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

Model Number	G34109
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Complaint received from dm via e-mail on 12aug2020--did 13aug2020.As reported to customer relations: "please see information regarding a complaint made by account (b)(6).Customer¿s account name and number.(b)(6).Contact person¿s name, telephone number and title.Dr.(b)(6) patient info (e.G.Pt id, age, gender, wt.).N/a.Procedure performed.Bilateral resonance metallic stent placement date of placement (dop).(b)(6) 2020.Date of event (doe).(b)(6) 2020.Catalog number of product (rpn).Rms-060022-r.Other products involved.No other products involved.Lot number(s).C1713983 (x2).Can used and/or unused product be returned? if so, when? no.Has product been contaminated with known contagions? no.What medications were being administered? n/a.What is the patient¿s current conditiona.Stable".Additional information provided by dm on 17aug2020: " what was the problem with the devices? the device failed to drain the kidney that was placed in the right ureter ((b)(4)) and the stent in the left ureter migrated down the ureter because of over dilation ((b)(4)).Can you clarify the dates and procedure listed in your e-mail? it indicates a placement date of (b)(6) 2020, an event date of (b)(6) 2020, and a procedure of bilateral rms placement¿was it a situation where one was placed in july in a patient and another was being placed in the same patient a month later? both stents were initially placed on (b)(6) 2020 and then removed on (b)(6) 2020 due to a perceived failure.Were the devices used in the same procedure? yes.How was/were the procedure(s) completed? the procedure following the incident was a simple stent exchange of both rms stents.".
Additional Manufacturer Narrative
Component code (annex g): g04122 - stent.1 x rms-060022-r of lot number c1713983 involved in this complaint was unavailable for return to cirl for evaluation.With the information provided, a document based investigation was conducted.This device was used in the left kidney and the investigation for the stent used in right kidney will be covered in (b)(4).Prior to distribution rms-060022-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-060022-r of lot number c1713983 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 with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1713983.The instructions for use, ifu which accompanies this device states the following; 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, the user is instructed that ¿hematuria and incontinence may indicate fistula formation.¿ as per the instructions for use states the following potential events: loss of renal function, infection, pain/discomfort, hydronephrosis, stent dislodgement / migration" there is not enough evidence to suggest that the customer did not follow the instructions for use.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, (ifu0020-17), stent migration is listed as a complication following the placement of this device.Complaint is confirmed based on customer testimony.One patient experienced one complication associated with the resonance (migration, n = 1) and their stent was removed.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.Related to mdr#3001845648-2020-00601.Initial report details: complaint received from dm via e-mail on 12aug2020--did 13aug2020.As reported to customer relations: "please see information regarding a complaint made by account (b)(6) hospital.1) customer¿s account name and number.(b)(6) hospital.2) contact person¿s name, telephone number and title.(b)(6) (urologist).3) patient info (e.G.Pt id, age, gender, wt.) n/a.4) procedure performed.Bilateral resonance metallic stent placement 5) date of placement (dop).(b)(6) 2020 6) date of event (doe).(b)(6) 2020 7) catalog number of product (rpn).Rms-060022-r.8) other products involved.No other products involved.9) lot number(s).C1713983 (x2).10) can used and/or unused product be returned? if so, when? no.11) has product been contaminated with known contagions? no.12) what medications were being administered? n/a.13) what is the patient¿s current condition."stable." additional information provided by dm on 17aug2020: " what was the problem with the devices? the device failed to drain the kidney that was placed in the right ureter (b)(4) and the stent in the left ureter migrated down the ureter because of over dilation (b)(4).Can you clarify the dates and procedure listed in your e-mail? it indicates a placement date of (b)(6) 2020, an event date of (b)(6) 2020, and a procedure of bilateral rms placement¿was it a situation where one was placed in july in a patient and another was being placed in the same patient a month later? both stents were initially placed on (b)(6) 2020 and then removed on (b)(6) 2020 due to a perceived failure.Were the devices used in the same procedure? yes.How was/were the procedure(s) completed? the procedure following the incident was a simple stent exchange of both rms stents.".

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10511846
• Report Number: 3001845648-2020-00602
• Device Sequence Number: 2993021
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)230304(10)C1713983
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: G34109
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C1713983
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention