.At this point, it was also observed that the patient had suffered a subarachnoid hemorrhage (sah).Since there was a concern that bleeding would increase if the complaint pulse rider was removed, protamine was administered, the pulserider anrd was fixed without being detached.A 4fr asahi fubuki guide catheter (asahi intecc) was delivered from the contralateral femoral to the internal carotid artery, from which a 4mm x 10mm shoryu balloon catheter (kaneka medix) was inflated within the m1 to attempt to achieve hemostasis.However, since sufficient hemostasis was not achieved, the physician attempted to perform coil embolization by detaching the pulserider anrd.It was then that the physician noticed that the pulserider anrd had migrated to the m1.It was reported in the complaint that ¿this might have been caused by placing someone¿s hand(s) on the delivery wire of the complaint pulse rider when other procedure was being performed.¿ the pulserider anrd was removed from the patient and hemostasis was attempted again using the shoryu balloon catheter.It was also mentioned that because the aneurysm neck was wide, simple coil embolization was judged to be difficult to execute.In order to place a neuroform atlas® stent system (stryker), an sl-10® microcatheter was delivered to m2 and the stent deployed.Angiography was performed and imaging beyond m1 proximal was not possible to be observed; it was mentioned that this was probably due to the prolonged hemostasis time with the shoryu balloon catheter.Protamine was administered again and imaging was performed several times, but blood vessels were beyond m1 proximal were not visualized.At this time at the discretion of the attending physician, the patient was sent to the operation room with the shoryu balloon catheter inflated; the patient underwent craniotomy and aneurysm clipping surgery.The event was considered serious.Patient has been hospitalized and her current condition is unknown.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3077440213) 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.Positioning difficulty, aneurysm perforation or rupture and subarachnoid hemorrhage 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 devices and the aneurysm perforation or rupture.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 and subarachnoid hemorrhage are considered a serious injury and the relationship of the devices to the aneurysm perforation cannot be clearly established, the event meets mdr reporting criteria.Moreover, the alleged device failure required additional surgical intervention both by the use of additional devices as well as conversion to open surgery to perform aneurysm clipping.The file will be re-reviewed if additional information is received at a later date.With the information available and without the complaint product available to be returned for analysis, the reported device 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.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.

Event Description

The healthcare professional reported that the 50-year-old female patient underwent a stent-assisted coil embolization procedure targeting an aneurysm on the middle cerebral artery (mca), a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3077440213) was used.After delivery of an 8fr asahi fubuki guide catheter (asahi intecc) to the origin of the internal carotid artery, a sofia¿ 6f intermediate catheter (microvention), a phenom¿ 21 microcatheter (medtronic) for the delivery of the pulserider anrd, and an sl-10® microcatheter (stryker) for coil embolization were delivered to the m1 segment of the mca.Information related to the aneurysm dimensions and characteristics were not provided.To deploy the pulserider anrd, the phenom 21 microcatheter was delivered to the proximal aneurysm and the pulserider anrd was retrogradely deployed.As the pulserider anrd faced improper orientation, adjustment with the torque device was repeated three times.It was reported that because the pulserider anrd faced proper orientation on the fourth time, the pulserider anrd was deployed.Angiography was performed to confirm whether the pulserider anrd was implanted outside the aneurysm on the m2 segment; it was found that both arches of the pulserider anrd had penetrated the aneurysm.At this point, it was also observed that the patient had suffered a subarachnoid hemorrhage (sah).Since there was a concern that bleeding would increase if the complaint pulse rider was removed, protamine was administered, the pulserider anrd was fixed without being detached.A 4fr asahi fubuki guide catheter (asahi intecc) was delivered from the contralateral femoral to the internal carotid artery, from which a 4mm x 10mm shoryu balloon catheter (kaneka medix) was inflated within the m1 to attempt to achieve hemostasis.However, since sufficient hemostasis was not achieved, the physician attempted to perform coil embolization by detaching the pulserider anrd.It was then that the physician noticed that the pulserider anrd had migrated to the m1.It was reported in the complaint that ¿this might have been caused by placing someone¿s hand(s) on the delivery wire of the complaint pulse rider when other procedure was being performed.¿ the pulserider anrd was removed from the patient and hemostasis was attempted again using the shoryu balloon catheter.It was also mentioned that because the aneurysm neck was wide, simple coil embolization was judged to be difficult to execute.In order to place a neuroform atlas® stent system (stryker), an sl-10® microcatheter was delivered to m2 and the stent deployed.Angiography was performed and imaging beyond m1 proximal was not possible to be observed; it was mentioned that this was probably due to the prolonged hemostasis time with the shoryu balloon catheter.Protamine was administered again and imaging was performed several times, but blood vessels were beyond m1 proximal were not visualized.At this time at the discretion of the attending physician, the patient was sent to the operation room with the shoryu balloon catheter inflated; the patient underwent craniotomy and aneurysm clipping surgery.The event was considered serious.Patient has been hospitalized and her current condition is unknown.Another concomitant device mentioned was a synchro soft guidewire (stryker).It was reported that when additional information is available, it will be reported.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 22-dec-2022.[additional information]: on 22-dec-2022, additional information was received.The information indicated that the patient is not in good condition and she has not been discharged from the hospital.The outcoming of the craniotomy and aneurysm clipping procedure is that the patient is not in good condition.The information indicated that the size of the pulserider anrd is correct and was selected based on the instructions for use (ifu).E.1: initial reporter phone: (b)(6).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): 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: 15955380
• MDR Text Key: 305494582
• Report Number: 3008114965-2022-00817
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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: 3077440213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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: 4FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC); 4MM X 10MM SHORYU BALLOON CATHETER (KANEKA MEDIX); 8FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC); NEUROFORM ATLAS® STENT SYSTEM (STRYKER); PHENOM¿ 21 MICROCATHETER (MEDTRONIC); SL-10® MICROCATHETER (STRYKER); SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION); SYNCHRO SOFT GUIDEWIRE (STRYKER)
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female