MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complaint called in by(b)(6) on 14sep2021.(b)(4), 14sep2021.As reported to customer relations: "per (b)(6) , physician said that stent migrated from the kidney down into the ureter, which required removal of the stent.Unknown if the issue was discovered during regular follow-up procedure or if patient presented with pain/discomfort, prompting the scan.No portion of the stent was left inside the patient.A polymer stent was placed where the resonance stent had been previously." did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Did the product cause or contribute to the need for additional procedures? yes if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Additional information provided by (b)(6) on 28sep2021: this is what i have so far in red: are any images available for review? n/a, yes, no - no.Please specify the storage conditions of the device at the facility, particularly those relating to light and temperature.¿ out of repstock.What disease mode was the physician trying to treat? ¿ extrinsic compression was the stent stored in strong light (e.G.In a pyxis machine) or in direct sunlight? - no.Was there difficulty advancing the stent to the target location? - no.Did the device come with a pigtail straightener? n/a, yes, no - yes.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a, before, after ¿ not sure what is being asked here.Rms is placed through a sheath.Did the user attempt to attach the tapered end of the stent to the inserter? n/a, yes, no ¿ rms does not have a tapered end.Was this device assembled outside of the body? n/a, yes, no ¿ n/a.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no - no.If yes, please specify what was observed and where on the device it was observed."--did (b)(6).Are any images available for review? n/a, yes, no.What instrument was used to remove the stent from the patient? please specify the storage conditions of the device at the facility, particularly those relating to light and temperature.What was the length of the indwell time? what disease mode was the physician trying to treat? was the stent stored in strong light (e.G.In a pyxis machine) or in direct sunlight? was there difficulty advancing the stent to the target location? how long was the stent in-dwelling? how often was the stent checked during the in-dwelling time? what method was used? was the patient using calcium supplementation? was force required to remove the stent? was encrustation evident on the stent? what is the source of the extrinsic compression? if caused by a tumor, what is the tumor type? what is the stage of the tumor? regarding the implant procedure: what type and size wire guide was used with the device (during implant).Did the device come with a pigtail straightener? n/a, yes, no.If yes, was the pigtail straightener used? n/a, yes, no.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a, before, after.Did the user attempt to attach the tapered end of the stent to the inserter? n/a, yes, no.Was this device assembled outside of the body? n/a, yes, no.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no.If yes, please specify what was observed and where on the device it was observed.

Manufacturer Narrative

Device evaluation the resonance ureteral stent metallic stent and positioner 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 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 all resonance ureteral stent metallic stent and positioner 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.It should be noted that the instructions for use (ifu0020) states the following: ¿warnings patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be more closely monitoring for possible stent encrustation.The stent must be removed if encrustation hampers drainage.Individual variations of interaction between stents and the urinary system are unpredictable¿.It should be noted the instructions for use (ifu) also state potential adverse events "potential adverse events associated with indwelling ureteral stents include: pain/discomfort, stent dislodgement/migration" there is sufficient evidence to suggest the user did not follow the ifu.This file is related to (b)(4) - user error- use of incorrect wire guide (report reference number 3001845648-2022-00016) image review n/a impression n/a root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a potential complication following the placement of this device.As per medical advisor ¿there are not enough details to make an accurate clinical assessment but it may be that concurrent treatment of the obstructive lesion would have lessened the compression on the stent, potentially allowing it to move.However, the pigtails of the stent are designed as an anti-migration feature.Other potential causes could have been an inappropriately sized stent, however the definitive cause of the stent migration is unknown.¿ summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient require any additional procedures due to this occurrence.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 URETERAL STENT METALLIC STENT AND POSITIONER
• 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: 12614171
• MDR Text Key: 277488912
• Report Number: 3001845648-2021-00722
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/27/2022

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 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: 09/14/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 06/23/2022
• 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