This mdr is being submitted due to the reported dysphagia which resulted in a two night hospitalization.The patient did not require intervention for the dysphagia and is now asymptomatic.The surgeon cannot confirm that the acell device was the cause of the reported symptoms.The surgeon is satisfied with the outcome of the patient.The acell device was not explanted and it is not available for evaluation.A review of the manufacturing records for this lot identified no deviations in the production process.The device was manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
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On 1/15/19, acell, inc.Was notified by a physician that their patient was complaining of having difficulty swallowing 9 weeks post-operative.The surgeon conducted a gastric bypass and hiatal hernia repair with an acell device on (b)(6) 2018.The patient presented with the symptoms at the er 9 weeks post-operative; an index ct scan was conducted which showed some narrowing.The patient was admitted to the hospital for 2 days.A ugi series and an egd with eus were performed.The results indicated the distal esophagus was patent with no obstruction and the eus revealed no significant fluid present.The patient did not require intervention for the dysphagia and is now asymptomatic.The surgeon cannot confirm that the acell device was related to the symptoms the patient reported and is satisfied with the outcome of the patient.The device was not explanted.
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