No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation 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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It was reported that during a bypass graft implantation from the right femoral artery to the right anterior tibial artery, the bypass graft allegedly tore while positioning it distally.Reportedly, the graft was removed and the health care provider switched to another site and successfully implanted another bypass graft.There was no reported patient injury.
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The device history records have been reviewed with special attention to the subassemblies, manufacturing process, and quality control inspection.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation was inconclusive for the alleged tear in the graft.Based upon the available information, the definitive root cause was unknown.Labeling review: the current instruction for use (ifu) states: eptfe grafts do not stretch (are non-elastic) in the longitudinal direction.The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation.Failure to cut the graft to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death.Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.When suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel.Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption.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 during a bypass graft implantation from the right femoral artery to the right anterior tibial artery, the bypass graft allegedly tore while positioning it distally.Reportedly, the graft was removed and the health care provider switched to another site and successfully implanted another bypass graft.There was no reported patient injury.
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