MAUDE Adverse Event Report: NEOTRACT, INC. UROLILFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Retention (2119)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Elderly man who had an elevated psa and obstructive lower urinary tract symptoms had urolift procedure with implants for benign prostatic hypertrophy one year ago.He initially had a urolift with 4 implants placed.He developed post-operative retention and ultimately had a repeat urolift with 6 implants.Patient's lower urinary tract symptoms worsened after the urolift procedure.Pt has had chronic pelvic pain, urgency incontinence and transient urinary retention after a urolift procedure.Cystoscopy revealed urolift clips within the bladder lumen on both sides at the bladder neck.He underwent a turp and complex removal of foreign body from gu tract approximately 5 months later which resolved his obstructive symptoms but little to help with his urge incontinence and pelvic pain.Follow-up cystoscopy demonstrated a few residual clips eroding into the urethra and a stitch protruding into the bladder.Ct scan demonstrates 5 residual clips on the left hand side in close proximity to the left ureter.Patient had redo transurethral resection of the prostate, left ureteral stent placement, robotic exploration of the retroperitoneum with removal of foreign bodies and repair of the bladder approximately 2 months ago.

• Brand Name: UROLILFT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4473 willow rd ste 100; pleasanton CA 94588
• MDR Report Key: 8543707
• MDR Text Key: 142889202
• Report Number: 8543707
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 67