MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE MALE SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number UNK-M-720088-01

Device Problems Material Frayed (1262); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Perforation (2001); Urinary Retention (2119); Discomfort (2330); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 06/02/2016

Event Type  Injury  

Event Description

It was reported by the plaintiff¿s attorney that the plaintiff allegedly had an original unknown sling implanted on (b)(6) 2016 due to post-prostatectomy stress incontinence, but explanted on (b)(6) 2016.This patient experienced complications post-surgery that consisted of urinary retention, recurring incontinence, infection, erosion, perforation, and discomfort.It was stated that on (b)(6) 2016, this patient experienced urinary retention, and a foley catheter was placed and removed on (b)(6) 2017, due to a bladder spasm.On (b)(6) 2016, this patient again saw his physician and was unable void, and was in "great discomfort." another foley catheter was placed at this time, but removed on (b)(6) 2016.After this, urinary retention continued, and this patient had to "self-catheterized four times daily." on (b)(6) 2016, this patient again visited his physician and soon after was diagnosed with an infection; his urine showed staph epidermidis.He was treated with an oral antibiotic, but it was stated that he had a "highly resistant tract infection," and was referred for intravenous antibiotic therapy on (b)(6) 2016.On (b)(6) 2016, the sling was removed, and it was noted that the sling had eroded in the bladder "which had perforated" the patient's urethra.The perforation was surgically repaired at this time as well.The removal and surgical repair of the perforation resulted in a 10-day hospitalization stay.No further patient complications were reported in relation to this event.

Event Description

Was reported the patient had an original unknown sling implanted on (b)(6) 2016 due to post-prostatectomy stress incontinence, but explanted on (b)(6) 2016.This patient experienced complications post-surgery that consisted of urinary retention, recurring incontinence, infection, erosion, perforation, and discomfort.It was stated that on (b)(6) 2016, this patient experienced urinary retention, and a foley catheter was implanted and removed on (b)(6) 2016, due to a bladder spasm.On (b)(6) 2016, this patient again saw his physician and was unable void, and was in "great discomfort." another foley catheter was implanted at this time, but removed on (b)(6) 2016.After this, urinary retention continued, and this patient had to "self-catheterized four times daily." on (b)(6) 2016, this patient again visited his physician and soon after was diagnosed with an infection; his urine showed staph epidermidis.He was treated with an oral antibiotic, but it was stated that he had a "highly resistant tract infection," and was referred for intravenous antibiotic therapy on (b)(6) 2016.On (b)(6) 2016, the sling was removed, and it was noted that the sling had eroded in the bladder "which had perforated" the patient's urethra.The perforation was surgically repaired at this time as well.The removal and surgical repair of the perforation resulted in a 10-day hospitalization stay.No further patient complications were reported in relation to this event.Additional information received indicated that on (b)(6) 2016, when the patient was noted to have lost 40 pounds since the implantation of the sling two months earlier, the patient underwent a cystoscopy (examination of the bladder and urethra with a lighted scope) under local anesthetic.Upon getting to the area where the male sling had been placed, the access was blocked by some unknown material.The physician discontinued the procedure and rescheduled it for on (b)(6) 2016, under general anesthesia, at which time the physician was again unable to pass the cystoscope into the bladder because of necrotic appearing (dead tissue) debris subsequently determined to be eroded mesh fibers from the male sling.The implantation of an artificial urinary sphincter was considered but ruled out because of the possibility of infection resulting from scar tissue caused by the eroded, failed sling.The patient also experienced emotional distress, pain and suffering.

Event Description

Was reported the patient had an original unknown sling implanted on (b)(6) 2016 due to post-prostatectomy stress incontinence, but explanted on (b)(6) 2016.This patient experienced complications post-surgery that consisted of urinary retention, recurring incontinence, infection, erosion, perforation, and discomfort.It was stated that on (b)(6) 2016, this patient experienced urinary retention, and a foley catheter was implanted and removed on 6/6/2017, due to a bladder spasm.On (b)(6) 2016, this patient again saw his physician and was unable void, and was in "great discomfort." another foley catheter was implanted at this time, but removed on 6/13/2016.After this, urinary retention continued, and this patient had to "self-catheterized four times daily." on (b)(6) 2016, this patient again visited his physician and soon after was diagnosed with an infection; his urine showed staph epidermidis.He was treated with an oral antibiotic, but it was stated that he had a "highly resistant tract infection," and was referred for intravenous antibiotic therapy on 7/15/2016.On (b)(6) 2016, the sling was removed, and it was noted that the sling had eroded in the bladder "which had perforated" the patient's urethra.The perforation was surgically repaired at this time as well.The removal and surgical repair of the perforation resulted in a 10-day hospitalization stay.No further patient complications were reported in relation to this event.Additional information received indicated that on (b)(6) 2016, when the patient was noted to have lost 40 pounds since the implantation of the sling two months earlier, the patient underwent a cystoscopy (examination of the bladder and urethra with a lighted scope) under local anesthetic.Upon getting to the area where the male sling had been placed, the access was blocked by some unknown material.The physician discontinued the procedure and rescheduled it for (b)(6) 2016, under general anesthesia, at which time the physician was again unable to pass the cystoscope into the bladder because of necrotic appearing (dead tissue) debris subsequently determined to be eroded mesh fibers from the male sling.The implantation of an artificial urinary sphincter was considered but ruled out because of the possibility of infection resulting from scar tissue caused by the eroded, failed sling.The patient also experienced emotional distress, pain and suffering.

Manufacturer Narrative

Additional information a1, a3, b7, d1, h6; corrected data - h6 patient codes.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 6807403
• MDR Text Key: 83144164
• Report Number: 2183959-2017-00074
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-M-720088-01
• Device Catalogue Number: UNK-M-720088-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability