EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00690103193954), received between May 22, 2017 and Mar 30, 2026 — classified as 1 death, 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (14 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (P140031, P200015); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jan 22, 2019Class IITerminated

   This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

   Z-0835-2019 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 30, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TPVR (TRANSCATHETER PULMONIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 (S3) VALVE IN A PRE-EXISTING SURGICAL VALVE, THE BALLOON TO THE 26MM COMMANDER DELIVERY SYSTEM (DS) RUPTURED WHILE THE S3 VALVE WAS BEING INFLATED AT +2ML NOMINAL VOLUME. THE DS WAS RETRIEVED THROUGH THE NON-EDWARDS SHEATH AND NO REMNANTS OF THE FRACTURED BALLOON WERE LEFT BEHIND IN THE PATIENT. NO DAMAGE TO THE S3 VALVE WAS NOTED. THE DS IS NOT AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714794 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST THAT DURING A TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT TPVR WITH A 26MM SAPIEN 3 VALVE, THE PULMONARY ARTERY CONDUIT WAS PRE-STENTED WITH A NON-EDWARDS CAORCTATION (CP) COVERED STENT THEN A NON-EDWARDS PERIPHERAL STENT WAS IMPLANTED INSIDE THAT. THEN OUR 26MM SAPIEN 3 VALVE WAS SUCCESSFULLY IMPLANTED IN THAT, BUT POST- DEPLOYMENT ASSESSMENT REVEALED A HIGHER-THAN-EXPECTED GRADIENT THAT WAS SUB VALVULAR. AN ANGIOGRAM REVEALED THERE WAS A CONTAINED RUPTURE OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AT THE LEADING EDGE OF THE STENTS. THE PHYSICIAN THEN IMPLANTED A LONG 6CM CP COVERED STENT THROUGHOUT THE PULMONARY ARTERY, COVERING THE NEWLY PLACED VALVE, LEAVING ABOUT 1CM OUT OF THE PROXIMAL END OF THE FIRST STENTS. THIS WAS AN ATTEMPT TO COVER THE TEAR/RUPTURE. THE PHYSICIAN THEN PLACED THIS 6CM STENT AND POST DILATED WITH A 30MM NON-EDWARDS CATHETER FOR APPOSITION. POST ANGIOGRAM SHOWED THAT THE RUPTURE WAS COVERED AND THERE WAS NO EXTRAVASATION. THE PHYSICIAN THEN NEEDED TO PLACE A SECOND VALVE INSIDE THE OTHER IMPLANTS AND DID THIS USING A 29MM SAPIEN 3 VALVE. THIS IS THE FUNCTIONING VALVE IN THE PATIENT. THE PATIENT

  Patient problems: Cardiac Perforation

  MAUDE report 23863102 ↗
• MalfunctionNov 21, 2025Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT DURING A TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT TPVR WITH A 26MM SAPIEN 3 VALVE, DURING VALVE DEPLOYMENT THE 26MM COMMANDER DELIVERY SYSTEM (DS) BALLOON BURST WHILE IMPLANTING THE VALVE. THE VALVE WAS IMPLANTED WITH ADDITIONAL VOLUME ADDED TO THE DELIVERY SYSTEM RECOMMENDED NOMINAL VOLUME +2CC WAS ADDED IN ORDER TO ACHIEVE A "SNUG FIT". FIRST THE IMPLANTER WENT WITH NOMINAL VOLUME, THEN KEPT ADDING VOLUME BETWEEN +1CC AND +2CC, WHICH IS WHEN THE BALLOON BURST. THERE WAS SOME DIFFICULTY WITHDRAWING THE BALLOON INTO THE GORE DRYSEAL SHEATH AS IT WAS GETTING STUCK AT THE TIP, SO THE SYSTEM WAS REMOVED FROM THE PATIENT AS ONE UNIT, AS INSTRUCTED IN THE DEVICE TRAINING MANUALS. DURING MANIPULATION OF THE DEVICES ON THE BACK TABLE, THE DELIVERY SYSTEM WAS PULLED FROM THE SHEATH, AND A PIECE OF THE BALLOON HAD SEPARATED. IT WAS THEN FOUND THAT THE BALLOON HAD SEPARATED. THE ROOT CAUSE OF THE BALLON BURST IS PERCEIVED TO BE THE EXTRA INFLATION ADDED TO THE BALLOON. THERE WAS NO PATIENT INJURY, AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616431 ↗
• InjurySep 8, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A VALVE-IN-VALVE TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE INVOLVING THE IMPLANTATION OF A NEW 26 MM SAPIEN 3 VALVE WITHIN AN EXISTING 26 MM SAPIEN 3 VALVE, DIFFICULTY WAS ENCOUNTERED IN ALIGNING THE NEW VALVE ONTO THE 26 MM COMMANDER DELIVERY SYSTEM BALLOON. THE VALVE ALIGNMENT DIFFICULTY OCCURRED DURING BOTH GROSS ALIGNMENT AND FINE ADJUST. ADDITIONALLY, MULTIPLE ATTEMPTS WERE REQUIRED BEFORE THE DELIVERY SYSTEM AND VALVE SUCCESSFULLY CROSS THE PRE-EXISTING VALVE. THE VALVE AND DELIVERY SYSTEM HAD BEEN PREPARED TO NOMINAL SPECIFICATIONS WITH AN ADDITIONAL 2 CC OF CONTRAST ADDED. DURING BALLOON INFLATION, THE DELIVERY SYSTEM BALLOON RUPTURED AND ATTEMPTS TO WITHDRAW THE DELIVERY SYSTEM WERE COMPLICATED BY A SPLIT IN THE 14FR ESHEATH+, WHICH RESULTED IN THE DELIVERY SYSTEM EXITING THROUGH THE SIDE OF THE ESHEATH+. PERCUTANEOUS RETRIEVAL OF THE DELIVERY SYSTEM WAS UNSUCCESSFUL. A SURGICAL CUTDOWN WAS PERFORMED TO REMOVE THE DELIVERY SYSTEM. ALTHOUGH THE BALLOON HAD RUPTURED, THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997274 ↗
• MalfunctionJul 2, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT DURING A TRANSFEMORAL TRANSCATHETER PULMONARY VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN 3 VALVE, THE BALLOON ON THE 26MM COMMANDER DELIVERY SYSTEM (DS) BURST IN THE J-HOOK UPON DELIVERY OF THE VALVE DUE TO SEVERE CALCIFICATION OF THE NON-EDWARDS PULMONARY CONDUIT. THE VALVE WAS SUCCESSFULLY IMPLANTED. THE BALLOON WAS RE-SHEATHED AS MUCH AS POSSIBLE IN THE MAIN PULMONARY ARTERY AND BROUGHT BACK TO INFERIOR VENA CAVA FOR FULL RECAPTURE. IT WAS DIFFICULT GETTING BURST BACK INTO THE 26F GORE DRYSEAL SHEATH. THE DELIVERY SYSTEM AND SHEATH WERE REMOVED AS ONE UNIT. UPON REMOVAL, IT WAS OBSERVED THAT THE SHEATH TIP WAS ALSO INVERTED SOME. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT IS IN STABLE CONDITION. THE DEGREE OF VASCULAR TORTUOSITY WAS MILD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386386 ↗
• InjuryAug 15, 2024Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH A 26 MM SAPIEN 3 VALVE INSIDE A CONDUIT, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED HORIZONTALLY DURING VALVE DEPLOYMENT. IT WAS NOTED THAT 21 CC OF VOLUME HAD BEEN INFLATED IN THE ATRION DEVICE BY PUSHING. THE ATRION DEVICE WAS THEN LOCKED, AND THE REMAINING 2 CC OF VOLUME WAS TWISTED. AFTER THE BALLOON RUPTURED, THERE WAS DIFFICULTY WITHDRAWING THE BALLOON BACK INTO THE NON-EDWARDS SHEATH. SUBSEQUENTLY, THE BALLOON WAS ABLE TO BE SUCCESSFULLY WITHDRAWN BY USING A SNARE DEVICE FROM THE CONTRALATERAL FEMORAL VEIN. THERE WAS NO MAJOR BLEEDING OR VASCULAR COMPLICATION REPORTED. IT WAS NOTED THAT THE BALLOON WAS ALMOST FULLY INFLATED WHEN IT BURST. THERE WAS APPROXIMATELY 0.5 TO 1 CC OF VOLUME LEFT IN THE ATRION DEVICE. THE VALVE WAS FULLY DEPLOYED BEFORE THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19993535 ↗
• MalfunctionApr 17, 2024Burst Container or Vessel; Difficult to Remove; Material Separation; Burst Container or Vessel; Difficult to Remove; Material Separation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 26 MM SAPIEN 3 VALVE IN THE PULMONIC POSITION IN A 25 MM EDWARDS SURGICAL VALVE VIA TRANSFEMORAL APPROACH. THE 25 MM EW SURGICAL VALVE WAS SUCCESSFULLY PRE-DILATED WITH 24 MM NON-EW BALLOON. DURING VALVE DEPLOYMENT, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED CIRCUMFERENTIALLY AND GOT STUCK ON THE NON-EW SHEATH. THE BALLOON WAS PULLED AS FAR AS POSSIBLE INTO THE SHEATH BUT WEREN'T ABLE TO PULL THE DELIVERY SYSTEM COMPLETELY INTO THE SHEATH. THE TEAM WAS ABLE TO REMOVE THE SYSTEM AS A UNIT FROM THE VESSEL WITHOUT ISSUE. THE 26 MM SAPIEN 3 VALVE WAS POST-DILATED. THE PATIENT WAS IN STABLE CONDITION WHEN THEY LEFT THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125299 ↗
• MalfunctionAug 18, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSFEMORAL TRANSCATHETER VALVE REPLACEMENT PROCEDURE OF A 26 MM SAPIEN 3 VALVE INSIDE A PRE-EXISTING NON-EDWARDS SURGICAL VALVE IN THE PULMONIC POSITION, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED AT THE END OF VALVE DEPLOYMENT. ON THE BACK TABLE, IT APPEARED THERE WAS A LONGITUDINAL TEAR. AS IT WAS UNCLEAR IF THE ENTIRE VOLUME HAD BEEN DELIVERED, A NON-EDWARDS BALLOON WAS USED TO POST-DILATE THE VALVE TO ENSURE IT WAS FULLY EXPANDED. IT WAS NOTED THAT THE NON-EDWARDS BALLOON WAS TAKEN UP TO 10 ATM. A POST-ANGIOGRAM PERFORMED WITH A MULTI-TRACK CATHETER REVEALED NO LEAK. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573169 ↗
• InjuryFeb 23, 2023Burst Container or Vessel; Difficult to Remove; Material Separation; Burst Container or Vessel; Difficult to Remove; Material Separation

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING THE PROCEDURE OF A 26 MM SAPIEN 3 VALVE IN THE PULMONIC VALVE IN A CONDUIT VIA TRANSFEMORAL APPROACH, THE BALLOON RUPTURED CIRCUMFERENTIALLY BEFORE FULL VOLUME WAS ACHIEVE. IT WAS A VERY CALCIFIED CONDUIT AND WAS PRE-STENTED WITH TWO PALMAZ STENTS PRIOR TO DEPLOYING THE S3 VALVE. INITIAL INFLATION/DEPLOYMENT OF VALVE WAS FINE; HOWEVER, A SECOND INFLATION WAS PERFORMED TO ENSURE FULL DEPLOYMENT OF VALVE. DIFFICULTY WAS NOTED WHEN RETRIEVING THE COMMANDER DELIVERY SYSTEM BACK INTO THE NON-EW SHEATH. MORE THAN NORMAL FORCE WAS USED TO RE-SHEATH THE DELIVERY SYSTEM/BALLOON AND EVIDENTLY THE CENTRAL/WORKING PART OF THE BALLOON SHEARED OFF INSIDE THE PATIENT. ECHO SHOWED THE BALLOON WAS IN THE RIGHT ATRIUM. A SNARE AND A CORE DEVICE WAS UTILIZED TO REMOVE THE LARGE BALLOON FRAGMENT. THE END RESULT WAS VERY GOOD AND PATIENT IS IN STABLE CONDITION. PER THE FCS RESPONSE, THERE WERE NO MISSING OR BALLOON FRAGMENTS. THERE WAS EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO THE INFLATION.

