EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) 9630PL29ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00690103210873), received between Jun 6, 2022 and Jun 19, 2025 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A CASE IN PULMONIC POSITION, AN ALTERRA DEVICE WAS PLACED IN THE PULMONARY ANNULUS WITHOUT DIFFICULTY. AS THE PHYSICIAN WAS TRACKING THE PULMONIC DELIVERY SYSTEM (PDS), THE PDS BUMPED INTO THE FIRST ALTERRA AS THE PHYSICIAN WAS ADVANCING IT THROUGH AND CAUSED IT TO DISLODGE. THE ALTERRA MIGRATED DISTAL INTO THE MAIN PULMONARY ARTERY. THE PDS WAS REMOVED AND A SECOND ALTERRA WAS PLACED TO SECURE A LANDING ZONE. THE DISTAL PORTION OF THE SECOND ALTERRA WAS PLACED IN THE PROXIMAL PORTION OF THE FIRST ALTERRA TO SECURE THE FIRST ALTERRA. THE TEAM THEN USED A COMMANDER DELIVERY SYSTEM TO PLACE A NEW 29 MM SAPIEN 3 VALVE IN THE ALTERRA WAIST. THE SYSTEMS WERE REMOVED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY.

  Patient problems: Insufficient Information

  MAUDE report 22294394 ↗
• InjuryMay 29, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 3 MONTHS POST-IMPLANT OF A 29 MM SAPIEN 3 VALVE AND ALTERRA PRE STENT IN THE PULMONIC POSITION WITHIN A TRANSANNULAR PATCH, THEY WERE NOTIFIED OF AN AORTIC TO PULMONARY ARTERY FISTULA IN THIS PATIENT. THE FISTULA CONNECTS THE SOV OF THE PA TO THE SOV IN THE AO, CLOSE TO THE LEFT MAIN. AN ECHO AND CT WERE COMPLETED. THE PATIENT WAS SCHEDULED TO BE CATHED ON (B)(6) AND WAS ASYMPTOMATIC. THE FISTULA WAS FOUND DUE TO A FOLLOW-UP ECHO. DURING THE IMPLANT PROCEDURE, AFTER THE TEAM DEPLOYED THE SAPIEN 3 VALVE IN THE PULMONIC POSITION USING THE PULMONIC DELIVERY SYSTEM (PDS). THE TEAM BEGAN TO PULL THE PDS OUT AND IT APPEARED TO GET CAUGHT ON THE TRICUSPID VALVE. THERE WAS SOME TENSION ON THE SYSTEM AND THE PHYSICIAN WAS UNABLE TO MOVE THE SYSTEM IN EITHER DIRECTION. AFTER SEVERAL ATTEMPTS TO MOVE THE SYSTEM, THE PHYSICIAN DECIDED TO SNARE THE SYSTEM AND CUT IT IN ORDER TO PULL IT OUT OF A GORE DRYSEAL SHEATH. THE PDS WAS CUT JUST OUTSIDE THE BODY AND WAS REMOVED THROUGH A GORE DRYSEAL FROM THE JUGULAR VEIN. THE PATIENT WAS SENT TO RECOVERY AFTERWARDS AND DISCHARGED HOME THE NEXT DAY. THE ROOT CAUSE OF THE PDS SYSTEM WITHDRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105749 ↗
• InjuryMar 31, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT IN THE ALTERRA PRE-STENT (ALP) CLINICAL STUDY UNDERWENT A TRANSFEMORAL TPVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE WITH ALTERRA PRESTENT IN THE PULMONIC POSITION. IT WAS CONFIRMED THAT THE ALTERRA PRESTENT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT AS INTENDED. NEXT, DURING WITHDRAWAL OF THE ALTERRA DS DEVICE FROM THE PRE-STENT, THE TEAM ENCOUNTERED DIFFICULTY/RESISTANCE AT THE LEVEL OF THE TRICUSPID ANATOMY. A NON-EDWARDS SHEATH WAS IN PLACE DURING THE INSERTION AND WITHDRAWAL OF THE ALTERRA PRESENT SYSTEM. DUE TO THE WITHDRAWAL ISSUES - WITH THE ALTERRA IN PLACE - THE TEAM BEGAN TO MANIPULATE THE "RECAPTURE" FUNCTION IN AN ATTEMPT TO TROUBLESHOOT. THE ALTERRA PRESTENT ITSELF WAS NOT RECAPTURED AS IT WAS FULLY DEPLOYED. DUE TO THE WITHDRAWAL ISSUES AND TO PREVENT ANY INJURY TO THE PATIENT, THE TEAM RE-ADVANCED THE ALTERRA DS BACK INSIDE THE DEPLOYED PRE-STENT TO SERVE AS ANATOMICAL PROTECTION AND WERE THEN ABLE TO SUCCESSFULLY COMPLETE TROUBLESHOOTING AND THEN WITHDRAW THE SYSTEM. AT THIS TIME, THERE WAS NO TR OBSERVED. NEXT, THE 29MM S3 WAS IMPLANTED SUCCESSFULLY WITHIN THE PRE-STENT. THERE WAS NO DYSFUNCTION AND THE PHYSICIAN WA

  Patient problems: Intraoperative Cardiac Valve Injury; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21730908 ↗
• MalfunctionNov 26, 2024Difficult or Delayed Positioning; Device Slipped; Difficult or Delayed Positioning; Device Slipped

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT A TRANSFEMORAL TPVR WITH A SAPIEN 3 AND ALTERRA IN A TRANSANNULAR PATCH. A REPORTED, THERE WAS DIFFICULTY DEPLOYING THE ALTERRA PRESTENT. ADDITIONAL DIFFICULTY WITH THE PULMONIC DELIVERY SYSTEM (PDS) TO ALIGN VALVE AND RECAPTURE BALLOON IN THE IVC. THE BLACK DEPLOYMENT WHEEL WAS COMPLETELY OPENED UNTIL IT COULD NOT ROTATE ANY MORE BUT THE OUTER CAPSULE OF THE ALTERRA DELIVERY SYSTEM REMAINED COVERING THE STENT CONNECTOR AND THE PROXIMAL PORTION OF ALTERRA. THE DEPLOYMENT WHEEL WAS THEN ROTATED CLOCKWISE TO "RECAPTURE" THE DEVICE SEVERAL TIMES AND SMALL RECAPTURE PROXIMALLY WAS NOTED. IT WAS THEN REDEPLOYED UNTIL IT WAS ROTATED FULLY AGAIN WITHOUT DEPLOYMENT. THE PHYSICIAN THEN PULLED ON THE ENTIRE SYSTEM TO RELEASE ANY TENSION BUILT UP. THE DEVICE CAME BACK IN THE MAIN PULMONARY ARTERY (MPA) AND THE CAPSULE OF THE DELIVERY SYSTEM FINALLY FULLY RETRACTED OFF THE STENT. IT WAS REMOVED FROM THE BODY WITHOUT COMPLICATION. A RIGHT ATRIAL LOOP WAS MADE TO ADVANCE THE PDS AND VALVE INTO THE ALTERRA STENT. AS THE PDS CAPSULE WAS RETRACTED OFF THE VALVE, THE VALVE JUMPED DISTAL TO THE WAIST OF ALTERRA. W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778653 ↗
• InjuryOct 1, 2024Failure to Advance; Device Damaged by Another Device; Difficult to Advance; Failure to Advance; Device Damaged by Another Device; Difficult to Advance

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH AN ALTERRA PRESTENT AND 29 MM SAPIEN 3 VALVE VIA THE RIGHT FEMORAL VEIN (RFV), THE SECOND PULMONIC DELIVERY SYSTEM WITH VALVE WAS UNABLE TO BE SUCCESSFULLY ADVANCED AND THE VALVE WAS UNABLE TO BE IMPLANTED. IT WAS NOTED THAT A DECISION HAD BEEN MADE TO SWITCH FROM A RFV APPROACH TO A RIGHT INTERNAL JUGULAR (RIJ) APPROACH PRIOR TO THE IMPLANT ATTEMPT USING THE SECOND PULMONIC DELIVERY SYSTEM AND SECOND VALVE. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE SECOND PULMONIC DELIVERY SYSTEM WITH VALVE, BUT THE ATTEMPTS WERE UNSUCCESSFUL. DUE TO EPISODES OF HEART BLOCK DURING THESE MANIPULATIONS, THE PROCEDURE WAS ABORTED. AFTER THE WITHDRAWAL OF THE SECOND PULMONIC DELIVERY SYSTEM AND VALVE, IT WAS NOTED THAT THE CS LEAD WAS DISPLACED, AND THE LEFT VENTRICLE (LV) WAS NO LONGER CAPTURING. THE SHEATHS WERE REMOVED FROM THE NECK AND GROIN AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS PROVIDED BY THE FCS REVEALING THE PATIENT WAS BROUGHT BACK APPROXIMATELY 6 DAYS LATER TO COMPLETE THE IMPLAN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Heart Block

  MAUDE report 20349107 ↗
• InjuryDec 14, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING THE PROCEDURE OF A 29 MM SAPIEN 3 VALVE WITH ALTERRA PRESENT IN THE PULMONIC POSITION VIA JUGULAR APPROACH, DIFFICULTY TRACKING THE INITIAL ALTERRA TO RIGHT PULMONARY ARTERY (RPA) DUE TO WIRE COURSE IN GROSSLY DILATED RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV) OVER STIFF GUIDEWIRE. AFTER MULTIPLE ATTEMPTS, THE WIRE WAS PLACED TO LEFT PULMONARY ARTERY (LPA) AND THE SAME ALTERRA WAS ABLE TO TRACK TO TARGET BUT WOULD NOT ORIENT IN A COAXIAL FASHION AFTER TWO ATTEMPTS. A PULMONARY HEMORRHAGE WAS THEN NOTED WITH FRANK BLOOD IN THE ET TUBE, DIFFICULTY VENTILATING AND DECLINING O2 SATURATION. APPROXIMATELY 250CC OF BRIGHT RED BLOOD WAS SUCTIONED, ANTICOAGULATION WAS REVERSED, AND THE LPA WAS BALLOON OCCLUDED. THE PATIENT WAS SCOPED TO VISUALIZE THE EXTENT OF THE PERFORATION. THE PATIENT SUBSEQUENTLY STABILIZED, AND THE DECISION WAS MADE TO PROCEED WITH THE RIGHT INTERNAL JUGULAR (RIJ) APPROACH WITHOUT ANTICOAGULATION. THE SECOND ALTERRA WAS PLACED VIA NON-EW ESHEATH WITHOUT COMPLICATION, FOLLOWED BY A SUCCESSFUL DELIVERY OF THV. THE PATIENT WAS STABLE AT COMPLETION. PER MEDICAL OPINION, THE ROOT CAUSE OF THE PULMONARY HEMORRHAGE/PER

  Patient problems: Perforation

  MAUDE report 18326486 ↗
• MalfunctionDec 12, 2023Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TPVR PROCEDURE WITH A 29MM SAPIEN VALVE IN AN ALTERRA PRESENT, THE TEAM WAS UNABLE TO DEPLOY THE SAPIEN 3 VALVE DUE TO THE PATIENT'S TORTUOUS ANATOMY AND KINKING OF THE PULMONIC DELIVERY SYSTEM VALVE HOUSING. UPON REMOVAL, THE VALVE WAS OBSERVED TO BE DAMAGED DUE TO ANATOMICAL TURNS FROM THE RIGHT VENTRICLE TO THE PULMONARY ARTERY. PER REPORT, THE ALTERRA PRESTENT SYSTEM WAS DEPLOYED AS PLANNED. THE CASE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311418 ↗
• MalfunctionJul 20, 2023Inflation Problem; Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A S3 AND ALTERRA PROCEDURE. TO IMPLANT A 29 MM SAPIEN 3 VALVE IN THE PULMONIC POSITION, DURING VALVE DEPLOYMENT. THE PULMONIC DELIVERY SYSTEM (PDS) APPEARED TO INFLATE DISTALLY A LOT MORE, BEFORE THE PROXIMAL END CAUGHT UP. THERE WAS NO INTERACTION BETWEEN THE PDS AND THE BRANCH PULMONARY ARTERIES. THE OPERATOR FELT THE DEVICE WAS STILL IN THE MAIN PULMONARY ARTERY (MPA). IT WAS BELIEVED, THAT THE PATIENT'S TORTUOUS ANATOMY CONTRIBUTED TO THE ISSUE. INFLATION WAS VERY SLOW AND THE VALVE WAS PROPERLY ALIGNED WITH THE RADIOPAQUE MARKER BAND. THE VALVE WAS STILL ABLE TO BE IMPLANTED SUCCESSFULLY WITH NO REPORTS OF A PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17365245 ↗
• MalfunctionJun 9, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 VALVE WITH ALTERRA IN THE PULMONIC POSITION, THE PULMONIC DELIVERY SYSTEM BALLOON BURST UPON FULL INFLATION OF NOMINAL VOLUME. THE VALVE WAS SUCCESSFULLY DEPLOYED WITH THE DELIVERY SYSTEM, ALTHOUGH BAV WAS DONE TO ENSURE FULL DEPLOYMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097318 ↗
• MalfunctionMar 9, 2023Deflation Problem; Deflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE OF A 29MM SAPIEN 3 VALVE IN THE PULMONIC POSITION, THERE WAS DEFLATION DIFFICULTY AS THE PULMONIC DELIVERY SYSTEM (PDS) WAS NOTED TO HAVE CONTRAST REMAINING IN THE BALLOON AFTER SUCCESSFUL VALVE DEPLOYMENT. THIS ALSO RESULTED IN DIFFICULTY WITHDRAWING THE PDS. A 60CC SYRINGE WAS ATTACHED TO THE PDS TO REMOVE THE REMAINING CONTRAST IN THE BALLOON. THE PDS WAS THEN ABLE TO BE WITHDRAWN SUCCESSFULLY WITHOUT ANY FURTHER DIFFICULTY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515747 ↗
• MalfunctionDec 19, 2022Burst Container or Vessel; Material Separation; Burst Container or Vessel; Material Separation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING AN ALTERRA TPVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN AN ALTERRA PRESTENT, THE PULMONIC DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT AND THERE WAS DIFFICULTY REMOVING THE DEVICE OUT OF THE VALVE/ALTERRA PRESTENT. THIS RESULTED IN THE SAPIEN 3 VALVE AND ALTERRA PRESTENT TO MOVE TOO PROXIMALLY INTO THE RIGHT VENTRICLE. IT WAS DECIDED TO ICE AND EVALUATE THE PATIENT WITH THE VALVE IN PLACE. THE VALVE WAS WORKING PERFECTLY, HOWEVER, THE OPERATOR DID NOT LIKE THAT THE VALVE AND PRESTENT MOVED. THE DECISION WAS MADE TO EXPLANT THE VALVE AND PRESTENT, AND IMPLANT A SURGICAL VALVE THE SAME DAY. PER REPORT, THE TEAM IS UNABLE TO DETERMINE IF THE BALLOON HAD BURST, OR IF THE MATERIAL OBSERVED ON THE DELIVERY SYSTEM WAS FROM THE DEVICE. HOWEVER, AS BEST PRACTICE, EDWARDS IS SUBMITTING THIS MDR BASED ON THIS INITIAL ACCUSATION OF THE BALLOON BURST UNTIL FURTHER EVALUATION CAN BE DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006253 ↗
• MalfunctionDec 13, 2022Deflation Problem; Deflation Problem

  AS REPORTED BY THE ALTERRA PAS CLINICAL STUDY, DURING A S3 + ALTERRA PROCEDURE OF A 29MM SAPIEN 3 VALVE IN THE PULMONIC POSITION, THE PULMONIC DELIVERY SYSTEM (PDS) BALLOON WOULD NOT FULLY DEFLATE AND THERE WAS DIFFICULTY WITHDRAWING THE PDS. THIS WAS NOTED POST SUCCESSFUL VALVE DEPLOYMENT. WHILE WITHDRAWING THE PDS THROUGH THE VALVE AND PRESTENT, THE BALLOON APPEARED TO STILL HAVE CONTRAST. SOME CONTRAST WAS REMOVED FROM THE ATRION DEVICE AND NEGATIVE PRESSURE WAS APPLIED. THE ATRION WAS THEN LEFT IN NEUTRAL. A SHADOW OF CONTRAST APPEARED TO REMAIN IN THE BALLOON. AN INSUFFLATOR WAS USED TO PULL THE REMAINING CONTRAST OUT. THE LUNDERQUIST WIRE WAS REMOVED AND REPLACED WITH A SOFTER ROSEN WIRE. THE PDS WAS WITHDRAWN SUCCESSFULLY FROM THE MAIN PULMONARY ARTERY (MPA). THE PDS WAS PULLED BACK TO THE INFERIOR VENA CAVA (IVC) WHERE THE BALLOON WAS RECOVERED. THE PDS WAS THEN ABLE TO BE WITHDRAWN FROM THE BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974083 ↗
• InjuryAug 3, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING AN ALTERRA TRANSFEMORAL TMVR PROCEDURE WITH A 29 MM SAPIEN 3 VALVE, A VASCULAR COMPLICATION OCCURRED UPON REMOVAL OF THE PULMONIC DELIVERY SYSTEM (PDS). THE PDS WAS REMOVED FROM THE PA AND INTO THE IVC; HOWEVER, THE SYSTEM WAS PULLED SO QUICKLY THAT THE TEAM WAS NOT ABLE TO CATCH THE FLURO IMAGING TO 'MARRY' THE CAPSULE TO THE TAPERED TIP PRIOR TO DEVICE REMOVAL. THIS LED TO THE TAPERED TIP GETTING "CAUGHT" IN THE VESSEL AND WAS UNABLE TO BE REMOVED. THE CAPSULE AND PART OF THE BALLOON WAS OUT OF THE PATIENT'S BODY, BUT THE TAPERED TIP REMAINED STUCK IN THE VASCULATURE. THE IMPLANTING PHYSICIAN ENLARGED THE VENOTOMY HOWEVER THE DEVICE STILL COULD NOT BE REMOVED. VASCULAR SURGERY WAS CALLED TO PERFORMED A CUTDOWN FOR DEVICE REMOVAL FROM THE FEMORAL VEIN. THE TAPERED TIP AND BALLOON WERE INTACT, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 15161576 ↗
• InjuryJul 21, 2022Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A SAPIEN 3 + ALTERRA PROCEDURE OF A 29MM SAPIEN 3 VALVE IN THE PULMONIC POSITION VIA TRANSFEMORAL VEIN APPROACH, THE BALLOON ON THE PULMONIC DELIVERY SYSTEM RUPTURED DURING VALVE DEPLOYMENT. THE PULMONIC DELIVERY SYSTEM WAS UNABLE TO BE WITHDRAWN FROM THE PATIENT. A SURGICAL CUTDOWN WAS PERFORMED AT THE ACCESS SITE TO WITHDRAW THE PULMONIC DELIVERY SYSTEM. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077795 ↗
• InjuryJun 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED BY FIELD CLINICAL SPECIALIST, DURING INSERTION OF THE PULMONIC DELIVERY SYSTEM, IT WAS NOTED TO DISLODGE THE RIGHT ATRIAL PACING LEAD DURING VALVE POSITIONING. MULTIPLE ATTEMPTS MADE TO GAIN 60/40 POSITIONING INSIDE ALTERRA WHICH INCLUDED WIRE POSITIONING, ATRIAL LOOP, AND CAPSULE REPOSITIONING. PATIENT WAS STABLE DURING THE PROCEDURE. LEAD REPLACEMENT / REPOSITIONING / OR REMOVAL IS SCHEDULED IN THE UPCOMING NEXT FEW WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603433 ↗