EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2026-01840
- Event Type
- Death
- Date Received
- March 17, 2026
- Date of Event
- March 14, 2026
- Report Date
- May 16, 2026
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000957346
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID {D-EVOLUTFX-2329}; PRODUCT LOT/SERIAL NUMBER {(B)(6)}; PRODUCT TYPE: {0195-HEARTVALVES}; IMPLANT DATE {NON-IMPLANTABLE} SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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.
UPDATED DATA: B5. H6. CORRECTED DATA: ADDITIONAL CODES. ANNEX F CODE WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH. 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.
UPDATED DATA: H2, H3, H6. IMAGE REVIEW: A PRE-IMPLANT PATIENT EXECUTIVE SUMMARY WAS NOT PROVIDED; THEREFORE, A COMPREHENSIVE PRE-PROCEDURAL ANATOMICAL ASSESSMENT COULD NOT BE CARRIED OUT. TWO INTRAPROCEDURAL FLUOROSCOPIC MEDIA FILES WERE SUBMITTED FOR REVIEW IN RELATION TO THE REPORTED EVENT. REVIEW OF THE AVAILABLE IMAGING DEMONSTRATES A DEPLOYED BIOPROSTHETIC VALVE. HOWEVER, DUE TO THE ABSENCE OF CONTRAST, VALVE POSITIONING CANNOT BE CONFIRMED. ADDITIONALLY, THERE IS EVIDENCE SUGGESTIVE OF A CATHETER POSITIONED WITHIN THE PERICARDIAL SPACE. THE REPORTED EVENT INDICATES THAT THE RIGHT VENTRICULAR PERFORATION OCCURRED SECONDARY TO THE TEMPORARY PACING LEAD, WHICH REQUIRED PERICARDIOCENTESIS; THIS INTERVENTION APPEARS CONSISTENT WITH THE IMAGING PROVIDED. THE SUBSEQUENT MEDIA FILE DEMONSTRATES ONGOING CARDIOPULMONARY RESUSCITATION EFFORTS. DESPITE THESE EFFORTS, THE PATIENT REPORTEDLY DIED DUE TO RIGHT VENTRICULAR PERFORATION. AS NO ADDITIONAL IMAGING WAS AVAILABLE FOR REVIEW, A COMPREHENSIVE ANALYSIS COULD NOT BE COMPLETED. 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.
UPDATED DATA: B5. H6. ADDITIONAL CODES. CORRECTED DATA: B2. LIFE THREATENING WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH. D. THIS IS A SYSTEM REPORT. THE SECTION D. INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING DEVICE(S) WHICH CANNOT BE EXCLUDED AS POTENTIAL CONTRIBUTING FACTORS TO THE ADVERSE EVENT: BRAND NAME: DELIV SYS D-EVOLUTFX-2329; PRODUCT ID: D-EV OLUTFX-2329; LOT: 0012801887; UDI: (B)(4); MANUFACTURED DATE: 2025-05-07; USE BY DATE: 2027-05-07; IMPLANT DATE: N/A; FDA SITE ID: (B)(4). H6. THE CODES PRESENT IN SECTION H6. CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. 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.
IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS SUCCESSFULLY PLACED AFTER CROSSING THE INDWELLING SURGICAL AORTIC VALVE. FOLLOWING THE PLACEMENT OF THE VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED FOR AN UNSPECIFIED REASON. UPON VESSEL CLOSURE, THE PATIENT BECAME HYPOTENSIVE DUE TO A RIGHT VENTRICULAR PERFORATION. A PERICARDIAL TAP WAS PERFORMED; HOWEVER FLUID ACCUMULATION PERSISTED. SURGICAL INTERVENTION WAS PERFORMED, HOWEVER THE PATIENT ULTIMATELY DIED.
IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS SUCCESSFULLY PLACED AFTER CROSSING THE INDWELLING SURGICAL AORTIC VALVE. FOLLOWING THE PLACEMENT OF THE VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED FOR AN UNSPECIFIED REASON. UPON VESSEL CLOSURE, THE PATIENT BECAME HYPOTENSIVE DUE TO A RIGHT VENTRICULAR PERFORATION. A PERICARDIAL TAP WAS PERFORMED, HOWEVER FLUID ACCUMULATION PERSISTED. SURGICAL INTERVENTION WAS PERFORMED, HOWEVER THE PATIENT ULTIMATELY DIED. ADDITIONAL INFORMATION WAS PREVIOUSLY REPORTED, BUT NOT CAPTURED IN THE INITIAL NARRATIVE: THE RIGHT VENTRICULAR PERFORATION WAS CAUSED BY THE TEMPORARY PACING LEAD. THE POST-IMPLANT BAV WAS PERFORMED DUE TO A MEAN GRADIENT OF 25 MILLIMETERS OF MERCURY (MM HG). PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. ADDITIONAL INFORMATION WAS RECEIVED THAT BEFORE THE TRANSCATHETER VALVE WAS IMPLANTED, THE MEAN GRADIENT WAS 45 MM HG. THE IMPLANT DEPTH ON BOTH THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC) WAS 5 MILLIMETERS (MM). THE PREVIOUSLY IMPLANT SURGICAL AORTIC VALVE WAS NOTED AS A CONTRIBUTING FACTOR TO THE HIGH MEAN GRADIENT. A NON-MEDTRONIC TEMPORARY PACING LEAD WAS USED; HOWEVER, IT WAS UNKNOWN WHEN THE PERFORATION OCCURRED. PER THE PHYSICIAN, THE DCS DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION, AND THE CAUSE OF DEATH WAS DUE TO THE RIGHT VENTRICULAR PERFORATION. THE DEATH WAS NOT CAUSED OR CONTRIBUTED BY THE PATIENT'S UNDERLYING MEDICAL HISTORY.
IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS SUCCESSFULLY PLACED AFTER CROSSING THE INDWELLING SURGICAL AORTIC VALVE. FOLLOWING THE PLACEMENT OF THE VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED FOR AN UNSPECIFIED REASON. UPON VESSEL CLOSURE, THE PATIENT BECAME HYPOTENSIVE DUE TO A RIGHT VENTRICULAR PERFORATION. A PERICARDIAL TAP WAS PERFORMED, HOWEVER FLUID ACCUMULATION PERSISTED. SURGICAL INTERVENTION WAS PERFORMED, HOWEVER THE PATIENT ULTIMATELY DIED. ADDITIONAL INFORMATION WAS PREVIOUSLY REPORTED, BUT NOT CAPTURED IN THE INITIAL NARRATIVE: THE RIGHT VENTRICULAR PERFORATION WAS CAUSED BY THE TEMPORARY PACING LEAD. THE POST-IMPLANT BAV WAS PERFORMED DUE TO A MEAN GRADIENT OF 25 MILLIMETERS OF MERCURY (MM HG). PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414961 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVFXPLUS-23 | 00763000957346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |