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

Catalog Number 201D

Device Problem Separation Failure (2547)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3070988613 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Event Description

As reported by the field, this was a stent assist coil embolization of a cerebral aneurysm using a 3mm x 8mm pulserider t arch (201d, 3070988613).The lesion was the basilar artery (ba-tip).Preparation, stent placement, and coil embolization were completed smoothly.The prowler select plus microcatheter (unknown product/lot number) for coil was removed to detach the pulserider.The detachment operation was performed asper the instructions for use (ifu).An error sound occurred in the second cycle, therefore, the delivery wire of the pulserider was re-sheathed by the microcatheter.When the microcatheter advanced to the leg marker and the delivery wire was pulled, only one leg of the pulserider was not detached, and the stent migrated.The delivery wire was pushed and the pulserider was successfully lifted.The delivery wire was pulled carefully, and detachment was successful.Although the pulserider was deviated from the initial position, the pulserider was able to be implanted safety, and the procedure was completed.After the pulserider was implanted, the condition of the patient was monitored for about five minutes, but there seemed to be no problem.A continuous flush was done.A guiding catheter (6fr roadmaster, goodman) was used.

Manufacturer Narrative

Product complaint #(b)(4).Section b5: additional information received indicated that the correct size of the device was used based on the ifu.No additional intervention was required.There was no report of any evidence of obstructed blood flow due to the event.The physician did not feel that the prolongation of the procedure was clinically significant.There was no alleged product malfunction with the prowler select.Section e1: initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, this was a stent assist coil embolization of a cerebral aneurysm using a 3mm x 8mm pulserider t arch (201d, 3070988613).The lesion was the basilar artery (ba-tip).Preparation, stent placement, and coil embolization was completed smoothly.The prowler select plus microcatheter (unknown product/lot number) for coil was removed to detach the pulserider.The detachment operation was performed as per the instructions for use (ifu).An error sound occurred in the second cycle, therefore, the delivery wire of the pulserider was re-sheathed by the microcatheter.When the microcatheter advanced to the leg marker and the delivery wire was pulled, only one leg of the pulserider was not detached, and the stent migrated.The delivery wire was pushed and the pulserider was successfully lifted.The delivery wire was pulled carefully, and detachment was successful.Although the pulserider deviated from the initial position, the pulserider was able to be implanted safety, and the procedure was completed.After the pulserider was implanted, the condition of the patient was monitored for about five minutes, there seemed to be no problem.A continuous flush was done.A guiding catheter (6fr roadmaster, goodman) was used.Additional information received indicated that the correct size of the device was used based on the ifu.No additional intervention was required.There was no report of any evidence of obstructed blood flow due to the event.The physician did not feel that the prolongation of the procedure was clinically significant.There was no alleged product malfunction with the prowler select.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3070988613 number, and no non-conformances related to the malfunction were identified.Failure to detach is a known potential failure associated with the use of the device.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Per the pulserider instructions for use (ifu): do not fully deploy and retrieve the implant more than 3 times.Excessive deployment cycles of the anchor section of the pulserider may reduce the radial force of the device which could impact the implant stability.Increased detachment time may occur when the delivery wire and microcatheter markers are not properly positioned, there is improper setup of continuous flush, embolic coils are present, or connections between detachment power supply and delivery wire or patient¿s groin (return electrode) are poor.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 14286851
• MDR Text Key: 299661679
• Report Number: 3008114965-2022-00319
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Device Lot Number: 3070988613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• 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: GUIDING CATHETER (6FR ROADMASTER, GOODMAN); UNKPROWLERSELECT