MITRACLIP
Report
- Report Number
- 2135147-2025-03940
- Event Type
- Malfunction
- Date Received
- July 18, 2025
- Date of Event
- June 25, 2025
- Report Date
- January 27, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- DRA
- UDI-DI
- 05415067037411
- PMA / PMN Number
- K190167
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED KNOB SLIPPAGE WAS CONFIRMED. THE REPORTED DIFFICULT OR DELAYED POSITIONING IN THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO IT BEING RELATED TO PATIENT OR PROCEDURAL /OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ANOTHER COMPLAINT REPORTED FOR KNOB SLIPPAGE AND APPEARS TO BE RELATED TO THE SAME POTENTIAL PRODUCT ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY POSITIONING APPEARS TO BE RELATED TO THE REPORTED KNOB SLIPPAGE. THE REPORTED KNOB SLIPPAGE WAS DETERMINED TO BE A POTENTIAL PRODUCT QUALITY ISSUE. THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXCEPTION AS THE COMPLAINT DESCRIPTION AND DEVICE CODE MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THEREFORE, EXCEPTION (ISSUE) 133059 AND ACTION 138821 ARE REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE POTENTIAL ROOT CAUSE TO BE RELATED TO MATERIAL VARIABILITY OF THE O-RING THICKNESS. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED KNOB SLIPPAGE WAS CONFIRMED. THE REPORTED DIFFICULT OR DELAYED POSITIONING IN THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO IT BEING RELATED TO PATIENT OR PROCEDURAL /OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ANOTHER COMPLAINT REPORTED FOR KNOB SLIPPAGE AND APPEARS TO BE RELATED TO THE SAME POTENTIAL PRODUCT ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY POSITIONING APPEARS TO BE RELATED TO THE REPORTED KNOB SLIPPAGE. THE REPORTED KNOB SLIPPAGE WAS DETERMINED TO BE A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE POTENTIAL ROOT CAUSE TO BE RELATED TO MATERIAL VARIABILITY OF THE O-RING THICKNESS. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.
IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, POSTERIOR PROLAPSE, AND PRE-EXISTING FLAIL. A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP XT WERE INSERTED. HOWEVER, WHILE APPLYING THE PLUS BUTTON ON THE SGC TO CORRECT THE AORTIC HUG, THE PLUS KNOB DID NOT ACHIEVE THE DESIRED DEFLECTION OF THE SGC, AND COULD NOT RELEASE THE AORTIC HUG. WHILE USING THE MITRACLIP XT TO CAPTURE THE POSTERIOR LEAFLET, INDEPENDENT CAPTURE FUNCTION WAS USED TO CAPTURE MORE OF THE POSTERIOR LEAFLET. HOWEVER, WHILE ATTEMPTING TO CAPTURE THE POSTERIOR LEAFLET USING THE INDEPENDENT CAPTURE FUNCTION FOR THE THIRD TIME, THE GRIPPER OF THE POSTERIOR LEAFLET COULD NOT BE LOWERED. DUE TO INSUFFICIENT PUNCTURE HEIGHT, THE CLIP COULD NOT RETRACT INTO THE LEFT ATRIUM. IT WAS NOTED THAT GRIPPER LIKELY BECAME CAUGHT ON THE LEAFLET, A NEW TENDON RUPTURE WAS OBSERVED, AND THE CLIP WAS UNABLE TO BE REMOVED. THEREFORE, THE CLIP WAS IMPLANTED WHERE IT WAS STUCK, ATTACHED TO BOTH LEATLETS. THE PROCEDURE WAS DISCONTINUED. NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR WAS REDUCED TO 3+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, POSTERIOR PROLAPSE, AND PRE-EXISTING FLAIL. A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP XT WERE INSERTED. HOWEVER, WHILE APPLYING THE PLUS BUTTON ON THE SGC TO CORRECT THE AORTIC HUG, THE PLUS KNOB DID NOT ACHIEVE THE DESIRED DEFLECTION OF THE SGC AND COULD NOT RELEASE THE AORTIC HUG. WHILE USING THE MITRACLIP XT TO CAPTURE THE POSTERIOR LEAFLET, INDEPENDENT CAPTURE FUNCTION WAS USED TO CAPTURE MORE OF THE POSTERIOR LEAFLET. HOWEVER, WHILE ATTEMPTING TO CAPTURE THE POSTERIOR LEAFLET USING THE INDEPENDENT CAPTURE FUNCTION FOR THE THIRD TIME, THE GRIPPER OF THE POSTERIOR LEAFLET COULD NOT BE LOWERED. DUE TO INSUFFICIENT PUNCTURE HEIGHT, THE CLIP COULD NOT RETRACT INTO THE LEFT ATRIUM. IT WAS NOTED THAT GRIPPER LIKELY BECAME CAUGHT ON THE LEAFLET, A NEW TENDON RUPTURE WAS OBSERVED, AND THE CLIP WAS UNABLE TO BE REMOVED. THEREFORE, THE CLIP WAS IMPLANTED WHERE IT WAS STUCK, ATTACHED TO BOTH LEATLETS. THE PROCEDURE WAS DISCONTINUED. NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR WAS REDUCED TO 3+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406752 | MITRACLIP | CATHETER, STEERABLE | DRA | ABBOTT MEDICAL | SGC0708 | 41127R1046 | 05415067037411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female |