Graftmaster 1012580-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 08717648176340), received between Aug 4, 2016 and May 13, 2026 — classified as 39 deaths, 171 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (109 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RUPTURE [PERFORATION] IN THE LEFT MAIN CORONARY ARTERY. THE 2.8X16MM GRAFTMASTER STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, THE STENT WAS NOTED TO BE EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED DUE TO THE IMPLANTATION OF THE GRAFTMASTER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165322 ↗
• InjuryFeb 18, 2026Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 4.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATM) BUT THE PERFORATION WAS NOT SEALED. THEREFORE THE 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 20 ATM BUT THE PERFORATION WAS NOT SEALED. THE 2.8X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 18 ATM BUT AGAIN THE PERFORATION WAS NOT SEALED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378356 ↗
• MalfunctionJan 2, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE RAMUS CORONARY ARTERY. THE 2.8 X 16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES BUT IT WAS NOT REPORTED IF THE PERFORATION WAS SEALED. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO ADVERSE EVENTS OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943202 ↗
• InjuryDec 23, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A FREE PERFORATION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.80X16MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. A NEW GRAFTMASTER COVERED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 23882286 ↗
• MalfunctionMar 27, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANEURYSM THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE GRAFTMASTER STENT WAS ADVANCED TO THE ANEURYSM AND WAS IMPLANTED AT 20 ATMOSPHERES (ATM); HOWEVER, POST STENT IMPLANTATION THE GRAFTMASTER STENT WAS NOTED TO BE EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713330 ↗
• InjuryDec 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PERFORATION IN THE PROXIMAL CIRCUMFLEX. A 2.8X16MM GRAFTMASTER WAS DEPLOYED TO TREAT A PERFORATION; HOWEVER ONLY 50% OF THE LESION WAS NOTED TO BE COVERED, THEREFORE AN ADDITIONAL GRAFTMASTER WAS DEPLOYED TO FULLY COVER THE PERFORATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICAL DELAY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891431 ↗
• MalfunctionOct 23, 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 LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.8X16 MM GRAFTMASTER COVERED STENT, WHICH WAS EXPIRED, WAS IMPLANTED AT 18 ATMOSPHERES, FUNCTIONED AS INTENDED, AND SEALED THE PERFORATION. THERE WAS PERICARDIAL EFFUSION DUE TO THE PERFORATION, AND THE PATIENT WAS PLACED ON IMPELLA PUMP. PERICARDIOCENTESIS WAS PERFORMED DUE TO THE EFFUSION AND THE PATIENT WAS TRANSFERRED TO A TERTIARY CARE CENTER. THE PATIENT ULTIMATELY EXPIRED AT THE OTHER HOSPITAL, DUE TO CARDIOGENIC SHOCK. THE PHYSICIAN STATED THAT THE GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE TO ANY ADVERSE EFFECTS, COMPLICATIONS OR THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516649 ↗
• DeathOct 14, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PERFORATION OCCURRED POST CORONARY ATHERECTOMY IN THE MID LEFT ANTERIOR DESCENDING (LAD). A 2.8X16 MM GRAFTMASTER COVERED STENT FAILED TO REACH THE LESION. A 2.8X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT FAILED TO SEAL THE PERFORATION. A 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED IN THE LEFT MAIN TO CIRCUMFLEX TO JAIL THE LAD AND SEALED THE PERFORATION; HOWEVER, THE PATIENT DECOMPENSATED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. AN EFFUSION WAS NOTED ON ECHOCARDIOGRAM AND PERICARDIAL DRAIN WAS PERFORMED. THE PATIENT CODED AND WAS GIVEN MEDICATION TO STABILIZE BLOOD PRESSURE. THE PATIENT WAS TRANSFERRED TO THE ICU POST PROCEDURE. THE PATIENT WAS DO NOT RESUSCITATE AND THEY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20440670 ↗
• InjuryOct 14, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PERFORATION OCCURRED POST CORONARY ATHERECTOMY IN THE MID LEFT ANTERIOR DESCENDING (LAD). A 2.8X16 MM GRAFTMASTER COVERED STENT FAILED TO REACH THE LESION. A 2.8X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT FAILED TO SEAL THE PERFORATION. A 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED IN THE LEFT MAIN TO CIRCUMFLEX TO JAIL THE LAD AND SEALED THE PERFORATION; HOWEVER, THE PATIENT DECOMPENSATED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. AN EFFUSION WAS NOTED ON ECHOCARDIOGRAM AND PERICARDIAL DRAIN WAS PERFORMED. THE PATIENT CODED AND WAS GIVEN MEDICATION TO STABILIZE BLOOD PRESSURE. THE PATIENT WAS TRANSFERRED TO THE ICU POST PROCEDURE. THE PATIENT WAS DO NOT RESUSCITATE AND THEY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440650 ↗
• InjuryAug 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH HEAVY CALCIFICATION. THE 3.5X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT THE PERFORATION; HOWEVER, THE STENT FAILED TO SEAL THE PERFORATION. THEREFORE ANOTHER 3.5X16MM GRAFTMASTER WAS IMPLANTED AND THE PERFORATION STILL DID NOT SEAL. A 2.8X16MM WAS THEN IMPLANTED AND THE PERFORATION WAS NOTED TO NOT SEAL. NEXT A 4X16MM GRAFTMASTER STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE 4X16MM GRAFTMASTER STENT FAILED TO CROSS THE FIRST PREVIOUSLY IMPLANTED 3.5X16MM GRAFTMASTER STENT. THEREFORE THE 4X16MM GRAFTMASTER STENT WAS REMOVED FROM THE PATIENT. DUE TO THE PERFORATION NOT BEING SEALED AND CONTINUING TO OOZE, PERICARDIOCENTESIS WAS PERFORMED AND THEN OPEN HEART SURGERY WAS PERFORMED TO PATCH THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005617 ↗
• InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL CIRCUMFLEX (CX)ARTERY. THE 2.80X16MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT DISLODGED FROM THE BALLOON IN THE MID CX. THE STENT GRAFT HAD TO BE DEPLOYED WHERE IT DISLODGED OUTSIDE THE TARGET LESION. ANOTHER 2.80X16MM GRAFTMASTER WAS ADVANCED AND THE STENT GRAFT DEPLOYED IN THE DISTAL CX HOWEVER THE PERFORATION WAS NOT SEALED. A 3.50X16MM GRAFTMASTER WAS ALSO DEPLOYED IN THE DISTAL CX HOWEVER AGAIN THE PERFORATION WAS NOT SEALED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19448170 ↗
• InjuryJun 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL CIRCUMFLEX (CX)ARTERY. THE 2.80X16MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT DISLODGED FROM THE BALLOON IN THE MID CX. THE STENT GRAFT HAD TO BE DEPLOYED WHERE IT DISLODGED OUTSIDE THE TARGET LESION. ANOTHER 2.80X16MM GRAFTMASTER WAS ADVANCED AND THE STENT GRAFT DEPLOYED IN THE DISTAL CX HOWEVER THE PERFORATION WAS NOT SEALED. A 3.50X16MM GRAFTMASTER WAS ALSO DEPLOYED IN THE DISTAL CX HOWEVER AGAIN THE PERFORATION WAS NOT SEALED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448160 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A PERFORATION. THE 2.80X16MM GRAFTMASTER STENT WAS IMPLANTED AND SEALED THE PERFORATION HOWEVER THERE WAS A CONCERN FOR STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 19352156 ↗
• InjuryMay 9, 2024Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL CIRCUMFLEX AND MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE AREA WAS DILATED WITH A NON-ABBOTT 2.0X20 MM BALLOON AND 2 NON ABBOTT STENT DELIVERY SYSTEMS (SDS) WERE ATTEMPTED TO BE ADVANCED BUT DID NOT CROSS. FURTHER PRE-DILATATION WAS PERFORMED AND AGAIN A NON-ABBOTT SDS FAILED TO CROSS. A MINI TREK BALLOON WAS ADVANCED AND INFLATED AND A FOURTH NON-ABBOTT SDS FAILED TO CROSS THE LESION. MORE PRE-DILATATION WAS PERFORMED AND ROTABLATION WAS PERFORMED. A NON-ABBOTT STENT WAS IMPLANTED AND POST DILATED. THE 2.8X16 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS SO MORE PRE-DILATATION WAS PERFORMED. THE 2.8X16 MM GRAFTMASTER WAS ADVANCED AGAIN AND IMPLANTED AT 14/15 ATMOSPHERES BUT DID NOT SEAL THE PERFORATION. ANOTHER 2.8X16 MM GRAFTMASTER WAS ADVANCED AND IMPLANTED AT 15 ATMOSPHERES BUT DID NOT SEAL THE PERFORATION. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS INTUBATED. A 5FR PIGTAIL CATHETER WAS INSERTED INTO THE PERICARDIAL SPACE AND A NON-ABBOTT BALLOON WAS ADVANCED AND INFLATED TO 15 ATMOSPHERES FOR 20 MINUTES. THE 3.5X16 MM GRAFTMASTER COVERED STENT WAS THEN ADVANCED

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pericardial Effusion; Ventricular Fibrillation

  MAUDE report 19281275 ↗
• InjuryMay 9, 2024Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL CIRCUMFLEX AND MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE AREA WAS DILATED WITH A NON-ABBOTT 2.0X20 MM BALLOON AND 2 NON ABBOTT STENT DELIVERY SYSTEMS (SDS) WERE ATTEMPTED TO BE ADVANCED BUT DID NOT CROSS. FURTHER PRE-DILATATION WAS PERFORMED AND AGAIN A NON-ABBOTT SDS FAILED TO CROSS. A MINI TREK BALLOON WAS ADVANCED AND INFLATED AND A FOURTH NON-ABBOTT SDS FAILED TO CROSS THE LESION. MORE PRE-DILATATION WAS PERFORMED AND ROTABLATION WAS PERFORMED. A NON-ABBOTT STENT WAS IMPLANTED AND POST DILATED. THE 2.8X16 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS SO MORE PRE-DILATATION WAS PERFORMED. THE 2.8X16 MM GRAFTMASTER WAS ADVANCED AGAIN AND IMPLANTED AT 14/15 ATMOSPHERES BUT DID NOT SEAL THE PERFORATION. ANOTHER 2.8X16 MM GRAFTMASTER WAS ADVANCED AND IMPLANTED AT 15 ATMOSPHERES BUT DID NOT SEAL THE PERFORATION. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS INTUBATED. A 5FR PIGTAIL CATHETER WAS INSERTED INTO THE PERICARDIAL SPACE AND A NON-ABBOTT BALLOON WAS ADVANCED AND INFLATED TO 15 ATMOSPHERES FOR 20 MINUTES. THE 3.5X16 MM GRAFTMASTER COVERED STENT WAS THEN ADVANCED

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pericardial Effusion; Ventricular Fibrillation

  MAUDE report 19281157 ↗
• InjuryJan 23, 2024Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS BEING INSERTED INTO A 5.5FRENCH (F) GUIDE LINER WHEN THE SHAFT OF THE DELIVERY SYSTEM WAS NOTED TO BE BENT AND STENT COULD NOT BE DEPLOYED SO IT WAS REMOVED UNDEPLOYED AND INTACT. ANOTHER 2.8X16MM GRAFTMASTER COVERED STENT COULD NOT PASS THE DISTAL LEFT MAIN AFTER BEING INSERTED INTO A 5.5FRENCH (F) GUIDE LINER. THE STENT WAS REMOVED INTACT. ANOTHER 2.5MM STENT WAS USED TO COMPLETE THE PROCEDURE. THE USE OF THE GRAFTMASTER COVERED STENTS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566788 ↗
• 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 18455775 ↗
• 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 18257143 ↗
• InjuryAug 10, 2023Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure

  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 17501827 ↗
• InjuryAug 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). AFTER AN INSTANTANEOUS WAVE-FREE RATIO (IFR) WAS PERFORMED TO CONFIRM THE LESION AREA, A 2.5X22MM NON-ABBOTT STENT WAS USED TO TREAT THE LESION; HOWEVER, A PERFORATION WAS NOTED IN THE LEFT VENTRICLE. A BALLOON ANGIOPLASTY WAS PERFORMED WITH A 2.5X20MM UNSPECIFIED BALLOON FOR SEVEN MINUTES, BUT IT DID NOT WORK; THEREFORE, A 2.8X16MM GRAFTMASTER WAS USED AT 18 ATMOSPHERES IN THE MIDDLE OF THE PREVIOUS STENT TO SEAL THE PERFORATION AND THE PATIENT DEVELOPED CHEST PAIN. AN ELECTROCARDIOGRAM (EKG) CONFIRMED ST ELEVATIONS WITHOUT EVIDENCE OF PERICARDIAL EFFUSION WHICH WAS TREATED WITH MEDICATION. THE PATIENT WAS HOSPITALIZED, AND WAS BEING MONITORED; HOWEVER, THE CHEST PAIN CONTINUED AND THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND CARDIAC ARREST; THEREFORE, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. AN ANGIOGRAPHY WAS PERFORMED, WHICH CONFIRMED THAT THE STENT WAS THROMBOSED. A CLOT WAS REMOVED WITH A NON-ABBOTT DEVICE AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AFTER THE CLOT WAS REMOVED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMAT

  Patient problems: Angina; Cardiac Arrest; Myocardial Infarction; Tachycardia; Thrombosis/Thrombus

  MAUDE report 17484369 ↗
• MalfunctionJun 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DISSECTION CAUSED BY ROTABLATION IN THE LEFT CIRCUMFLEX (CX) CORONARY ARTERY WITH MODERATE CALCIFICATION. THE 2.80X16MM GRAFTMASTER WAS IMPLANTED AT 22 ATMOSPHERES AND THE DISSECTION WAS SEALED. IT WAS NOTED AFTER USE THAT THE DEVICE IS EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087332 ↗
• InjuryJun 7, 2023Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

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

  Patient problems: Foreign Body In Patient; Low Blood Pressure/ Hypotension; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion; Pericardial Effusion

  MAUDE report 17079388 ↗
• InjuryMay 8, 2023Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.8X26MM GRAFTMASTER WAS ATTEMPTED TO ADVANCE; HOWEVER, MET RESISTANCE WITH THE HEAVY CALCIFICATION AND FAILED TO CROSS. IT WAS NOTED THE STENT STRUTS BECAME FLARED. THREE ADDITIONAL (2.8X16MM, 2.8X16MM, 3.5X16) GRAFTMASTER COVERED STENT DELIVERY SYSTEMS (SDS) WERE ADVANCED, BUT ALL BECAME KINKED AT THE PROXIMAL SHAFT DURING ADVANCEMENT DUE TO RESISTANCE WITH THE ANATOMY. ALL THREE GRAFTMASTER SDS SEPARATED AT THE PROXIMAL SHAFT DURING REMOVAL. THE PATIENT WAS TRANSFERRED TO OUTSIDE FACILITY FOR CORONARY ARTERY BYPASS GRAFT (CABG) EMERGENT; HOWEVER, WAS DENIED. THEREFORE, THE PATIENT RETURNED AND THE PERFORATION WAS COILED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886366 ↗
• InjuryMay 8, 2023Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.8X26MM GRAFTMASTER WAS ATTEMPTED TO ADVANCE; HOWEVER, MET RESISTANCE WITH THE HEAVY CALCIFICATION AND FAILED TO CROSS. IT WAS NOTED THE STENT STRUTS BECAME FLARED. THREE ADDITIONAL (2.8X16MM, 2.8X16MM, 3.5X16) GRAFTMASTER COVERED STENT DELIVERY SYSTEMS (SDS) WERE ADVANCED, BUT ALL BECAME KINKED AT THE PROXIMAL SHAFT DURING ADVANCEMENT DUE TO RESISTANCE WITH THE ANATOMY. ALL THREE GFRAFTMASTER SDS SEPARATED AT THE PROXIMAL SHAFT DURING REMOVAL. THE PATIENT WAS TRANSFERRED TO OUTSIDE FACILITY FOR CORONARY ARTERY BYPASS GRAFT (CABG) EMERGENT; HOWEVER, WAS DENIED. THEREFORE, THE PATIENT RETURNED AND THE PERFORATION WAS COILED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886365 ↗
• InjuryMay 3, 2023Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.8X16MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS AND BECAME STUCK. RESISTANCE WAS FELT AND THE DEVICE SEPARATED AT THE SHAFT. THE SEPARATED PORTION WAS REMOVED WHEN THE GUIDE WIRE WAS REMOVED. ANGIOPLASTY WAS USED TO SUCCESSFULLY SEAL THE PERFORATION. IT WAS NOTED THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861784 ↗