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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2018

Event Type  Injury  

Event Description

Tsurusaki et al 2018 indwelling of full-length metallic ureteral stents as an initial treatment for patients with untreated malignant ureteral obstruction to examine the efficacy and safety of a full-length metallic ureteral stent (ms), resonance, we retrospectively evaluated 16 cases (22 ureteral units) with indwelling ms as the initial treatment for patients with untreated malignant ureteral obstruction (muo).All patients had undergone ms insertion by the retrograde approach without cystoscopy, with indirect stent placement under fluoroscopy, as a new method that can be performed even if the number of medical staff is one less than that required.Both serum creatinine and estimated glomerular filtration rate values in all cases improved significantly (p<0.001).Moreover, ms failure occurred in only one patient and the stent patency rate was 93.8%.Stent-related complications were observed in four patients.Two patients experienced stent dislodgement, and one each had fever and acute pyelonephritis, although none of the complications were life-threatening.After the introduction of ms in our hospital, the rate of percutaneous nephrostomy in muo patients excluding those not suited for indwelling ms, clearly decreased from 80% to 20%.This is the first report on the clinical evaluation of indwelling ms as the initial treatment of muo in japan, and this report indicates that ms is a very useful choice in terms of effectiveness, safety, medical cost, and reduction in the workload of medical staff.We believe that the indwelling ms will become a standard initial treatment for patients with untreated muo in the future.Ms failure occurred in only one patient and the stent patency rate was 93.8%.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Supplemental mdr being submitted due to updated description of event, gender and age on 20-sept-2022 tsurusaki et al 2018 indwelling of full-length metallic ureteral stents as an initial treatment for patients with untreated malignant ureteral obstruction to examine the efficacy and safety of a full-length metallic ureteral stent (ms), resonance, we retrospectively evaluated 16 cases (22 ureteral units) with indwelling ms as the initial treatment for patients with untreated malignant ureteral obstruction (muo).All patients had undergone ms insertion by the retrograde approach without cystoscopy, with indirect stent placement under fluoroscopy, as a new method that can be performed even if the number of medical staff is one less than that required.Both serum creatinine and estimated glomerular filtration rate values in all cases improved significantly (p<0.001).Moreover, ms failure occurred in only one patient and the stent patency rate was 93.8%.Stent-related complications were observed in four patients.Two patients experienced stent dislodgement, and one each had fever and acute pyelonephritis, although none of the complications were life-threatening.After the introduction of ms in our hospital, the rate of percutaneous nephrostomy in muo patients excluding those not suited for indwelling ms, clearly decreased from 80% to 20%.This is the first report on the clinical evaluation of indwelling ms as the initial treatment of muo in japan, and this report indicates that ms is a very useful choice in terms of effectiveness, safety, medical cost, and reduction in the workload of medical staff.We believe that the indwelling ms will become a standard initial treatment for patients with untreated muo in the future.Procedural description: for anaesthesia, general anaesthesia was used in 2 cases, lumbar anaesthesia in 5 cases, and no anaesthesia in 9 cases.As a general rule, female patients underwent the operation without anaesthesia.The operation was performed by retrograde stenting in all cases.First, using a cystoscope, a 5 fr tip ureteral catheter was inserted into the ureteral orifice under fluoroscopic guidance.After the renal pelvis was reached retrograde urography was renal pelvis.Thereafter, a guide wire was inserted and the ureteral catheter and cystoscope were removed.Next, a ureteral sheath (fig.1(a)) was inserted over the guide wire.The ms was inserted into the lumen of the sheath and pressed with a pusher until the ms formed a loop in the renal pelvis (fig.1(b)).While holding and confirming the position of the ms, the ureteral sheath was gradually withdrawn.When the tip of the pusher reached the lower edge of the pubic symphysis, the ureteral sheath was completely removed.After confirming by fluoroscopy that the lower end of the ms had looped in the bladder, the operation was ended.When there was resistance to the insertion of the ms, insertion was made possible by using the outer tube of the cystoscope to straighten the sheath within the bladder.The median age was 66.7 years (range 44-84).The gender split was 6 male cases and 10 female cases.Ms failure occurred in only one patient and the stent patency rate was 93.8%.

Event Description

Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2023.

Manufacturer Narrative

Device evaluation this file was opened to capture the event of metallic stent failure in the literature article ¿tsurusaki et al 2018¿.The resonance stent set device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all rms devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Review of historical data: historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use (ifu0020) inform of the potential adverse events associated with indwelling ureteral stents; ¿stent dislodgement/migration, stent encrustation, stent failure , tissue ingrowth , ureteral reflux.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.A possible root cause of inherent risk of device is determined based on the available information.Stent failure is a known potential adverse event which is noted in the instructions of use for the device.Confirmation of complaint complaint is confirmed based on customer testimony.Corrective action/ correction complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation according to the customer a resonance metallic stent failed.Complaint is confirmed based on customer and/or rep testimony.A possible root cause could be attributed to the inherent risk of device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15416753
• MDR Text Key: 299836908
• Report Number: 3001845648-2022-00638
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 08/16/2022; 08/16/2022
• Supplement Dates FDA Received: 10/18/2022; 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 66 YR
• Patient Sex: Female