Graftmaster 1012581-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 08717648176395), received between Aug 9, 2016 and Mar 16, 2026 — classified as 21 deaths, 113 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (56 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 147 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN AN UNSPECIFIED LESION. A 4.0X16 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE IMPLANTED AT 12 ATMOSPHERES BUT IT WAS NOT REPORTED IF THE DEVICE SEALED THE PERFORATION. A 3.5X16 MM GRAFTMASTER WAS USED BUT IT WAS NOT REPORTED IF THE STENT WAS IMPLANTED. A 4.5X16 MM GRAFTMASTER COVERED STENT WAS USED BUT IT WAS NOT REPORTED IF THE STENT WAS IMPLANTED. THE PERFORATION WAS ULTIMATELY SEALED IN AN UNSPECIFIED WAY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607923 ↗
• InjuryFeb 16, 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 24347928 ↗
• InjuryDec 19, 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 MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 4.0X19 MM GRAFTMASTER AND A 3.5X16 MM GRAFTMASTER COVERED STENT WERE IMPLANTED. THE 3.5X16 MM GRAFTMASTER CLOSED OFF A SIDE BRANCH [OCCLUSION] BUT DID NOT CAUSE OR CONTRIBUTE TO ADVERSE EVENTS OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23854312 ↗
• InjuryDec 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 3.50X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED HOWEVER THE PERFORATION WAS NOT SEALED THEREFORE ANOTHER 4.0X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED. 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 23852070 ↗
• InjuryNov 14, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION. THE 3.5X16MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 18 ATMOSPHERES AND NOTED TO SEAL THE PERFORATION. HOWEVER, POST PROCEDURE IT WAS NOTED THE COVERED STENT "ABRUPT CLOSURE" [OCCLUDED]; HOWEVER, IT IS UNKNOWN IF TREATMENT WAS PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23557804 ↗
• DeathSep 2, 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 LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X16 GRAFTMASTER STENT WAS IMPLANTED AND NOTED TO SEAL THE PERFORATION. IT WAS NOTED PATIENT DIED TWO DAYS LATER WITH CARDIAC TAMPONADE. NO SIGNIFICANT CLINICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade

  MAUDE report 22932707 ↗
• 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 22803679 ↗
• InjuryMay 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT THERE WAS STILL EXTRAVASATION OF CONTRAST PROXIMAL TO THE STENT EDGE DUE TO THE PERFORATION BEING LARGER THAN ANTICIPATED AND THE POSITION OF THE STENT. THEREFORE, THE 4.0X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AND SEALED THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118298 ↗
• InjuryApr 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS OBTAINED. IT WAS REPORTED THE 3.50X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED HOWEVER THE PERFORATION WAS NOT SEALED. THE PERFORATION WAS LARGER THAN IT APPEARED ANGIOGRAPHICALLY AND EXTENDING FROM THE OSTIAL LAD INTO THE LEFT MAIN (LM). THE LM COULD NOT BE TREATED WITH A COVERED STENT AS THE LEFT CIRCUMFLEX (LCX) WOULD HAVE BEEN COMPROMISED. THE PATIENT WAS ALSO ON EPTIFIBATIDE, WHICH LIKELY MADE THE PERFORATION MORE DIFFICULT TO SEAL. A NON-ABBOTT COVERED STENT WAS THEN IMPLANTED HOWEVER THE PERFORATION STILL DID NOT SEAL. THE PERFORATION WAS TREATED WITH SURGICAL EVACUATION OF THROMBUS AND PACKING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880760 ↗
• InjuryAug 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN 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 20028012 ↗
• InjuryAug 21, 2024Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  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 20011130 ↗
• InjuryJul 26, 2024Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN ARTERIAL EXTRAVATION IN A BRANCH OFF OF THE LEFT COMMON FEMORAL ARTERY. THE 3.50X16MM GRAFTMASTER STENT WAS IMPLANTED. A COIL WAS ADDITIONALLY IMPLANTED TO SEAL THE PERFORATION. 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 19840597 ↗
• 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 19448190 ↗
• InjuryMay 9, 2024Improper or Incorrect Procedure or Method; Failure to Advance; Patient-Device Incompatibility; Difficult to Advance; Improper or Incorrect Procedure or Method; Failure to Advance; Patient-Device Incompatibility; Difficult to Advance

  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; Unspecified Heart Problem

  MAUDE report 19281648 ↗
• InjuryDec 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED; HOWEVER, THE PERFORATION WAS NOT SEALED. WHILE THE GRAFTMASTER COVERED STENT REPORTEDLY DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS, THE PATIENT ULTIMATELY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18337764 ↗
• MalfunctionNov 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE GRAFTMASTER COVERED STENTS, 2.8X19MM, 4.0X19MM AND 3.5X16MM, WERE ALL IMPLANTED, HOWEVER, DID NOT SEAL THE PERFORATION. THE PERFORATION WAS DISCOVERED TO BE LARGER THAN INITIALLY ANTICIPATED/ VISUALIZED ANGIOGRAPHICALLY AND THE GRAFTMASTER STENTS WERE THE CORRECT SIZE IMPLANT USED (LENGTH OR DIAMETER) FOR THE SIZE OF THE PERFORATION. HOWEVER, POSSIBLY THE MAIN REASON THE PERFORATION DID NOT COMPLETELY SEAL WAS DUE TO THE HEAVY CALCIFICATION AND THE STENTS HAD POOR WALL APPOSITION. THE USE OF THE GRAFTMASTER DID NOT CAUSE ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THE PERFORATION EVENTUALLY SEALED ON IT'S OWN AFTER 1 DAY. THE PATIENT REQUIRED A PERICARDIAL DRAIN WHICH WAS EVENTUALLY REMOVED AND WAS NOT INTENDED TO TREAT THE PERFORATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155418 ↗
• InjuryAug 30, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH 95% STENOSIS AND HEAVY CALCIFICATION. THE 3.5X16MM GRAFTMASTER COVERED STENT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED INTACT. THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. HOWEVER, THE PATIENT DIED DUE TO CARDIOGENIC SHOCK AND HAD DECLINING HEALTH PRIOR TO THE USE OF THE GRAFTMASTER. NO AUTOPSY WAS PERFORMED. CARDIOGENIC SHOCK WAS TREATED WITH VASOPRESSOR AND AN IMPELLA. IN THE OPINION OF THE PHYSICIAN, THE USE OF GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO THE CARDIOGENIC SHOCK OR DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650277 ↗
• InjuryAug 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE FIRST 2 GRAFTMASTER COVERED STENTS, BOTH 2.8X16MM, WERE THE CORRECT SIZES IMPLANTED BUT FAILED TO SEAL THE PERFORATION DUE TO THE PERFORATION BEING LARGER THAN ANTICIPATED. A THIRD AND FOURTH GRAFTMASTER COVERED STENT OF THE SAME SIZE, 3.5X16MM, WHICH WERE LARGER SINCE A SMALLER SIZE WAS NOT AVAILABLE IN THE LAB WERE ALSO IMPLANTED, HOWEVER, STILL FAILED TO SEAL EXACERBATING THE EXISTING PERFORATION. THE PERFORATION WAS ULTIMATELY SEALED BY REVERSING THE ANTI-COAGULATION MEDS AND INFLATING A BALLOON IN THE DISTAL LM-PROXIMAL LCX FOR INTENTIONAL THROMBUS FORMATION TO TAMPONADE THE DISTAL LEFT MAIN (LM) TO THE LCX ARTERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 17603455 ↗
• InjuryAug 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE FIRST 2 GRAFTMASTER COVERED STENTS, BOTH 2.8X16MM, WERE THE CORRECT SIZES IMPLANTED BUT FAILED TO SEAL THE PERFORATION DUE TO THE PERFORATION BEING LARGER THAN ANTICIPATED. A THIRD AND FOURTH GRAFTMASTER COVERED STENT OF THE SAME SIZE, 3.5X16MM, WHICH WERE LARGER SINCE A SMALLER SIZE WAS NOT AVAILABLE IN THE LAB WERE ALSO IMPLANTED, HOWEVER, STILL FAILED TO SEAL EXACERBATING THE EXISTING PERFORATION. THE PERFORATION WAS ULTIMATELY SEALED BY REVERSING THE ANTI-COAGULATION MEDS IN ORDER FOR THROMBUS FORMATION TO FORM FROM THE DISTAL LEFT MAIN (LM) TO THE LCX . THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: INTENTIONAL THROMBUS FORMATION AFTER BALLOON INSERTED IN DISTAL LM-PROXIMAL LCX AND INFLATED TO TAMPONADE THE CX VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 17552533 ↗
