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

Catalog Number 211DCT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia Stroke (4418); Unspecified Nervous System Problem (4426)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The initial reporter phone: (b)(6).[conclusion]: the event was reported via pulserider pms (post-market study), that on (b)(6) 2022, a patient underwent a pulserider-assisted coil embolization procedure targeting an unruptured aneurysm on the right middle cerebral artery (mca) using a pulserider t 3mm 10mm arch aneurysm neck reconstruction device (anrd) (211dct / 3068658422).The target aneurysm measurements were as follows: height 9.4, maximum diameter 10.3, dome width 7.8, aneurysm neck diameter 7.3, and the dome/neck ratio 1.1.The pulserider and coil placement were successful.On (b)(6) 2022, it was reported that the patient experienced a cerebral infarction which occurred ipsilateral to the target aneurysm.No medical action was taken.The patient¿s nihss score was a total of 3 points (5 a - > 1, 6 a - > 1, 11 - > 1).It was reported that the patient recovered on (b)(6) 2022.The treating physician commented that the event was ¿non-serious.The causal relationship with the complaint pulse rider cannot be ruled out.A causal relationship with the procedure cannot be ruled out.¿ the complaint documented that it is unknown if a continuous flush was maintained through the concomitant prowler select plus microcatheter.On 18-aug-2022, additional information was received.The information indicated that the patient is 80 years old; all other patient related information is unknown.There was no bleeding issue reported.The patient received nihss test on 2(b)(6) 2022, and the result was 3 and as follows: 5a (left arm): hanging down within 10 seconds; 6a (left leg): hanging down within 10 seconds; and 11 (extinction / inattention): mild to moderate impairment.The treating physician thought that the device and the procedure both contributed to the cerebral infarction.There was no malfunction nor device performance issue with respect to the pulserider anrd during the procedure.It was unknown if continuous flush was maintained through the microcatheter.The information reiterated that no medical intervention was required for this cerebral infarction; the patient is reported as already recovered on (b)(6) 2022.It was unknown if the reported event resulted in the prolongation of the patient¿s hospitalization.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3068658422) 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.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.Cerebral infarction is a known potential complication associated with the pulserider anrd and is listed in the instructions for use (ifu) as such.Although the device performed as intended with no malfunction/issue reported, and no new patient consequences have occurred related to the use of the device, the relationship of the reported event to the pulserider device cannot be excluded.Furthermore, per the treating physician¿s assessment ¿non-serious.The causal relationship with the complaint pulse rider cannot be ruled out.A causal relationship with the procedure cannot be ruled out¿.Based on the additional information received on 18-aug-2022, the patient¿s nihss scoring of 3 was specifically from the abnormal drifting of the left upper & lower extremities, and the evidence of mild to moderate impairment resulting from the cerebral infarction.Therefore, this event meets mdr reporting criteria as a ¿serious injury.¿ based on the manufacturing documentation review, 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.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.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 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 event was reported via pulserider pms (post-market study), that on (b)(6) 2022, a patient underwent a pulserider-assisted coil embolization procedure targeting an unruptured aneurysm on the right middle cerebral artery (mca) using a pulserider t 3mm 10mm arch aneurysm neck reconstruction device (anrd) (211dct / 3068658422).The target aneurysm measurements were as follows: height 9.4, maximum diameter 10.3, dome width 7.8, aneurysm neck diameter 7.3, and the dome/neck ratio 1.1.The pulserider and coil placement were successful.On (b)(6) 2022, it was reported that the patient experienced a cerebral infarction which occurred ipsilateral to the target aneurysm.No medical action was taken.The patient¿s nihss score was a total of 3 points (5 a - > 1, 6 a - > 1, 11 - > 1).It was reported that the patient recovered on (b)(6) 2022.The treating physician commented that the event was ¿non-serious.The causal relationship with the complaint pulse rider cannot be ruled out.A causal relationship with the procedure cannot be ruled out.¿ the complaint documented that it is unknown if a continuous flush was maintained through the concomitant prowler select plus microcatheter.On 18-aug-2022, additional information was received.The information indicated that the patient is 80 years old; all other patient related information is unknown.There was no bleeding issue reported.The patient received nihss test on (b)(6) 2022, and the result was 3 and as follows: 5a (left arm): hanging down within 10 seconds; 6a (left leg): hanging down within 10 seconds; and 11 (extinction / inattention): mild to moderate impairment.The treating physician thought that the device and the procedure both contributed to the cerebral infarction.There was no malfunction nor device performance issue with respect to the pulserider anrd during the procedure.It was unknown if continuous flush was maintained through the microcatheter.The information reiterated that no medical intervention was required for this cerebral infarction; the patient is reported as already recovered on (b)(6) 2022.It was unknown if the reported event resulted in the prolongation of the patient¿s hospitalization.

• 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
• 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: 15305386
• MDR Text Key: 298768173
• Report Number: 3008114965-2022-00543
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005307
• UDI-Public: 859030005307
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 211DCT
• Device Lot Number: 3068658422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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: MICROCATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR