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

Catalog Number RMS-060024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

The physician is meeting the rep on the (b)(6) to receive additional details and determine the source of the bleeding.A follow up report will be submitted within 30 days with the additional details and investigation conclusions.

Event Description

During a meeting with a cook rep and a physician, the physician informed the cook rep of an event involving a resonance metallic ureteral stent.The physician indicated the stent was indwelling in the patient more than 12 months when the patient started to develop complications with an artery close to the ureter.This complication involved open surgery with excessive bleeding.The patient died.The physician stated the patients death was due to bleeding and was not related to the removal of the stent.There is currently no link between the device and the patient death.No device malfunction has been reported.The physician is meeting the rep on the (b)(6) to receive additional details and determine the source of the bleeding.A follow up report will be submitted within 30 days with the additional details and investigation conclusions.

Manufacturer Narrative

The information received in the complaint form confirmed the device involved in this complaint to be an rms-060024 device.The device involved in the complaint was not available to be returned for evaluation or the lot number was not provided; with the information provided a document based investigation was carried out.The cook rep initially reported the following complaint issue: ¿the product was used for a patient with a cancer and was left inside for longer than the recommended usage.This could have affected one of the arteries by cutting it.The physician informed me about a case on a not a perfect indication (ureteral cancer or bladder cancer) that he inserted one resonance and left in a patient for more than 12 months indwelling time.The patient after these 12 months had a complication with a vein/artery very close to the ureter that required a surgery with other complications.' further clarification was received as follows: 'the complication during open surgery was bleeding.The patient died as a result of bleeding.Additional information was requested from the physician as follows: 'he stated the stent was indwelling for 13 months.The patient had pelvic cancer surgery, colon cancer and consequently radiotherapy.There was no issue noted with the device prior to this event.The complication with the artery was confirmed before removing the device.He stated the bleeding did not occur during a procedure that was been carried out to specifically remove the device.He stated the cause of death as per the patient death report ¿ fistula ureter iliac colic, dic disseminate intravascular coagulation¿'.Clinical input received stated 'it appears that the patient had a number of the risk factors for arterioureteral fistulas.On the patient death report it looks like they are confirming the presence of a arterioureteral fistula.The patient had many of the risk factors for creation of a arterioureteral fistula, including cancer, pelvic surgery, radiotherapy, and ureteral stenting.So it would not be unreasonable to expect the stent to have contributed to the formation of the fistula, which, in turn, lead to the bleeding'.A definitive cause was unable to be determined because the device was not returned and the actual use conditions could not be duplicated.The indwelling time was 13 months and the patient had pelvic cancer surgery, colon cancer and consequently radiotherapy which are the risk factors for arterioureteral fistulas.The doctor stated on the patient death report fistula ureter iliac colic, dic disseminate intravascular coagulation.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 manufacturing records for this device.The rms-060024 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.¿ a warning on the instructions for use, advises the following: ¿the stent must not remain indwelling more than twelve months¿.If the patient¿s status permits, the stent may be replaced with a new stent.¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).¿ a final warning indicates that: potential adverse events associated with indwelling ureteral stents include fistula formation including arterioureteral fistula.Customer quality assurance will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is been submitted due to the receipt of additional information and the conclusion of the investigation.Reference investigation for details of the event.

• 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: 5466314
• MDR Text Key: 39226291
• Report Number: 3001845648-2016-00057
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

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: RMS-060024
• 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: 02/01/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• 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): Death; Required Intervention