MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number RMS-060026-R

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Urinary Retention (2119); Migration (2249)

Event Type  Injury  

Event Description

The following article was received for review on the 19 january 2014.'outcomes of metallic stents for malignant ureteral obstruction; from the division of urologic surgery, duke university medical center, durham, north carolina.The journal of urology, vol 188, 851-855, september 2012.The article indicates the study interval to be september 2010 through july 2011.The pts involved in the study underwent placement of the cook manufactured metallic resonance stent for malignant ureteral obstruction.The info which the article indicated stent migration was noted in these cases.It may be noted that two cases had previously been logged in 2011 by a physician involved in the study.Cook ireland had not previously received the article related to the study.This report is being sent in relation to the third pt where one resonance stent migrated distally.This stent migration was associated with significant hydronephrosis and was managed with metallic stent replacement.

Manufacturer Narrative

The following article was received from review on the january 19, 2014: 'outcome of metallic stents for malignant ureteral obstruction; from the division of urologic surgery, duke university medical center, durham, north carolina.The journal of urology, vol 188, 851-855, september 2012.The article indicates the study interval to be september 2010 through july 2011.The pts involved in the study underwent placement of the cook manufactured metallic resonance stent for malignant ureteral obstruction.The info within the article indicated stent migration was noted in three cases.It may be noted that two cases had previously been logged in 2011 by a physician involved in the study.Cook ireland had not previously received the article related to the study.This report is being sent in relation to the third pt where one resonance stent migrated distally.This stent migration was associated with significant hydronephrosis and was managed with metallic stent replacement.Add'l contact info was received as follows: "stent placed in a retrograde fashion with fluoroscopic guidance.Final fluoroscopy images were obtained to confirm proper stent position before concluding the procedure.Stent migrated distally and no stents required removal for recurrent infection".A definitive cause for the customer's complaint was unable to be determined because the actual use conditions could not be duplicated in the alb setting.Due to a variety of clinical conditions such as pt anatomy or progression of disease state.Cook ireland could not reproduce the actual conditions of device usage.The device involved in the complaint was not available to be returned for eval.With the info provided, a document based investigation was carried out.The rpn for this complaint was not provided but is most likely: rms-xxxxxx-r (as per article stent length is between 20 and 28cm), therefore rms-060026-r has been used in this complaint for logging purposes.The lot number of the resonance metal stent was not provided, therefore it was not possible to check if any of the affected lot remained in stock.Prior to distribution, resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.As the lot number of the device involved in this complaint was not provided, it was not possible to conduct a review of the device mfg records for this device.The rms-060026-r devices are used for temporary stenting of the ureter in adult pts with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use, hydronephrosis and stent migration are listed as potential adverse events associated with indwelling ureteral stents.As per instructions for use, users are cautioned as follows: "individual variations of interaction between stents and the urinary system are unpredictable.Use of this device should be based upon consideration of risk-benefit factors as they apply to your pt, informed consent should be obtained to maximize pt compliance with f/u procedures".A warning on the instructions for use, advises the following: "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film)".A final warning indicates tht: "individual variations of interaction between stents and the urinary system are unpredictable".The complaint was confirmed based on the customers testimony of adverse events occuring as a result of the rms device.As stated above stent migration and hydronephrosis are known potential adverse events associated with placement of this device.In this instance the stent migration was managed with metallic stent replacement.No further adverse effects to this pt were detailed in the article.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; EI ; 61334440
• MDR Report Key: 3640726
• MDR Text Key: 19569689
• Report Number: 3001845648-2014-00028
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060026-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention