Graftmaster 1012581-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 08717648176401), received between Aug 1, 2016 and Aug 10, 2026 — classified as 12 deaths, 109 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (41 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193057 ↗
• InjuryJun 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT OCCURRED AFTER STENTING WITH A NON-ABBOTT 3.5X26 MM DRUG ELUTING STENT. A NON-ABBOTT STENT WAS DEPLOYED AND SERIAL POST DILATATION WAS PERFORMED BUT THERE WAS CONTINUED BLEEDING. THE PATIENT BEGAN EXPERIENCING HYPOTENSION DESPITE FLUID BOLUSES. NOREPINEPHRINE WAS PROVIDED AND PERICARDIOCENTESIS WAS PERFORMED WITH ECHOCARDIOGRAPHY CONFIRMING A RAPIDLY DEPLOYING EFFUSION WITH RIGHT VENTRICLE COLLAPSE CONSISTENT WITH CARDIAC TAMPONADE. BEFORE PLACEMENT OF THE PERICARDIAL DRAIN, AN AGITATED SALINE STUDY WAS PERFORMED CONFIRMING LOCATION AND THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES. THIS STENT DID NOT SEAL THE PERFORATION SO A 4.0X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES OVERLAPPING THE FIRST GRAFTMASTER. DESPITE MULTIPLE INFLATIONS THE BLEEDING CONTINUED AND INFLATION WAS PERFORMED WITH A 4.0 MM NC NON-ABBOTT BALLOON FOR 30 SECOND EPISODES. THERE WERE TWO EPISODES OF POLYMORPHIC VENTRICULAR TACHYCARDIA AND ELECTRICAL CARDIOVERSION WAS PERFORMED. THE PATIENT WAS STRUGGLING WITH DYSPNEA, DISCOMFORT AND NAUSEA. AFTER R

  Patient problems: Dyspnea; Nausea; Pain; Tachycardia

  MAUDE report 25627337 ↗
• InjurySep 24, 2025Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). A 3.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 20 ATMOSPHERES (ATM) AND THE PERFORATION APPEARED SEALED POST STENT PLACEMENT. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) AND THEY WENT INTO FULL ARREST SO THE PATIENT WAS BROUGHT BACK TO THE CATH LAB TO RE-EVALUATE THE PERFORATION. BLUSHING WAS SEEN SO AN IMPELLA PUMP WAS PLACED AND THE 4.0X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 17 ATM. THE 4.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATM. REPORTEDLY, THE PERFORATION APPEARED SEALED POST STENT PLACEMENT; HOWEVER, THE PATIENT ULTIMATELY EXPIRED DUE TO UNSPECIFIED COMPLICATIONS. THE GRAFTMASTER DEVICES REPORTEDLY DID NOT CAUSE OR CONTRIBUTE TO ADVERSE EVENTS OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137750 ↗
• InjuryAug 14, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.50X16MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO COVER A PERFORATION HOWEVER FAILED TO CROSS THE LESION. A 3.50X19MM AND 2.80X26MM RX GRAFTMASTER ALSO FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING A 4.0X16MM GRAFTMASTER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803553 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 12 ATMOSPHERES AND SEALED THE PERFORATION; HOWEVER, A CLOT BURDEN WAS NOTED. A MANUAL THROMBECTOMY CATHETER WAS USED TO OPEN THE STENT FROM THE CLOT BURDEN. A 4.0X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 12 ATMOSPHERES AND SEALED THE PERFORATION. THE 4.0X16 MM GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE TO ADVERSE EVENTS OR COMPLICATIONS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22118418 ↗
• InjuryFeb 11, 2025Difficult or Delayed Positioning; Patient-Device Incompatibility; Difficult or Delayed Positioning; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, WHICH OCCURRED POST ANGIOPLASTY AND CORONARY LITHOTRIPSY. THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATM) HOWEVER THE PERFORATION WAS NOT SEALED. THE 3.5X26 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATM HOWEVER THERE WAS STILL EXTRAVASATION AND THE PATIENT DECOMPENSATED, WENT INTO SHOCK AND ULTIMATELY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock

  MAUDE report 21358270 ↗
• InjuryJan 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE RIGHT CORONARY ARTERY. A 3.5X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED AND SEALED THE DISTAL AREA OF THE PERFORATION; HOWEVER, STILL LEAKED. ANOTHER 4.0X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED AND SEALED THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211063 ↗
• InjuryAug 5, 2024Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE CIRCUMFLEX ARTERY. A 3.5X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 19 ATMOSPHERES (ATMS), BUT THE PERFORATION WAS NOT SEALED AS IT WAS NOTED THE STENT DEPLOYED PROXIMAL TO THE PERFORATION. A SECOND 3.5X26MM GRAFTMASTER WAS DEPLOYED AT 19 ATMS AND SEALED THE PERFORATION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907046 ↗
• InjuryJun 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND CHANGES IN AN ELECTROCARDIOGRAM (EKG); THEREFORE, THE STENTING WAS PERFORMED AND A PERFORATION WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATM); HOWEVER, THERE WAS NO CHANGE IN PERFORATION OR DEGREE OF CONTRAST EXTRAVASATION DESPITE 1:1 SIZING. BALLOON TAMPONADE WAS PERFORMED; HOWEVER, THE PERFORATION WAS STILL NOT RESOLVED. THE PATIENT WAS EXPERIENCING ATRIAL FIBRILLATION AND CPR WAS PERFORMED. TWO MORE COVERED STENTS WERE IMPLANTED FOLLOWED BY ADDITIONAL BALLOONING TO RESOLVE THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Cardiac Tamponade

  MAUDE report 19516628 ↗
• InjuryMay 30, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE CIRCUMFLEX CORONARY ARTERY. THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 18 ATMOSPHERES AND SEALED THE PERFORATION; HOWEVER, THE STENT WAS TOO LONG FOR THE AREA AND CAUSED LOSS OF THE SIDE BRANCH AT THE RAMUS ARTERY. THE VESSEL WAS RE-OPENED WITH KISSING BALLOONS. ECHO WAS PERFORMED AND SLIGHT PERICARDIAL EFFUSION WAS NOTED SO THE PATIENT WAS TRANSFERRED AND MONITORED. THERE WERE NO OTHER PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pericardial Effusion

  MAUDE report 19428154 ↗
• InjuryMar 29, 2024Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT MAIN TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE 4.0X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED IN THE OSTIAL LAD, A 3.5X19 MM GRAFTMASTER WAS IMPLANTED IN THE LEFT MAIN CORONARY ARTERY AND A 2.8X19 MM GRAFTMASTER WAS IMPLANTED IN THE PROXIMAL LAD. REPORTEDLY, THE DEVICES WERE IMPLANTED WITHOUT ISSUE BUT THE PERFORATION WAS NOT SEALED. THE PATIENT DEVELOPED MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND THE PATIENT WAS SHOCKED AND MEDICATION GIVEN. HOWEVER, THE PATIENT REPORTEDLY EXPIRED DUE TO VENTRICULAR FIBRILLATION AND UNCONTROLLED PERFORATION. IN THE PHYSICIAN'S OPINION, THE PATIENTS HEALTH WAS DECLINING TOWARDS DEATH PRIOR TO USE OF THE GRAFTMASTER DEVICES AND THE GRAFTMASTER DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. ALTHOUGH REQUESTED, VERY FEW DETAILS WERE RECEIVED; THEREFORE, THE RELATIONSHIP, IF ANY, OF THE GRAFTMASTER DEVICES TO THE REPORTED PATIENT EFFECTS ARE UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 19007988 ↗
