MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

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

Patient Problems Erosion (1750); Fever (1858); Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Citation: han jy, et al.Short-medium term outcomes of altis single-incision sling for stress urinary incontinence in an asian single-centre.Continence 9/2022, volume 3, pages 100498.B3 date of event: date of publication.D6a implant date: patients were implanted between (b)(6) 2017 and (b)(6) 2018.

Event Description

According to the available information, a retrospective study found that among 83 patients the following events were reported: perioperatively: blood transfusion, unspecified postoperative complication, fever, voiding difficulty, catheterization, and tape loosening.Hospitalizations were also reported, though it was unclear whether this referred to prolonged, unexpected hospitalization.One patient who underwent sling implant along with a concomitant surgery developed atrial fibrillation, which was co-managed with a cardiologist and the patient recovered well.It was unclear whether the atrial fibrillation was related to the sling.The patient who experienced voiding difficulty had undergone sling implant only, and subsequently required re-admission within the first month for tape loosening.Postoperatvely (postoperative complications were recorded at 1, 6, 12, and 24 months): dyspareunia, buttock pain, reoperation, de novo urinary urge incontinence, urinary tract infection, vaginal tape extrusion, and readmission.The patients who experienced vaginal tape extrusion were managed with either topical vaginal oestrogen or surgical revision.One of the patients reported to have dyspareunia was found to have a tight perineum and subsequently underwent a successful fenton¿s operation with resolution of symptoms.

Event Description

According to the available information, the article reported complications from a retrospective study in singapore.Complications reported were dyspareunia, extrusion, fever, infection, pain, resurgery, incontinence.

Manufacturer Narrative

The reported complications were identified in the risk management documents or ifu as known possible harms.Complaints will be reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17260682
• MDR Text Key: 318551152
• Report Number: 2125050-2023-00780
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 519650
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 60 YR
• Patient Sex: Female