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No medical images were provided to the manufacturer.A surgical report was provided to the manufacturer and is currently under review.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Manufacturing review: the device history records were reviewed and the lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection: the product was returned.No tears, holes, or perforations were noted on the returned device.No clamp marks were noted on the returned device.Dimensional evaluation: the shunt was measured and found to be within product specifications.Medical records review: medical records were provided.A surgical procedure was performed to place a carotid shunt in the right internal carotid artery.The shunt did not stay in place despite it being sutured into the carotid.The shunt was exchanged for a new shunt that was sutured in place without incident.The patient was hemodynamically stable at the conclusion of the surgery.Image review: based on the images provided, a digital measurement from a 3d reconstruction of the bilateral carotids demonstrated a 75% stenosis in the right internal carotid and a patent left carotid can be confirmed.Conclusion: the device was returned.Images and medical records were provided.The evaluation of the returned device found all measurements to meet the required specifications.The investigation is confirmed for slippage of the device, as the medical records state that the shunt moved once sutured in place.The investigation is inconclusive for incorrect size for patient, as the returned device met specifications and the actual size of the artery could not be confirmed.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: current instructions for use ( ifu): important: there are various techniques used in placing and affixing carotid bypass shunts.These shunts should be used only by qualified physicians thoroughly familiar with endarterectomy and patch-graft angioplasty techniques.Carotid bypass shunts are influenced by three significant factors: the size, configuration and disease state of the artery; the design and dimensions of the shunt; the stabilization technique to hold the shunt in place.Stabilization can be accomplished by many techniques, including vessel loops, umbilical-type tapes, heavy ligatures, tourniquets, or surgical clamps.Surgical clamps should be appropriate in size and design for the shunt chosen.Warning: when there is an incompatibility between the stabilizing technique, the artery and the shunt, slippage can occur.In order to avoid slippage and/or vessel damage or disruption when the clamp technique is utilized, users should ensure that the clamps they employ are compatible in size and design with the particular shunt they intend to use.Suggested insertion techniques: non t-shaped shunts.The carotid arteries should be isolated, tourniquet loops placed, and the arterial incision made.The proper size shunt must be chosen, determined at the time of surgery, based on the surgeon¿s experience and training.Forcing a shunt that is too large into an artery may cause vessel disruption.Insert the shunt into the artery.Care should be taken not to dislodge plaque, clot, or to raise intimal flaps.The bypass shunt is held in place by tension on the tourniquet loops.The endarterectomy is then performed.When the endarterectomy is completed, using standard cardiovascular techniques, which may include patch-graft angioplasty, the shunt is removed and the incision is closed.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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It was reported that the carotid bypass shunt allegedly slipped out of the artery.It was further reported that the diameter size of the shunt was allegedly incorrect in relation to the javid clamps.Reportedly, surgical intervention was required to complete the procedure.Patient status was reported as unknown.New information received: medical records were received and reviewed.A surgical procedure was performed to place a shunt in the internal carotid artery, as a recent ct scan demonstrated a 75% stenosis of the right carotid artery.An endarterectomy was performed to remove the soft plaque from the right carotid artery.The shunt did not remain in place despite being sutured into the internal carotid artery; therefore, the shunt was exchanged for another that was sutured in place without incident.Post shunt placement, a ct scan demonstrated good retro grade filling in the cerebral arteries and interior carotid arteries.
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