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

Catalog Number 211D

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thromboembolism (2654)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported by a healthcare professional that a female underwent a pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an unruptured basilar artery aneurysm.The 3mm, 10mm arch pulserider t aneurysm neck reconstruction device was implanted in the aneurysm neck with rotation.The coil embolization was started by using an unknown cerenovus coil and a completive coil.The embolization was continued without any particular problem up to the seventh coil.When the 8th coil (competitive product) was inserted, the coil kicked back and came out of the neck.Therefore, the coil's position was adjusted and pushed to the neck.When imaging was performed, bilateral pca was not imaged.Therefore, the physician raised the position of the pulserider.The phenom, medtornic microcatheter (mc) was regional crossed into the bilateral pca, an atlas stent was induced in each and placed in the form of a y-stent in an overlapping to the pulserider.After that, bilateral pca became visible.The procedure was completed.After the end of the procedure, it was confirmed that the patient was conscious and that the limbs were behaving.The device was prepared per the instructions for use (ifu).It was reported that the pulserider ¿might have dropped a little during coiling¿.The patient was not a patient who is likely to develop a thrombus, and dapt was also conducted as usual this time.A possible cause other than the product was that thrombus formed by the coils were scattered in the bilateral pca.The site where coil embolization was performed this time was coil embolized about ten years ago.This time it was retreatment.A continuous flush was done.The lesion was aca (a1).Additional information was received on (b)(6) 2022 indicating that during coil embolization, the following cerenovus coils were used: glx120408/30641982, glx120410/30663169, gly120615/l16408, and gly120721/30670817.However, in the opinion of the physician, the thrombus was not related to the cerenovus coils.The blood vessel characteristics were normal, and the aneurysm measurements were 3 mm high, 12 mm wide, 6 mm deep, and 8.9 mm neck.There was no misalignment of the axes of the pcas on both sides.The procedure was delayed for 20 minutes, but it was not clinically significant.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter name and address: initial reporter phone: (b)(6).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 by a healthcare professional that a female underwent a pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an unruptured basilar artery aneurysm.The 3mm, 10mm arch pulserider t aneurysm neck reconstruction device was implanted in the aneurysm neck with rotation.The coil embolization was started by using an unknown cerenovus coil and a completive coil.The embolization was continued without any particular problem up to the seventh coil.When the 8th coil (competitive product) was inserted, the coil kicked back and came out of the neck.Therefore, the coil's position was adjusted and pushed to the neck.When imaging was performed, bilateral pca was not imaged.Therefore, the physician raised the position of the pulserider.The phenom, medtornic microcatheter (mc) was regional crossed into the bilateral pca, an atlas stent was induced in each and placed in the form of a y-stent in an overlapping to the pulserider.After that, bilateral pca became visible.The procedure was completed.After the end of the procedure, it was confirmed that the patient was conscious and that the limbs were behaving.The device was prepared per the instructions for use (ifu).It was reported that the pulserider ¿might have dropped a little during coiling¿.The patient was not a patient who is likely to develop a thrombus, and dapt was also conducted as usual this time.A possible cause other than the product was that thrombus formed by the coils were scattered in the bilateral pca.The site where coil embolization was performed this time was coil embolized about ten years ago.This time it was retreatment.A continuous flush was done.The lesion was aca (a1).Additional information was received indicating that during coil embolization, the following cerenovus coils were used: glx120408/30641982, glx120410/30663169, gly120615/l16408, and gly120721/30670817.However, in the opinion of the physician, the thrombus was not related to the cerenovus coils.The blood vessel characteristics were normal, and the aneurysm measurements were 3 mm high, 12 mm wide, 6 mm deep, and 8.9 mm neck.There was no misalignment of the axes of the pcas on both sides.The procedure was delayed for 20 minutes, but it was not clinically significant.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 3064923916 number, and no non-conformances related to the malfunction were identified.Cerebral thrombosis is known potential complication associated with the use of the pulserider anrd device.Based on the information provided, it appears that the pulserider anrd failed to maintain the coils within the confines of the target aneurysm.There could be thrombosis formation, which could have led to cerebral ischemia.Since the relationship between the pulserider anrd and the reported event cannot be excluded, the event will be conservatively reported to the fda with the classification of ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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: 14601259
• MDR Text Key: 293342670
• Report Number: 3008114965-2022-00402
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 859030005130
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 211D
• Device Lot Number: 3064923916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• 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
• Treatment: COMPETITIVE COIL; GALAXY G3 6MM X 15CM; GALAXY G3 7MM X 21CM; GALAXY G3 XSFT 4MM X 10CM; GALAXY G3 XSFT 4MM X 8CM; PHENOM MICROCATHETER, MEDTORNIC; PULSERIDER T, 3MM, 10MM ARCH
• Patient Sex: Female