ALTIS SINGLE INCISION SLING SYSTEM
Report
- Report Number
- 2125050-2025-00369
- Event Type
- Malfunction
- Date Received
- March 6, 2025
- Date of Event
- February 20, 2025
- Report Date
- June 13, 2025
- Manufacturer
- COLOPLAST A/S
- Product Code
- PAH
- UDI-DI
- 05708932467407
- PMA / PMN Number
- K121562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED. 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.
AN ALTIS SLING AND DETACHED DYNAMIC SUTURE WERE RECEIVED FOR EVALUATION. EXAMINATION OF THE SLING REVEALED THE MIDDLE PORTION OF THE MESH WAS RETURNED WITH BOTH THE STATIC AND DYNAMIC SIDES OF THE ANCHOR DETACHED. MICROSCOPIC EXAMINATION OF BOTH SIDES OF THE RETURNED MESH REVEALED STRAIGHT EDGES, INDICATING BOTH ENDS OF THE MESH WERE MOST LIKELY CUT OUT WITH SHARP INSTRUMENTATION TO REMOVE. THE DYNAMIC SUTURE WAS EXAMINED, AND IT WAS NOTED THAT THE DYNAMIC ANCHOR WAS MISSING FROM THE SUTURE. THE INFORMATION RECEIVED INDICATED THAT 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. IT WAS REPORTED BY THE PHYSICIAN THAT THERE WAS DIFFICULTY PLACING THE DYNAMIC ANCHOR INITIALLY AND THE PATIENT HAD A HIGH BMI. THIS MAY HAVE CONTRIBUTED TO THE ISSUES EXPERIENCED DURING THE IMPLANT. THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS CONFIRMED IN VEEVA TO BE ASSOCIATED. 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. DEVICES MET SPECIFICATION PRIOR TO RELEASE.
ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE PHYSICIAN WAS INTRODUCING THE DYNAMIC ANCHOR INTO THE OBTURATOR MEMBRANE AND DURING THE TENSIONING OF THE SLING, THE SUTURE SEPARATED FROM THE MESH ON THE DYNAMIC ANCHOR SIDE. THERE WAS SLIGHT TROUBLE PLACING THE INITIAL DYNAMIC ANCHOR. ANCHORS LEFT IN PLACE, BUT MESH WAS REMOVED AT DEEPEST LOCATION POSSIBLE. DYNAMIC SIDE OF SUTURE WAS REMOVED. THE LOOPED END OF SUTURE AND MOST OF THE MESH WERE RETRIEVED. A SECOND ALTIS WAS PLACED QUICKLY AND SUCCESSFULLY.
ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE PHYSICIAN WAS INTRODUCING THE DYNAMIC ANCHOR INTO THE OBTURATOR MEMBRANE AND DURING THE TENSIONING OF THE SLING, THE SUTURE SEPARATED FROM THE MESH ON THE DYNAMIC ANCHOR SIDE. THERE WAS SLIGHT TROUBLE PLACING THE INITIAL DYNAMIC ANCHOR. ANCHORS LEFT IN PLACE, BUT MESH WAS REMOVED AT DEEPEST LOCATION POSSIBLE. DYNAMIC SIDE OF SUTURE WAS REMOVED. THE LOOPED END OF SUTURE AND MOST OF THE MESH WERE RETRIEVED. A SECOND ALTIS WAS PLACED QUICKLY AND SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 486315 | ALTIS SINGLE INCISION SLING SYSTEM | FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER | PAH | COLOPLAST A/S | 9510795_5196502400 | 05708932467407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female |