MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Renal Failure (2041); Obstruction/Occlusion (2422)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

"navetta, 2019 ¿tandem resonance metallic double-j ureteral stents in a single ureter for salvage management of chronic ureteral obstruction¿ we report our experience placing tandem resonance stents (trs) in a single ureter of patients who failed management with a single resonance stent.We report our experience in a small series of patients whose ureteral obstruction was managed in this fashion due to failure of a single resonance stent and declined placement of a pcn.Hydronephrosis on follow-up imaging and renal failure were the most common reasons for failure of a single resonance stent, with rates of 100% and 71.4%, respectively 4 patients with a median age of 62 years were managed with trs.Please also note, although we cannot confirm the exact rpn of the resonance metallic double-j ureteral stents used it had the potential to be any one of the following: rms-060012-r, rms-060014-r, rms-060016-r, rms-060018-r, rms-060020-r, rms-060022-r, rms-060024-r, rms-060026-r, rms-060028-r, rms-060030-r.As confirmed by clinical advisor, renal failure was a cascading effect of the hydronephrosis and both adverse events are related.

Event Description

Supplemental report is being submitted due to the completion of the investigation on the 02 nov 2020.

Manufacturer Narrative

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 journal article.Complaint files (b)(4), (b)(4)(ref mdr# 3001845648-2020-00590), (b)(4)(ref mdr# 3001845648-2020-00591) & (b)(4)(ref mdr# 3001845648-2020-00592) were opened as a result of this paper.Within the attached paper in "table 1 -characteristics of four patients who received tandem resonance metallic double-j ureteral stents for salvage management of chronic ureteral obstruction", described the adverse effects experienced by the 4 patients discussed in the paper.This compliant file (b)(4)/ ref mdr# 3001845648-2020-00589 relates to all 4 patients in study had a single rms fail prior to the study.Compliant file (b)(4) relates to patient # 2 where tandem resonance stents (trs) failed due to hydronephrosis and renal failure which was managed with a nephrostomy.Also captured in this file, is the user error of the incorrect wire guide used to place the four stents.Compliant file (b)(4) relates to patient # 4 where trs failed due to flank pain and renal failure and was managed by a nephrostomy.Also captured in this file, is the user error of the incorrect wire guide used to place the two stents.Complaint file (b)(4) relates to overall off label of the placement of tandem resonance stents (trs).A device was also used on one patient with dystrophic calcifications treated (not extrinsic compression), also off-label use.The file (b)(4) captures the off label use of 8 of the stents of which 14 in total where used off label.Also captured in this file, is the user error of the incorrect wire guide used to place the eight stents.The paper describes the tandem placement of resonance metallic double-j ureteral stents in a single ureter.It goes on to state that seven renal units from four patients were managed with trs.Therefore, as two rms stents were placed simultaneously side by side in seven renal units that equates to a total of 14 rms stents being placed off label.However as 6 /14 cases of off label use are already captured in (b)(4)( 4/14) and (b)(4) (2/14), the file (b)(4) captures the remaining 8 cases of off label use.As per the medical advisor - the simultaneously placing two rms stents in tandem (side-by-side) in one ureter has been advised as off-label use despite there being no specific contraindications to this in the ifu and also there is no guidance for placing stents in tandem.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 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 states the following potential events: loss of renal function, pain/discomfort, hydronephrosis".A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.It maybe as the result of compression by a tight stricture, as per instructions for use, diminished urine drainage/ stent occlusion is listed as a complication following the placement of the device.It should be noted two patients had muo from metastatic colon cancer and two patients had benign disease that was not amenable to surgical repair.Complaint is confirmed based on customer testimony.All 4 patients in study had a single rms fail prior to the study.Hydronephrosis 100% with one resonance stent.1 patient required nephrostomy.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10506858
• MDR Text Key: 206108557
• Report Number: 3001845648-2020-00589
• 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: 11/02/2020

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2019
• 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: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention