Graftmaster 1012582-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 08717648176449), received between Aug 17, 2016 and Jul 13, 2026 — classified as 9 deaths, 52 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (25 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 68 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.0X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED HOWEVER IT FAILED TO SEAL THE PERFORATION. A SECOND GRAFTMASTER WAS IMPLANTED TO COMPLETELY 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 25795960 ↗
• InjuryJun 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CORONARY PERFORATION. THE 4.0X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT DID NOT SEAL THE PERFORATION. ANOTHER 4.0X16 MM GRAFTMASTER WAS IMPLANTED AND SEALED THE PERFORATION AFTER PROLONGED POST DILATATION. THE DEVICES DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25625028 ↗
• 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 24607809 ↗
• InjuryAug 21, 2024Failure to Advance; Failure to Advance

  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 20013017 ↗
• InjuryFeb 7, 2024Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE 4.5X16MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. THEREFORE, ANOTHER 4.0X16MM GRAFTMASTER WAS ATTEMPTED TO CROSS; HOWEVER, FAILED DUE RESISTANCE WITH ANATOMY. WHEN ATTEMPTING TO REMOVE THE GRAFTMASTER, IT WAS PULLED BACK A BIT, RESISTANCE WAS FELT WITH ANATOMY AND THE SHAFT SEPARATED. THE SEPARATED PORTION WAS EMBEDDED INTO THE VESSEL USING AN UNKNOWN DRUG COATED STENT. A THIRD 4.5X19MM GRAFTMASTER WAS USED SUCCESSFULLY TO COVER THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18664477 ↗
• InjuryFeb 6, 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 GRAFT TO THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.0X16MM GRAFTMASTER STENT CAUSED A PERFORATION TO THE GRAFT. THE STENT WAS NOT IMPLANTED. THE PERFORATION WAS TREATED WITH PERCUTANEOUS ANGIOPLASTY WITH A BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 18650004 ↗
• InjuryDec 24, 2023Improper 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 A VERY LARGE PERFORATION OF A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). THE 4.0X16MM GRAFTMASTER STENT WAS IMPLANTED AT 19 ATMOSPHERES (ATMS). THE CORRECT SIZE IMPLANT WAS USED FOR THE PERFORATION BUT FAILED TO SEAL. TWO OTHER NON-ABBOTT COVERED STENTS WERE IMPLANTED BUT FAILED TO SEAL AS WELL. THE PATIENT HEALTH WAS ALREADY DECLINING TOWARD DEATH AS SOON AS THE LESION PERFORATED. THE PATIENT THEN WENT INTO ASYSTOLE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR 45 MINUTES BUT THE PATIENT DIED DUE TO THE PERFORATION. IN THE OPINION OF THE PHYSICIAN, THE USE OF THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO PATIENT'S ASYSTOLE OR DEATH IN ANY WAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18389991 ↗
• InjuryOct 5, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS GIVEN IV PAIN MEDICINE FOR THE CHEST PAIN AND BLOOD PRESSURE CONTROL, AND FLUIDS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Hematoma; Swelling/ Edema

  MAUDE report 17878477 ↗
• InjuryMay 25, 2023Improper 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 RIGHT CORONARY ARTERY. THE 4.0X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 12 ATMOSPHERES; HOWEVER, A PERFORATION WAS STILL NOTED. A SECOND 4.0X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED AND SEALED PERFORATION. POST DILATATION WAS PERFORMED WITH AN UNSPECIFIED 4.5 BALLOON. 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 17006073 ↗
• MalfunctionJan 27, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PIN HOLE PERFORATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE PROCEDURE WAS INTRAVASCULAR ULTRASOUND (IVUS) GUIDED. PRE-DILATION WAS PERFORMED WITH A 3.5MM NON-COMPLIANT BALLOON, THEN A 3.5X12MM NON-ABBOTT STENT WAS IMPLANTED AND POST DILATATION WAS PERFORMED USING A 4.0MM NON-COMPLIANT BALLOON. A PIN-HOLE PERFORATION WAS THEN NOTED. THE RIGHT COMMON FEMORAL VEIN WAS ACCESSED AND A 7FRENCH (FR) SHEATH WAS INSERTED, AND TAMPONADE OCCURRED. EMERGENT PERICARDIOCENTESIS WAS PERFORMED FOR THE PERICARDIAL TAMPONADE WITH AUTOTRANSFUSION VIA LEFT FEMORAL SHEATH. PATIENT BECAME HEMODYNAMICALLY STABLE. A 4.0X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATMS); HOWEVER, DID NOT SEAL THE PERFORATION EVEN THOUGH THE CORRECT SIZE IMPLANT WAS USED FOR THE SIZE OF THE PERFORATION. THERE WERE NO ISSUES WITH DEPLOYMENT OF THE STENT. THE GRAFTMASTER DID NOT EXACERBATE THE EXISTING PERFORATION. THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THE PATIENT DIED DUE TO PERICARDIAL HEMATOMA AND TAMPONADE THAT LED TO CARDIAC ARREST. IN THE PHYSICIAN'S OPINION, THE USE OF THE GRAFTMASTER DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16254119 ↗
• DeathNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT REPORT THAT THE PROCEDURE WAS TO TREAT AN OCCLUDED MID RIGHT CORONARY ARTERY (MRCA). THE PATIENT PRESENTED WITH A CARDIAC ARREST AT HOME AND PROVIDE WITH CARDIOPULMONARY RESUSCITATION (CPR). IN THE ER THE PATIENT ARRESTED AGAIN AND WAS NOTED TO BE IN VENTRICULAR FIBRILLATION, MULTIPLE DEFIBRILLATIONS AND INTUBATED. MEDICATION WAS ALSO PROVIDED; HOWEVER, ARRIVAL TO THE CATH LAB PATIENT ARRESTED AGAIN REQUIRING SEVERAL DEFIBRILLATIONS. IT WAS NOTED THAT THE OCCLUDED ARTERY HAD LARGE THROMBUS BURDEN REQUIRING MULTIPLE RUNS OF ASPIRATION THROMBECTOMY AND IMPLANTATION OF TWO UNSPECIFIED DRUG-ELUTING STENTS. A PERFORATION WAS NOTED IN THE MRCA AND TWO (3.5X16MM AND 2.8X16MM) GRAFTMASTERS; HOWEVER, BOTH FAILED TO SEAL. A THIRD 4.0X16MM GRAFTMASTER WAS DEPLOYED AND SEAL THE PERFORATION. HOWEVER, IT WAS NOTED PATIENT EXPIRED AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874688 ↗
• InjurySep 15, 2022Break; Material Rupture; Material Separation; Failure to Advance; Break; Material Rupture; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED RIGHT CORONARY ARTERY (RCA). AN ATHERECTOMY DEVICE AND WAS ABLE TO CROSS THE LESION AFTER FOUR ATTEMPTS. ANGIOGRAPHY REVEALED A PERFORATION IN THE PROXIMAL MID VESSEL. A 2.5X20MM NON-ABBOTT BALLOON WAS INFLATED AND A SECOND ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY. DUE TO PATIENT'S DEBILITY, PRE-DILATATION WAS PERFORMED WITH A 3.0X15 NON-ABBOTT BALLOON AT 12 ATMOSPHERES (ATMS) AT 20 SECONDS WITH MULTIPLE INFLATIONS THROUGHOUT THE PROXIMAL MID VESSEL. A 2.8X16MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO CROSS INTO THE RCA; HOWEVER, IT FAILED AS THE STENT BECAME STUCK WITH AT THE PROXIMAL PORTION OF THE GUIDE CATHETER. DELAY TO TREAT THE PERFORATION WAS NOTED DUE TO THE FAILURE TO CROSS. ANOTHER 2.8X26MM GRAFTMASTER SDS WAS ATTEMPTED TO CROSS THROUGH THE LEFT IN THE RCA; HOWEVER, ALSO BECAME STUCK WITH THE GUIDE CATHETER. DELAY TO TREAT THE PERFORATION WAS NOTED DUE TO THE FAILURE TO CROSS. A 2.75X38MM NON-ABBOTT STENT WAS DEPLOYED MID VESSEL, BUT PERFORATION WAS STILL NOTED. A 3.0X18MM NON-ABBOTT BALLOON WAS INFLATED TO 15 ATMS 20 SECONDS THROUGHOUT THE LENGTH OF THE STENT; HOWEVER, THE PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428683 ↗
• InjurySep 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INTERVENTION TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, A PERFORATION OCCURRED FROM A NON-ABBOTT DEVICE. A 4X16MM GRAFTMASTER STENT WAS IMPLANTED, FOLLOWED BY POST-DILATATION WITH A NON-ABBOTT BALLOON, WITH CONTINUED EXTRAVASATION AS THE GRAFTMASTER STENT DID NOT SEAL THE PERFORATION. WHILE WAITING FOR AN ADDITIONAL COVERED STENT, A NON-ABBOTT DES WAS THEN RAPIDLY ADVANCED TO THE DISTAL LAD, OVERLAPPING WITH THE DISTAL EDGE OF THE 3X28MM NON-ABBOTT DES AND DEPLOYED. A 2ND NON-ABBOTT WIRE WAS ADVANCED INTO THE LAD TO RECANALIZE THE DIAGONAL 2 ARTERY, AND A PERFORATION OCCURRED. A 3.5X16MM GRAFTMASTER COVERED STENT WAS PLACED AT THE SITE OF THE PERFORATION AND DEPLOYED AT NOMINAL PRESSURE. AT THIS TIME THE PATIENT WAS NOTED TO BE IN PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND A SMALL TO MODERATE PERICARDIAL EFFUSION WAS NOTED. CARDIOPULMONARY RESUSCITATION (CPR) WAS IMMEDIATELY STARTED ALONG WITH MEDICATIONS ADMINISTERED BUT THE PATIENT WENT INTO VENTRICLE TACHYCARDIA AND DEFIBRILLATION WAS PERFORMED. THE BLEEDING CONTINUED AND THE PATIENT EXPIRED ON (B)(6) 2022. PER THE PHYSICIAN, THE USE OF THE GRAFTMASTER DEVICES DID NOT CAUSE ADDITIONAL COM

  Patient problems: Cardiac Arrest; Extravasation; Perforation; Pericardial Effusion; Tachycardia

  MAUDE report 15374068 ↗
• 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 14990368 ↗
• InjuryMay 12, 2022Improper 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 PROXIMAL RIGHT CORONARY ARTERY. A 4X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 19 ATMOSPHERES, BUT THE PERFORATION WAS NOT SEALED. ADDITIONAL POST DILATATION WITH A NON-ABBOTT BALLOON AT 22 ATMOSPHERES HAD TO BE PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376932 ↗
• InjuryApr 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 16 ATMOSPHERES, BUT POST STENT DEPLOYMENT IT WAS NOTED THAT THE PERFORATION WAS NOT SEALED AS THE STENT WAS INUNDATED WITH LOTS OF CALCIUM AND COULD NOT BE WELL APPOSED. BALLOONING WAS PERFORMED TO SEAL THE PERFORATION AND FURTHER APPOSE THE STENT IMPLANT. THERE WERE NO NOTED DIFFICULTIES DURING DEPLOYMENT OF THE STENT. 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 14214710 ↗
• InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.5X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES, BUT THE PERFORATION WAS NOT SEALED. ANOTHER 3.5X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES, BUT THE PERFORATION STILL DID NOT SEAL. THEN A 4X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES, BUT THE PERFORATION STILL DID NOT SEAL. AN UNSPECIFIED BALLOON WAS USED TO PERFORM FURTHER DILATATION FOR 2 MINUTES AT 20 ATMOSPHERES. THE PERFORATION THEN SEALED SUCCESSFULLY WITHOUT ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188421 ↗
• MalfunctionMar 11, 2022Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A PERFORATED LOCATION IN THE RIGHT CORONARY ARTERY. IT WAS NOTED THIS WAS A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) PATIENT WITH SEVERE THREE VESSEL DISEASE. A PERFORATION TO RIGHT CORONARY ARTERY OCCURRED WHILE BALLOONING VESSEL. A 4.00X16 GRAFTMASTER WAS INSERTED, INFLATED TO 20 ATMOSPHERES (ATMS) AND IMPLANTED. HOWEVER, THE PERFORATION WAS UNABLE TO BE SEALED. THE PATIENT THEN PASSED AWAY, BUT THE PHYSICIAN STATED THE IMPLANTED GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. THERE AS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13740259 ↗
• InjuryMar 10, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT AFTER A PERFORATION, CAUSED BY ANOTHER DEVICE, WAS NOTED IN THE RIGHT CORONARY ARTERY, A GRAFTMASTER COVERED STENT WAS ADVANCED BUT FAILED TO REACH THE PERFORATION DUE TO THE ANATOMY AND THE STRUTS BECAME FLARED. THE DEVICE WAS REMOVED SUCCESSFULLY WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER GRAFTMASTER WAS IMPLANTED, WITHOUT ISSUE, SEALING THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727348 ↗
• InjuryDec 14, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE MID LEFT CIRCUMFLEX (MLCX) ARTERY. A 4X16MM GRAFTMASTER RX WAS ADVANCED, BUT FAILED TO REACH THE PERFORATION AND WAS REMOVED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006781 ↗
• InjuryNov 22, 2021Improper or Incorrect Procedure or Method; Failure to Advance; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Failure to Advance; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FREE PERFORATION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 4.0X16MM RX GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED AND IT WAS NOTED THAT THE FIRST STENT WOULD NOT PASS TO THE PERFORATION DUE TO THE BULKINESS OF THE STENT. A SECOND 2.8X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED TO THE SAME TARGET LESION AT 14 ATMS, HOWEVER, THE STENT WOULD NOT EXPAND TO COVER THE PERFORATION DISTALLY DUE TO CALCIFICATION AND DID NOT SEAL THE PERFORATION. THE PERFORATION APPEARED TO BE MORE PROXIMAL OR MID VESSEL BUT INVOLVED DISTAL AREA AS WELL. THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK, CORONARY PERFORATION AND CORONARY ARTERY DISEASE. IT WAS REPORTED THAT THE PATIENT WAS DECLINING TOWARDS DEATH PRIOR TO USE OF THE GRAFTMASTER STENTS AND USE OF THE GRAFTMASTER STENTS DID NOT CAUSE ANY ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12855855 ↗
