ALTIS SINGLE INCISION SLING SYSTEM
Report
- Report Number
- 2125050-2025-01131
- Event Type
- Malfunction
- Date Received
- July 11, 2025
- Date of Event
- June 12, 2025
- Report Date
- October 22, 2025
- Manufacturer
- COLOPLAST A/S
- Product Code
- PAH
- UDI-DI
- 05708932467407
- PMA / PMN Number
- K121562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN ALTIS SLING AND TWO INTRODUCERS WERE RECEIVED FOR EVALUATION. EXAMINATION OF THE SLING REVEALED THE STATIC ANCHOR ATTACHED TO THE MESH. MICROSCOPIC EXAMINATION OF THE STATIC ANCHOR REVEALED THE TINES TO BE BENT OUTWARD, INDICATING THE ANCHOR HAD BEEN IMPLANTED AND REMOVED. THE DYNAMIC ANCHOR AND TENSIONER WERE NOT RECEIVED. MICROSCOPIC EXAMINATION OF THE DYNAMIC SUTURE APPEARED TO BE ROUGH AND IRREGULAR, INDICATING STRESS WAS EXERTED. BLOOD RESIDUE WAS NOTED ON THE SLING AND INTRODUCERS. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER INTRODUCER. THE INFORMATION RECEIVED INDICATED THE DYNAMIC SUTURE DETACHED DURING THE PROCEDURE. QUALITY CONFIRMED THE DETACHED DYNAMIC SUTURE. AS THE DYNAMIC ANCHOR AND TENSIONER WERE NOT RECEIVED, IT WAS CONCLUDED THAT THE DETACHMENT OF THE DYNAMIC SUTURE MOST LIKELY OCCURRED DURING THE TENSIONING PART OF THE PROCEDURE. DETAIL WAS NOT PROVIDED AS IF THERE WERE ANY ISSUES THAT MAY HAVE OCCURRED PRIOR TO THE DETACHMENT. AS THE DETACHMENT ENDS OF THE DYNAMIC SUTURE WERE ROUGH AND IRREGULAR, THIS INDICATED THAT EXCESS STRESS WAS MOST LIKELY EXERTED TO RESULT IN THE SEPARATION NOTED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A PREVENTATIVE CAPA (CAPA-000303) HAS BEEN HISTORICALLY OPENED FOR THE ALTIS PRODUCT LINE TO INVESTIGATE INCREASED RATES OF MESH TO SUTURE OR ANCHOR TO SUTURE BOND FAILURES WHICH IS BEING REPORTED IN THIS COMPLAINT.
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. THERE WERE NO NONCONFORMING REPORTS CONFIRMED IN VEEVA TO BE ASSOCIATED. A PREVENTATIVE CAPA HAS BEEN HISTORICALLY OPENED FOR THE ALTIS PRODUCT LINE TO INVESTIGATE INCREASED RATES OF MESH TO SUTURE OR ANCHOR TO SUTURE BOND FAILURES WHICH IS BEING REPORTED IN THIS COMPLAINT. THERE WERE SEVERAL COMPLAINTS IDENTIFIED AGAINST THIS LOT: HOWEVER, WITH VARIOUS FAILURE MODES. THEREFORE, THIS IS NOT CONSIDERED A TREND. DEVICES MET SPECIFICATION PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ACCORDING TO THE AVAILABLE INFORMATION THE PHYSICIAN PLACED THE STATIC AND DYNAMIC ANCHOR, AND WHEN PULLING ACROSS THE MIDLINE, THE SUTURE SNAPPED AT THE DYNAMIC ANCHOR SITE. THE DYNAMIC ANCHOR WAS LEFT IN THE PATIENT, AND THE STATIC ANCHOR CAME OUT WITH THE SLING. ANOTHER SLING WAS PLACED WITHOUT ANY CHALLENGES.
ACCORDING TO THE AVAILABLE INFORMATION THE PHYSICIAN PLACED THE STATIC AND DYNAMIC ANCHOR, AND WHEN PULLING ACROSS THE MIDLINE, THE SUTURE SNAPPED AT THE DYNAMIC ANCHOR SITE. THE DYNAMIC ANCHOR WAS LEFT IN THE PATIENT, AND THE STATIC ANCHOR CAME OUT WITH THE SLING. ANOTHER SLING WAS PLACED WITHOUT ANY CHALLENGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 873855 | ALTIS SINGLE INCISION SLING SYSTEM | FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER | PAH | COLOPLAST A/S | 9937882_5196502400 | 05708932467407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |