MAUDE Adverse Event Report: UNKNOWN STENT; STENT, RENAL

Patient Problems Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Sepsis (2067); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Patient's daughter reported that patient had a stent placed to kidney prior to chemo.Once iv (intra venous) chemo completed, pt (patient) went to have stent removed.Surgeon was unable to remove.Founds "lots of stones." pt developed infection with e-coli that progressed to sepsis.Pt spent several weeks in hospital and long-term care facility for rehab.Md (medical doctor) able to remove stent on 3rd surgery.Pt received new stent and catheter.Both were removed this past friday ((b)(6) 2024).Pt has been discharged from long-term care facility and is recovering at home.Hospitalization is unrelated to nubeqa.No additional info available at this time.Reported to cvs/caremark by: patient/caregiver.

• Brand Name: STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18740214
• MDR Text Key: 335865064
• Report Number: MW5151783
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: NUBEQA 300MG.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male