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

Model Number 201-D

Device Problems Unstable (1667); Separation Failure (2547); Patient-Device Incompatibility (2682)

Patient Problem Thromboembolism (2654)

Event Date 01/13/2021

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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report from the field indicated that a female patient underwent a 3mm, 8mm arch pulserider t (211d/ w3439-01) assisted coil embolization procedure of a unruptured aneurysm at the basilar artery (ba) tip and experienced a thrombus that developed at the origin of the left posterior cerebral artery (pca).A shuttle sheath guiding catheter was inserted into the right femoral artery (fa) and delivered to the right vertebral artery (va).From there, a dd6 guiding catheter was directed up and a prowler select plus microcatheter was delivered to the region near the neck.The pulserider device was inserted through the same route and used as per the instructions for use (ifu).The pulserider device was ¿reinserted¿ five times and placed outside the aneurysm at the same angle to cover the neck.Next, a microcatheter for coil was delivered into the aneurysm using a trans-cell approach and coil embolization commenced.A total of thirteen coils were implanted.The physician was about to complete the procedure, however an angiography confirmed that a thrombus developed at the origin of the pca.Consequently, an intra-arterial injection of ozagrel sodium was administered.The thrombus was not completely dissolved after a while but the blood flow improved.Therefore, the physician pressed the detachment button twice to remove the pulserider device and the microcatheter was raised.The marker of the leg moved.After that, the button was pressed several times but immediately the beep sounded and blinked red.As a result, the cable and power supply were exchanged and the deployment button was pressed twice.The marker of the pulserider leg got stuck when the microcatheter was pushed up.The delivery wire was pressed, detachment was confirmed, and the procedure was completed.The patient remained hospitalized because a mri after the procedure exhibited stable thrombus with no symptoms.The doctor does not believe this event is considered serious because the patient was asymptomatic and the lesion was treated from the procedure.As per the doctor¿s opinion, the thrombus might have been related to the coil mass protruding out a little from the artery.The product is not available for investigation.At this time, no further information was provided.

Manufacturer Narrative

Product complaint # (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.B5: additional information received on 26-feb-2021 indicated that the female patient was asymptomatic at the time of the event.She has since been discharged from the hospital.The size/brand of coil (s) that protruded from the aneurysm into the parent artery was not reported.Complaint conclusion: a report from the field indicated that a female patient underwent a 3mm, 8mm arch pulserider t (211d/ w3439-01) assisted coil embolization procedure of a unruptured aneurysm at the basilar artery (ba) tip and experienced a thrombus that developed at the origin of the left posterior cerebral artery (pca).A shuttle sheath guiding catheter was inserted into the right femoral artery (fa) and delivered to the right vertebral artery (va).From there, a dd6 guiding catheter was directed up and a prowler select plus microcatheter was delivered to the region near the neck.The pulserider device was inserted through the same route and used as per the instructions for use (ifu).The pulserider device was ¿reinserted¿ five times and placed outside the aneurysm at the same angle to cover the neck.Next, a microcatheter for coil was delivered into the aneurysm using a trans-cell approach and coil embolization commenced.A total of thirteen coils were implanted.The physician was about to complete the procedure, however an angiography confirmed that a thrombus developed at the origin of the pca.Consequently, an intra-arterial injection of ozagrel sodium was administered.The thrombus was not completely dissolved after a while but the blood flow improved.Therefore, the physician pressed the detachment button twice to remove the pulserider device and the microcatheter was raised.The marker of the leg moved.After that, the button was pressed several times but immediately the beep sounded and blinked red.As a result, the cable and power supply were exchanged and the deployment button was pressed twice.The marker of the pulserider leg got stuck when the microcatheter was pushed up.The delivery wire was pressed, detachment was confirmed, and the procedure was completed.The patient remained hospitalized because a mri after the procedure exhibited stable thrombus with no symptoms.The doctor does not believe this event is considered serious because the patient was asymptomatic and the lesion was treated from the procedure.As per the doctor¿s opinion, the thrombus might have been related to the coil mass protruding out a little from the artery.Additional information received on 26-feb-2021 indicated that the female patient was asymptomatic at the time of the event.She has since been discharged from the hospital.The size/brand of coil (s) that protruded from the aneurysm into the parent artery was not reported.The device remains implanted and thus is not available for investigation, since no device has been received for analysis, no product investigation can be performed.A review of manufacturing documentation associated with this lot w3439-01 presented no issues during the manufacturing or inspection processes related to the reported complaint.Coil herniation, failure to detach, and thrombosis are known potential complications that may be associated with the use of the pulserider anrd in the treatment of intracranial aneurysms.Per the pulserider instructions for use (ifu): do not fully deploy and retrieve the implant more than 3 times.Excessive deployment cycles of the anchor section of the pulserider may reduce the radial force of the device which could impact the implant stability.Increased detachment time may occur when the delivery wire and microcatheter markers are not properly positioned, there is improper setup of continuous flush, embolic coils are present, or connections between detachment power supply and delivery wire or patient¿s groin (return electrode) are poor.With the amount of information available and without the return of the associated devices (s), it is not possible to determine the root cause of the event.However, there are clinical and procedural factors that may have contributed to the event rather than the design or manufacture of the device.Failure to detach - system fault with attempt to detach could lead to vessel damage, coil prolapse or migration, cerebral thrombosis, vessel occlusion, and/or ischemia/infarct.Furthermore, the failure of the anrd to maintain the coil mass within the confines of the target aneurysm may have caused the thrombosis formation with the need for medical treatment and prolonged hospitalization.The file will be re-reviewed if additional information is received at a later date.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.Section h6: medical device problem code - device instability - prior to detachment (a051207) is to be removed from the initial medwatch report.

Manufacturer Narrative

Product complaint # (b)(4).The device remains implanted and thus is not available for investigation, since no device has been received for analysis, no product investigation can be performed.A review of manufacturing documentation associated with this lot w3439-01 presented no issues during the manufacturing or inspection processes related to the reported complaint.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 11280464
• MDR Text Key: 233327871
• Report Number: 3008114965-2021-00072
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: W3439-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DD6 GUIDING CATHETER; PROWLER SELECT PLUS MICROCATHETER; SHUTTLE SHEATH GUIDING CATHETER
• Patient Outcome(s): Required Intervention