PENDITURE LAA EXCLUSION SYSTEM
Received Apr 22, 2026 · Event occurred Mar 6, 2026
Report 1219930-2026-02622 · MDR key 24950080
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR · Male
- Atrial Fibrillation
- Increased Respiratory Rate
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THROUGH THE CLIP-IT CLINICAL POST-MARKET STUDY, THAT FOLLOWING A PROCEDURE INVOLVING USE OF THE PENDITURE (CLIP/DELIVERY SYSTEM) ON THE (B)(6) 2026 (TWO MONTHS POST IMPLANT), THE CUSTOMER REPORTED THE PATIENT EXPERIENCED SHORTNESS OF BREATH WITH EXERTION. DURING A 12-MONTH FOLLOW-UP PHONE CALL, THE INDIVIDUAL REPORTED SHORTNESS OF BREATH SPECIFICALLY WHEN WALKING UPHILL AND CLIMBING STAIRS, REPRESENTING A WORSENING IN FUNCTIONAL STATUS WITH NEW YORK HEART ASSOCIATION CLASSIFICATION CHANGING FROM CLASS I TO CLASS II. THE OUTCOME OF THIS AE WAS NOT RECOVERED/NOT RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE INVESTIGATOR AS POSSIBLY RELATED TO THE PENDITURE CLIP AND PENDITURE DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE PENDITURE CLIP BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM.