Email from business partner with an adverse event report filed by their sales representative.Incident report, dated on (b)(6) 2023, lists six (6) occurrences of infection of femoral endarterectomies over the past 9 months following repair using the vascure for vascular.Repair device (model #: unknown, lot #: unknown) and no specified implant date(s).The report from the sales representative states "they don't know if it was due to the patch; they typically would see 1-2 infections over a year." all patients were reported as having "no infections present at the time of initial surgery".Patients reported to have developed the infections between 2-6 weeks post-operatively.All patients reported now as doing well; no deaths reported.The reported 6 events will be filed in 3 different adverse event reports specific to the patient and health event codes associated with each event - specifically mdr 3005619880-2023-00005, (patient 1), mdr (patient 2 [this report]), and mdr 3005619880-2023-00007 (patients 3 - 6).This mdr is opened for patient #2.This patient was reported to have a "blowout" due to suture line bleeding.This patient also reportedly developed an infection.The event was resolved by "clear[ing] the infection and go[ing] back in to stop the bleeding from the blowout" in a follow-up procedure.No additional information was provided despite repeated inquiries.Should any additional information of significance be received, a follow-up report will be filed.
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Manufacturing review of the vascure for vascular repair device history record for the reported event could not be completed, as the lot/serial number was not provided.Without additional information regarding this event, it is difficult to know if the description of the patch "blowout" is a failure of the patch itself, if the patch was displaced by the infection that developed post-operatively, or if the suture-line bleeding was related to the procedure or any anticoagulants prescribed to the patient.It can be deduced that the patch site was noted to have displayed characteristics that required intervention, such as swelling.There is no mention of symptoms related to infection or further treatment for infection.Infections for this complaint (encompassing six patients) were reported to have developed between 2-6 weeks post-operative and patient 2 was not identified specifically nor was the treatment specified other than to report the infection was cleared out and bleeding arrested.There was no mention of the patch being replaced, repaired or other treatment to mitigate.The root cause of the infection was likely procedure-related and could occur regardless of the use of the device.Had the physician believed the patch to be the source of the infection, it is likely he would have removed the patch; there was no such report in any of the six infections reported.The root cause of the infection is possibly due to a nosocomial infection and the device was not a direct contributor.The device was sterilized with ethylene oxide gas and was supplied to the end user as a sterile device.Post-operative infection and nosocomial infection are known potential complications of any surgical procedure.The root cause of the device dehiscence is unknown.It is unknown if this dehiscence was a failure of the patch.There are several possible causes beside failure of the patch, including the presence of infection, failure of the suture line due to surgical technique, or related to the likely anticoagulant therapy typically used in these patients.It is noted that per the instructions for use provided with the finished vascure for vascular repair device, infection and patch dehiscence/ rupture (deterioration) are listed as potential complications associated with an endarterectomy procedure and device usage.Should elutia receive any additional details of significance related to these events, a supplemental report will be filed.
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