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 Problems Aneurysm (1708); Intracranial Hemorrhage (1891)

Event Date 11/08/2022

Event Type  Death  

Event Description

It was reported from a personal interaction that during an endovascular embolization of a middle cerebral artery (mca) bifurcation aneurysm on a female patient, a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3076825514) aneurysm neck reconstruction device (anrd) was implanted with difficulty and deployed in a hybrid position.It was also stated that coiling of the aneurysm has been difficult and that the first/framing target 3d 5×10 coil (strykerneurovascular) was unable to be fit.One target 360 4.5×12 (strykerneurovascular), two ultra 3×6 (unknown manufacturer) and four nano (2×4), (2×3), (2×3), (1.5× 3) (unknown manufacturer) coils have been used.Concomitant devices used comprise a fubuki 8fr guiding catheter (asahi-intecc), a dac sofia 6fr catheter (microvention,) and a psp sl-10 microcatheter (strykerneurovascular).With the above system, the patient vitals became unstable during coiling.It was further stated the following: ¿icpc an was terminated due to deterioration of the patient's vitals.After hemostasis, ct was taken to confirm intracerebral hemorrhage.There is a possibility of intracerebral hemorrhage due to aneurysm perforation.It is unknown if any additional treatment was taken and will be¿ it was reported that the patient has been hospitalized.Her current health status is not known.It is unknown if a continuous flush was maintained throughout the procedure.It was stated that the anrd has deployed as per the instructions for use (ifu).No further information was provided at the time of complaint initiation.

Manufacturer Narrative

Product complaint # (b)(4).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3076825514 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.

Manufacturer Narrative

Product complaint # (b)(4).B2.Date of death: is not available.Section b5: additional information was received on 01-dec-2022.Summary of additional information provided: the condition of the patient is unknown, but the sales rep obtained information that the patient expired.Additional information was received on 6-dec-2022 indicated that the physician had a difficult time implanting the pulserider in the desired position because the physician needed to manipulate the psp (prowler select plus microcatheter) several times by moving it back and forth inside the vessel in order to deliver it to the desired position.Afterward, he/she needed to manipulate the pulserider implant several times as well to position it the desired way.No cnv coils were used.Psp is referring to the prowler select plus microcatheter."icpc an was terminated" refers to the internal carotid-posterior communicating artery aneurysm.There was a plan to treat the icpc aneurysm after the mca aneurysm was treated, but the icpc was not treated.It¿s unknown if any medical and or surgical intervention was performed.The rep only knows that a ct scan was taken right after the complaint event.The patient expired.Images of the procedure have been received and are pending review by the cerenovus sr.Medical affairs director, the device remains implanted, therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3076825514 number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).The received medical imaging was reviewed by cerenovus sr.Medical affairs director on 02-jan-2023.Complaint conclusion: it was reported from a personal interaction that during an endovascular embolization of a middle cerebral artery (mca) bifurcation aneurysm on a female patient, a pulserider t, 3mm, 8mm arch (catalog 201d/lot 3076825514) aneurysm neck reconstruction device (anrd) was implanted with difficulty and deployed in a hybrid position.It was also stated that coiling of the aneurysm has been difficult and that the first/framing target 3d 5×10 coil (strykerneurovascular) was unable to fit.One target 360 4.5×12 (strykerneurovascular), two ultra 3×6 (unknown manufacturer), and four nano (2×4), (2×3), (2×3), (1.5× 3) (unknown manufacturer) coils have been used.Concomitant devices used comprise a fubuki 8fr guiding catheter (asahi-intecc), a dac sofia 6fr catheter (microvention,) and a psp sl-10 microcatheter (strykerneurovascular).With the above system, the patient vitals became unstable during coiling.It was further stated the following: ¿icpc an was terminated due to deterioration of the patient's vitals.After hemostasis, ct was taken to confirm intracerebral hemorrhage.There is a possibility of intracerebral hemorrhage due to aneurysm perforation.It is unknown if any additional treatment was taken and will be¿ it was reported that the patient has been hospitalized.Her current health status is not known.It is unknown if a continuous flush was maintained throughout the procedure.It was stated that the anrd has deployed as per the instructions for use (ifu).No further information was provided at the time of complaint initiation.Additional information received indicated that the patient expired.Further additional information received reported that the physician had a difficult time implanting the pulserider in the desired position because the physician needed to manipulate the psp (prowler select plus microcatheter) several times by moving it back and forth inside the vessel in order to deliver it to the desired position.Afterward, he/she needed to manipulate the pulserider implant several times as well to position it the desired way.No cnv coils were used.Psp is referring to the prowler select plus microcatheter."icpc an was terminated" refers to the internal carotid-posterior communicating artery aneurysm.There was a plan to treat the icpc aneurysm after the mca aneurysm was treated, but the icpc was not treated.It¿s unknown if any medical and or surgical intervention was performed.The rep only knows that a ct scan was taken right after the complaint event.The received medical imaging was reviewed by cerenovus sr.Medical affairs director on 02-jan-2023 and the assessment reads as follows: "the review is based on 4 video¿s that show the ap and lateral projection of biplane angiography.The first two video¿s show the first hour of fluoroscopy time, the second an additional 51 minutes.The procedure is dated (b)(6), 2022 (or (b)(6) 2022).The videos were reviewed in a vacuum of knowledge (no medical history, no aneurysm dimensions, no presence during the procedure, no knowledge on procedural difficulties) with only the summarized description above.There is an approach through the right groin with a guide sheath, a distal access catheter and two microcatheters.The contrast run shows two aneurysms, one with an intermediate neck size at the right middle cerebral artery (mca) bifurcation, which is the target aneurysm for treatment, and one at the right posterior communicating artery (pcom).The navigation to the aneurysm is performed with the microcatheter that is used to put a pulse rider device (prd).The microcatheter is brought to the aneurysm and the prd device is advanced.The deployment is attempted around 11 times with the patels opening either in the mca or in a hybrid position with one patel in the aneurysm.It seems that the microcatheter cannot be advanced into the aneurysm despite a number of attempts visible in the footage where the prd is used to guide the catheter.There seem to have been difficulties with acquiring the right roadmap, since there were adaptations to the table position to meet the mask.The shape of the pcom aneurysm can no longer be objectively interpreted for this review due to these movements.The prd position achieved at 57 minutes (17.05h local time) on lateral projection seems to have been accepted as the final deployment, after which the coiling microcatheter was navigated into the aneurysm passing the prd.Subsequently there were a number of attempts to place the first coil, which was re-sheated twice and finally removed and replaced with another one.The aneurysm was subsequently filled with coils and control angiography runs were made after the first coil (footage 2, lateral 24 minutes) and the third coil (footage 2, lateral 28 minutes).At that time there was fluoroscopy of the groin region which seems to show a partial detached coil in the microcatheter, that was at that time removed from the aneurysm (at 18.01h local time).The microcatheter was thereafter repositioned into the aneurysm and three more coils were placed.After that a 3d rotational angiography was performed (of which the reconstructions are not made available for this review).The prd was detached at 18.49 local time and the microcatheter removed.The ap and lateral control run show rapid filling of the external carotid artery and slower flow from the internal carotid artery into the mca, compared to pre-coiling, which can amongst the internal carotid artery around the distal access catheter or an increased intracranial pressure.Regarding the statement in the summary: ¿the patient vitals became unstable during coiling¿, this is not clear from the images since there is no clinical data visible.A clear cause for the unstable situation cannot be detected from the footage and may be uni- or multifactorial, the slow flow may however point to an intracranial pressure increase, which can develop with a hemorrhage.An extravasation of blood/contrast is not visible on the available footage".The device was not returned as it remains implanted.A manufacturing record evaluation was performed for the finished device 3076825514 number, and no non-conformances related to the malfunction were identified.Positioning difficulty and intracranial hemorrhage secondary to the vessel or aneurysm perforation are known potential procedural complications associated with the pulserider anrd.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.In addition, per the additional information received on 01-dec-2022 & 06-dec-2022, the patient expired.Since the relationship of the device to the reported event cannot be clearly established, 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.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.This medwatch report was initially submitted on 12-jan-2023 as a follow up 1 resulting in a duplicate report.Section g6: follow up number was updated to 2.

• 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: 15885835
• MDR Text Key: 304518286
• Report Number: 3008114965-2022-00791
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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: 3076825514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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: DAC SOFIA 6FR CATHETER (MICROVENTION).; FUBUKI 8FR GUIDING CATHETER (ASAHI-INTECC).; PROWLER SELECT PLUS MICROCATHETER.; PSP SL-10 MICROCATHETER (STRYKERNEUROVASCULAR).
• Patient Outcome(s): Death; Hospitalization