Edwards Certitude Delivery SystemRecalls & reported problems across all models

We found 7 models of Edwards Certitude Delivery System by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2021 and Jun 17, 2026 — classified as 1 death, 18 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Edwards Certitude Delivery System problems

Edwards Certitude Delivery System models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  9 reports
• EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS29

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 death9 reports
• Edwards Certitude Delivery System 9630TA26

  Prosthesis, Mitral Valve, Percutaneously Delivered
  9 reports
• Edwards Certitude Delivery System 9630TA23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  5 reports
• Edwards Certitude Delivery System 9630TA29

  Prosthesis, Mitral Valve, Percutaneously Delivered
  4 reports
• EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS23

  Prosthesis, Mitral Valve, Percutaneously Delivered
  3 reports
• Edwards Certitude Delivery System 9630TA20

  Prosthesis, Mitral Valve, Percutaneously Delivered
  1 report

Recent Edwards Certitude Delivery System adverse event reports

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

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY IMPLANT PATIENT REGISTRY, THE PATIENT EXPIRED ON THE NIGHT OF THE OPEN VALVE-IN-MAC (MITRAL ANNULAR CALCIFICATION) PROCEDURE USING A 29 MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT ENDED UP HAVING A BLEED IN THE OPERATING ROOM THAT IMPLANTER ATTRIBUTED TO A LEFT VENTRICLE (LV) PERFORATION FROM THE WIRE. THE IMPLANTER FIXED THE PERFORATION, AND THE PATIENT WAS STABLE GOING UPSTAIRS AND LATER IN THE EVENING THE PATIENT'S CONDITION DETERIORATED RAPIDLY LEADING TO THEM OPENING THE CHEST AGAIN. ACCORDING TO THE IMPLANTER THERE WAS BRUISING ON THE HEART AND MORE BLEEDING THAT HE SUSPECTED WAS FROM BALLOONING/EXPANDING THE VALVE IN THE MITRAL CALCIUM. THEY WERE UNABLE TO STOP THE BLEEDING AND THE PATIENT EXPIRED. FOLLOW-UP INFORMATION FROM THE FIELD CLINICAL SPECIALIST (FCS) INDICATED THAT THE DELIVERY SYSTEM REMAINED OVER THE GUIDEWIRE AND WAS UTILIZED TO STABILIZE THE BALLOON, WITH THE INTENT OF PREVENTING THE NOSE CONE OF THE CERTITUDE SYSTEM FROM CONTACTING THE VENTRICULAR WALL. DESPITE THESE PRECAUTIONS, IT WAS REPORTED THAT THE GUIDEWIRE MAY HAVE RESULTED IN VENTRICULAR INJURY.

  Patient problems: Cardiac Perforation

  MAUDE report 25539681 ↗
• MalfunctionMay 21, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A LEFT TRANSAPICAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA VALVE, THE BALLOON ON THE 26MM CERTITUDE DELIVERY SYSTEM RUPTURED AT THE END OF VALVE DEPLOYMENT, BLOOD WAS SEEN IN THE SYRINGE. THE VALVE WAS FULLY DEPLOYED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242877 ↗
• MalfunctionMay 18, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A DEVICE-RELATED EVENT OCCURRED DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE INVOLVING A 26 MM SAPIEN 3 ULTRA VALVE DELIVERED VIA A CATHETER-BASED DELIVERY SYSTEM. THE PROCEDURE WAS PERFORMED VIA LEFT CAROTID ACCESS IN A NATIVE TRICUSPID AORTIC VALVE. DURING VALVE DEPLOYMENT, THE DELIVERY SYSTEM BALLOON RUPTURED DURING INFLATION WHEN THE BALLOON WAS FULLY EXPANDED. THE VALVE WAS ABLE TO BE FULLY DEPLOYED, AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. BLOOD WAS OBSERVED IN THE INFLATION SYRINGE AT THE TIME OF THE EVENT. NO LEAKAGE FROM THE DELIVERY SYSTEM WAS OTHERWISE NOTED, AND NO DAMAGE WAS IDENTIFIED TO OTHER EDWARDS DEVICES USED DURING THE PROCEDURE. THERE WAS NO REPORTED DIFFICULTY WITH WITHDRAWAL OF THE DELIVERY SYSTEM. ADDITIONAL PROCEDURAL DETAILS INCLUDE THAT NO PRE-DILATION (BAV) WAS PERFORMED PRIOR TO IMPLANTATION, AND APPROXIMATELY 2 CC OF ADDITIONAL VOLUME WAS ADDED TO THE BALLOON PRIOR TO INFLATION. VALVE ALIGNMENT WAS NOT PERFORMED IN A STRAIGHT SEGMENT OF THE ANATOMY. THE ANNULUS DEMONSTRATED MODERATE CALCIFICATION, INCLUDING CALCIUM EXTENDING FROM THE ANNULUS INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210463 ↗
• MalfunctionApr 16, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A LEFT-SIDE TRANS CAROTID TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE BALLOON TO THE 26MM CERTITUDE DELIVERY SYSTEM (DS) BURST WHILE BEING DEPLOYED. THE DS WAS NOT ABLE TO BE REMOVED THROUGH THE 18FR CERTITUDE SHEATH; THE DS AND SHEATH HAD TO BE REMOVED TOGETHER AS A UNIT. A SECOND AND NEW 18FR CERTITUDE SHEATH WAS THEN INSERTED INTO THE CAROTID ARTERY TO FINISH CLOSING THE ARTERIOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900613 ↗
• MalfunctionMar 26, 2026Burst Container or Vessel; Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT WAS UNDERGOING A TRANSCAROTID VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23 MM SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS BEING IMPLANTED INSIDE A NON-EDWARDS VALVE. DURING THE PROCEDURE, THERE WAS RESISTANCE WHEN ADVANCING THE CERTITUDE DELIVERY SYSTEM WITH VALVE THROUGH THE 21FR CERTITUDE SHEATH, BUT THE DELIVERY SYSTEM WITH VALVE WAS ABLE TO EXIT THE TIP OF THE SHEATH. AFTER EXITING THE TIP OF THE SHEATH, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE STRUTS OF THE NON-EDWARDS VALVE. IT WAS NOTED THAT THE IMPLANTING TEAM WAS BEHIND THE STRUTS OF THE NON-EDWARDS VALVE. THE DELIVERY SYSTEM CROSSED THE STRUTS AT THE MID VALVE PART OF THE VALVE AND WAS ON THE OUTSIDE OF THE NON-EDWARDS VALVE. THE SHEATH WAS PULLED BACK AND THEN THE SHEATH WAS USED TO PROVIDE MORE SUPPORT WHEN IT WAS NOTICED THAT THE TIP OF THE CERTITUDE SHEATH HAD "BROKE OFF". THE TIP OF THE SHEATH WAS NOTED TO BE STUCK AROUND THE SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS NOT DEPLOYED. THE DELIVERY SYSTEM WITH VALVE AND SHEATH WERE REMOVED AS A SINGLE UNIT. A NEW 21FR CERTITUDE SHEATH AND 23 MM CERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703096 ↗
• InjuryNov 10, 2025Difficult to Insert; Difficult to Insert

