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 Headache (1880); Ruptured Aneurysm (4436)

Event Date 06/21/2022

Event Type  Injury  

Event Description

The healthcare professional reported that during a coil embolization procedure targeting a basilar artery aneurysm, the 36-year-old female patient experienced a ruptured aneurysm.Details of the procedure is as follows: a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3070988613) was used at the bifurcation aneurysm.The orientation of the pulserider was adjusted several times for deployment at the target lesion, and the pulserider anrd was deployed in the appropriate orientation via a prowler select plus microcatheter (catalog and lot# unknown).When contrast agent was used for flow confirmation, it was confirmed that there was a rupture in the aneurysm and the inflow into the extravascular space.The coil(s) was implanted and the clinical course was monitored, and the procedure was completed.A continuous flush was maintained through the microcatheter.It was reported that the patient did not experience serious symptoms, only a mild headache remained.At the time of the complaint initiation, the patient was still hospitalized.There were no problems after the procedure.Additional medical treatment was not performed during the procedure.No further treatment is planned.Per the physician¿s opinion on possible causes of the aneurysm rupture other than the pulserider anrd are the guidewire, a chikai black 14 guidewire (asahi-intecc) and the microcatheter.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(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 available / reported.[conclusion]: the healthcare professional reported that during a coil embolization procedure targeting a basilar artery aneurysm, the 36-year-old female patient experienced a ruptured aneurysm.Details of the procedure is as follows: a pulserider t 3mm, 8mm arch aneurysm neck reconstruction device (anrd) (201d / 3070988613) was used at the bifurcation aneurysm.The orientation of the pulserider was adjusted several times for deployment at the target lesion, and the pulserider anrd was deployed in the appropriate orientation via a prowler select plus microcatheter (catalog and lot# unknown).When contrast agent was used for flow confirmation, it was confirmed that there was a rupture in the aneurysm and the inflow into the extravascular space.The coil(s) was implanted and the clinical course was monitored, and the procedure was completed.A continuous flush was maintained through the microcatheter.It was reported that the patient did not experience serious symptoms, only a mild headache remained.At the time of the complaint initiation, the patient was still hospitalized.There were no problems after the procedure.Additional medical treatment was not performed during the procedure.No further treatment is planned.Per the physician¿s opinion on possible causes of the aneurysm rupture other than the pulserider anrd are the guidewire, a chikai black 14 guidewire (asahi-intecc) and the microcatheter.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3070988613) 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.Aneurysm perforation or rupture and headaches are known complications associated with the use of the pulse rider device and are mentioned in the instructions for use (ifu) as such.Both the pulse rider and the prowler devices performed as intended and no new patient consequences have occurred related to the use of the devices.However, the relationship between the pulse rider, the prowler, and the reported event cannot be excluded.Per the physician¿s opinion, ¿possible causes, other than the pulse rider device, are the guidewire and the microcatheter¿.Therefore, the event will be conservatively reported to the fda with the classification of ¿serious injury.¿ 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00464.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: 14958042
• MDR Text Key: 295505618
• Report Number: 3008114965-2022-00463
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3070988613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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: CHIKAI BLACK 14 GUIDEWIRE (ASAHI-INTECC); MICROCATHETER
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 36 YR
• Patient Sex: Female