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

Catalog Number 211D

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

Patient Problems Thromboembolism (2654); Ischemia Stroke (4418)

Event Date 12/20/2021

Event Type  Injury  

Event Description

It was reported by a healthcare professional that the patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm and experienced thromboembolism during the procedure.Intra-arterial prasugrel, ozagrel, and urokinase were administered as treatment.The physician made an attempt to recanalize the left a2 with the guidewire and microcatheter, however, this attempt was unsuccessful.The left a2 was not able to be captured.Imaging showed slow flow but enhanced left a2.It was stated ¿when the guidewire was induced in the left ic on the side of the patient¿s body and imaging was performed, it was not confirmed at the left a2, but it was confirmed that collaterals derived from the mca region and the periphery of the left a2, which was enhanced from the left ic earlier.¿ the procedure was completed.Concomitant devices included a 6f shuttle sheath (cook medical), 6f cerulean dd6 catheter (medikit), rebar 18 microcatheter (medtronic), and sl-10 microcatheter (stryker).The pulserider 10t, 2.7- 3.5mm anrd (211d/ 3051697701) was deployed at the left a2 partially intra-aneurysmal (hybrid approach).The sl-10 microcatheter was inserted into the target lesion with via trans-cell approach.Coil embolization was started with 7mm x 21cm galaxy g3 coils, and a total of ten coils were implanted.Activated clotting time (act) was over 350 seconds.Finally, when the pulserider anrd was detached and imaging was performed, a delay in contrast medium was observed at the left distal a2 segment which was determined to be thrombotic embolism.¿after a while, imaging was performed, became it was not confirmed beyond the left a2¿.The physician commented that there was occlusion due to thrombus in the left a2.When the patient woke up after the procedure, the patient was able to respond, and mobility of both upper limbs and lower limbs was confirmed.Antiplatelet effectiveness was not tested prior to the procedure.Additional information received indicated that the reporting physician noted that the relationship between the pulserider anrd and the reported event cannot be ruled out.There is a possibility that the antiplatelet drug was not effective because the preoperative verifynow was not measured.At present, the cause of the event is unknown.The event did not lead to a stroke.There were no alleged product malfunctions associated with the pulserider anrd.

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3051697701 number, and no non-conformance's related to the malfunction were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00017.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch report: b4, b5, g3, g6, h2, h6 ( health effect - clinical code), h10 and concomitant products.Section b5: additional information received on 19-jan-2022 and 21-jan-2022 indicated that there was no reported device malfunctions.The physician commented that the relationship between the device and the event cannot be denied at this time, but the root cause of the event is unknown.The physician also commented that it was possible that the antiplatelet drug was not effective.The event did not result in a stroke.There were a total of ten cerenovus coils implanted during the procedure: eight galaxy g3, one galaxy g3 xsft, and one galaxy g3 mini.The reason for the occurrence of thrombosis was considered to be that the antithrombotic agent of aspirin/clopidogrel, which was administered before the operation, was not effective.The patient may have been resistant to clopidogrel.After surgery, clopidogrel was replaced to effient, and the patient was discharged from the hospital in good health due to asymptomatic infarction.The patient is now being followed up on an outpatient basis.H6 ( health effect - clinical code): thromboembolism has been removed from the complaint file and ischemia stroke has been added as a health effect clinical code based on additional information.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 patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm and experienced thromboembolism during the procedure.Intra-arterial prasugrel, ozagrel, and urokinase were administered as treatment.The physician made an attempt to recanalize the left a2 with the guidewire and microcatheter, however, this attempt was unsuccessful.The left a2 was not able to be captured.Imaging showed slow flow but enhanced left a2.It was stated ¿when the guidewire was induced in the left ic on the side of the patient¿s body and imaging was performed, it was not confirmed at the left a2, but it was confirmed that collaterals derived from the mca region and the periphery of the left a2, which was enhanced from the left ic earlier.¿ the procedure was completed.Concomitant devices included a 6f shuttle sheath (cook medical), 6f cerulean dd6 catheter (medikit), rebar 18 microcatheter (medtronic), and sl-10 microcatheter (stryker).The pulserider 10t, 2.7- 3.5mm anrd (211d/3051697701) was deployed at the left a2 partially intra-aneurysmal (hybrid approach).The sl-10 microcatheter was inserted into the target lesion with via trans-cell approach.Coil embolization was started with 7mm x 21cm galaxy g3 coils, and a total of ten coils were implanted.Activated clotting time (act) was over 350 seconds.Finally, when the pulserider anrd was detached and imaging was performed, a delay in contrast medium was observed at the left distal a2 segment which was determined to be thrombotic embolism.¿after a while, imaging was performed, became it was not confirmed beyond the left a2¿.The physician commented that there was occlusion due to thrombus in the left a2.When the patient woke up after the procedure, the patient was able to respond, and mobility of both upper limbs and lower limbs was confirmed.Antiplatelet effectiveness was not tested prior to the procedure.Additional information received indicated that per the reporting physician, the relationship between the pulserider anrd and the reported event cannot be ruled out.There is a possibility that the antiplatelet drug was not effective because the preoperative verifynow was not measured.At present, the cause of the event is unknown.Additional information received on 29-dec-2021 was reviewed.Summary of additional information received: the event did not lead to a stroke.There were no alleged product malfunctions associated with the pulserider anrd.Additional information received on 19-jan-2022 and 21-jan-2022 indicated that there was no reported device malfunctions.The physician commented that the relationship between the device and the event cannot be denied at this time, but the root cause of the event is unknown.The physician also commented that it was possible that the antiplatelet drug was not effective.The event did not result in a stroke.There were a total of ten cerenovus coils implanted during the procedure: eight galaxy g3, one galaxy g3 xsft, and one galaxy g3 mini.The reason for the occurrence of thrombosis was considered to be that the antithrombotic agent of aspirin/clopidogrel, which was administered before the operation, was not effective.The patient may have been resistant to clopidogrel.After surgery, clopidogrel was replaced to effient, and the patient was discharged from the hospital in good health due to asymptomatic infarction.The patient is now being followed up on an outpatient basis.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 3051697701 number, and no non-conformances related to the malfunction were identified.Cerebral infarction is a known potential complication associated with the use of the pulserider anrd and galaxy g3 coil in the intracranial arteries.With the information provided, it is not possible to determine the root cause of the event.However, there are patient, procedural, and pharmacological factors that may have contributed to the reported event.There is no indication that the devices malfunctioned or that it is related to the device design or manufacturing process.Cerebral infarction is considered a serious injury which may require medical/surgical intervention and prolonged hospitalization and the relationship of the devices to the event cannot be excluded.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.This is one of eleven products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00016, 3008114965-2022-00017, 3008114965-2022-00083, 3008114965-2022-00084, 3008114965-2022-00085, 3008114965-2022-00086, 3008114965-2022-00087, 3008114965-2022-00088, 3008114965-2022-00089, 3008114965-2022-00090 and 3008114965-2022-00091.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13204785
• MDR Text Key: 288803984
• Report Number: 3008114965-2022-00016
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 211D
• Device Lot Number: 3051697701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• 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: 6F CERULEAN DD6 CATHETER (MEDIKIT); 6F SHUTTLE SHEATH (COOK MEDICAL); FOUR GALAXY G3 5MM X 15CM; GALAXY G3 4MM X 12CM; GALAXY G3 7MM X 21CM; GALAXY G3 MINI 2MM X 3CM; GALAXY G3 XSFT 3MM X 6CM; REBAR 18 MICROCATHETER (MEDTRONIC); SL-10 MICROCATHETER (STRYKER); TWO GALAXY G3 5MM X 10CM
• Patient Outcome(s): Required Intervention