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, THE 26 MM CERTITUDE DELIVERY SYSTEM AND 26 MM SAPIEN 3 ULTRA RESILIA VALVE WERE INSERTED INTO THE 18FR CERTITUDE SHEATH, BUT THE SYSTEM WOULD NOT ADVANCE THROUGH THE LOADER. THE DELIVERY SYSTEM AND VALVE WERE REMOVED. A SECOND 26 MM CERTITUDE DELIVERY SYSTEM AND 26 MM SAPIEN 3 ULTRA RESILIA VALVE WERE PREPARED. PRIOR TO INSERTING THE SECOND DELIVERY SYSTEM AND VALVE INTO THE CERTITUDE SHEATH, AN ATTEMPT WAS MADE TO ADVANCE THE DELIVERY SYSTEM AND VALVE THROUGH THE LOADER. THE DELIVERY SYSTEM AND VALVE WERE UNABLE TO ADVANCE THROUGH THE LOADER. NO ATTEMPT WAS MADE TO INSERT THE DELIVERY SYSTEM AND VALVE INTO THE CERTITUDE SHEATH. A DECISION WAS MADE TO USE A 26 MM COMMANDER DELIVERY SYSTEM. AT THIS POINT, THE PATIENT REQUIRED BLOOD TRANSFUSIONS DUE TO BLEEDING AROUND THE SHEATH SITE. IT WAS INDICATED THAT THE DIFFICULTY USING THE SAPIEN 3 ULTRA RESILIA VALVE WITH THE CERTITUDE DELIVERY SYSTEM CREATED A DELAY IN PROCEEDING WITH VALVE IMPLANTATION, WHICH ALLOWED FOR EXTRA BLEEDING TIME. A THIRD 26 MM SAPIEN 3 ULTRA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23513681 ↗
• MalfunctionOct 23, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSAORTIC TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE CERTITUDE DELIVERY SYSTEM BALLOON HAD RUPTURED AT THE END OF INFLATION. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO MAJOR VASCULAR COMPLICATIONS. AS PER FOLLOW-UP WITH THE FCS, THIS WAS A DIRECT AORTIC APPROACH WITH EXISTING CUTDOWN. A TWO-STAGE DEPLOYMENT WAS SUGGESTED, BUT THE PHYSICIAN PROCEEDED WITH FULL VOLUME, AND THE VALVE APPEARED FULLY EXPANDED ON FLUOROSCOPY AND ECHOCARDIOGRAPHY. THE VALVE WAS ABLE TO BE FULLY DEPLOYED. NO EXTRA VOLUME WAS ADDED PRIOR TO INFLATION. BLOOD WAS NOT SEEN IN THE SYRINGE, AND VALVE ALIGNMENT WAS PERFORMED WITHOUT DIFFICULTY IN A STRAIGHT SECTION. WITHDRAWAL OF THE DELIVERY SYSTEM WAS CHALLENGING, AND THE SYSTEM COULD NOT BE PULLED BACK INTO THE SHEATH. NO DAMAGE WAS NOTED TO OTHER EDWARDS DEVICES, AND THERE WERE NO PATIENT INJURIES OR COMPLICATIONS. THE PATIENT WAS STABLE AND DISCHARGED. THE PERCEIVED ROOT CAUSE WAS HEAVY STJ CALCIUM. AS PER FOLLOW-UP WITH THE VCC, THE PATIENT DID VERY POORLY POST TAVR AND PASSED AWAY ON POST OP DAY 3. THE PRESUMED CAUSE OF DEATH WAS NOTED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369702 ↗
• InjuryAug 5, 2025Unintended Movement; Unintended Movement

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAORTIC TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE VALVE EMBOLIZED DURING DEPLOYMENT. WHILE ADVANCING THE SAPIEN 3 VALVE THROUGH THE 21FR CERTITUDE SHEATH, THE TEAM NOTED THE VALVE SLIPPED BACK ON THE DELIVERY SYSTEM BALLOON. THE TEAM MADE THE DECISION TO PRECEDE WITH DEPLOYMENT, AND DURING DEPLOYING, THE VALVE SLIPPED BACK FURTHER ON THE BALLOON AND MOVED AORTIC. THE TEAM MADE A FEW ATTEMPTS TO RETRIEVE THE VALVE VIA THE TRANSAORTIC SITE WITHOUT SUCCESS. THEREFORE, THE DECISION WAS MADE TO OPEN THE AORTA AND PERFORM AN AORTIC VALVE REPLACEMENT WITH A 25MM INSPIRIS RESILIA VALVE. THE IMPLANT WAS SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723143 ↗
• InjuryMay 27, 2025Difficult or Delayed Positioning; Difficult to Remove; Device Slipped; Difficult or Delayed Positioning; Difficult to Remove; Device Slipped

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA CAROTID ACCESS, THE 29MM CERTITUDE DELIVERY SYSTEM WAS UNABLE TO CROSS THE HEAVILY CALCIFIED AORTIC VALVE. THE PHYSICIAN TRIED A NON-EDWARDS BAV BALLOON AND A BUDDY BALLOON UNSUCCESSFULLY. AFTER SEVERAL ATTEMPTS TO CROSS THE VALVE, WITH THE VALVE REMOVED, THE TEAM DECIDED TO ABORT THE CASE. THE VALVE WAS THEN UNSUCCESSFUL AT GOING BACK INTO THE CERTITUDE SHEATH AND ON THE WAY OUT, SHREDDED THE CAROTID. THE PATIENT "SUPPOSEDLY HAD MULTIPLE POSITION WEAR AND THE CAROTID TORE IN MULTIPLE PARTS". THE SURGEON HAD TO PLACE A PATCH TO FIX IT. THE PATIENT WAS STABLE POST OP AND EVENTUALLY WAS DISCHARGED HOME. ADDITIONAL INFORMATION NOTED THERE WAS NO DAMAGE OBSERVED ON ANY OF THE DEVICES. THERE WAS NO RETAINED VOLUME IN THE BALLOON CAUSING THE WITHDRAWAL DIFFICULTIES. WHEN THE TEAM TRIED TO PULL BACK THE BALLOON BACK INTO THE SHEATH THE VALVE MOVED OFF OF THE BALLOON AND THEY WEREN'T ABLE TO GET IT FULLY INTO THE SHEATH. THE PATIENT WAS "TREATED WITH MDT".

