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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028715.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.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.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.Interference or friction between devices is a known occurrence.Removal and exchange of devices is common routine practice in endovascular procedures.If resistance is encountered, the system being inserted should be withdrawn as a unit to prevent injury.In this case it is done without loss of intracranial target position.This is a common practice during procedures and is recommended in product instructions for use (ifu).Since the vast majority of diagnostic and interventional angiographic procedures utilize multiple device exchanges, an increased potential for patient injury is remote.However, a stent incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.In this case, the deployment difficulty and incomplete stent expansion required a second stent to be implanted in order to preclude patient harm.It remains unclear if the partially expanded enterprise stent obtained vessel wall apposition and the removal of the stent resulted in vessel damage, or if the resistance encountered resulted in excessive force from the user.Because the patient suffered from a cerebral hemorrhage and the listed scenarios cannot be ruled out at this time, the event meets us fda reporting criteria under 21 cfr 803 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 post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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 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.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 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.
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The healthcare professional reported that the patient who presented with a middle cerebral artery stenosis underwent a vascular stent placement procedure on (b)(6) 2023.The procedure began at about 09:50 am.After balloon dilation, stent implantation was initiated.The physician encountered some resistance during the process of delivering the stent, a 4mm x 23mm enterprise 2 (encr402312 / 8028715).The physician started to release the stent, but it did not fully open or expand as intended.The physician retracted the stent and switched to a new one to complete the procedure at about 12:00 noon.It was reported that the patient experienced mydriasis (dilated pupils) on that night, and cerebral hemorrhage was suspected.Then the patient underwent a craniotomy.No further information is available at the time of the complaint initiation related to the outcome of the craniotomy and condition of the patient.On 10-aug-2023, additional information was received from the cerenovus sales representative.The information indicated that the patient is a 70-year-old male with a history of hypertension.The patient has been discharged.No information could be obtained related to where he had been discharged to.Information related to the craniotomy and whether it was successful in resolving the cerebral hemorrhage was unobtainable.It was not known if the physician who performed the stent placement procedure was the physician who later performed the craniotomy.Anonymized images / angiographs of the procedure are unobtainable.Information related to the type of hemorrhage suspected (intraparenchymal or subarachnoid), source of suspected hemorrhage, etiology of the suspected hemorrhage, and if there was any physical deficit associated with the suspected hemorrhage is also unobtainable.The microcatheter used was a 150cm x 5cm prowler select plus microcatheter (606s255x).An adequate, continuous flush was maintained through the microcatheter.Another device reportedly went through the same microcatheter without issue.The information indicated that the temperature indicator label on the inner pouch of the enterprise was checked and found to be within acceptable criteria.The 4mm x 23mm enterprise 2 (encr402312 / 8028715) was the stent reported as impeded in the microcatheter and had the issue with the expansion; the stent was retracted and discarded.The replacement stent was another 4mm x 23mm enterprise 2 (encr402312) from the same lot (8028715); it was used with the original 150cm x 5cm prowler select plus microcatheter to complete the procedure.The balloon catheter used during the procedure was a neuro lps¿ intracranial balloon dilation catheter (sinomed).
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