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

Model Number 211-D

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

Patient Problem Ischemia Stroke (4418)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that the female patient underwent a pulserider-assisted coil embolization procedure of a recanalized, previously clipped middle cerebral artery (mca) aneurysm on (b)(6) 2021 and suffered from a cerebral infarction during the post-operative course.The timing of the stroke relative to the procedure was not reported.During the procedure, a prowler select plus microcatheter (product code and lot number unknown) was used with the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / lot# unknown).It was not clear if continuous flush had been maintained.It was reported that the product is not available for investigation.On 08-oct-2021, additional information was received.The information indicated that on wednesday, (b)(6) 2021, between 1pm and 4pm, the pulserider anrd was successfully implanted after several attempts at a recanalized, previously clipped middle cerebral artery (mca) aneurysm.The pulserider was allegedly used as per the ifu.The lot number of the pulserider device was 3056488801.Coil embolization began with three coils: 8mm x 30cm complex extrasoft (kaneka medix), 3mm x 8cm galaxy g3 (gly120308 / lot unknown), and a 1mm x 3cm galaxy g3 mini (glm910030 / lot unknown) were used.Final contrast was done and it was confirmed that there was no problem with reflux.The procedure was completed.On the same day at approximately 11 pm, the patient complained of left-side paralysis; she did not have aphasia.Computed tomography (ct) and angiography confirmed an occlusion at the m2 segment of the mca.Although the m2 was temporarily opened via percutaneous transluminal angioplasty (pta) and stenting (atlas stent), the artery immediately re-occluded.The procedure was completed as is.It was last reported that the patient remains hospitalized, and rehabilitation will be scheduled in the near future.The patient was prescribed dual antiplatelet therapy (dapt) before the procedure with aspirin clopidogrel.The effect of aspirin was confirmed but the effect of clopidogrel was poor.Prasugrel and albatron were additionally prescribed.The physician commented that ¿there was a possibility that the antiplatelet drug was not effective.¿ the physician commented that the causal relationship with the pulserider device cannot be ruled out, ¿but it does not seem to be a problem with the complaint product.¿ the aneurysm had completely disappeared in the image taken at the time of the m2 occlusion.It is possible that rapid thrombus formation caused the occlusion up to m2.With the placement of the complaint pulse rider, coiling up to the neck was possible.¿there was a possibility that the first coil was too long, which may have expanded the aneurysm.¿ the actual cause of the event was not identified.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3056488801) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Cerebral infarction is a known potential adverse event that may be associated with the use of the pulserider in the intracranial arteries and is listed in the ifu as such.With the information provided, it is not possible to determine the root cause of the stroke.However, there are patient, procedural, and pharmacological factors that may have contributed with no indication of a device defect or quality issue.Since a cerebral infarction is a serious injury which required medical/surgical intervention and prolonged hospitalization and the relationship of the device to the reported event cannot be disassociated.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that the female patient underwent a pulserider-assisted coil embolization procedure of a recanalized, previously clipped middle cerebral artery (mca) aneurysm on (b)(6) 2021 and suffered from a cerebral infarction during the post-operative course.The timing of the stroke relative to the procedure was not reported.During the procedure, a prowler select plus microcatheter (product code and lot number unknown) was used with the pulserider 10t, 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (211d / lot# unknown).It was not clear if continuous flush had been maintained.It was reported that the product is not available for investigation.On 08-oct-2021, additional information was received.The information indicated that on wednesday, (b)(6) 2021, between 1pm and 4pm, the pulserider anrd was successfully implanted after several attempts at a recanalized, previously clipped middle cerebral artery (mca) aneurysm.The pulserider was allegedly used as per the ifu.The lot number of the pulserider device was 3056488801.Coil embolization began with three coils: 8mm x 30cm complex extrasoft (kaneka medix), 3mm x 8cm galaxy g3 (gly120308 / lot unknown), and a 1mm x 3cm galaxy g3 mini (glm910030 / lot unknown) were used.Final contrast was done and it was confirmed that there was no problem with reflux.The procedure was completed.On the same day at approximately 11 pm, the patient complained of left-side paralysis; she did not have aphasia.Computed tomography (ct) and angiography confirmed an occlusion at the m2 segment of the mca.Although the m2 was temporarily opened via percutaneous transluminal angioplasty (pta) and stenting (atlas stent), the artery immediately re-occluded.The procedure was completed as is.It was last reported that the patient remains hospitalized, and rehabilitation will be scheduled in the near future.The patient was prescribed dual antiplatelet therapy (dapt) before the procedure with aspirin clopidogrel.The effect of aspirin was confirmed but the effect of clopidogrel was poor.Prasugrel and albatron were additionally prescribed.The physician commented that ¿there was a possibility that the antiplatelet drug was not effective.¿ the physician commented that the causal relationship with the pulserider device cannot be ruled out, ¿but it does not seem to be a problem with the complaint product.¿ the aneurysm had completely disappeared in the image taken at the time of the m2 occlusion.It is possible that rapid thrombus formation caused the occlusion up to m2.With the placement of the complaint pulse rider, coiling up to the neck was possible.¿there was a possibility that the first coil was too long, which may have expanded the aneurysm.¿ the actual cause of the event was not identified.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to include the additional event information received on 04-nov-2021.[additional information]: on 04-nov-2021, additional information was received.The information indicated that the patient visited the hospital around 11 pm on (b)(6) 2021 because of left-sided paralysis.A stroke at the right m2 segment was found by computed tomography (ct).The procedure was performed on (b)(6) 2021 from 1 pm to approximately 4 pm.There was device performance issue with the pulserider anrd.In the opinion of the physician, the aneurysm was adequately treated; the procedure ended with confirmation that the aneurysm was adequately treated.E.1: the initial reporter phone: (b)(6).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 ; 949789-868
• MDR Report Key: 12677781
• MDR Text Key: 277868777
• Report Number: 3008114965-2021-00500
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005130
• UDI-Public: 00859030005130
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 211-D
• Device Catalogue Number: 211D
• Device Lot Number: 3056488801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: 8MM X 30CM COMPLEX EXTRASOFT (KANEKA); GALAXY G3 3MM X 8CM; GALAXY G3 MINI 1MM X 3CM; MICROCATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female