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 22090118 ↗
• InjuryMay 19, 2025Burst Container or Vessel; Material Fragmentation; Difficult to Remove; Burst Container or Vessel; Material Fragmentation; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSAORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, THE 26 MM CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED ON SINOTUBULAR JUNCTION (STJ) CALCIUM WHEN IT WAS AT FULL INFLATION. THE DELIVERY SYSTEM HAD BEEN NOMINALLY PREPPED. UPON WITHDRAWAL OF THE DELIVERY SYSTEM THROUGH THE SHEATH, THE RUPTURED BALLOON "UMBRELLAED" AROUND THE SHEATH WHICH RESULTED IN DIFFICULTY REMOVING THE DELIVERY SYSTEM. SUBSEQUENTLY, THE DELIVERY SYSTEM AND SHEATH WERE ABLE TO BE REMOVED AS A UNIT. THE BALLOON WAS NOTED TO BE IN SEVERAL PIECES. THE LARGER HOLE MADE IN THE AORTA WAS REPAIRED UPON THE REMOVAL OF ALL THE DEVICES. THE PATIENT TOLERATED THE PROCEDURE WELL. ADDITIONAL INFORMATION WAS PROVIDED REVEALING THE VALVE WAS BELIEVED TO BE FULLY DEPLOYED AND AS A RESULT, A POST-DILATION WAS NOT PERFORMED. ALTHOUGH THE BALLOON WAS NOTED TO BE IN SEVERAL PIECES, IT APPEARED THAT ALL THE PIECES WERE ABLE TO BE RETRIEVED. THE PATIENT WAS STABLE DURING THE TAVR PROCEDURE. IN REGARD TO THE INJURY DUE TO WITHDRAWAL DIFFICULTY WITH BURST BALLOON, IT WAS REPAIRED WITH SUTURES.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 22045084 ↗
• MalfunctionMay 5, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSAORTIC APPROACH, THE 23 MM CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED WITH A LONGITUDINAL TEAR AT THE END OF DEPLOYMENT. A 23 MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY IMPLANTED. THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. CAUSE WAS UNKNOWN. THE DELIVERY SYSTEM WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965181 ↗
• MalfunctionMar 17, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSCAROTID TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING DEPLOYMENT. THE VALVE WAS SUCCESSFULLY DEPLOYED. THE SHEATH AND CERTITUDE DELIVERY SYSTEM WERE REMOVED. PATIENT IS CURRENTLY IN RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617829 ↗
• InjuryFeb 21, 2025Burst Container or Vessel; Difficult to Remove; Material Separation; Burst Container or Vessel; Difficult to Remove; Material Separation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING AN INNOMINATE ARTERY TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED TOWARDS THE END OF DEPLOYMENT. PER TEE, THE VALVE WAS WELL DEPLOYED WITH NO LEAKAGE, SO THE TEAM ATTEMPTED TO BRING THE DELIVERY SYSTEM BACK INTO THE SHEATH, HOWEVER RESISTANCE WAS MET. AFTER MULTIPLE MANEUVERS, THE FRONT NOSE CONE AND DISTAL PORTION OF THE BALLOON BECAME DETACHED FROM THE REST OF THE DELIVERY SYSTEM. THE TEAM ELECTED TO TRY TO SNARE THE REMAINING PART OF THE SYSTEM WHILE ON THE WIRE, BUT WAS UNABLE TO AFTER MULTIPLE ATTEMPTS. SO THE TEAM ELECTED TO ATTEMPT SNARING THE REMAINING PARTS OF THE SYSTEM VIA FEMORAL ACCESS WITH A 22FR DRYSEAL. THIS ATTEMPT WAS SUCCESSFUL. ANGIOS AND TEE WERE PERFORMED, AND THE TEAM FELT THEY DIDN'T SEE ANY INJURY TO THE PATIENT. THE PATIENT WAS TRANSFUSED DUE TO BLOOD LOSS. PER REPORT, THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435675 ↗
• InjuryJan 30, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSCAROTID APPROACH, A NATIVE BASILICA OF THE LEFT LEAFLET WAS PERFORMED WITH EFFACED SINUSES. THE RIGHT CORONARY WAS ALSO WIRED BECAUSE OF POTENTIAL RISK OF CORONARY OCCLUSION WITH AN EFFACED SINUS. BASILICA, CAROTID ACCESS, CORONARY ACCESS, CERTITUDE SHEATH PLACEMENT AND VALVE DEPLOYMENT WERE ALL ACHIEVED WITH SUCCESS. POST VALVE DEPLOYMENT ON TRANSESOPHAGEAL ECHO, THERE WAS TRIVIAL LEAK BELOW THE LEFT CUSP. ON ANGIOGRAM, THE LEAK WAS MUCH WORSE, AND THE DECISION WAS MADE TO POST DILATE WITH 1 ADDITIONAL CC OF VOLUME. WHEN THIS WAS PERFORMED, THE CERTITUDE BALLOON RUPTURED CIRCUMFERENTIALLY. UPON TRYING TO REMOVE THE BALLOON THROUGH THE CERTITUDE SHEATH, THE FLANGES GOT CAUGHT ON AND WOULD NOT ALLOW THE DELIVERY SYSTEM TO BE REMOVED. THE SURGEON REMOVED THE SHEATH WITH THE BALLOON FLANGES FLARED WHICH DISSECTED THE LEFT CAROTID ARTERY. THE PROCEDURE TURNED INTO A VASCULAR REPAIR WITH A GRAFT ADDED TO THE LEFT CAROTID ARTERY. THE PATIENT LEFT THE TABLE ALIVE AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 21275887 ↗
• InjuryJan 17, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PER REPORT, A VASCULAR SURGEON WAS CALLED TO PATCH A DISSECTION AT THE ACCESS SITE. THE PATIENT REMAINED STABLE.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 21183170 ↗

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