As reported in the literature by brophy et al.(2021), a retrospective review was conducted of patients who underwent extra-anatomical stent (eas) placement between november 2012 and january 2021.Ten patients underwent a total of 33 eas procedures, using the paterson-forrester subcutaneous urinary diversion stent.The mean age at the time of the primary procedure was 58 years (range 43-63).Three patients were male and seven were female.All patients had benign ureteric obstruction, with retroperitoneal fibrosis the most common cause of obstruction.All patients had a nephrostomy in place, and all had failed trials of internalizing the nephrostomy.All patients had chronic kidney disease with a median estimated gfr (glomerular filtration rate) of 36 (range was 10-77).All had undergone exchange of their nephrostomy catheter within one month of primary eas insertion.Primary eas insertion was performed under general anesthesia, using cystoscopy and fluoroscopic guidance.Antibiotics were given prophylactically.Subsequent exchanges were performed under either general or spinal anesthesia.During the initial procedure, a subcutaneous tract is made in stages and the eas is passed through a sheath with the proximal end placed in the renal pelvis.A needle puncture is then made in the bladder and using cystoscopy, a guidewire and sheath are inserted into the bladder, and the distal end of the stent is inserted via the sheath.The incisions are then closed.Outpatient follow-up was performed at six weeks and routine exchanges were planned at twelve months.Case 10 in article: the proximal end of the stent migrated out of the calyx, causing cutaneous erosion within three months.A covering nephrostomy was placed, and the stent was removed from the proximal end, without anesthesia.The patient received oral antibiotics.Placement of another eas will be considered once the cutaneous infection has resolved.In the same article, one patient (case 1) experienced migration of the stent- will be reported under patient identifier (b)(6).One patient (case 9) developed urosepsis- will be reported under patient identifier (b)(6).One patient (case unknown) experienced bladder irritation requiring exteriorization of the stent- reported under patient identifier 354824.One patient (case 6) experienced bladder irritation requiring exteriorization of the stent- reported under patient identifier (b)(6).Reference: brophy, et al.(2021).Extra-anatomical stents in benign ureteric obstruction: experience and outcomes.Journal of endourology.Https://doi.Org/10.1089/end.2021.0340.
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.Event description: as reported in the literature by brophy et al.(2021), a retrospective review was conducted of patients who underwent extra-anatomical stent (eas) placement between november 2012 and january 2021.Ten patients underwent a total of 33 eas procedures, using the paterson-forrester subcutaneous urinary diversion stent.The mean age at the time of the primary procedure was 58 years (range 43-63).Three patients were male and seven were female.All patients had benign ureteric obstruction, with retroperitoneal fibrosis the most common cause of obstruction.All patients had a nephrostomy in place, and all had failed trials of internalizing the nephrostomy.All patients had chronic kidney disease with a median estimated gfr (glomerular filtration rate) of 36 (range was 10-77).All had undergone exchange of their nephrostomy catheter within one month of primary eas insertion.Primary eas insertion was performed under general anesthesia, using cystoscopy and fluoroscopic guidance.Antibiotics were given prophylactically.Subsequent exchanges were performed under either general or spinal anesthesia.During the initial procedure, a subcutaneous tract is made in stages and the eas is passed through a sheath with the proximal end placed in the renal pelvis.A needle puncture is then made in the bladder and using cystoscopy, a guidewire and sheath are inserted into the bladder, and the distal end of the stent is inserted via the sheath.The incisions are then closed.Outpatient follow-up was performed at six weeks and routine exchanges were planned at twelve months.Case 10 in article: the proximal end of the stent migrated out of the calyx, causing cutaneous erosion within three months.A covering nephrostomy was placed, and the stent was removed from the proximal end, without anesthesia.The patient received oral antibiotics.Placement of another eas will be considered once the cutaneous infection has resolved.In the same article, one patient (case 1) experienced migration of the stent- will be reported under patient identifier (b)(6).One patient (case 9) developed urosepsis- will be reported under patient identifier (b)(6).One patient (case unknown) experienced bladder irritation requiring exteriorization of the stent- reported under patient identifier (b)(6).One patient (case 6) experienced bladder irritation requiring exteriorization of the stent- reported under patient identifier (b)(6).Reference: brophy, et al.(2021).Extra-anatomical stents in benign ureteric obstruction: experience and outcomes.Journal of endourology.Https://doi.Org/10.1089/end.2021.0340.Investigation - evaluation reviews of, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of relevant manufacturing documents was conducted.It was concluded that current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: warnings/precautions caution: maximum indwelling time is three (3) months.Note: it is recommended that the stent be fluoroscopically monitored every month suggested instructions for using paterson-forrester subcutaneous urinary diversion stent set caution: surgeon must place clamp on the upper most end of the stent, otherwise, stent may be inadvertently pulled from kidney.The surgeon may elect to place a temporary 2-0 silk suture around this portion of the stent and temporarily secure it to the skin.It is not known how long this stent was indwelling before it migrated, whether the stent was anchored by the surgeon either with a suture or clamp, or if the stent was fluoroscopically monitored on a monthly basis.Cook could not determine the cause of the of the stent migration.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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