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

Model Number	201-D
Medical Device Problem Codes	Positioning Failure (1158); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a pulserider-assisted coil embolization of a ruptured anterior communicating artery (acom) aneurysm, an approach was made from the right femoral artery with a 9f sheath.A 9f optimo¿ balloon guide catheter (tokai medical) was advanced toward the left internal carotid artery (ica).From there, a sofia¿ 6f intermediate catheter (microvention) was advanced to the left anterior cerebral artery (aca)-a1 segment.From this route, a prowler select plus microcatheter was advanced to the front of the aneurysm on the acom, and the complaint product, a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3060357804) was inserted for implant.The pulserider andr was advanced, but the direction of the leaflet did not fit.After changing the direction about five times, the device was deployed as intended and the pulserider was implanted.The prowler select plus microcatheter was lowered to the detach point, but the marker of the leg did not open well (only about half of the blood vessel opened), and there is a possibility that the delivery wire was entangled and not being able to detach.Therefore, the microcatheter was removed and in considering the deployment condition of the leaflet, the physician changed the pulserider t 3mm, 8mm arch anrd to the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d).The direction was changed about three times, but the leg was firmly opened unlike the pulserider t 3mm, 8mm arch anrd and continued with the procedure.It was reported that a continuous flush was maintained through the microcatheter.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.Initial reporter address line 1: (b)(6).[conclusion]: the healthcare professional reported that during a pulse rider-assisted coil embolization of a ruptured anterior communicating artery (acom) aneurysm, an approach was made from the right femoral artery with a 9f sheath.A 9f optimo¿ balloon guide catheter (tokai medical) was advanced toward the left internal carotid artery (ica).From there, a sofia¿ 6f intermediate catheter (microvention) was advanced to the left anterior cerebral artery (aca)-a1 segment.From this route, a prowler select plus microcatheter was advanced to the front of the aneurysm on the acom, and the complaint product, a pulse rider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3060357804) was inserted for implant.The pulse rider andr was advanced, but the direction of the leaflet did not fit.After changing the direction about five times, the device was deployed as intended and the pulse rider was implanted.The prowler select plus microcatheter was lowered to the detach point, but the marker of the leg did not open well (only about half of the blood vessel opened), and there is a possibility that the delivery wire was entangled and not being able to detach.Therefore, the microcatheter was removed and in considering the deployment condition of the leaflet, the physician changed the pulse rider t 3mm, 8mm arch anrd to the pulse rider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d).The direction was changed about three times, but the leg was firmly opened unlike the pulse rider t 3mm, 8mm arch anrd and continued with the procedure.It was reported that a continuous flush was maintained through the microcatheter.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (3060357804) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.With the information available and without the product available for analysis, the reported issue documented in the complaint could not 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, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 05-jan-2022.[additional information]: the healthcare professional reported that during a pulserider-assisted coil embolization of a ruptured anterior communicating artery (acom) aneurysm, an approach was made from the right femoral artery with a 9f sheath.A 9f optimo¿ balloon guide catheter (tokai medical) was advanced toward the left internal carotid artery (ica).From there, a sofia¿ 6f intermediate catheter (microvention) was advanced to the left anterior cerebral artery (aca)-a1 segment.From this route, a prowler select plus microcatheter was advanced to the front of the aneurysm on the acom, and the complaint product, a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3060357804) was inserted for implant.The pulserider andr was advanced, but the direction of the leaflet did not fit.After changing the direction about five times, the device was deployed as intended and the pulserider was implanted.The prowler select plus microcatheter was lowered to the detach point, but the marker of the leg did not open well (only about half of the blood vessel opened), and there is a possibility that the delivery wire was entangled and not being able to detach.Therefore, the microcatheter was removed and in considering the deployment condition of the leaflet, the physician changed the pulserider t 3mm, 8mm arch anrd to the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d).The direction was changed about three times, but the leg was firmly opened unlike the pulserider t 3mm, 8mm arch anrd and continued with the procedure.It was reported that a continuous flush was maintained through the microcatheter.There was no report of any patient adverse event or complication.On 05-jan-2022, additional information was received.The information indicated that the target was a 4mm x 9mm wide bowl-shaped aneurysm with a 7.5mm neck.The vessel was moderately tortuous, range of general tortuosity.The device and the microcatheter were carefully advanced as a unit until the microcatheter tip was positioned just proximal to the aneurysm neck and at the level of the vessel bifurcation.The delivery wire and the microcatheter were gently pulled back until the excess slack was removed and the tip of the microcatheter began to move.The implant was deployed with the distal arch section position in alignment with the branch arteries.It was verified that the implant was fully deployed by confirming that the delivery wire marker was distal to the microcatheter tip marker.The information indicated that there may be some flexibility in the a1, but the degree of opening was clearly different from the 211d device.¿even if there was a spasm, it does not seem that the spasm was released during the time that the product was placed with the substitute (it was about 10 minutes).¿ there was no report that the device appeared damaged.There was no blood flow restriction / reduction as a result of the reported issue.The event did not result in a clinically significant delay in the procedure.E.1: the initial reporter phone:(b)(6).The initial reporter email address is not available / reported.Updated sections: b.4, e.1, e.3, g.3, g.6.H.2, and h.10.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
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13019539
• Report Number: 3008114965-2021-00610
• Device Sequence Number: 4803717
• Product Code: NJE
• UDI-Device Identifier: 00609960000893
• UDI-Public: 00609960000893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: H160002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3060357804
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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: 9F OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL); MICROCATHETER; SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION)
• Patient Sex: Unknown