MAUDE Adverse Event Report: TELEFLEX / NEOTRACT, INC. UROLIFT ; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

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

Patient Problems Stroke/CVA (1770); Death (1802); Renal Failure (2041); Urinary Tract Infection (2120)

Event Date 07/05/2019

Event Type  Death  

Event Description

My father had a urolift device implanted.Within two weeks he developed a urinary tract infection.After a week of treatment with oral antibiotics, the urine backed into his kidney causing kidney failure and precipitated a stroke.After approx 10 days of hospitalization he had another stroke which ultimately caused his death.Fda safety report id # (b)(4).

• Brand Name: UROLIFT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): TELEFLEX / NEOTRACT, INC.
• MDR Report Key: 9426195
• MDR Text Key: 169809888
• Report Number: MW5091477
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 95 YR
• Patient Weight: 84