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

Model Number G34110

Device Problem Off-Label Use (1494)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 03/24/2023

Event Type  Injury  

Event Description

As initially reported to customer relations: a female patient had a stent placement in (b)(6) 2022 in which the resonance stent, g34110, was implanted.On (b)(6) 2023 the patient underwent a stent replacement procedure.Rms indwelling for 9 months.Could not be removed due to resistance of inflammatory tissue in the ureter near the stricture, stent looked to be "burrowed" into the urothelium along the length of the upper ureter.It appeared that the inflammed tissue may have lodged between the coils of the rms.There was no resistance noted in the ureter closest to the bladder.Imflammary tissue was deemed by dr.Jonat to not be cancer.Pigtail of stent may have been lodged in a calyx/parychema, but not certain.Visualization was poor due to the inflammatory tissue breaking off and floating in the field of view.As the rms could not be removed due to resistance, the decision was made to leave it in place and not risk evulsing the right ureter.There was no encrustation on the rms and the patient has no history of nickel allergy.Patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? yes if yes, please describe.The rms has been left in place.2.Was the patient hospitalized or was there prolonged hospitalization? yes 3.Did the patient require any additional procedures due to this occurrence? yes if yes, please describe.The rms has been left in place and may never be removed due to the risk to the patient.A black silicone ureteral stent was placed next to the rms without issue and the case was ended.[the physician] will be meeting with his urology colleagues next week to discuss long term options including leaving the rms in place or, in the worst case removal of the patient's right kidney.4.Did the product cause or contribute to the need for additional procedures? yes if yes, please specify additional procedures and provide details.The rms has been left in place and may never be removed due to the risk to the patient.A black silicone ureteral stent was placed next to the rms without issue and the case was ended.[the physician] will be meeting with his urology colleagues next week to discuss long term options including leaving the rms in place or, in the worst case removal of the patient's right kidney.5.Has the complainant reported any adverse effects on the patient due to this occurrence? yes 6.Has the complainant reported that the product caused or contributed to the adverse effects? yes please specify adverse effects and provide details.Potential that the rms stent may have to lft in place permanently due to risk of evulsing the right ureter.Patient/event info - note 0 rpn prefix: stpv-083070-rms rms dpsci 2.1 general questions for all complaints: 2.1.1 are any images available for review? district manager is to confirm with facilty.2.1.2 what was the target location for the stent? normal placement, right ureter, pigtails in kidney and bladder.2.1.3 did anything have to be removed from the patient? stent was not able to be removed-- see event description - if yes, please specify: (i) what part of the body the device was removed from? stent was not able to be removed-- see event description (ii) what device was removed? stent was not able to be removed-- see event description (iii) what instrument was used to remove it? stent was not able to be removed-- see event description 2.1.4 please specify the storage conditions of the device at the facility, particularly those relating to light and temperature.Stored in urology cart in urology suite, cool temperature, moderate lighting.Rms stored in its box, so light cannot effect it.2.1.5 why was the stent removed? n/a, exchange, other if other, please detail why the stent was removed.Stent was in place for 9 months, this was to be an exchange for a new rms stent.Stent was unable to be removed due the possible tissue ingrowth.2.1.6 if the stent was removed what was used to complete the procedure? stent was not able to be removed-- see event description 2.1.7 what was the length of the indwell time? rms indwelling for 9 months.2.1.8 what disease mode was the physician trying to treat? proximal stricture in right ureter.2.1.9 what type and size wire guide was used with the device? n/a 2.1.10 did the device come with a pigtail straightener? yes if yes, was the pigtail straightener used? not specified 2.1.11 did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a, rms is placed via a delivery system that includes a sheath.2.1.12 did the user attempt to attach the tapered end of the stent to the inserter? n/a, rms is a closed end stent.2.1.13 was this device assembled outside of the body? yes 2.1.14 did the patient require any additional procedures as a result of this event? see event description 2.1.15 what intervention (if any) was required? see event description 2.1.16 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? see event description 2.1.17 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no if yes, please specify what was observed and where on the device it was observed.2.3 should the event involve metallic resonance (rms) stents, request the following: 2.3.1 was the stent stored in strong light (e.G.In a pyxis maching) or in direct sunlight? no.It is stored in it¿s own box.2.3.2 was there difficulty advancing the stent to the target location? no 2.3.3 how long was the stent in-dwelling? rms indwelling for 9 months.2.3.4 what was used to remove the stent? stent was not able to be removed-- see event description 2.3.5 how often was the stent checked during the in-dwelling time? no.What method was used? n/a 2.3.6 was the patient using calcium supplementation? not specified 2.3.7 was force required to remove the stent? stent was not able to be removed-- see event description 2.3.8 was encrustation evident on the stent? here was no encrustation on the rms and the patient has no history of nickel allergy.2.3.9 what is the source of the extrinsic compression? no extrinsic compression, had patient ureteral stricture.If caused by a tumor, what is the tumor type? n/a.What is the stage of the tumor? n/a.

Manufacturer Narrative

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

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation: the rms-060024-r device of lot number c1837027involved 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.Document review: prior to distribution rms-060024-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 rms-060024-r of lot number c1837027 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1837027.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." 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 review: definitive root cause of off label use can be concluded based on customer/rep testimony.It is known that the rms device was used on a patient with no extrinsic compression.As per ifu, the rms device is intended to be used for ¿temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿ summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient underwent a stent replacement procedure as a result of 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: 16775289
• MDR Text Key: 313637214
• Report Number: 3001845648-2023-00253
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)240604(10)C1837027
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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 Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1837027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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: 60 YR
• Patient Sex: Female