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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

As reported to customer relations via email "dr.(b)(6), urologist, from (b)(6) came to our cook booth friday afternoon between 16:00 and 17:00 (about 7 hours ago), while i was talking to other customers, held a resonance metallic stent from our display table and said in french: this, doesn¿t work.I replied : we should make an incident report; if it stops draining, it would be considered a product malfunction and cook will replace it for the hospital.She said : no, because of this, one of our patients ended-up in palliative care: we installed it in a patient and it stopped working, one doctor tried to remove it but couldn¿t.We were then interrupted but the other customers i was talking to and she said: i will come back.Additional information provided: the patient was not hers but her colleague.The patient was a female that underwent radiotherapy, the patient had a radiotherapeutic ureteral stricture and was frequently stented until it was decided that they place a resonance stent in her, when the stent stopped working, one dr tried to remove it but couldn¿t, they found out that the resonance stent was outside the collecting system due to a perforation, they decided against performing a radical nephrectomy because of other co-morbidity factors, in agreement with the patient, she was placed in palliative care and the process of assistance in dying, which is legal in qc, was signed and engaged.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: the resonance stent set device of an unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.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 all resonance stent set devices are subject to visual inspections 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) states the following: ¿patient should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub-film).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.It should also be noted the instructions for use also state ¿individual variations of interactions between stents and the urinary system are unpredictable¿.There is no sufficient evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to stent patency or the patients progressive malignant disease.As per medical advisors input ¿there is not enough clinical information to make an accurate assessment but based on the information available please note the following.In this case it is possible that stent failed to maintain patency after x time (it doesn't say how long stent was in situ for before it stopped working) either because of 1.Long indwell time and possible subsequent encrustation or 2.Progressive ureteral obstruction from primary disease or 3.Erosion of stent through weakened ureteral tissue or 4.Perforation of the anatomy during attempt to remove stent.Since the patient was considered unsuitable for nephrectomy it is likely that she was placed in palliative care due to her progressive malignant disease and in another circumstances the next step would have been surgical intervention.Please note the stent is indicated for external obstruction ie.Not for ureteral strictures which would be internal.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required additional procedure to remove the stent an decided against performing a radical nephrectomy because of other co-morbidity factors, in agreement with the patient, she was placed in palliative care and the process of assistance in dying, which is legal in qc, was signed and engaged.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 16-jun-2022.

Event Description

Supplemental follow-up report is being submitted due to the re-completion of the investigation on 07/09/2023.

Manufacturer Narrative

Device evaluation: the resonance stent set devices of unknown lot # were not available for evaluation, therefore a document based investigation will be carried out.Lab evaluation: n/a.Manufacturing records: 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.Review historical data as per instructions for use (ifu0020): ¿used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.Intended for one time use.¿ there is evidence to suggest the user did not follow the instructions for use which accompany this device.Image review: n/a.Root cause review: a definitive root cause can be attributed to off label use.When the device is used outside of its validated state it is not possible to definitively state how the device will perform.The intended use for rms devices is to treat patients with extrinsic ureteral obstruction.It is known in this case the device was used to treat a radiotherapeutic ureteral stricture with intrinsic obstruction which is contrary to the intended use.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction.Complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation.The complaint was raised from testimony provided by the customer.According to the customer the patient ended up in palliative care.Investigation findings conclude a definitive root cause of off label use of the device used in a patient with radiotherapeutic ureteral stricture with intrinsic obstruction.Complaint is confirmed based on customer and/or rep testimony.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: 12914924
• MDR Text Key: 286130199
• Report Number: 3001845648-2021-00827
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2023

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
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 11/09/2021
• Supplement Dates FDA Received: 07/13/2022; 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Female