PENDITURE LAA EXCLUSION SYSTEM
Received Apr 23, 2026 · Event occurred Apr 20, 2026
Report 1219930-2026-02642 · MDR key 24963187
Device
Product problems
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF A PENDITURE CLIP, IT WAS REPORTED THAT IMMEDIATELY AFTER THE PROCEDURE, SECURE GRASPING WAS CONFIRMED ON AND X-RAY; HOWEVER, ON THE CURRENT X-RAY IMAGES, DISPLACEMENT IS OBSERVED AND THE TIP IS NO LONGER ADEQUATELY GRASPING. IT IS SUSPECTED THAT DISPLACEMENT MAY HAVE OCCURRED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
SECTION E INITIAL REPORTER: THE FIRST AND LAST NAMES AND PHONE NUMBER OF THE INITIAL REPORT ARE NOT AVAILABLE DUE TO REGIONAL PRIVACY LAWS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE WAS FOR LEFT ATRIAL APPENDAGE CLOSURE ONLY. NO ABNORMALITIES WERE OBSERVED IN THE APPENDAGE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS DEPLOYED ON A BEATING HEART. THE DEVICE WAS INSERTED FROM THE LEFT INTERCOSTAL SPACE. CORRECTION D6A (IMPLANTED DATE) H3 (DEVICE EVALUATED?): THESE FIELD HAVE BEEN UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.