  Patient problems: Insufficient Information

  MAUDE report 16427616 ↗
• MalfunctionNov 4, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TPVR PROCEDURE WITH A 26 MM SAPIEN 3 VALVE, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED AT THE END OF INFLATION DUE TO A CALCIFIED PULMONARY CONDUIT. THE VALVE WAS DEPLOYED AND THE DELIVERY SYSTEM AND 24FR DRYSEAL WERE REMOVED AS A UNIT WITHOUT COMPLICATION. A 26MM ATLAS GOLD BALLOON WAS INSERTED TO POST DILATE WITHOUT COMPLICATION. THE PATIENT WAS TRANSFERRED TO THE UNIT IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734548 ↗
• InjurySep 9, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TPVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN A COVERED STENT INSIDE OF PALMAZ STENT, THE BALLOON RUPTURE AT THE END OF VALVE DEPLOYMENT DUE TO A CALCIFIED CONDUIT. UPON REMOVAL OF THE DELIVERY SYSTEM AND VALVE INTO A NON-EDWARDS SHEATH, THE TIP OF THE BALLOON AND NOSE CONE SHEARED OFF INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THE NOSE CONE AND TIP WERE SNARED AND BROUGHT DOWN INTO THE INFERIOR VENA CAVA BEFORE BEING RETRIEVED AND REMOVED THROUGH FEMORAL ACCESS SITE. PER REPORT, THE TWO STENTS WERE IMPLANTED PRIOR TO THE FCS ARRIVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395272 ↗
• InjuryAug 9, 2022Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, THE PATIENT UNDERWENT A TRANSFEMORAL TRANSCATHETER VALVE REPLACEMENT VALVE-IN-VALVE PROCEDURE FOR A 26MM SAPIEN 3 VALVE IN A FREESTYLE VALVE IN PULMONIC POSITION. AFTER DELIVERY OF A 24MM COVERED STENT INSIDE THE FREESTYLE VALVE, THE 26MM S3 VALVE WAS CRIMPED ON THE COMMANDER DELIVERY SYSTEM AND LOADED THROUGH THE BACK OF A 26F DRYSEAL SHEATH. AFTER MANY ATTEMPTS, THE PHYSICIAN COULD NOT PASS THE VALVE THROUGH THE COVERED STENT TO DELIVER IT. IT WAS DECIDED TO BRING THE VALVE BACK INTO THE 26F DRYSEAL SHEATH. THERE WAS SOME TORTUOSITY IN THE ANATOMY WHILE DRAWING IT BACK INTO THE SHEATH. IT WAS NOT ALIGNING WELL SO IT WAS DECIDED TO PULL THE SHEATH AND THE VALVE OUT AS ONE, HOWEVER, WHEN PULLING THE SHEATH AND SYSTEM BACK AS ONE, THE VALVE CAME OFF THE TIP OF THE DELIVERY SYSTEM AND WAS FLOATING ON THE WIRE IN THE RIGHT VENTRICLE (RV). THE PATIENT WAS TAKEN TO SURGERY FOR THE REMOVAL OF THE SYSTEM AND THE VALVE. AS THE PATIENT WAS STABLE WITH THE STENT ON THE WIRE IN THE RV, THEY DID NOT WANT TO REMOVE THE DELIVERY SYSTEM BEFORE SURGERY FOR CONCERN OF LOSING THE WIRE POSITION. PER THE PHYSICIAN, IT SEEMED AS THOUGH THE SYSTEM WAS CAUGHT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195474 ↗
• MalfunctionJul 15, 2022Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED, PRIOR TO IMPLANTATION OF A 26MM SAPIEN 3 ULTRA VALVE, MULTIPLE LEFT PULMONARY ARTERY AND RIGHT PULMONARY ARTERY STENTS WERE PLACED AND EXTENDED DOWN TOWARD THE RIGHT VENTRICULAR OUTFLOW TRACT. DURING VALVE DEPLOYMENT IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 26MM SAPIEN 3 ULTRA, THE COMMANDER DELIVERY SYSTEM (DS) BALLOON BURST CIRCUMFERENTIALLY/TRANSVERSE WHEN NEARLY FULLY INFLATED. THIS WAS LIKELY DUE TO DISTAL PORTION OF BALLOON CONTACTING THE EDGE OF ONE OF THE PULMONARY ARTERY (PA) STENTS. DUE TO THE BALLOON RUPTURE, THEY COULD NOT GET THE DS BALLOON FULLY INTO THE NON-EDWARDS SHEATH. THE DELIVERY SYSTEM WAS CAUGHT IN THE TIP OF THE NON-EDWARDS SHEATH AND WAS REMOVED FROM THE PATIENT WITH THE DISTAL TIP OF BALLOON AND NOSECONE WAS REPORTED TO BE OUTSIDE THE TIP OF THE NON-EDWARDS SHEATH. THE PATIENT WAS REPORTED DOING VERY WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028330 ↗
• MalfunctionJun 21, 2022Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  DELIVERY SYSTEM BALLOON RUPTURE DURING A PULMONIC VALVE IN VALVE PROCEDURE. AS REPORTED BY AN EDWARDS CLINICIAN SPECIALIST, DURING A COMPASSIONATE PULMONIC VALVE IN VALVE PROCEDURE, A 26MM SAPIEN 3 VALVE WAS DEPLOYED IN A PRE-EXISTING SURGICAL VALVE IN THE MAIN PULMONARY ARTERY. DURING VALVE DEPLOYMENT, AS THE LAST ML WAS BEING ADDED TO THE COMMANDER DELIVERY SYSTEM, THE BALLOON RUPTURED. THE BALLOON SEPARATED. THE WIRE, NOSE CONE, AND RUPTURED BALLOON WERE SNARED AND SUCCESSFULLY PULLED INTO THE SHEATH. THE DEVICES WERE REMOVED FROM THE PATIENT. THE VALVE WAS FULLY DEPLOYED AND REMAINS IMPLANTED IN THE PATIENT. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754920 ↗
• InjuryMar 29, 2022Fluid/Blood Leak; Difficult to Remove; Fluid/Blood Leak; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE, THE BALLOON DID NOT INFLATE DURING VALVE DEPLOYMENT AND THE DECISION WAS MADE TO REMOVE THE DEVICES. THE OUTFLOW PORTION OF THE VALVE INFLATED SLIGHTLY. UPON REMOVAL OF THE DEVICES, THE VALVE WAS EMBEDDED IN THE ILIAC, AND THE VASCULAR SURGEON HAD TO PERFORM A CUTDOWN. THE PROCEDURE WAS ABORTED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 13944956 ↗
• MalfunctionNov 22, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING DEPLOYMENT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE PULMONIC POSITION INSIDE A CONDUIT, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED. THE VALVE WAS SUCCESSFULLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857906 ↗
• InjuryOct 22, 2021Burst Container or Vessel; Physical Resistance/Sticking; Burst Container or Vessel; Physical Resistance/Sticking

  AS REPORTED BY FILED CLINICIAN SPECIALIST, A 25MM SURGICAL VALVE FAILED DUE TO PULMONIC INSUFFICIENCY. A 26MM BALLOON WAS TAKEN UP AND BVF WAS PERFORMED. THE 26MM SAPIEN 3 (S3) VALVE WAS PREPPED +1CC AND ADVANCED WITHOUT DIFFICULTY. THE VALVE WAS DEPLOYED IN GOOD POSITION. IN THE PROCESS OF TRYING TO PULL THE DELIVERY SYSTEM BALLOON BACK OUT OF THE VALVE IT WAS NOTED THAT THE OUTFLOW OF THE S3 FRAME WAS BENDING INWARD DUE TO BEING CAUGHT ON THE DELIVERY BALLOON. THE SYSTEM WAS READVANCED DISTALLY, ROTATED, AND TRIED TO REMOVE AGAIN UNSUCCESSFULLY. THE DECISION WAS MADE TO REINFLATE THE DELIVERY BALLOON, UNFORTUNATELY THE BALLOON RUPTURED DUE TO MAKING CONTACT TO THE POINT OF THE S3 OUTFLOW FRAME. THE DELIVERY SYSTEM WAS TRIED TO BE REMOVED AGAIN BUT IT WAS STILL STUCK. A SECOND SITE OF VENOUS ACCESS WAS OBTAINED IN THE LFV TO ADVANCE A SECOND BALLOON TO HELP FREE THE DELIVERY SYSTEM FROM THE VALVE. THE BALLOON WAS ADVANCED ACROSS THE S3 AND INFLATED MULTIPLE TIMES BEFORE THE COMMANDER DELIVERY SYSTEM COULD BE REMOVED LEAVING THE S3 OUTFLOW FRAME BENT STILL. THE DELIVERY SYSTEM WOULD NOT COME COMPLETELY BACK INTO THE SHEATH. THE NOSE CONE WAS STILL OUTSIDE OF THE SHEATH. THE DELIVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685031 ↗
• InjurySep 16, 2021Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  DURING DEPLOYMENT OF A 26 MM SAPIEN VALVE IN THE PULMONIC POSITION IN THE SURGICAL VALVE VIA TRANSFEMORAL APPROACH, THE BALLOON RUPTURED. THE BALLOON TELESCOPED ONTO ITSELF AND THE DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE DRY SEAL SHEATH. RIGHT JUGULAR ACCESS WAS OBTAINED AND A 25MM SNARE WAS ADVANCED THROUGH AN 18FR SHEATH. THE BALLOON WAS SNARED. IN AN ATTEMPT TO PULL AND ADVANCE THE BALLOON INTO THE 18FR SHEATH THE DISTAL END OF THE BALLOON FRACTURED. THE DELIVERY SYSTEM WAS REMOVED FROM THE RIGHT FEMORAL VEIN ACCESS. AND THE DISTAL/FRACTURED PORTION OF THE BALLOON WAS REMOVED FROM THE RIGHT JUGULAR VEIN ALONG WITH THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484895 ↗
• DeathApr 16, 2021Material Rupture; Material Rupture

  AS REPORTED BY AN EDWARDS FIELD CLINICAL SPECIALIST, REGARDING A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE 26MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED WHILE DEPLOYING THE VALVE WHEN IT WAS FULLY INFLATED WITH NOMINAL VOLUME, THE RIGHT CORONARY SINUS ALSO RUPTURED. THE PATIENT WAS OPENED TO IDENTIFY THE RUPTURE AND APPLY A PATCH. THE 26MM SAPIEN 3 VALVE WAS REMOVED AND A SURGICAL VALVE WAS IMPLANTED. THE PATIENT DID NOT SURVIVE THE PROCEDURE.

  Patient problems: Rupture

  MAUDE report 11679048 ↗
• MalfunctionMar 23, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  AS REPORTED, DURING A PULMONIC VALVE REPLACEMENT VIA THE JUGULAR APPROACH, DIFFICULTIES WERE ENCOUNTERED DURING THE ADVANCEMENT OF THE 26MM SAPIEN 3 VALVE AND COMMANDER DELIVERY SYSTEM DUE TO THE PATIENT ANATOMY. FOLLOWING MANIPULATION OF THE DELIVERY SYSTEM, THE VALVE WAS POSITIONED IN THE PULMONARY ARTERY. DURING VALVE DEPLOYMENT, THE DELIVERY SYSTEM BALLOON WOULD NOT INFLATE. THE INFLATOR/DEFLATOR WAS TURNED MULTIPLE TIMES WHILE THE PLUNGE WAS PUSHED. THE BALLOON WAS FINALLY ABLE TO BE INFLATED AND THE VALVE WAS DEPLOYED. FOLLOWING VALVE DEPLOYMENT, THE INFLATOR/DEFLATOR WAS NOT ABLE TO BE DEFLATED. THE DELIVERY SYSTEM HANDLE WAS TURNED AND ROTATED COUNTERCLOCKWISE MULTIPLE TIMES. THE BALLOON WAS ABLE TO BE DEFLATED ENOUGH TO REMOVE IT FROM THE VALVE. DEFLATION OF THE BALLOON CONTINUED UNTIL THE DELIVERY SYSTEM WAS ABLE TO BE PULLED BACK INTO THE SHEATH AND REMOVED FROM THE PATIENT. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. ON POSTOPERATIVE DAY (POD) 1, AN INCREASE IN TRICUSPID REGURGITATION WAS REPORTED. PER MEDICAL OPINION, THIS MAY BE DUE TO THE MANIPULATION OF THE DEVICES DURING THE PULMONIC PROCEDURE. NO ACTIONS WERE REPORTED. THE VALVE REMAINS IMPLANTED IN THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554411 ↗
• MalfunctionMar 11, 2021Material Rupture; Material Rupture

