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

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Gao, 2021, the resonance and the allium ureteral stents in the treatment of non-malignant refractory ureterostenosis.18 patients underwent the procedure using a resonance stent.Intraoperative placement of ureteral stents was usually under fluoroscopic guidance.For resonance stents, 24 cm ones were chosen for patients shorter than 165 cm, 26 cm for patients between 165 and 175 cm, and 28 cm for patients taller than 175 cm.Resonance stents were replaced yearly.11 patients experienced encrustation.Resonance stents had encrustation formed on the bladder and lower ureteral stents, the blood creatinine, gfr and ct images showed no signs of aggravated obstruction.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation: the resonance stent set device of unknown lot # was not available for evaluation, therefore a document based investigation will be carried out.The following complaints were raised in relation to this literature paper: (b)(4) (report reference number - 3001845648-2021-00768) - gao 2021: moderate to severe oab.(b)(4) (report reference number - 3001845648-2021-00767) - gao 2021: recurrent urinary tract infections.(b)(4) - gao 2021: pain.(b)(4) (report reference number - 3001845648-2021-00756) - gao 2021: displacement/migration.(b)(4) (report reference number - 3001845648-2021-00757) - gao 2021: stent encrustation.As the lot # of the resonance stent set device is unknown it is not possible to carry out a review of the manufacturing records.However, prior to distribution all resonance stent set 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.It should be noted that the instructions for use (ifu0020-18) states the following: "potential adverse events associated with indwelling ureteral stents include: stent encrustation.¿ there is evidence to suggest the user did not follow the instructions for use which accompany this device.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause can be attributed to a procedural related effect as the ifu which accompanies this device lists stent encrustation as a known complication associated with the use of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial report, 11 patients experienced encrustation.Resonance stents had encrustation formed on the bladder and lower ureteral stents, the blood creatinine, gfr and ct images showed no signs of aggravated obstruction.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

Supplemental follow-up mdr correction report is being submitted due to the update to the imdrf coding and investigation conclusions.

Manufacturer Narrative

Device evaluation: the resonance stent set device of unknown lot # was not available for evaluation, therefore a document based investigation will be carried out.The following complaints were raised in relation to this literature paper: pr 344554 (report reference number - 3001845648-2021-00768) - gao 2021: moderate to severe oab pr 344559 (report reference number - 3001845648-2021-00767) - gao 2021: recurrent urinary tract infections -(b)(4)- - gao 2021: pain -(b)(4)- (report reference number - 3001845648-2021-00756) - gao 2021: displacement/migration pr 344562 (report reference number - 3001845648-2021-00757) - gao 2021: stent encrustation lab evaluation: n/a image review: n/a document review including ifu review; as the lot # of the resonance stent set device is unknown it is not possible to carry out a review of the manufacturing records.However, prior to distribution all resonance stent set 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.It should be noted that the instructions for use states the following: "potential adverse events associated with indwelling ureteral stents include: stent encrustation.¿ there is evidence to suggest the user did not follow the instructions for use which accompany this device.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause can be attributed to a procedural related effect as the ifu which accompanies this device lists stent encrustation as a known complication associated with the use of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial report, 11 patients experienced encrustation.Resonance stents had encrustation formed on the bladder and lower ureteral stents, the blood creatinine, gfr and ct images showed no signs of aggravated obstruction.Complaints of this nature will continue to be monitored for 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: 12712430
• MDR Text Key: 284632177
• Report Number: 3001845648-2021-00757
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/07/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/30/2021; 04/07/2021
• Supplement Dates FDA Received: 12/15/2021; 04/25/2023
• 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 Age: 56 YR
• Patient Sex: Male