MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Missing Information (4053)

Patient Problems Urinary Frequency (2275); Intermenstrual Bleeding (2665)

Event Type  Injury  

Manufacturer Narrative

The authors concluded that: procedure seems to be safe and effective for treatment of stress urinary incontinence (sui).Altis shows good subjective results, and high subjective cure rate, even if major complication was reported.More consistent evidence is needed to confirm our results; abstract clinical study.

Event Description

According to the available information, though not verified, information received on 09/01/2020: the study was conducted in (b)(6).The authors concluded that: procedure seems to be safe and effective for treatment of stress urinary incontinence (sui).Altis shows good subjective results and high subjective cure rate, even if major complication was reported.More consistent evidence is needed to confirm our results.Demographic information is presented for age (but doesn¿t state whether it is median age or mean age), premenopausal surgery, bmi, parity, vaginal or cesarean delivery, hysterectomy, genetic factors, smoking, high-impact exercise or work, drugs, sui during pregnancy and diabetes.On 09/03/2020, at 09:18 am (gmt-5:00) added by uskmmc (b)(6): three-year follow-up in patients with urinary stress incontinence treated with altis® single-incision sling: short-term: urinary retention n=5 (one was resolved with ¿relaxation of sling¿; four resolved with catheter and prednisone).Bladder bleeding n=1 (intra-operative event which resolved with use of a ¿local bonding agent¿).Dyspareunia n=2; mesh extrusion n=1 (3 months after implant); urge urinary incontinence n=1 (this presented immediately after implant and it is possible it was pre-existing but was not detected pre-op).Long-term: de novo uui n=1 (>2 years); recurrent sui n=1 (>1 year).

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10624202
• MDR Text Key: 214735039
• Report Number: 2125050-2020-00917
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 10/03/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1