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

Catalog Number 201D

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

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

Event Date 03/23/2022

Event Type  Injury  

Event Description

The healthcare professional reported that a (b)(6) year-old male patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an anterior communicating artery (acom) aneurysm and experienced slight bleeding during the procedure.The procedure was interrupted.Post-operative computed tomography (ct) scan is scheduled.No additional procedures have been performed nor are planned.The patient has reportedly been in stable condition.Because the bleeding was slight, the treating physician considered it mild in severity.Per the treating physician: "when i tried to re-sheath the pulserider for alignment place at the time of the pulserider deployment, the microcatheter was being advanced as the leaf part was kept deployed, which may have stimulated the inside of the aneurysm.¿ details of the procedure is as following: the asahi fubuki guide catheter (asahi intecc), distal access catheter (dac) (size / brand not specified), and the prowler select plus microcatheter (product code / lot# unknown) were advanced, and the pulserider 8t, 2.7 - 3.5mm anrd (201d / lot# unknown) was deployed.When the position of the complaint device was being adjusted, the microcatheter was being advanced as the leaf part was kept deployed.At that time, there was no issue during pulserider deployment.However, slight bleeding was confirmed when the fourth coil (size / brand not specified) was inserted.It was reported that a continuous flush was not done.It was reported that the complaint pulserider anrd is not available to be returned for evaluation.On 27-mar-2022, additional information was received.The lot number of the pulserider device is 3070988606.No information is available related to the type of bleed experienced by the patient nor of the source of the bleed.The procedure was stopped and computed tomography (ct) scan was performed when the slight bleed was observed.The pulserider device was implanted; there was no device performance issue or malfunction associated with the pulserider anrd.The size and brand of the fourth coil is not available; but the fourth coil was implanted when the procedure was interrupted.There was no mention from the physician whether the prowler select plus microcatheter was suspected to be involved in the reported bleed.On 31-mar-2022, additional information was received.The information indicated that the patient experienced a subarachnoid bleed.The physician¿s assumption is that when the pulserider device was deployed in the aneurysm, the leaflet was pushed down while the device was opening and stimulation was made at this time.No medical / surgical intervention was required nor performed to address the slight bleed.The physician did not suspect any involvement of the prowler select plus microcatheter (an incomplete lot number was provided: 3025997).There was device performance issue / malfunction associated with the pulserider; the physician moved the leaflet forward while keeping it open during the alignment.The following coils were used during the procedure: a 3.5mm x 7.5cm g3 xsft, a 2.5mm x 4cm g3 mini, a 2.5mm x 4.5cm g3 mini, and a 2mm x 3cm g3 mini.The information indicated that the fourth coil was not able to be inserted, as a result, it was removed and not implanted as previously reported.The physician does not think the fourth coil may have contributed to the reported bleed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not provided / reported.[conclusion]: the healthcare professional reported that a (b)(6) year-old male patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an anterior communicating artery (acom) aneurysm and experienced slight bleeding during the procedure.The procedure was interrupted.Post-operative computed tomography (ct) scan is scheduled.No additional procedures have been performed nor are planned.The patient has reportedly been in stable condition.Because the bleeding was slight, the treating physician considered it mild in severity.Per the treating physician: "when i tried to re-sheath the pulserider for alignment place at the time of the pulserider deployment, the microcatheter was being advanced as the leaf part was kept deployed, which may have stimulated the inside of the aneurysm.¿ details of the procedure is as following: the asahi fubuki guide catheter (asahi intecc), distal access catheter (dac) (size / brand not specified), and the prowler select plus microcatheter (product code / lot# unknown) were advanced, and the pulserider 8t, 2.7 - 3.5mm anrd (201d / lot# unknown) was deployed.When the position of the complaint device was being adjusted, the microcatheter was being advanced as the leaf part was kept deployed.At that time, there was no issue during pulserider deployment.However, slight bleeding was confirmed when the fourth coil (size / brand not specified) was inserted.It was reported that a continuous flush was not done.It was reported that the complaint pulserider anrd is not available to be returned for evaluation.On 27-mar-2022, additional information was received.The lot number of the pulserider device is 3070988606.No information is available related to the type of bleed experienced by the patient nor of the source of the bleed.The procedure was stopped and computed tomography (ct) scan was performed when the slight bleed was observed.The pulserider device was implanted; there was no device performance issue or malfunction associated with the pulserider anrd.The size and brand of the fourth coil is not available; but the fourth coil was implanted when the procedure was interrupted.There was no mention from the physician whether the prowler select plus microcatheter was suspected to be involved in the reported bleed.On 31-mar-2022, additional information was received.The information indicated that the patient experienced a subarachnoid bleed.The physician¿s assumption is that when the pulserider device was deployed in the aneurysm, the leaflet was pushed down while the device was opening and stimulation was made at this time.No medical / surgical intervention was required nor performed to address the slight bleed.The physician did not suspect any involvement of the prowler select plus microcatheter (an incomplete lot number was provided: 3025997).There was device performance issue / malfunction associated with the pulserider; the physician moved the leaflet forward while keeping it open during the alignment.The following coils were used during the procedure: a 3.5mm x 7.5cm g3 xsft, a 2.5mm x 4cm g3 mini, a 2.5mm x 4.5cm g3 mini, and a 2mm x 3cm g3 mini.The information indicated that the fourth coil was not able to be inserted, as a result, it was removed and not implanted as previously reported.The physician does not think the fourth coil may have contributed to the reported bleed.Note: the pulserider instructions for use (ifu) warns the following: do not attempt to torque or rotate the device with the distal section deployed.Torquing the device with the implant deployed and engaged in the vasculature may result in fracture of the device which could make removal difficult or impossible and may cause vessel damage or dissection.The ifu also states that a continuous heparinized saline flush should be maintained through the microcatheter using the rhv side port.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3070988606) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, we are closing this investigation.Subarachnoid hemorrhage secondary to aneurysm perforation is a condition which can cause permanent damage/death or may require additional intervention to preclude permanent damage/death.Furthermore, the relationship of the pulserider anrd to the reported event cannot be excluded.Therefore, this event is considered serious and mdr reportable.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.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.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14079426
• MDR Text Key: 293365175
• Report Number: 3008114965-2022-00236
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 859030005154
• 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
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Device Lot Number: 3070988606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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: 4F CERULEAN INTERMEDIATE CATHETER (MEDIKIT); ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC); MICROCATHETER; TRAXCESS® GUIDEWIRE (TERUMO)
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male