  AS REPORTED BY EDWARDS FIELD CLINICAL SPECIALIST, DURING DEPLOYMENT OF A 26MM SAPIEN 3 VALVE IN A PRE EXISTING NON EDWARDS SURGICAL VALVE IN THE TRICUSPID POSITION, THE 26MM COMMANDER DELIVERY SYSTEM BALLOON RUPTURED, AND THE VALVE WAS NOT DEPLOYED. UPON REMOVING THE DELIVERY SYSTEM AND VALVE FROM THE BODY YOU COULD SEE THE STENT STRUTS (FROM PRE EXISTING VALVE) HAD PUNCTURED THE BALLOON. THE SHEATH, DELIVERY SYSTEM AND VALVE WERE REMOVED FROM THE BODY. A 24FR NON EDWARDS SHEATH WAS INSERTED, A SECOND 26MM SAPIEN 3 VALVE AND 26 MM COMMANDER DELIVERY SYSTEM WAS PREPPED AND DELIVERED SUCCESSFULLY. PATIENT WAS REPORTED AS 'DOING VERY WELL'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463560 ↗
• InjuryFeb 9, 2021Material Separation; Material Separation

  DURING A TRANSFEMORAL TAVR PROCEDURE, A 26MM SAPIEN 3 VALVE WAS DEPLOYED IN THE AORTIC ANNULUS. POST DEPLOYMENT, MODERATE PARAVALVULAR LEAK (PVL) WAS OBSERVED. THE VALVE WAS POST DILATED WITH AN ADDITIONAL 2CC OF FLUID, REDUCING THE PVL TO NONE-TRACE. SATISFIED WITH THE VALVE DEPLOYMENT, THE COMMANDER DELIVERY SYSTEM WAS WITHDRAWN. DURING WITHDRAWAL, THE DELIVERY SYSTEM BECAME STUCK IN THE ESHEATH JUST BELOW THE SKIN. ADDITIONAL FORCE WAS USED DURING THE ATTEMPT TO WITHDRAWAL THE DELIVERY SYSTEM, RESULTING IN THE SEPARATION OF THE BALLOON/NOSE CONE/HYPOTUBE. THE DELIVERY SYSTEM AND SEPARATED BALLOON/NOSE CONE REMAINED FULLY CONTAINED INSIDE THE SHEATH. THE ESHEATH, DELIVERY SYSTEM AND SEPARATED BALLOON/NOSE CONE WERE REMOVED AS A UNIT. FOLLOWING THE WITHDRAWAL OF THE DEVICES, A LINER DISSECTION WAS NOTED IN THE PROXIMAL FEMORAL ARTERY. A BALLOON WAS INFLATED TO RESOLVE THE DISSECTION. THE VALVE REMAINS IMPLANTED IN THE PATIENT. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 11301718 ↗
• InjuryApr 18, 2018Material Rupture; Torn Material

  FEMORAL TAVR CASE. PT NEEDED A SECOND VALVE PLACED, SO A SECOND VALVE AND DELIVERY SYSTEM WERE OPENED. UPON REMOVAL OF FEMORAL DELIVERY SYSTEM BALLOON RUPTURED AND FEMORAL SHEATH TORN. UNABLE TO SAFELY REMOVE SHEATH WITHOUT PERFORMING FEMORAL CUT DOWN. FEMORAL CUT DOWN PERFORMED AND SHEATH REMOVED.

  Patient problems: Tissue Damage

  MAUDE report 7457910 ↗
• InjuryApr 12, 2018Material Rupture; Torn Material

  FEMORAL TAVR CASE. PT NEEDED SECOND VALVE PLACED, SO SECOND VALVE AND DELIVERY SYSTEM WERE OPENED. UPON REMOVAL OF FEMORAL DELIVERY SYSTEM BALLOON RUPTURED AND FEMORAL SHEATH TORN. UNABLE TO SAFELY REMOVE SHEATH WITHOUT PERFORMING FEMORAL CUT DOWN. FEMORAL CUT DOWN PERFORMED AND SHEATH REMOVED.

  Patient problems: No Information

  MAUDE report 7428563 ↗
• MalfunctionMay 22, 2017Inflation Problem; Material Rupture

  DURING POST-PLACEMENT DILATION OF TRANSCATHETER AORTIC VALVE REPLACEMENT, THE TAVR DEPLOYMENT SYSTEM BALLOON WAS OVERINFLATED TO IMPROVE EXPANSION OF THE HEART VALVE AND THE BALLOON RUPTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6587300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031, P200015. One submission often covers many models, so check the product and lot details in each record.

• Z-2435-2018 · Jun 11, 2018 · Terminated
  Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Z-0293-2018 · Jul 21, 2017 · Terminated
  Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delive