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

Model Number 201-D

Device Problem Difficult to Advance (2920)

Patient Problem Ruptured Aneurysm (4436)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device remains implanted., therefor, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077900509 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported by a personal interaction that a 79-year-old female patient underwent an endovascular embolization using a pulserider t, 3mm, 8mm arch at the middle cerebral artery (mca).Per the event description, the complaint pulserider was used as a ¿torque¿ prior to the physician deciding the position for the implant.However, there was resistance.The compliant device was implanted as ¿extra¿, and contrast was injected to confirm there was a rupture.A catheter for the coil (phenom) was inserted and coiling was performed.There was no bleeding confirmed by final angiography and the procedure was completed.Other concomitant devices used were a synchro 2 guidewire (stryker), an 80cm fubuki 6fr gs guiding catheter (asahi intecc), a prowler select plus microcatheter and a vecta71 intermediate catheter (stryker).Additional information was received on (b)(6) 2023.Summary of additional information provided: the patient did not fully return to consciousness but was able to raise their hands.The patient gradually recovered.Initially, deployment in antegrade was assumed, but it was changed to deployment in retrograde according to the behavior of the complaint pulserider.It was an aneurysm that there were three blobs and an irregular shape and a major axis of about 5.7 mm.One of the three blebs is considered a bleeding point.When the physician looked at the bleeding point from the working angle, the bleb was located in the lateral direction of the mother vessel.It was unknown when the bleeding occurred, but the physician thinks that the leaflet of the complaint pulse rider may have put force on the bleb.The cause of resistance is unknown.Because the patient had severe arteriosclerosis and it was difficult to raise the guiding catheter, it might have been related.When applying torque several times, the resistance gradually became stronger and stronger.When the physician tried to deploy the complaint pulserider, the microcatheter went down to proximal due to reaction, so the physician gave up deploying it in antegrade and deployed it in retrograde.Due to this resistance, there was a slight jumping behavior (the complaint pulse rider opens vigorously) when the complaint pulse rider was deployed.

Manufacturer Narrative

Product complaint # (b)(4).Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported by a personal interaction that a 79-year-old female patient underwent an endovascular embolization using a pulserider t, 3mm, 8mm arch at the middle cerebral artery (mca).Per the event description, the complaint pulserider was used as a ¿torque¿ prior to the physician deciding the position for the implant.However, there was resistance.The compliant device was implanted as ¿extra¿, and contrast was injected to confirm there was a rupture.A catheter for the coil (phenom) was inserted and coiling was performed.There was no bleeding confirmed by final angiography and the procedure was completed.Other concomitant devices used were a synchro 2 guidewire (stryker), an 80cm fubuki 6fr gs guiding catheter (asahi intecc), a prowler select plus microcatheter and a vecta71 intermediate catheter (stryker).Additional information was received on 24-feb-2023.Summary of additional information provided: the patient did not fully return to consciousness but was able to raise their hands.The patient gradually recovered.Initially, deployment in antegrade was assumed, but it was changed to deployment in retrograde according to the behavior of the complaint pulserider.It was an aneurysm that there were three blobs and an irregular shape and a major axis of about 5.7 mm.One of the three blebs is considered a bleeding point.When the physician looked at the bleeding point from the working angle, the bleb was located in the lateral direction of the mother vessel.It was unknown when the bleeding occurred, but the physician thinks that the leaflet of the complaint pulse rider may have put force on the bleb.The cause of resistance is unknown.Because the patient had severe arteriosclerosis and it was difficult to raise the guiding catheter, it might have been related.When applying torque several times, the resistance gradually became stronger and stronger.When the physician tried to deploy the complaint pulserider, the microcatheter went down to proximal due to reaction, so the physician gave up deploying it in antegrade and deployed it in retrograde.Due to this resistance, there was a slight jumping behavior (the complaint pulse rider opens vigorously) when the complaint pulse rider was deployed.The device remains implanted., therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3077900509 number, and no non-conformances related to the malfunction were identified.Aneurysm rupture is a known potential complication associated with the use of the pulserider anrd and is mentioned in the instruction for use (ifu) as such.Severe resistance/friction can lead to device 'freeze-up'.If loss of cerebral target position occurs in the intra-cranial vasculature, continued attempts to manipulate the devices increase the potential for perforation or other vascular injuries.Per the information provided, ¿it was unknown when bleeding occurred, but the physician thinks that the leaflet of the complaint pulse rider may have put force on the bleb¿ that caused the bleeding.Therefore, this event will be reported to the usfda reportable under 21 cfr 803 with a 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, 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16478984
• MDR Text Key: 310617586
• Report Number: 3008114965-2023-00146
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3077900509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: 80CM FUBUKI 6FR GS GUIDING CATHETER (ASAHI INTECC); PHENOM CATHETER; PROWLER SELECT PLUS MICROCATHETER; SYNCHRO 2 GUIDEWIRE (STRYKER); VECTA71 INTERMEDIATE CATHETER (STRYKER)
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female