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

Model Number 211-D

Device Problems Positioning Failure (1158); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during the pulserider-assisted procedure with the target lesion being a bifurcating anterior communicating artery (acom) aneurysm with severe vessel tortuosity at the proximal region, the pulserider t, 3mm, 10 mm arch aneurysm neck reconstruction device (anrd) (211d / 3051697717) did not orientate / position as the physician intended.Torque was applied and the pulserider anrd was retracted many times, but it did not position well.It was reported that the pulserider anrd fully deployed outside the lesion twice.It appeared to be twisted at the body and leg part when it deployed the second time.The physician stopped using the pulserider anrd.It was reported that the procedure was completed ¿by making y-stent¿ with two 21mm neuroform atlas stents (stryker).There was no report of any patient adverse event / complication.The complaint device is reported as not available to be returned for evaluation and analysis.

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.[conclusion]: the healthcare professional reported that during the pulserider-assisted procedure with the target lesion being a bifurcating anterior communicating artery (acom) aneurysm with severe vessel tortuosity at the proximal region, the pulserider t, 3mm, 10 mm arch aneurysm neck reconstruction device (anrd) (211d / 3051697717) did not orientate / position as the physician intended.Torque was applied and the pulserider anrd was retracted many times, but it did not position well.It was reported that the pulserider anrd fully deployed outside the lesion twice.It appeared to be twisted at the body and leg part when it deployed the second time.The physician stopped using the pulserider anrd.It was reported that the procedure was completed ¿by making y-stent¿ with two 21mm neuroform atlas stents (stryker).There was no report of any patient adverse event / complication.The complaint device is reported as not available to be returned for evaluation and analysis.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (3051697717) 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 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 provided in the complaint and without the product available for analysis, the reported issues by the customer cannot be confirmed.Based on the review of the manufacturing documentation, 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.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 (b)(6) 2021.[additional information]: the healthcare professional reported that during the pulserider-assisted procedure with the target lesion being a bifurcating anterior communicating artery (acom) aneurysm with severe vessel tortuosity at the proximal region, the pulserider t, 3mm, 10 mm arch aneurysm neck reconstruction device (anrd) (211d / 3051697717) did not orientate / position as the physician intended.Torque was applied and the pulserider anrd was retracted many times, but it did not position well.It was reported that the pulserider anrd fully deployed outside the lesion twice.It appeared to be twisted at the body and leg part when it deployed the second time.The physician stopped using the pulserider anrd.It was reported that the procedure was completed ¿by making y-stent¿ with two 21mm neuroform atlas stents (stryker).There was no report of any patient adverse event / complication.The complaint device is reported as not available to be returned for evaluation and analysis.On (b)(6) 2021, additional information was received.The information confirmed that the procedure was targeting a bifurcating anterior communicating artery (acom).It is unknown if 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 pulserider device was removed.It is unknown if the device or concomitant devices appeared damaged.Repositioning was needed and the implant was retracted within the microcatheter.The device could not be torqued as intended, and as a result, the physician gave up trying to use the device and the device was removed from the patient.The microcatheter was not removed with the pulserider device.(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, 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
• MDR Report Key: 12321023
• MDR Text Key: 280688542
• Report Number: 3008114965-2021-00360
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 00859030005130
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 211-D
• Device Catalogue Number: 211D
• Device Lot Number: 3051697717
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PULSERIDER ACCESSORY CABLES