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

Catalog Number RMS-060024-R

Device Problem Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.User facility: (b)(6).

Event Description

As initially reported to customer relations via phone discussion with the district manager: a female patient of undisclosed age underwent a bilateral ureteral stent placement procedure approximately seven (7) months prior.During a follow up to discuss time to exchange the stent it was noted that one of the stents had migrated.The migration of the stent is and has not caused any harm to the patient.The physician will schedule a procedure to exchange the stents due to indwell time not the migration.The patient has requested to use the same type (resonance) stent when exchanged.Therefore, the physician and district manager are in discussion of using a different length size stent.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? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.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.0 rpn prefix: stpv-083070-rms rms dpsci.General questions for all complaints: what are the current storage conditions? are the stents stored in their boxes? na.Did the device make patient contact? yes.Once the device comes in contact with the patient, request the following for 3 previoulsy mentioned prefixes: did anything have to be removed from the patient? physician is planning to exchange due to indwell time, not migration.If yes, from what part of the body and what instrument was used to remove it? current storage conditions.Na.Why was the stent removed? (exchange? or other issue?) has not been removed yet but will be time for exchange.What was the length of the indwell time? approximately 7 months.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? na.What wire guide did they use? glidewire.Did they attempt to attach the tapered end of the stent to the inserter? na.Was this device assembled outside the body? na.Did the device come with a pigtail straightener? na.If yes, was the pigtail straightener used? should the event involve metallic resonance (rms) stents, request the following: was the stent stored in strong light (e.G.In a pyxis maching) or in direct sunlight? na.Was there difficulty advancing the stent to the target location? no.How long was the stent in-dwelling? 7 months.What was used to remove the stent? not removed yet- remains in the patient.How often was the stent checked during the in-dwelling time? na what method was used? blood/urine testing.Was the patient using calcium supplementation? na.Was force required to remove the stent? was encrustation evident on the stent? n/a not removed yet- remains in the patient.What is the source of the extrinsic compression? na.If caused by a tumor, what is the tumor type? na.What is the stage of the tumor? na.

Event Description

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

Manufacturer Narrative

Device evaluation: the rms-060024-r of lot number unknown was not returned to cirl for a lab evaluation.Therefore, a document based investigation was completed.Document review: as the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all rms-060024-r 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 (ifu0020-18) states the following: ¿warnings: these stents are not intended as permanent indwelling devices.The stent must not remain indwelling more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent.Patients should be checked at regular interval utilizing techniques such as abdominal x-ray (kub film).Patient using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage.¿ it may be noted that according to the instructions for use, ifu0020-18, the user is instructed that ¿hematuria and incontinence may indicate fistula formation.¿ per the instructions for use (ifu0020-18) states the following potential events: loss of renal function, infection, pain/discomfort, stent dislodgement / migration" there is no 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 patient anatomy, as per instructions for use stent migration is listed as a complication following the placement of this device.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11016125
• MDR Text Key: 253111025
• Report Number: 3001845648-2020-00956
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060024-R
• 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
• Date Manufacturer Received: 11/20/2020
• 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; Hospitalization
• Patient Sex: Female