Cardica PAS-Port Proximal Anastomosis System FG-000001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 11814900000017), received between Feb 14, 2019 and May 15, 2020 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathMay 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT AN OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) DUE TO TRIPLE VESSEL CORONARY ARTERY DISEASE. AS PART OF THE PROCEDURE, THE SURGEON USED THE PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (CLIP) WITH A SAPHENOUS VEIN GRAFT TO COMPLETE THE PROXIMAL ANASTOMOSIS OF A CORONARY ARTERY BYPASS. FOLLOWING DEPLOYMENT OF THE CLIP, THE SURGEON NOTED THE CLIP HAD PENETRATED THROUGH THE ANTERIOR WALL OF THE AORTA WHERE IT SHOULD HAVE BEEN AFFIXED, BUT RATHER WAS AFFIXED TO THE POSTERIOR WALL OF THE AORTA. BLEEDING WAS SEEN AT THE POSTERIOR WALL OF THE ASCENDING AORTA. THE SURGICAL STAFF MANUALLY STOPPED THE BLEEDING AND PLACED THE PATIENT ON CARDIOPULMONARY BYPASS TO REMOVE THE CLIP, REPAIR THE SITE OF BLEEDING, AND COMPLETE THE CORONARY ARTERY BYPASS SURGERY. SUBSEQUENTLY, BLEEDING WAS AGAIN NOTED FROM THE POSTERIOR WALL OF THE AORTA AND REQUIRED FURTHER REPAIR. THE PATIENT'S CONDITION BECAME UNSTABLE REQUIRING AN INTRA-AORTIC BALLOON PUMP AND PERCUTANEOUS CARDIOPULMONARY SUPPORT PRIOR TO COMPLETION OF THE SURGERY. ON (B)(6) 2020, THE PATIENT UNDERWENT FURTHER CHEST SURGERY FOR INCREASED BLEEDING FROM A SITE ASSOCIATED WITH USE OF A TEMPORARY PACEMAKER. NO BLEEDING WAS NOTED AT THE PREV

  Patient problems: Blood Loss; Death; Great Vessel Perforation; Left Ventricular Dysfunction; Multiple Organ Dysfunction Syndrome; Right Ventricular Dysfunction; Shock, Postoperative

  MAUDE report 10063511 ↗
• InjuryMar 3, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING AN OFF-PUMP CORONARY ARTERY BYPASS. FOLLOWING DEPLOYMENT OF THE IMPLANT TO THE AORTA, THE SURGEON TRIED TO REMOVE THE DELIVERY DEVICE BUT FOUND IT WAS DIFFICULT TO REMOVE. THE SURGEON "STRONGLY PULLED THE DEVICE," WHICH CAUSED SEPARATION OF THE ANATOMOSIS BETWEEN THE AORTA AND THE SAPHENOUS VEIN GRAFT (SVG) WHICH HAD BEEN FORMED BY USE OF THE IMPLANT. THE SURGEON THEN COMPLETED THE BYPASS BY SUTURING THE SAME SVG AT AN ALTERNATE AORTIC LOCATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Blood Loss

  MAUDE report 9781250 ↗
• InjuryJul 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS UNDERGOING AN ON-PUMP BEATING HEART CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THE SURGEON ELECTED TO USE THE PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM TO ANASTOMOSE THE PROXIMAL PORTION OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE AORTA. AS REPORTED, THE CONDITION OF THE AORTA WAS "NOT GOOD". AFTER DEPLOYING THE PAS-PORT CLIP, THE SURGEON LIFTED THE DEPLOYMENT PORTION OF THE DEVICE WHILE HOLDING THE CLIP/SVG WITH FORCEPS. THE CLIP DISLODGED FROM THE ANASTOMOSIS SITE, WHICH REQUIRED THAT THE SURGEON REPAIR THE AORTIC ANASTOMOSIS SITE. THE SURGEON COMPLETED THE CABG PROCEDURE. FOLLOWING SURGERY, IT WAS REPORTED THAT THE PATIENT WAS INITIALLY UNCONSCIOUS. THE CAUSE WAS NOT REPORTED BUT A CEREBRAL INFARCTION WAS RULED OUT. THE PATIENT SUBSEQUENTLY REGAINED CONSCIOUSNESS AND IMPROVED SUCH THAT THE PATIENT IS TOLERATING FOOD CONSUMPTION.

  Patient problems: Loss of consciousness

  MAUDE report 8786235 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OFF-PUMP CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, A PAS-PORT DEVICE WAS USED. THE SURGEON DEPLOYED THE IMPLANT AND THE ANASTOMOSIS WAS SUCCESSFULLY CREATED. FOLLOWING IMPLANTATION, TWO SEVERE LEAKAGES WERE NOTED AT THE IMPLANT SITE. THE SURGEON CLAMPED THE AORTA AND REMOVED THE IMPLANT. THE SURGICAL PROCEDURE WAS CONVERTED TO AN ON-PUMP CABG. AN ENCLOSE II PROXIMAL ANASTOMOSIS ASSIST DEVICE (VITALITEC INTERNATIONAL, INC.) WAS LATER USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Blood Loss

  MAUDE report 8356450 ↗
• InjuryFeb 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE'S CLIP WAS USED TO CREATE THE PROXIMAL ANASTOMOSIS OF A BYPASS GRAFT DURING OPEN CARDIAC BYPASS SURGERY. APPROXIMATELY TWO HOURS AFTER CREATING THE ANASTOMOSIS AND PRIOR TO COMPLETION OF THE SURGERY, THE GRAFT DISLODGED FROM THE AORTA. WHILE USING A PUMP-OXYGENATOR, THE SURGEON REMOVED THE CLIP FROM THE GRAFT AND SUTURED THE GRAFT TO ANOTHER LOCATION. THE PROCEDURE WAS COMPLETED.

  Patient problems: Failure to Anastomose

  MAUDE report 8341327 ↗