HARMONY DELIVERY CATHETER SYSTEM
Report
- Report Number
- 9612164-2026-00811
- Event Type
- Malfunction
- Date Received
- February 13, 2026
- Date of Event
- February 11, 2026
- Report Date
- April 27, 2026
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NPV
- UDI-DI
- 00763000341367
- PMA / PMN Number
- P200046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID HARMONY-25 (K041359); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A; EXPLANT DATE N/A 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. 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.
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.
IMAGE REVIEW: THE INITIAL HARMONY DEPLOYMENT ATTEMPT RESULTED IN THE DISTAL END DROPPING BELOW THE RIGHT PULMONARY ARTERY (RPA) OSTIUM. ALTHOUGH OFF-LABEL, THE IMPLANTERS CHOSE TO BAIL OUT BY RETRIEVING THE VALVE INTO THE NON-MEDTRONIC SHEATH. DURING THE SECOND DEPLOYMENT ATTEMPT, THEY WERE ABLE TO KEEP THE VALVE HIGHER AGAINST THE ROOF OF THE BIFURCATION. A FASTER UNCOVERING ALLOWED THE DISTAL END TO STAY HIGHER, IN THEIR DESIRED POSITION. TO RETRIEVE OR REPOSITION THE HARMONY® TPV VALVE AND ONCE THE STRUTS HAVE MADE CONTACT WITH THE ANATOMY DURING DEPLOYMENT IT IS NOT RECOMMENDED. THIS IS LISTED AS A WARNING/PRECAUTION. PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, THE DELIVERY CATHETER SYSTEM (DCS) WAS RECEIVED WITHOUT A VALVE LOADED WITHIN THE CAPSULE. THE DEVICE WAS RECEIVED WITH THE CAPSULE FULLY OPENED. DEFORMATION WAS EVIDENT TO THE CAPSULE. THE DEVICE WAS RECEIVED WITH THE NOSECONE DETACHED. A KINK WAS OBSERVED IN THE PEEK INNER SHAFT JUST PROXIMAL TO THE HANDLE EDGE. A KINK WAS ALSO OBSERVED ON THE PROXIMAL PEEK INNER SHAFT. THE DEVICE WAS RECEIVED WITH THE PEEK INNER SHAFT PARTIALLY ADVANCED, AND THE HOLDING COIL WAS PARTIALLY RETRACTED. THE PEEK INNER SHAFT COULD BE ADVANCED AND RETRACTED WITH RESISTANCE DUE TO THE KINKS ON THE PEEK INNER SHAFT. THE TUOHY BORST BODY APPEARED TO ROTATE THE HOLDING COIL WHEN ROTATED. THE HEMOSTASIS VALVE ACTUATOR APPEARED TO LOCK WHEN ROTATED CLOCKWISE AND UNLOCK WHEN ROTATED COUNTERCLOCKWISE. THE PROXIMAL HANDLE ACTUATOR APPEARED TO LOCK WHEN ROTATED CLOCKWISE AND UNLOCK WHEN ROTATED COUNTERCLOCKWISE. A HARMONY TPV-25 VALVE WAS SUCCESSFULLY LOADED ONTO THE DCS WITH SLIGHT RESISTANCE. ON RETRACTION OF THE CAPSULE VIA RETRACTION OF THE HAEMOSTASIS VALVE BODY, THE VALVE DEPLOYED WITH SLIGHT RESISTANCE. THE VALVE WAS RELEASED FROM THE HOLDING COIL VIA ROTATION OF THE TUOHY BORST BODY WITHOUT ISSUE. THE REPORTED EVENT FOR POSITIONING DIFFICULTY COULD NOT BE CONFIRMED IN THE ANALYSIS. THE REPORTED EVENT FOR DISLODGED DCS COULD NOT BE CONFIRMED IN THE ANALYSIS. UPDATED DATA: B5., D9., H3., H6. 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 IMPLANT OF A TRANSCATHETER VALVE, THE RIGHT PULMONARY ARTERY (RPA) WIRE POSITION WAS USED DURING DEPLOYMENT USING A NON-MEDTRONIC GUIDEWIRE. THE "CARROT" WAS LAUNCHED DEEP INTO THE RPA SUB BRANCH. THE DELIVERY CATHETER SYSTEM (DCS) WAS PULLED AND THE VALVE WAS COVERED BACK TOWARDS THE MAIN PULMONARY ARTERY UNTIL THE RADIOGRAPHIC MARKER BAND OF THE DCS WAS NOTED TO "FLOP" OVER FROM THE RPA OSTIUM TO THE MIDDLE OF THE BIFURCATION ROOF. AFTER UNCOVERING ROWS 1-2 OF THE VALVE FRAME, ONE OF THE CROWNS OF THE RIGHT SIDE OF THE VALVE FRAME "SLIPPED" DOWN BELOW THE "ARMPIT" OF THE RPA. ADDITIONALLY, INADVERTENT UNCOVERING OF ROW 3 OCCURRED, AND THE FRAME OUTFLOW RESTED IN A "KINKED" POSITION. SUBSEQUENTLY, THE VALVE WAS RESHEATHED USING A 26 FRENCH NON-MEDTRONIC INTRODUCER SHEATH DUE TO THE LOW AND TILTED POSITION OF THE PATIENT'S ANATOMY. A NEW VALVE AND NEW DCS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE DEPTH OF IMPLANT CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS STILL ATTACHED TO THE DCS COIL AND WAS PARTIALLY RECAPTURED IN THE CAPSULE WHEN THE VALVE FRAME SLIPPED DOWN.
ADDITIONAL INFORMATION WAS RECEIVED THAT A A NOSE CONE SEPARATION WAS NOT NOTED DURING THE IMPLANT PROCEDURE AND THAT THE ENTIRE DELIVERY CATHETER SYSTEM (DCS) WAS INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312925 | HARMONY DELIVERY CATHETER SYSTEM | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI | NPV | MEDTRONIC IRELAND | HARMONY-DCS | 0012824770 | 00763000341367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | SEE H11... |