Harmony™ HARMONY-DCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00763000341367), received between Feb 17, 2022 and May 27, 2026 — classified as 11 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 22, 2026Open, Classified

   Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

   Z-2624-2026 · Root cause: Process control · FDA record ↗

2. Mar 2, 2022Open, Classified

   There is potential for the capsule bond to break during the procedure.

   Z-0927-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF A TRANSCATHETER PULMONARY VALVE IMPLANT PROCEDURE, AN ACCESS SITE ANEURYSM WAS IDENTIFIED WITHIN THE SAME DAY. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND PERCUTANEOUS ANEURYSM EMBOLIZATION WAS CARRIED OUT ONE DAY FOLLOWING THE PROCEDURE. ENDOVASCULAR HEMOSTASIS WAS THEN ACHIEVED. PER THE PHYSICIAN, THE ANEURYSM WAS CAUSED BY A HIGH-LEVEL PUNCTURE. PER THE PHYSICIAN, THERE IS A CAUSAL RELATIONSHIP BETWEEN THE TECHNIQUE AND THE PATIENT COMPLICATION.

  Patient problems: Aneurysm

  MAUDE report 25306473 ↗
• InjuryMay 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER PULMONIC VALVE, HEMOPTYSIS, A DECREASE IN SPO2, AND A DECREASE IN BLOOD PRESSURE WERE CONFIRMED DUE TO A RIGHT PULMONARY ARTERY PERFORATION. SUBSEQUENTLY, 4 MILLIMETER (MM) AND 6 MM PLUGS WERE IMPLANTED, AND VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED. SUBSEQUENTLY, THE BLEEDING RESOLVED AND THE PATIENT WAS RETURNED TO THE ROOM.

  Patient problems: Great Vessel Perforation; Hemoptysis; Low Blood Pressure/ Hypotension

  MAUDE report 25209374 ↗
• InjuryApr 9, 2026Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED, DURING THE ATTEMPTED IMPLANTATION OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPV), IN A PATIENT WITH TORTUOUS ANATOMY AND A SMALL LEFT PULMONARY ARTERY (LPA) ACUTE ANGLE, THE TORTUROUS ANATOMY POSED PROCEDURAL CHALLENGES FROM THE START OF THE CASE. AFTER PERFORMING SEVERAL ATRIAL LOOP ATTEMPTS TO PLACE THE VALVE IN THE OPTIMAL POSITION, THE IMPLANT TEAM DID NOT FEEL IT WAS SAFE TO CONTINUE WITH THE SAME DELIVERY CATHETER SYSTEM (DCS) AND OPTED TO USE A SECOND DCS. DURING THE ATTEMPT TO PLACE THETPV IN THE OPTIMAL POSITION, THE PATIENT¿S ACUTE LPA ANGLE CONTRIBUTED TO HEMODYNAMIC INSTABILITY. THE SYSTEM WAS SUBSEQUENTLY WITHDRAWN FROM THE PATIENT¿S BODY, AND THE PROCEDURE WAS ABORTED PER THE ANESTHESIOLOGIST¿S RECOMMENDATION. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PRODUCT ISSUE.

  Patient problems: Hemodynamic instability

  MAUDE report 24834927 ↗
• InjuryMar 3, 2026Difficult or Delayed Positioning; Difficult to Open or Close; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER PULMONARY VALVE IMPLANT PROCEDURE, THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED INTO THE PATIENT AND ADVANCED THROUGH THE PATIENT'S ANATOMY. THE VALVE WAS THEN DEPLOYED UP TO ROW 3, WITH THE USE OF A GUIDEWIRE IN THE RIGHT PULMONARY ARTERY POSITION. ANGIOGRAPHY THEN REVEALED VIA THE LATERAL VIEW THAT THE ROW 1 VALVE CROWNS WERE TOO LOW ON THE PULMONARY ARTERY AND THAT THE VALVE ITSELF WAS TILTED. SUBSEQUENTLY, IT WAS ATTEMPTED TO RECAPTURE THE VALVE INTO THE DCS. HOWEVER, THE VALVE WAS NOT ABLE TO BE RECAPTURED INTO THE DCS. IN RESPONSE, THE PHYSICIAN PULLED THE DCS, VALVE, AND NON-MEDTRONIC (GORE) 26 FRENCH (FR) INTRODUCER SHEATH INTO THE PATIENT¿S RIGHT VENTRICLE. WHEN THE ENTIRE SYSTEM WAS PULLED INTO THE RIGHT VENTRICLE, SUSTAINED VENTRICULAR TACHYCARDIA OCCURRED. THIS SUSTAINED VENTRICULAR TACHYCARDIA LASTED FOR 3 TO 4 MINUTES, BUT NO TREATMENT WAS PROVIDED BECAUSE THE PATIENT'S BLOOD PRESSURE REMAINED STABLE. WITH THE VALVE AND DCS INSIDE THE INTRODUCER SHEATH, THE ENTIRE SYSTEM WAS MOVED TO THE INFERIOR VENA CAVA TO UNSURE NO DAMAGE WAS DONE TO THE TRICUSPID VALVE. THE PHYSICIAN WAS THEN ABLE TO FURTHER ALIGN AND PULL THE DCS AN

  Patient problems: Arrhythmia

  MAUDE report 24495665 ↗
• MalfunctionFeb 13, 2026Difficult or Delayed Positioning; Device Dislodged or Dislocated

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334411 ↗
• MalfunctionDec 8, 2025Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS NOT DEPLOYED STRICTLY DUE TO ANATOMICAL ISSUES AND NO ISSUES WITH THE VALVE D EPLOYMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744660 ↗
• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER VALVE, THE GUIDEWIRE AND NON-MEDTRONIC (DRYSEAL) SHEATH WERE INSERTED WITHOUT ANY ISSUES. THE DELIVERY CATHETER SYSTEM (DCS) WAS ADVANCED INTO THE RIGHT PULMONARY ARTERY (RPA), AND DISTAL TIP LAUNCH AND MARRIAGE WERE PERFORMED WITHOUT ANY PROBLEMS. UPON DEPLOYMENT TO ROW 2 WITHIN THE RPA, THE FLOWERING TECHNIQUE WAS PERFORMED; HOWEVER, THE OUTFLOW SIDE OF THE VALVE ON THE LEFT PULMONARY ARTERY (LPA) DROPPED SLIGHTLY DUE TO THE PATIENT'S DEEP SEPTUM CAUSING A "KINK" IN THE OUTFLOW CROWN OF THE VALVE. SUBSEQUENTLY, THE VALVE WAS RECAPTURED TO AIM FOR A HIGHER IMPLANT POSITION. THE DCS WAS CHECKED AND THERE WAS NO DEFORMATION OF THE CAPSULE, FRAME OR COIL. THEREFORE, THE DCS WAS ADVANCED INTO THE RPA, AND THE OUTFLOW SIDE OF THE VALVE WAS DEPLOYED IN THE MAIN PULMONARY ARTERY (MPA) USING THE POP-UP TECHNIQUE. THE OUTFLOW SIDE OF THE VALVE ON THE LPA DROPPED SLIGHTLY AGAIN; HOWEVER, DEPLOYMENT WAS CONTINUED UP TO ROWS 3-4. DURING DEPLOYMENT, A KINK WAS OBSERVED AT THE JUNCTION OF ROWS 2/3, AND RECAPTURE WAS PERFORMED. THE DCS WAS ADVANCED INTO THE RPA AGAIN AND DEPLOYED UP UNTIL ROW 1 USING THE FLOWERING TECHNIQUE. DEPLOYMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360623 ↗
• MalfunctionMay 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PREPARATION FOR A TRANSCATHETER PROCEDURE, THE DISTAL BLUE ACTUATOR OF THE HARMONY¿ DELIVERY CATHETER SYSTEM (DCS) WOULD NOT LOCK TO FLUSH THE CAPSULE. AS A RESULT, THE PRODUCT WAS NOT USED TO COMPLETE THE PROCEDURE. A NEW DELIVERY CATHETER SYSTEM WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029239 ↗
• InjuryMay 6, 2025Difficult to Open or Close; Patient Device Interaction Problem; Difficult to Open or Close; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WITH EXPERIENCED IMPLANTERS, THE INTENT WAS TO USED RIGHT PULMONARY ARTERY (RPA) GUIDEWIRE POSITION WITH A NON-MEDTRONIC GUIDEWIRE. THE DELIVERY CATHETER SYSTEM (DCS) WAS ADVANCED AND THE NOSE CONE WAS LAUNCHED INTO THE RPA. AS THE ROWS 1-3 WERE BEING UNCOVERED AT THE ROOF OF THE BIFURCATION ACCORDING TO THE PRE-CASE PLANNING, THE GUIDEWIRE "JUMPED" FROM THE RPA TO THE LEFT PULMONARY ARTERY (LPA). THIS RE-ORIENTED THE VALVE AND FORCED IT TO MOVE LOWER THAN WAS PLANNED. AS RESULT, THE DEPLOYED VALVE, WHICH WAS NOT YET RELEASED, WAS RECAPTURED THROUGH THE 26 FR 65 CENTIMETER (CM) NON-MEDTRONIC SHEATH. DIFFICULTY TO RECAPTURE WAS REPORTED. GUIDEWIRE PERFORATION OF THE DISTAL RIGHT PULMONARY ARTERY WITH HEMOPTYSIS AND BLEEDING FROM THE ENDOTRACHEAL (ET) TUBE OCCURRED. THIS REQUIRED COLD SALINE IRRIGATION, CONTINUED INTUBATION, AND ADMISSION TO THE PEDIATRIC CARDIAC INTENSIVE CARE UNIT. THE HEMOGLOBIN LEVEL PRE-IMPLANT MEASURED 13.1 GRAMS PER DECILITER (G/DL). THE HEMOGLOBIN LEVEL POST VALVE IMPLANT MEASURED 10.6 G/DL. THE PERFORATION RESULTED IN IN PROLONGED HOSPITALIZATION. A NEW GUIDEWI

  Patient problems: Hemoptysis; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 21969621 ↗
• InjuryMay 1, 2025Difficult or Delayed Activation; Malposition of Device; Device Dislodged or Dislocated; Intravalvular regurgitation; Difficult or Delayed Activation; Malposition of Device; Device Dislodged or Dislocated; Intravalvular regurgitation

  IT WAS REPORTED THAT PRIOR TO THE INITIAL IMPLANT OF THE HARMONY-25 VALVE, IT WAS NOTED THAT THE SCREENING REPORT HAD "FAILED". DURING DISCUSSIONS REGARDING THE SCREENING REPORT WITH THE IMPLANTING PHYSICIAN, TWO TECHNIQUES WERE CONSIDERED FOR IMPLANTING THE VALVE AT THE DESIRED ANNULUS LOCATION. THE FIRST PLAN WAS TO PLACE THE VALVE AT THE ANNULUS, TAKE AN ANGIOGRAM TO CONFIRM STABILITY OF THE VALVE, AND THEN RELEASE THE VALVE. THE IMPLANTING PHYSICIAN WANTED TO OPEN THE INITIAL PORTION OF THE VALVE, ROWS ONE AND TWO, UNDER THE ROOF OF THE BIFURCATION. AS THE VALVE WOULD BE ANNULAR AT THIS POINT, IT COULD BE STARTED MIDWAY IN THE PULMONARY ARTERY. THE IMPLANTING PHYSICIAN COULD THEN BRING VALVE TO DESIRED LOCATION. THE OTHER TECHNIQUE IMPLANTING PHYSICIAN DISCUSSED WAS OPENING ROWS ONE AND TWO IN ONE OF THE PULMONARY ARTERIES. SUBSEQUENTLY, THE VALVE WOULD BE BROUGHT BACK TO DESIRED POINT AND THE REMAINDER OF THE ROWS WOULD BE OPENED. THE DECISION WAS MADE TO OPEN THE ROWS HIGH UP AND THEN BRING THE VALVE DOWN INTO DESIRED POSITION. DURING THE MANEUVER TO BRING VALVE TO DESIRED LOCATION IT WAS NOTED THAT THE VALVE BEGAN TO RELEASE. APPROXIMATELY FOUR SUTURE LOOPS WERE DEPLOYED. TH

  Patient problems: Foreign Body In Patient; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 21943955 ↗
• MalfunctionApr 29, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WAS AN OUT OF BOX ANOMALY WITH A DELIVERY CATHETER SYSTEM (DCS), SPECIFICALLY INCORRECT LABELING, WHERE THE DCS WAS SENT TO THE MEDTRONIC SALES REPRESENTATIVE AS A DEMONSTRATION PRODUCT, BUT WAS NOT LABELLED AS A DEMO. UPON OPENING THE PACKAGING, THE DCS CONTAINED A COMMERCIAL LABEL AND WAS NOT USED FOR ANY PROCEDURE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THE SUSPECT DCS WAS SENT OUT BY MEDTRONIC MARKETING FOLLOWING A DISCUSSION WITH A SALES TEAM WHO HAD REQUESTED ANOTHER DEMO DCS. "THIS IS NOT THE NORMAL DEMO ORDER PROCESS." IT WAS FURTHER CLARIFIED THIS INSTANCE ONLY CONTAINED ONE DCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930954 ↗
• MalfunctionFeb 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO LOADING THE TRANSCATHETER VALVE, UPON FIRST INSPECTION OF THE DELIVERY CATHETER SYSTEM (DCS), A CAPSULE TEAR WAS OBSERVED ON THE DCS. IT WAS NOTED THAT THE TEAR EXTENDED FROM THE RADIOPAQUE MARKER INTO THE CAPSULE. THE DAMAGED DCS WAS REPLACED WITH A NEW DCS TO COMPLETE THE PROCEDURE, AND THE VALVE WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471834 ↗
• MalfunctionFeb 11, 2025Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE PRE-CASE ANALYSIS INDICATED THE DIFFICULTY LEVEL OF THE IMPLANT PROCEDURE DUE TO THE SINGLE 1MM IMPLANT LANDING ZONE AND COMPLEX PATIENT ANATOMY. DURING THE ATTEMPTED IMPLANT, THE RIGHT PULMONARY ARTERY WIRE POSITION WAS USED. DURING DEPLOYMENT, IT WAS NOTED THAT WITH STRUTS 1 AND 2 DEPLOYED HIGH IN THE MAIN PULMONARY ARTERY (MPA) AT BIFURCATION AND AT RECOMMENDED LANDING ZONE, THE VALVE DROPPED DOWN INTO THE MPA WHEN ATTEMPTING TO DEPLOYED STRUTS 3-6. SUBSEQUENTLY, THE VALVE DEPLOYMENT WAS UNSUCCESSFUL DUE TO THE COMPLEX PATIENT ANATOMY WITH 1MM LANDING ZONE AND INABILITY TO MAINTAIN NECESSARY HIGH IMPLANT POSITION. AN ATTEMPT WAS MADE TO USE THE DCS TO RESHEATHED THE VALVE BUT WAS NOT SUCCESSFUL. MULTIPLE ATTEMPTS TO ADVANCE THE 26F NON-MEDTRONIC SHEATH INTO THE MPA TO SHEATH THE PARTIALLY DEPLOYED VALVE WERE MADE WITHOUT SUCCESS. IN ADDITION, THE PARTIALLY DEPLOYED VALVE (STRUTS 1 AND 2 UNSHEATHED) WAS THEN PULLED THROUGH TRICUSPID VALVE AND THEN SHEATHED INTO THE NON-MEDTRONIC SHEATH AT THE INFERIOR VENA CAVA LEVEL. THE VALVE WAS RESHEATHED DUE TO LOW ANATOMICAL POS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360514 ↗
• MalfunctionFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE INTO THE NATIVE VALVE, THE INITIAL ATTEMPT FOR GUIDEWIRE POSITION WAS WITH THE LEFT PULMONARY ARTERY, BUT DURING DEPLOYMENT OF THE FIRST TWO ROWS OF THE VALVE FRAME STENTS THE VALVE DISLODGED. THE VALVE WAS RECAPTURED INTO THE DELIVERY CATHETER SYSTEM (DCS) AND INTO THE NON-MEDTRONIC (DRYSEAL) SHEATH AND THEN WITHDRAWN FROM THE PATIENT. A NEW VALVE AND DCS WERE PREPPED AND SUCCESSFULLY DELIVERED VIA THE RIGHT PULMONARY ARTERY. THERE WAS A PROCEDURAL DELAY OF LESS THAN 30 MINUTES. THE PHYSICIAN REPORTED THAT THE DISTAL END WAS NOT HIGH ENOUGH AT THE START OF VALVE DEPLOYMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351262 ↗
• MalfunctionFeb 6, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A TRANSCATHETER PROCEDURE INVOLVING THE HARMONY-25 VALVE IN A PATIENT WITH TORTUOUS ANATOMY, A PRE-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED DUE TO THICKENED LEAFLETS. THE LEFT PULMONARY ARTERY WIRE POSITION WAS USED DURING DEPLOYMENT, WHICH LED TO THE VALVE DROPPING IN POSITION AND NOT ALLOWING COAXIAL ALIGNMENT. THE VALVE WAS RECAPTURED ONCE DUE TO THESE POSITIONING CHALLENGES AND WITHDRAWN FROM THE PATIENT. A CHANGE OUT OF THE VALVE AND DELIVERY CATHETER SYSTEM WAS PERFORMED AND A NEW VALVE WAS IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT AN INTRODUCER SHEATH WAS USED TO RESHEATH THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322432 ↗
• MalfunctionFeb 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TRANSCATHETER PROCEDURE INVOLVING THE HARMONY¿ DELIVERY CATHETER SYSTEM, DAMAGE WAS NOTED TO THE DELIVERY CATHETER SYSTEM, SPECIFICALLY WITH THE SIDE PORT, PRIOR TO INSERTION INTO THE PATIENT. THE ISSUE WAS IDENTIFIED WHILE OPENING THE CAPSULE PRIOR TO LOADING. AN ADDITIONAL STOP COCK WAS ATTACHED AS A RESPONSE TO THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313982 ↗
• MalfunctionJan 16, 2025Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSCATHETER VALVE REPLACEMENT PROCEDURE INVOLVING A PULMONARY BIOPROSTHETIC VALVE, THERE WERE POSITIONING DIFFICULTIES DURING DEPLOYMENT, AND THE DISTAL STRUT BACKFOLDED WHEN THE VALVE WAS UNSHEATHED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED USING THE INTRODUCER SHEATH AND DELIVERY CATHETER SYSTEM (DCS) AND WITHDRAWN FROM THE PATIENT. A NEW VALVE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S TORTUOUS ANATOMY CONTRIBUTED TO THESE ISSUES AND THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. IT WAS REPORTED THAT THE RIGHT PULMONARY ARTERY WIRE POSITION WAS USED DURING DEPLOYMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE LOADING PROCESS OF THE SECOND VALVE AND DCS, AN ACTUATOR SEPARATION WAS NOTED. THERE WAS A DELAY OF 8 MINUTES DUE TO THE DCS ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21171805 ↗
• MalfunctionJan 6, 2025Flushing Problem; Detachment of Device or Device Component; Material Deformation; Flushing Problem; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROXIMAL HANDLE ACTUATOR WAS NEVER USED AS THE ISSUE WITH THE DELIVERY CATHETER SYSTEM (DCS) OCCURRED PRIOR TO THE VALVE BEING FULLY LOADED AND BEFORE ENTERING THE PATIENT. SUBSEQUENTLY THE VALVE WAS UNLOADED FROM THE DCS AND LOADED ONTO A NEW DCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085354 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Product Quality Problem; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Product Quality Problem; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON REMOVAL OF THE FIRST DELIVERY CATHETER SYSTEM (DCS) FROM THE PACKAGING, IT WAS OBSERVED THAT THE ACTUATOR HAD SEPARATED FROM THE REST OF THE DEVICE. SUBSEQUENTLY, A NEW DCS WAS PREPARED. UPON REMOVAL OF THE SECOND DCS FROM PACKAGING, HOWEVER, THE FLUSH PORT CAME OFF.  THE PHYSICIAN PLACED THE FLUSH PORT BACK ON THE HEMOSTASIS VALVE BODY, AND THE SECOND DCS WAS USED FOR THE IMPLANT OF THE VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THE ACTUATOR DID NOT SEPARATE, IT WAS STILL IN PLACE, BUT WAS NOT SEALED. IT WAS REPORTED TO BE LEAKING AND COULD NOT BE TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087166 ↗
• InjuryJul 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DELIVERY CATHETER SYSTEM (DCS) WAS ACCESS VIA THE RIGHT FEMORAL ACCESS SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19740380 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED A NON-MEDTRONIC INTRODUCER SHEATH HAD BEEN USED DURING THE IMPLANT PROCEDURE. THE PHYSICIAN REPORTED THAT THE DELIVERY CATHETER SYSTEM (DCS) DID NOT CAUSE OR CONTRIBUTE TO THE ABSCESS. THE CAUSE OF THE ABSCESS WAS NOT REPORTED.

