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

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Kobayashi et al 2021, ¿patency period of a metallic ureteral stent and its determinants in patients with malignant ureteral obstruction: a prospective review¿.We performed stent placement in 21 patients, bilaterally in six and unilaterally in 15 patients.One month after placement of the polymer ureteral stent, we replaced it with a metallic ureteral stent.We inserted the 8.3-fr metallic ureteral stent introducer over the guide-wire under fluoroscopic guidance and advanced it to the ureteropelvic junction.We confirmed that the proximal curl of the stent was located in the renal pelvis and the distal curl was located in the bladder.The length of the metallic ureteral stent was determined according to the length of the ureter.We did not perform balloon dilation of ureteral strictures.Obstruction occurred in five patients, of whom two easily underwent stent exchange.The patient in case 5 experienced disease progression and stent obstruction after chemotherapy withdrawal.Although she resumed chemotherapy after stent exchange, she was eventually diagnosed as having progressive disease and stent obstruction occurred thereafter.One patient did not require stent exchange due to best supportive care.The other two patients were in poor general condition and did not require additional treatment.The extracted metallic ureteral stents did not display apparent encrustation macroscopically.Obstruction occurred in five patients, of whom two easily underwent stent exchange.

Manufacturer Narrative

Device evaluation the unknown devices of unknown lot number involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation ¿ n/a.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution rms 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) lists diminished urine drainage/ stent occlusion as a known potential adverse event associated with rms procedures.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patient pre-existing conditions.As per the ifu, diminished urine drainage/ stent occlusion is listed as a known potential adverse event associated with rms procedures.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, two patients easily underwent stent exchange.One patient experienced disease progression and stent obstruction after chemotherapy withdrawal.Although she resumed chemotherapy after stent exchange, she was eventually diagnosed as having progressive disease and stent obstruction occurred thereafter.One patient did not require stent exchange due to best supportive care.The other two patients were in poor general condition and did not require additional treatment.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 12769089
• MDR Text Key: 283976658
• Report Number: 3001845648-2021-00791
• 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
• Report Date: 07/11/2022

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: 09/08/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 08/09/2022
• 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 Sex: Female