• InjuryAug 9, 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 17491909 ↗
• DeathAug 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 3.5X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATMS) BUT DID NOT SEAL THE PERFORATION. THE PATIENT DIED DUE TO RCA PERFORATION AND SUDDEN CARDIAC DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437755 ↗
• InjuryMay 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION AT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). PATIENT PRESENTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFRACTION (STEMI) AND THE LAD WAS BALLOONED; HOWEVER WITHOUT DISTAL FLOW. THE LESION WAS STENTED WITH A NON-ABBOTT STENT AND SUBSEQUENTLY ON PURSUING LOW PRESSURE INFLATION IN THE MID TO DISTAL LAD AND IT WAS NOTED THE PATIENT DEVELOPED A CORONARY PERFORATION. A 2.80X26MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO RESISTANCE WITH ANATOMY AND THE TIP BECAME BENT. TWO GRAFTMASTERS (2.8X16MM, 3.5X26MM) WERE IMPLANTED NEXT SUCCESSFULLY SEALING THE AREA OF THE PERFORATION THE DEVICES COVERED. ANOTHER TWO GRAFTMASTERS WERE IMPLANTED (3.5X16MM, 4.0X26MM) HOWEVER, THESE FAILED TO SEAL. A DROP IN BLOOD PRESSURE WAS NOTED PERICARDIOCENTESIS WAS PURSUED WITH PLACEMENT OF A PIGTAIL CATHETER WITH IMPROVEMENT IN BLOOD PRESSURE. BALLOON DILATATION WAS PERFORMED WITH UNSPECIFIED NON-ABBOTT BALLOONS THAT SEALED THE PERFORATION AND NO SIGNIFICANT PERICARDIAL EFFUSION WAS NOTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920124 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY WITH HEAVY TORTUOSITY AND 99% STENOSIS. A 6FR SHEATH WAS INTRODUCED AND TWO NON-ABBOTT CATHETERS WERE USED TO PERFORMED THE ANGIOGRAM. A WHISPER GUIDE WIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION. TWO NON-ABBOTT GUIDE WIRES WERE ADVANCED WITH RESISTANCE IN THE ANATOMY. ANGIOPLASTY WAS PERFORMED WITH A 2.5X15 UNSPECIFIED BALLOON AND A 3.5X18MM NON-ABBOTT STENT WAS IMPLANTED IN THE PROXIMAL PORTION OF THE BEND TO STRAIGHTEN THE TORTUOSITY. FOLLOWING THIS, BALLOON ANGIOPLASTY WAS PERFORMED WITH A NON-COMPLIANT (NC) BALLOON AND A 3.5X12MM NON-ABBOTT STENT WAS PLACED. POST-PROCEDURE ANGIOGRAM SHOWED A PERFORATION WITH A DROP IN HEART RATE AND BLOOD PRESSURE. DURING A STAT ECHOCARDIOGRAM, A CARDIAC TAMPONADE WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED SUCCESSFULLY. A 3.50X16MM GRAFTMASTER WAS USED TO SEALED THE PERFORATION. FOLLOWING THE PERICARDIOCENTESIS AND PLACEMENT OF THE GRATMASTER STENT, THE BLOOD PRESSURE AND HEART RATE IMPROVED. AFTER THE PROCEDURE THE PATIENT WAS STABILIZED AND EXTUBATED BUT DEVELOPED A THROMBOSIS INSIDE THE GRAFTMASTER. AN EMER

  Patient problems: Cardiogenic Shock; Pulmonary Edema; Thrombosis/Thrombus

  MAUDE report 16919790 ↗
• 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 16886872 ↗
• DeathMar 24, 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 THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WHEN A PERFORATION OCCURRED. A 3.5X16 MM GRAFTMASTER COVERED STENT AND A 2.8X16 MM GRAFTMASTER COVERED STENT WERE IMPLANTED WHICH SEALED THE PERFORATION. REPORTEDLY, THE GRAFTMASTER COVERED STENTS DID NOT CAUSE OR CONTRIBUTE TO ADVERSE EVENTS OR COMPLICATIONS; HOWEVER, THE PATIENT DIED LATER WHILE THEY WERE IN THE SURGICAL INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612393 ↗