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

Model Number 201-D

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

Patient Problems Aneurysm (1708); Obstruction/Occlusion (2422)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, age, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.Initial reporter address: (b)(6).[conclusion]: the healthcare professional reported that a male patient underwent a pulserider-assisted coil embolization of an anterior communicating artery and experienced aneurysm perforation during the procedure.It was reported that the pulserider 8t, 2.7 ¿ 3.5mm (201d / 3053447105) aneurysm neck reconstruction device (anrd) was reportedly used in accordance with the instructions for use (ifu).An 8fr roadmaster guiding catheter (goodman) was placed at the internal carotid artery (ica), a dd6 guiding catheter (medikit) was advanced coaxially and implanted at the c4 segment of the ica.A prowler select plus microcatheter (product code & lot number unknown) was placed at the proximal portion of the aneurysm via a synchro guidewire (stryker).The pulserider anrd was inserted an advanced through the microcatheter.While adjusting the direction of the pulserider anrd, the pulserider leaflet pinched the aneurysm bleb resulting in extravasation.Protamine was immediately administered, and blood flow was blocked using a syouryu balloon catheter (kaneka medix).The microcatheter was advanced into the aneurysm.A total of eight optima coils (balt) were used for embolization.Hemostasis was achieved but the contralateral a2 blood flow disappeared.An sl-10® microcatheter (stryker) was delivered to the contralateral a2 and a 4mm x 12mm neuroform atlas® stent (stryker) was implanted.The procedure was completed because blood flow in the a2 segment was confirmed.The patient remains hospitalized.The physician commented that the adverse event is related to the pulserider because the aneurysm bleb was pinched by the pulserider leaflet.The pulserider device is not available for evaluation.On 17 august 2021, additional information was received.The information indicated that at present, there are no major complications.The patient is doing as well.No additional treatment will be provided at present.The physician deemed the event as not serious because the patient has returned to his preoperative state.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (3053447105) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.Aneurysm perforation or rupture and vessel occlusion are known potential adverse events associated with the use of the pulserider anrd in the intracranial arteries and are listed in the ifu as such.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 device and the reported event.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device selection, device manipulation, device interaction, and operator technique that may have contributed to the event rather than the design or manufacture of the device.The treating physician stated that the aneurysm perforation was caused by manipulation of the pulserider leaflet.Furthermore, aneurysm perforation is a serious injury which in this case required emergent medical and surgical intervention and ultimately led to vessel occlusion with the need for stenting to restore blood flow.Thus, 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.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 a male patient underwent a pulserider-assisted coil embolization of an anterior communicating artery and experienced aneurysm perforation during the procedure.It was reported that the pulserider 8t, 2.7 ¿ 3.5mm (201d / 3053447105) aneurysm neck reconstruction device (anrd) was reportedly used in accordance with the instructions for use (ifu).An 8fr roadmaster guiding catheter (goodman) was placed at the internal carotid artery (ica), a dd6 guiding catheter (medikit) was advanced coaxially and implanted at the c4 segment of the ica.A prowler select plus microcatheter (product code & lot number unknown) was placed at the proximal portion of the aneurysm via a synchro guidewire (stryker).The pulserider anrd was inserted an advanced through the microcatheter.While adjusting the direction of the pulserider anrd, the pulserider leaflet pinched the aneurysm bleb resulting in extravasation.Protamine was immediately administered, and blood flow was blocked using a syouryu balloon catheter (kaneka medix).The microcatheter was advanced into the aneurysm.A total of eight optima coils (balt) were used for embolization.Hemostasis was achieved but the contralateral a2 blood flow disappeared.An sl-10® microcatheter (stryker) was delivered to the contralateral a2 and a 4mm x 12mm neuroform atlas® stent (stryker) was implanted.The procedure was completed because blood flow in the a2 segment was confirmed.The patient remains hospitalized.The physician commented that the adverse event is related to the pulserider because the aneurysm bleb was pinched by the pulserider leaflet.The pulserider device is not available for evaluation.On 17 august 2021, additional information was received.The information indicated that at present, there are no major complications.The patient is doing as well.No additional treatment will be provided at present.The physician deemed the event as not serious because the patient has returned to his preoperative state.