• InjuryMar 18, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.50X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION DUE TO THE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED WITH MULTIPLE BALLOON INFLATIONS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921421 ↗
• InjuryFeb 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. ROTATIONAL ATHERECTOMY WAS PERFORMED IN THE MID LAD. A 6FRENCH (F) GUIDE CATHETER WAS ADVANCED VIA THE RADIAL SHEATH. A WHISPER GUIDE WIRE ADVANCED INTO THE LARGE DIAGONAL. A 2.0X12MM OVER-THE-WIRE (OTW) BALLOON WAS ADVANCED OVER THE ROTATIONAL ATHERECTOMY WIRE AND USED TO EXCHANGE FOR A LONG WHISPER WIRE. FLOW INTO THE DIAGONAL WAS COMPROMISED AND ATTEMPTED TO WIRE THE DIAGONAL USING A WHISPER WIRE WITHOUT SUCCESS DUE TO THE ANATOMY. EVENTUALLY RESULTED IN A PERFORATION. A 2.5X38MM NON-ABBOTT STENT WAS IMPLANTED BUT PERFORATION PERSISTED. THE 3.0X26MM NON-ABBOTT STENT WAS IMPLANTED BUT DESPITE EFFORTS AT BALLOON TAMPONADE PERFORATION PERSISTED. THE FIRST 2.8X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT COULD NOT BE DELIVERED DISTALLY DUE TO VESSEL TORTUOSITY AND RIGID NATURE OF THE COVERED STENT. MULTIPLE BALLOON INFLATIONS WERE PERFORMED HOPING TO OBTAIN ADEQUATE HEMOSTASIS WITHOUT SUCCESS. UNCLEAR IF THERE WAS A LEAK IN THE INITIAL STENT. A SECOND 2.8X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT THE MID PORTION BUT ATTEMPTED TO IMPLANT DISTALLY BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748055 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  SUBSEQUENT TO THE INITIALLY FILED MDR REPORT. INFORMATION WAS RECEIVED, INDICATING THAT THE GRAFTMASTER WAS IMPLANTED WITHOUT ISSUE TO SEAL A PERFORATION IN THE SAPHENOUS VEIN GRAFT (SVG). THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. ALTHOUGH THE GRAFTMASTER STENT DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION, THIS EVENT HAS BEEN REPORTED; THEREFORE, IT WILL REMAIN REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 18732016 ↗
• InjuryJan 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE RIGHT CORONARY ARTERY (RCA). BALLOON TAMPONADE WAS PERFORMED USING A 4.0X12 NON-COMPLIANT BALLOON FOR 10 MINUTES AND IMPROVED THE APPEARANCE BUT BLEEDING DUE TO THE PERFORATION CONTINUED. THE 3.5X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED OVERLAPPING ANOTHER 4.0X19MM GRAFTMASTER COVERED STENT DUE TO A LARGE PERFORATION AND ONE COVERED STENT WAS NOT LONG ENOUGH TO FULLY SEAL THE PERFORATION. HOWEVER, THERE WAS STILL ONGOING BLEEDING FROM THE PERFORATION SO AN ADDITIONAL GRAFTMASTER COVERED STENT, 4.0X19MM, WAS IMPLANTED IN THE MIDDLE. THE COVERED STENTS WERE ABLE TO SEAL THE PERFORATION. THE USE OF THE GRAFTMASTER DID NOT CAUSE ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485595 ↗
• InjuryJan 5, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE A PERFORATION OCCURRED AFTER A NON-ABBOTT STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (MRCA). AN ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH THREE GRAFTMASTER COVERED STENTS (3.5X19MM, 2.8X19MM AND 2.8X16MM) BUT THEY FAILED TO CROSS DUE TO PROXIMAL CALCIFICATION. A NON-ABBOTT BALLOON FOLLOWED BY IMPLANTATION OF A NON-ABBOTT STENT WAS USED TO TREAT THE PERFORATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455759 ↗
• InjuryDec 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT TWO 2.8X16MM AND 3.5X19MM GRAFTMASTER COVERED STENTS FAILED TO SEAL THE PERFORATION. IT WAS NOTED THAT THE FIRST GRAFTMASTER USED WAS THOUGHT TO HAVE SEALED THE PERFORATION; HOWEVER, LATER DURING THE PROCEDURE THE PERFORATION WAS NOTED AND THE SECOND GRAFTMASTER FAILED TO SEAL. THE PATIENT HAD TO BE TRANSFERRED TO A DIFFERENT HOSPITAL WHERE IT IS BELIEVED A THIRD GRAFTMASTER WAS USED TO SEAL THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257147 ↗
• InjuryAug 10, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE RIGHT CORONARY ARTERY. THE 3.5X16MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. A 2.8X19MM GRAFTMASTER WAS ADVANCED AND DEPLOYED SUCCESSFULLY; HOWEVER, THE PERFORATION WAS LARGER THAN EXPECTED. A 2.8X16MM GRAFTMASTER COVERED STENT WAS ADVANCED TO THE PERFORATION; HOWEVER, DURING INFLATION THE DEVICE WOULD NOT INFLATE EVEN AT 20 ATMOSPHERES. IT WAS NOTED THE GRAFTMASTER MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT. THEREFORE, AN ADDITIONAL GRAFTMASTERS 3.5X19MM WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. A 2.8X16MM GRAFTMASTER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND SEAL THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502048 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRE-DILATATION WAS PERFORMED USING A 3.0X20MM TREK BALLOON AT 8 ATMOSPHERES (ATMS) FOR 20 SECONDS. NEXT, A 3.5X28MM XIENCE SKYPOINT STENT WAS DEPLOYED IN THE PROXIMAL TO MID LAD AT 14 ATMS FOR 30 SECONDS, HOWEVER, THE DISTAL THIRD OF THE STENT APPEARED SLIGHTLY UNDER-EXPANDED RELATED TO CALCIFIC DISEASE. A 4.0X20MM NON-COMPLIANT TREK BALLOON WAS USED FOR POST DILATATION OF THE DISTAL THIRD OF THE XIENCE SKYPOINT STENT AT 12 ATMS FOR 20 SECONDS AND THE PROXIMAL PORTION AT 16 ATMS FOR 20 SECONDS. THE PATIENT THEN HAD A PULSELESS ELECTRICAL ACTIVITY CARDIAC ARREST WITH A SUDDEN DROP IN BLOOD PRESSURE. PATIENT BECAME UNCONSCIOUS. ANGIOGRAPHY SHOWED A LARGE FREE-FLOWING PERFORATION EXTENDING FROM THE DISTAL THIRD OF THE STENT INTO THE PERICARDIUM. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED AND DOSES OF INTRAVENOUS EPINEPHRINE WAS GIVEN. A STAT ECHOCARDIOGRAM SHOWED ANTERIOR PERICARDIAL EFFUSION. IMMEDIATELY AFTER RECOGNIZING THE PERFORATION, THE 4.0X20MM TREK BALLOON WAS RE-INFLATED AT 12 ATMS AND ANGIOGRAPHY SHOWED ADEQUATE CONTROL OF THE PERICARDIAL EFFUSION. AFTER LEAVING THE B

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Perforation of Vessels

  MAUDE report 16762422 ↗
• InjuryJan 26, 2023Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFRACTION (STEMI) AND AN UNSPECIFIED 2.5X12MM BALLOON WAS ADVANCED INFLATED TO 6 ATMOSPHERES; HOWEVER, ANGIOGRAM REVEALED SMALL BRANCH PERFORATION AT THE PROXIMAL CIRCUMFLEX. ATTEMPT TO SEAL PERFORATION VIA TAMPONADE, BUT ADVANCED A 3.5X19MM GRAFTMASTER COVERED STENT AND DEPLOYED AT 18 ATMOSPHERES. THE BALLOON WAS EXCHANGED WITH A 2.5X20MM NON-ABBOTT BALLOON AND PROLONG INFLATION FOR ADDITIONAL SEALING FOR 8 TO 10 MINUTES AS TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TTE) IMAGING COULD NOT CONFIRM GRAFTMASTER SEALED AND WALL APPOSITION. THE FINAL ANGIOGRAM SHOWED EXCELLENT TIMI 3 FLOW OVER THE MAIN CIRCUMFLEX ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247907 ↗