• MalfunctionJul 27, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH A RIGHT CORONARY ARTERY (RCA) PERFORATION. A 4.0X16MM GRAFTMASTER STENT, USED AFTER THE LABELED EXPIRATION DATE, WAS IMPLANTED IN THE RCA SEALING THE PERFORATION. A DEVICE MALFUNCTION WAS NOT REPORTED. PER PHYSICIAN, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235406 ↗
• InjuryJun 4, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT PATIENT PRESENTED IN DECLINING HEALTH. DURING A CORONARY INTERVENTION, A LARGE PERFORATION OCCURRED IN THE SAPHENOUS VEIN GRAFT (SVG). A 4.8X16MM RX GRAFTMASTER COVERED STENT WAS ADVANCED TO THE PERFORATION AND DEPLOYED AT 15 ATMOSPHERES (ATM) BUT WAS DEPLOYED TOO PROXIMAL IN THE PERFORATION AND DID NOT SEAL THE PERFORATION. A 4.0X16MM RX GRAFTMASTER, WAS THEN ADVANCED AND DEPLOYED AT 15 ATM BUT THE PERFORATION FAILED TO SEAL. AT SOME POINT POST PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST AND DIED. IN THE OPINION OF THE PHYSICIAN, THE USE OF THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH IN ANY WAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Perforation

  MAUDE report 11939769 ↗
• InjuryMay 19, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Off-Label Use; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY WITH 99% STENOSIS AT THE MID SEGMENT. A SPARTACORE GUIDE WIRE WAS ADVANCED TO THE LESION WITH NO ISSUES REPORTED. A 4.0X60 MM BALLOON WAS UNABLE TO ADVANCE SO A 3.0X40 MM BALLOON WAS INSERTED AND INFLATED UP TO 12 ATMOSPHERES (ATM). POST DILATATION ANGIOGRAM SHOWED NO COMPLICATIONS. THE PREVIOUS 4.0X60 MM BALLOON WAS RE-ADVANCED AND INFLATED TO 8 ATM. POST DILATATION ANGIOGRAM SHOWED A DISSECTION WITH CONSTRUCT EXTRAVASATION. A 4.00X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 16 ATM, BUT THE DISSECTION WAS NOT SEALED. THE GRAFTMASTER POSSIBLY EXACERBATED THE DISSECTION. IT WAS ALSO NOTED THERE WAS SLOW FLOW AFTER IMPLANT OF THE GRAFTMASTER. ANOTHER 4.00X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED OVERLAPPING THE PREVIOUS GRAFTMASTER DISTALLY AT 13 ATM BUT AGAIN THE DISSECTION WAS NOT SEALED. FOLLOW UP ANGIOGRAM SHOWED A DIFFERENT SITE OF DISSECTION FURTHER DOWN WHICH WAS CONSISTENT WITH SPIRAL DISSECTION. THE PATIENT WAS SENT TO FEMORAL POPLITEAL BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 11851959 ↗
• InjuryMay 19, 2021Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY WITH 99% STENOSIS AT THE MID SEGMENT. A SPARTACORE GUIDE WIRE WAS ADVANCED TO THE LESION WITH NO ISSUES REPORTED. A 4.0X60 MM BALLOON WAS UNABLE TO ADVANCE SO A 3.0X40 MM BALLOON WAS INSERTED AND INFLATED UP TO 12 ATMOSPHERES (ATM). POST DILATATION ANGIOGRAM SHOWED NO COMPLICATIONS. THE PREVIOUS 4.0X60 MM BALLOON WAS RE-ADVANCED AND INFLATED TO 8 ATM. POST DILATATION ANGIOGRAM SHOWED A DISSECTION WITH CONSTRUCT EXTRAVASATION. A 4.00X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 16 ATM, BUT THE DISSECTION WAS NOT SEALED. THE GRAFTMASTER POSSIBLY EXACERBATED THE DISSECTION. IT WAS ALSO NOTED THERE WAS SLOW FLOW AFTER IMPLANT OF THE GRAFTMASTER. ANOTHER 4.00X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED OVERLAPPING THE PREVIOUS GRAFTMASTER DISTALLY AT 13 ATM BUT AGAIN THE DISSECTION WAS NOT SEALED. FOLLOW UP ANGIOGRAM SHOWED A DIFFERENT SITE OF DISSECTION FURTHER DOWN WHICH WAS CONSISTENT WITH SPIRAL DISSECTION. THE PATIENT WAS SENT TO FEMORAL POPLITEAL BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Vascular Dissection

  MAUDE report 11851881 ↗