  Patient problems: Abscess

  MAUDE report 19225950 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE, THE PATIENT HAD A TRICUSPID TEAR WHEN THE COIL OF THE DELIVERY CATHETER SYSTEM (DCS) WAS GOING BACK INTO THE SHEATH. PATIENT EXPERIENCED MODERATE TRICUSPID REGURGITATION AFTER THE INCIDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cusp Tear; No Clinical Signs, Symptoms or Conditions; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18192180 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS REPORTED THAT NO HOSPITALIZATION WAS REQUIRED. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) AND SUTURE REPAIR OF THE WOUND WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE ED, THREE HOURS AFTER PRESENTING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17690498 ↗
• MalfunctionOct 11, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE THE IMPLANTER WAS MARRYING THE VALVE TO THE RADIOPAQUE MARKER BAND, THE CAPSULE OF THE DELIVERY CATHETER SYSTEM (DCS) FRACTURED. THE IMPLANTER IMMEDIATELY NOTED THE CAPSULE FRACTURE AND MANIPULATED THE DISTAL TIP BACK INTO THE CAPSULE. THE DCS WAS ABLE TO BE WITHDRAWN INTO THE NON-MEDTRONIC SHEATH. THE DCS AND SHEATH WERE ABLE TO BE SUCCESSFULLY REMOVED FROM THE BODY. THE PATIENT'S PRESSURE REMAINED STABLE. A REPLACEMENT SHEATH WAS INSERTED. A SECOND VALVE AND DCS WERE PLACED AND THE VALVE WAS ABLE TO BE IMPLANTED WITHOUT COMPLICATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584821 ↗
• MalfunctionJul 28, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING BENCH DEMONSTRATION IN PEER-TO-PEER TRAINING, A DELIVERY CATHETER SYSTEM (DCS) CAPSULE BOND BREAK OCCURRED AFTER TWO TO THREE USES IN THE WATER BATH. THE CAPSULE BREAK OCCURRED WHILE IN MEDTRONIC CONTROL AND DID NOT OCCUR IN A CLINICAL CASE, THEREFORE NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126468 ↗