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

Catalog Number RMS-060026-R

Device Problem Partial Blockage (1065)

Patient Problem Occlusion (1984)

Event Date 03/20/2014

Event Type  Injury  

Event Description

A patient had a renal scan on (b)(6) 2014 which showed a severe obstruction.The stent was very encrusted causing blockage.Overall effect of kidney function was not affected as a result of this incident.The doctor made comments stating this patient may not have been a good candidate for this device.The device was removed and replaced with two plastic stents placed side by side.A section of the device did not remain inside the patient's body.Two plastic stents were placed side by side in patient to replace complaint device.According to the initial reporter, there was no harm to the patient and the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

There was no (b)(4) device of lot c904596 in stock at the time of the investigation.As the device is not available to be returned, a document based investigation was carried out.An image was provided.The customer complaint could be confirmed as the image provided confirmed that the stent was encrusted.A summary of comments received from the relevant product manager was as follows: stent encrustation is a common occurrence with urinary stents.The severity varies depending on the patient especially with patients who are known stone formers there is a higher risk of stent encrustation which may be what the doctor was referring to when he said the patient was not a good candidate." as the device was not returned for evaluation, we are unable to conclusively determine the root cause of this complaint.Resonance stent 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, ifu, removal or replacement of a resonance stent is standard procedure.Potential adverse events associated with indwelling ureteral stents listed in the instructions for use, ifu include and are not limited to stent encrustation.A warning on the instructions for use, ifu, advises the following: "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).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." from the information provided the stent was implanted on 12/18/2013 and removed from the patient on (b)(6) 2014 as a renal scan performed on the day of removal showed severe encrustation.A final warning in the instructions for use, ifu indicates that: "individual variations of interaction between stents and the urinary system are unpredictable." prior to distribution all resonance stent devices are subject to visual inspections to ensure device integrity.A review of the manufacturing records for lot number c904596 did not reveal any discrepancy related to the complaint issue.From the information provided the patient did not experience any adverse effects due to this occurrence.The device was successfully removed and replaced with two plastic stents.Complaints of this nature will continue to be monitored for potential emerging trends.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: 3848611
• MDR Text Key: 4617829
• Report Number: 3001845648-2014-00084
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2016
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C904596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention