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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); No Information (3190)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

Information pertaining to user facility as follows: department of urology, (b)(6).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Miyazaki, 2019, ¿the resonance® metallic ureteral stent in the treatment of malignant ureteralobstruction: a prospective observational study.¿ stent obstruction occurred in eight patients: six females and two males -although four of these eight patients underwent percutaneous nephrostomy construction and the other two patients were treated by ureteral stent exchange, two patients needed no further intervention because of their short life expectancy.

Event Description

The investigation was concluded on the 10-sep-2021, this supplement report is being submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the unknown rms devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article - "miyazaki - the resonance metallic ureteral stent in the treatment.The paper describes the resonance metallic ureteral stent in the treatment of malignant ureteral obstruction: a prospective observational study.46 patients were studied over 1 year period.Within the paper in "fig 1 -flow chart with the patient survival/outcomes", described the adverse effects experienced by the 46 patients discussed in the paper.Complaint files (b)(4) (3001845648-2020-00599) , (b)(4) (3001845648-2020-00600) , (b)(4) (3001845648-2020-00969) were opened as a result of this paper.This compliant file (b)(4) relates to stent obstruction that occurred in eight patients: six females and two males -although four of these eight patients underwent percutaneous nephrostomy construction and the other two patients were treated by ureteral stent exchange, two patients needed no further intervention because of their short life expectancy.Compliant file (b)(4) relates to pain and stent migration.Of the 46 patients, two patients had at least one complication associated with the resonance (migration, n = 1) and their stent was removed.(b)(4) file will capture 1 case of stent migration.Compliant file (b)(4) relates to the adverse effect of febrile urinary tract infection.Of the 46 patients, two patients had at least one complication associated with the resonance febrile urinary tract infection and their stent was removed.Compliant file (b)(4) relates to the number of male patients in whom the resonance stent could be left in place until the end of study was only one, and thus the resonance stent may be painful for male patients.The complaint file pr 308439 relates to the 15 male patients who experienced pain.Complaint file (b)(4) relates to the use error of not removing the rms stents after 12 months indwell period, the qty of patients affected is 5 (based on 70-80% of 7 patients remaining in the study) document review: as the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution rms-060026-r devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for the unknown rms device could not be completed as the lot number was unknown.It should be noted that the instructions for use (ifu0020-17) states the following: intended use " used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.Intended for one-time use" ¿warnings these stents are not intended as permanent indwelling devices.The stent must not remain indwelling more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent.Patients should be checked at regular interval utilizing techniques such as abdominal x-ray (kub film).Patient using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿ it may be noted that according to the instructions for use, ifu0020-17, the user is instructed that ¿hematuria and incontinence may indicate fistula formation.¿ per the instructions for use (ifu0020-17) states the following potential events: diminished urine drainage/ stent occlusion, loss of renal function, pain/discomfort, hydronephrosis, stent dislodgement / migration." there is not enough evidence to suggest that the customer did not follow the instructions for use (ifu0020-17).5.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient anatomy, as per instructions for use, (ifu0020-17), stent occlusion is listed as a complication following the placement of this device.Summary: complaint is confirmed based on customer testimony.Stent obstruction that occurred in eight patients: six females and two males -although four of these eight patients underwent percutaneous nephrostomy construction and the other two patients were treated by ureteral stent exchange, two patients needed no further intervention because of their short life expectancy.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10511775
• MDR Text Key: 206301372
• Report Number: 3001845648-2020-00598
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention