|
MEDOS INTERNATIONAL SARL PULSERIDER T, 4MM, 10MM ARCH; INTRACRANIAL NEUROVASCULAR STENT
|
Back to Search Results |
|
| Model Number 213-D |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problem
Thromboembolism (2654)
|
| Event Date 02/04/2023 |
|
Event Type
Injury
|
|
Event Description
|
|
The healthcare professional reported that on (b)(6) 2023, during an endovascular embolization procedure with the target at the basilar artery (ba) tip, the complaint device, a pulserider, 3.5-4.5mm, 10mm, t shape (213d / lot#: unknown) was implanted via a prowler select plus microcatheter (catalog / lot#: unknown) with continuous flush maintained.The procedure was completed.It was then reported that ¿after heparin was cut, thrombosis was confirmed past 3 to 4 days after the procedure.The patient was being monitored with medical treatment, but around on (b)(6) 2023, it was found out that it would be better to perform an additional procedure, and an atlas stent was additionally placed.The patient has been stable after implantation of the atlas stent.¿ the patient was reported to have been hospitalized; the thrombosis has been stable.No additional medical treatment will be performed.On 27-feb-2023, the japan team translated the memo that was included in the complaint.A summary of the memos is below: the first memo (memo 1).In the anterior circulation, a flexor® shuttle® 7fr guiding sheath (cook medical), two (2) tactics microcatheters (technocrat corporation), and distal access ¿(dac) for both.¿ graphic of aneurysm showed the parent vessel to be 3.5mm in width.System: 6fr asahi fubuki guide catheter (asahi intecc) x ¿f 90cm str¿ 0.035¿ asahi silverway® guidewire (asahi intecc) 6fr countdown jb2 inner catheter (medikit co, ltd) distal tip is 4fr.Axs vecta 71 catheter (stryker) phenom¿ 17 microcatheter (medtronic) prowler select plus (psp) microcatheter synchro2¿ standard guidewire (stryker).The pulserider anrd was deployed.Torque was applied for approximately 2 times.The angle did not match when confirming from the lateral view.It was matched when the pulserider anrd was deployed fully.Cone beam computed tomography (ct) was conducted five (5) times thinner.Confirm if the mesh covered the neck from the top view.Coils: 1) 4-8mm x 15 cm ied coil (kaneka), 2) 3-5mm x 20 cm ied coil (kaneka), 3) 3-5mm x 15 cm ied coil (kaneka), 4) 2-3mm x 10 cm ied coil (kaneka), 5) 3mm x 6cm galaxy g3 xsft (glx120306) ¿(+1 removed 3-6 unit).The list of coils continues into the second memo (memo 2): 6) 3mm x 4cm galaxy g3 xsft (glx120304), 7) 2.5mm x 3.5cm galaxy g3 xsft (glx122535), 8) 2mm x 2cm galaxy g3 xsft (glx120202), 9) 1.5mm x 4cm galaxy g3 mini (glm915040), 10) 1.5mm x 4cm galaxy g3 mini (glm915040), 11) 1.5mm x 4cm galaxy g3 mini (glm915040).Memo 2 includes the following: ¿want to deploy wider, xsft to the back, mini.¿ 3-4 ba tip, 2-3 ic top, 3d data.On 08-mar-2023, additional information was received.The information indicated that the patient was discharged from the hospital on (b)(6) 2023.The patient¿s current condition is stable; the patient will be moved to the outpatient department in the middle or the end of march.The physician commented that there may have been a combination of these three (3) following causes: (1) when the sl 10 was delivered to the right pca for placement of the atlas, the pca was not reflected by contrast imaging from the gc.This means 0.57 mm, which suggests that the pca itself was very thin.(2) drug eruption was suspected with clopidogrel, so administration was discontinued early.Bayaspirin was also not effective, and the drug was switched to efient, but efient was not effective.(3) the physician put too many coils which may have caused the coil mass to fall and the right pca to collapse.
|
| |
|
Manufacturer Narrative
|
|
Manufacturer¿s ref.No: (b)(4).Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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 thrombosis is a known potential complication associated with the use of the pulserider anrd and is mentioned in the instruction for use (ifu) as such.Per the information provided, the device performed as intended and no new patient consequences have occurred related to the use of the device.However, the relationship between the adverse event and the use of the device cannot be excluded and therefore could be a remote factor, the event will be conservatively reported to the usfda reportable under title 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.
|
| |
|
Manufacturer Narrative
|
|
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 19-mar-2023.[additional information]: on 19-mar-2023, additional information was received.The information indicated that the lot number of the pulserider anrd is unknown.The thrombosis event occurred ¿around 04-feb-2023.¿ there was no bleeding noted during the procedure that may have caused the thrombus.The information confirmed there was no intra-operative bleed.The atlas stent was implanted on 18-feb-2023 and after that, anti-platelet medication effient was used.The posterior cerebral artery (pca) blood flow was restored after the placement of the atlas stent.The information indicated that the atlas stent was placed between the right pca and the basilar artery (ba).It was not known if there was any device migration in relation to the pulserider anrd.In relation to whether there were any device malfunctions / performance issues with respect to the pulserider anrd during the procedure, the information indicated that ¿there is a view that if the coil is packed too much, the pulserider may fall under the weight of the coil.¿ the reported thrombosis was confirmed during the patient¿s hospitalization.The information indicated that the patient was hospitalized ¿at the end of january.Pulserider procedure was performed on (b)(6) 2023.Stent(s) were added on (b)(6) 2023.¿ the patient was discharged on (b)(6) 2023.Per the physician, ¿there were multiple causes such as overpacking of coils, the patient¿s anti-platelet medication not working, etc.¿ that may have caused or contributed to the thrombus.The physician did not suspect any involvement of the prowler select plus microcatheter to the reported thrombus.The catalog and lot number of the prowler select plus microcatheter is not known.The patient was reportedly discharged from the hospital with no particular symptoms but was under follow-up observation.The patient is reported to be in stable condition.Cerebral thrombosis is a known potential complication associated with the use of the pulserider anrd and is mentioned in the instruction for use (ifu) as such.Per the information provided, the device performed as intended and no new patient consequences have occurred related to the use of the device.However, the relationship between the adverse event and the use of the device cannot be excluded and therefore could be a remote factor, the event will be conservatively reported to the usfda reportable under title 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.E.1: 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.
|
| |
|
Search Alerts/Recalls
|
|
|