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 09 september 2021.[additional information]: the healthcare professional reported that a male patient underwent a pulserider-assisted coil embolization of an anterior communicating artery and experienced aneurysm perforation during the procedure.It was reported that the pulserider 8t, 2.7 ¿ 3.5mm (201d / 3053447105) aneurysm neck reconstruction device (anrd) was reportedly used in accordance with the instructions for use (ifu).An 8fr roadmaster guiding catheter (goodman) was placed at the internal carotid artery (ica), a dd6 guiding catheter (medikit) was advanced coaxially and implanted at the c4 segment of the ica.A prowler select plus microcatheter (product code & lot number unknown) was placed at the proximal portion of the aneurysm via a synchro guidewire (stryker).The pulserider anrd was inserted an advanced through the microcatheter.While adjusting the direction of the pulserider anrd, the pulserider leaflet pinched the aneurysm bleb resulting in extravasation.Protamine was immediately administered, and blood flow was blocked using a syouryu balloon catheter (kaneka medix).The microcatheter was advanced into the aneurysm.A total of eight optima coils (balt) were used for embolization.Hemostasis was achieved but the contralateral a2 blood flow disappeared.An sl-10® microcatheter (stryker) was delivered to the contralateral a2 and a 4mm x 12mm neuroform atlas® stent (stryker) was implanted.The procedure was completed because blood flow in the a2 segment was confirmed.The patient remains hospitalized.The physician commented that the adverse event is related to the pulserider because the aneurysm bleb was pinched by the pulserider leaflet.The pulserider device is not available for evaluation.On 17 august 2021, additional information was received.The information indicated that at present, there are no major complications.The patient is doing as well.No additional treatment will be provided at present.The physician deemed the event as not serious because the patient has returned to his preoperative state.On 09 september 2021, additional information was received.Per the information received, anonymized procedural films / images are not available.The reason for the blood flow reduction is not clear, but the placement of the 4mm x 12mm neuroform atlas stent at the lesion site resulted in confirmation of blood flow.At the last information follow-up, the patient¿s status has improved but the patient is still in the hospital.The physician did not encounter any positioning issue with the pulserider anrd; no malfunction nor issue have been reported.The device was removed from the patient without any additional intervention.The procedure was completed when the sl-10 microcatheter (stryker) was delivered to the contralateral a2 segment and the 4mm x 12mm neuroform atlas stent was implanted.Blood flow in the a2 segment was confirmed.There is no additional intervention required nor planned, as no malfunction nor issue has been reported.Aneurysm perforation or rupture and vessel occlusion are known potential adverse events associated with the use of the pulserider anrd in the intracranial arteries and are listed in the ifu as such.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 device and the reported event.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device selection, device manipulation, device interaction, and operator technique that may have contributed to the event rather than the design or manufacture of the device.The treating physician stated that the aneurysm perforation was caused by manipulation of the pulserider leaflet.Furthermore, aneurysm perforation is a serious injury which in this case required emergent medical and surgical intervention and ultimately led to vessel occlusion with the need for stenting to restore blood flow.The event also led to prolongation of existing hospitalization.Thus, 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.E.1: the 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
• MDR Report Key: 12385222
• MDR Text Key: 269747437
• Report Number: 3008114965-2021-00389
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (y/n): N
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3053447105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4MM X 12MM NEUROFORM ATLAS® STENT (STRYKER); 8FR ROADMASTER GUIDING CATHETER (GOODMAN); DD6 GUIDING CATHETER (MEDIKIT); MICROCATHETER; SL-10® MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); SYOURYU BALLOON CATHETER (KANEKA MEDIX)
• Patient Outcome(s): Life Threatening; Required Intervention