• InjuryDec 13, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. THE 3.5X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO THE ANATOMY. IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED [FLARED] WITH GRAFT MATERIAL UPON REMOVAL AND THE STENT WAS EXPIRED. A GUIDELINER WAS INSERTED TO HELP AND ANOTHER 3.5X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE USED BUT FAILED TO CROSS DUE TO THE ANATOMY AS WELL. THERE WERE NO OTHER ISSUES NOTED. A THIRD 2.8X19MM GRAFTMASTER COVERED STENT WAS USED THAT SEALED THE PERFORATION. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969298 ↗
• InjuryDec 13, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. THE 3.5X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO THE ANATOMY. IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED [FLARED] WITH GRAFT MATERIAL UPON REMOVAL AND THE STENT WAS EXPIRED. A GUIDELINER WAS INSERTED TO HELP AND ANOTHER 3.5X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE USED BUT FAILED TO CROSS DUE TO THE ANATOMY AS WELL. THERE WERE NO OTHER ISSUES NOTED. A THIRD 2.8X19MM GRAFTMASTER COVERED STENT WAS USED THAT SEALED THE PERFORATION. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969285 ↗
• InjuryJul 14, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED DURING AN INTERVENTION TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.5X19MM GRAFTMASTER COVERED STENT WAS ADVANCED AND IMPLANTED, BUT FAILED TO SEAL THE PERFORATION. NEXT A 4X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED, BUT THE PERFORATION REMAINED UNSEALED. IT IS UNKNOWN IF THE PERFORATION WAS EVER SEALED; HOWEVER, SOMETIME AFTER THE FULL INTERVENTION, THE PATIENT EXPERIENCED PULSELESS ELECTRICAL ACTIVITY (PEA ARREST) AND COULD NOT BE RESUSCITATED. THE PATIENT DIED. PER THE PHYSICIAN, THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021866 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT MAIN CORONARY ARTERY. LITHOTRIPSY WAS PERFORMED AND A XIENCE SKYPOINT STENT AND A NON-ABBOTT STENT WERE IMPLANTED. A SIGNIFICANT PERFORATION WAS NOTED AFTER THE NON-ABBOTT STENT PLACEMENT. A 4.0X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AND PARTIALLY SEALED THE PERFORATION AFTER THE PATIENT'S BLOOD PRESSURE DROPPED. A 3.5X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AND PARTIALLY SEALED THE PERFORATION AFTER CPR WAS STARTED. WHEN THE VESSEL WAS INITIALLY STENTED, IT WAS REPORTED THAT THE VESSEL "CRUMBLED" AND COULD NOT SUSTAIN THE COVERED STENT. THE PATIENT EXPIRED; HOWEVER, IT WAS REPORTED THE GRAFTMASTER COVERED STENTS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS AS THEY WERE USED PURELY AS RESCUE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 14990792 ↗
• InjuryJul 11, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE MID RIGHT CORONARY ARTERY. A 4.5X19MM RX GRAFTMASTER COVERED STENT WAS BEING ADVANCED BUT FAILED TO CROSS DUE TO ANATOMY. THEN A 3.5X19MM RX GRAFTMASTER WAS ADVANCED AND ALSO FAILED TO CROSS DUE TO ANATOMY. ANOTHER UNSPECIFIED COVERED STENT WAS USED TO SUCCESSFULLY SEAL THE PERFORATION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982106 ↗