This event still meets the requirements of a serious injury report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 ".A ¿serious injury¿ is an injury or illness that: - ¿necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure¿ and section 2.5 "it should also be noted that a device does not have to malfunction for it to cause or contribute to a serious injury".Device evaluation: the evo device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.This file was created from the attached journal article.A total of twenty five patients were identified in this retrospective study of 35 procedures over an 8-year period.The stents used were as follows: 11endomaxx (merit), 11 wallflex (boston scientific), 5 polyflex (boston scientific), and 3 evolution cook endoscopy) were used.This file captures fistula site bleeding.(ref.Att."silon 2017.Pdf").Due to the limited information provided in this literature, we cannot confirm if the evo stent's used were partially/ fully covered and used for benign or malignant indication.Documents review including ifu review: as the evo stent is unknown device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (partially and fully covered esophageal stent) devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, ifu0061-5, which informs the user about the potential complications "additional complications include, but are not limited to : perforation, hemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Therefore risk will not be complete due to the limitation of available information.A possible root cause could be attributed to patient condition related, as per instructions for use, perforation, hemorrhage are listed as a potential complication following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.This event still meets the requirements of a serious injury report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 ".A ¿serious injury¿ is an injury or illness that: - ¿necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure¿ and section 2.5 "it should also be noted that a device does not have to malfunction for it to cause or contribute to a serious injury".- attachment: [silon 2017.Pdf].
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