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

Model Number 201-D

Device Problem Positioning Failure (1158)

Patient Problem Ischemia Stroke (4418)

Event Date 07/14/2021

Event Type  Injury  

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 the patient underwent a pulserider-assisted coil embolization of an aneurysm on the middle cerebral artery (mca) and developed paralysis after the procedure.The patient was discharged from the hospital after the paralysis had improved.The pulserider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3054562207) was used in accordance with the instructions for use (ifu), but the device was difficult to place and repeatedly moved in and out.As a result, the thrombus and atheroma in the blood vessel attached to the device may have migrated to the periphery and caused the paralysis.The physician commented that the paralysis event was not serious.The pulserider device remains implanted and therefore, not available to be returned.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3054562207) 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.Difficulty or inability to position the device and embolic stroke are known complications that can occur with the use of the pulserider in stent-assisted coiling procedures.With the information provided, it is not possible to determine the root cause of the event.However, there are patient and procedural factors that may have contributed to the event rather than the design or manufacture of the device.The reported thromboembolic event resulted in paralysis (i.E., embolic stroke) and necessitated prolongation of existing hospitalization.Furthermore, the relationship of the pulserider anrd to the reported event cannot be excluded.Therefore, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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.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.

Event Description

The healthcare professional reported that the patient underwent a pulserider-assisted coil embolization of an aneurysm on the middle cerebral artery (mca) and developed paralysis after the procedure.The patient was discharged from the hospital after the paralysis had improved.The pulserider 8t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3054562207) was used in accordance with the instructions for use (ifu), but the device was difficult to place and repeatedly moved in and out.As a result, the thrombus and atheroma in the blood vessel attached to the device may have migrated to the periphery and caused the paralysis.The physician commented that the paralysis event was not serious.The pulserider device remains implanted and therefore, not available to be returned.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to include the initial reporter information received on (b)(6) 2021.(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, 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
• MDR Report Key: 12436274
• MDR Text Key: 277726306
• Report Number: 3008114965-2021-00410
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• 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: 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3054562207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization