MAUDE Adverse Event Report: NEPHROURETERAL STENT; STENT, URETERAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); Urinary Tract Infection (2120); Chills (2191); Thrombosis/Thrombus (4440)

Event Date 02/07/2021

Event Type  Injury  

Event Description

Moffitt study staff were notified of the event on (b)(6) 2021 initial submission date of the report (b)(6) 2021.Subject (b)(6) is a (b)(6) female with cervical cancer who initiated treatment on (b)(6) on (b)(6) 2021.The subject is currently in week 3 receiving a total of: 1 dose of atezolizumab of 1200 mg in 20 ml with her most recent dose on (b)(6) 2021 and 3 fractions of sbrt 800 cgy per fraction on (b)(6) 2021.Sae event: g2 fever and g2 uti.This event started on (b)(6) 2021.Patient (b)(6) presented to moffitt cancer center on (b)(6) 2021 with complaints of a fever (102.4 upon admission), chills, and left leg/ankle swelling.Ua consistent with infection which was treated with ceftriaxone.Ct a/p on (b)(6) 2021 consistent with cystitis.Impression notes state interval resolution of left hydroureteronephrosis following nephroureteral stent placement, though, there is persistent delayed enhancement of the left kidney which could be infectious/inflammation.Diffuse wall thickening and enhancement of the bladder wall, possibly attributable to infection/inflammation.Patient (b)(6) had us doppler ven of lower extremity on (b)(6) 2021 which showed no sonographic evidence of dvt in left lower extremity.No leukocytosis at time of admission and patient remained afebrile overnight.No further urologic intervention necessary.On (b)(6) 2021, patient's magnesium level was 1.4 mg/dl and potassium level was low at 3.3 mmol/l­ replaced with kci and magnesium sulfate.Patient was stable at time of discharge and script was sent to patient's pharmacy for bactrim ds for 7 days.

• Brand Name: NEPHROURETERAL STENT
• Type of Device: STENT, URETERAL
• MDR Report Key: 11337667
• MDR Text Key: 232626972
• Report Number: MW5099431
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Weight: 80