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

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

The lot # of the resonance metal stent was not provided the complaint was confirmed based on the customers testimony of adverse events occurring as a result of usage of the rms device published in an article from a us study.¿ exchange to a conventional polymer ureteral stent in patient who appeared not to tolerate the composition of the metallic stents.¿ the device involved in the complaint was not available to be returned for evaluation.With the information provided a document based investigation was carried out.Prior to distribution, resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in the procedures referenced above and attached.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 manufacturing records for this device.The (b)(4) devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.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 patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.¿ complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This event was noted following a review of the following article: baumgarten as, hakky ts, carrion re, et al.A single-institution experience with metallic ureteral stents: a cost-effective method of managing deficiencies in ureteral drainage.Int braz j urol.2014;40(2):225-231.Summary of the event involving placement of resonance metallic stents as follows: the patients undergoing chronic ureteral stent placement in the context of a cystectomy and urinary diversion, consisting of either a cutaneous ureterostomy or ileal conduit, ureteral stents were placed under local, regional, or general anesthesia with the assistance of fluoroscopy.Once a retro-grade pyleogram was performed, a guidewire was successfully placed into the collecting system, the cylindrical outer sheath was passed into the renal pelvis, and the wire was removed.The proximal stent was uncurled, and then advanced through the sheath using a pusher.Under fluoroscopy a push-pull technique was used to overly advance the sheath while placing the stent.The proximal stent curl was noted in the renal pelvis, and the outer sheath was removed, causing the distal curl to uncurl.At the completion of the procedure, the final fluoroscopy image was shot and saved to confirm proper placement of the stent.Medical agents were not used to alleviate irritative or voiding symptoms unless symptoms were severe, in which case, oral anticholingeric medications were prescribed.Patients were seen at 6 months post-metallic stent placement to assess symptomatology, as well as serum creatinine.Exchange to a conventional polymer ureteral stent in two patients who appeared not to tolerate the composition of the metallic stents.As two resonance stents placed within two different patients are referenced within this article two separate reports have been submitted.Reference also report # 3001845648-2016-00066.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5492917
• MDR Text Key: 40114527
• Report Number: 3001845648-2016-00067
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2016

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: UNKNOWN
• 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: 02/16/2016
• Initial Date FDA Received: 03/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention