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

Catalog Number 201D

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Ischemia Stroke (4418)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Lot ¿ the lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The company is seeking this information through the event investigation.

Event Description

It was reported via post-market studies that on (b)(6) 2022 an (b)(6) patient with no history of brain or neurologic surgery, underwent coil embolization using a pulserider t, 3mm, 8mm arch (product code: 201d) to treat an unruptured aneurysm in the right middle cerebral artery (mca).The pulserider was successfully placed where one wing was deployed in the cerebral aneurysm.The concomitant device used was an exselsior sl10 microcatheter.It is unknown if a continuous flush was done.On (b)(6) 2022 the patient experienced a cerebral infarction on the same side as the target cerebral aneurysm.The stroke occurred in the perfusion area of the implanted vessel.No medical treatment was given.Failure to maintain the coil mass was due to the reported adverse event.On (b)(6) 2022, the patient recovered, but there was an unspecified sequela.The patient¿s nihss score was 8 points in total.The physician assessed the event as serious due to unspecified sequela.A causal relationship with the device can be denied.A causal relationship to the procedure cannot be denied.Additional information was received on (b)(6) 2022 indicated that the patient¿s baseline neurological status was mrs score= 2.On (b)(6) 2022 and the nihss score= 0.On (b)(6) 2022.The target aneurysm had the following characteristics: neck size was 4.7, parent artery diameter was 3.1, height was 6.3, the width was 9.2, and the neck to dome ratio was 1.6.The symptom associated with the cerebral infarction was an nihss score of 5a= 4, 6a= 3 and the total score was 8.The physician suspected the cause that contributed to the cerebral infarction was the procedure.It¿s unknown if the cerebral infarction required prolongation of the existing hospitalization.The current status of the patient including the date of hospital discharge is also unknown.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported via post-market studies that on (b)(6) 2022 an 87-year-old patient with no history of brain or neurologic surgery, underwent coil embolization using a pulserider t, 3mm, 8mm arch (product code: 201d) to treat an unruptured aneurysm in the right middle cerebral artery (mca).The pulserider was successfully placed where one wing was deployed in the cerebral aneurysm.The concomitant device used was an exselsior sl10 microcatheter.It is unknown if a continuous flush was done.On (b)(6) 2022 the patient experienced a cerebral infarction on the same side as the target cerebral aneurysm.The stroke occurred in the perfusion area of the implanted vessel.No medical treatment was given.Failure to maintain the coil mass was due to the reported adverse event.On (b)(6) 2022, the patient recovered, but there was an unspecified sequela.The patient¿s nihss score was 8 points in total.The physician assessed the event as serious due to unspecified sequela.A causal relationship with the device can be denied.A causal relationship to the procedure cannot be denied.Additional information was received on 19-may-2022 indicating that the patient¿s baseline neurological status was mrs score= 2 on (b)(6) 2022 and the nihss score= 0 on (b)(6) 2022.The target aneurysm had the following characteristics: neck size was 4.7, parent artery diameter was 3.1, height was 6.3, the width was 9.2, and the neck to dome ratio was 1.6.The symptom associated with the cerebral infarction was an nihss score of 5a= 4, 6a= 3 and the total score was 8.The physician suspected the cause that contributed to the cerebral infarction was the procedure.It¿s unknown if the cerebral infarction required prolongation of the existing hospitalization.The current status of the patient including the date of hospital discharge is also unknown.The device remains implanted; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Infarction and neurological sequelae are known potential complications associated with the use of the pulserider anrd and are listed in the instructions for use (ifu) as such.If the anrd does not hold the embolic coils within the aneurysm sack, there could be thrombosis formation, which could lead to cerebral ischemia.With the amount of information, it is not possible to draw a clinical conclusion between the device and the reported events.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.Furthermore, the relationship of the pulserider anrd to the reported event cannot be excluded.Thus, the event is considered serious and mdr reportable.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 were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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: 14496344
• MDR Text Key: 292608564
• Report Number: 3008114965-2022-00371
• Device Sequence Number: 1
• Product Code: NJE
• 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,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 87 YR