Graftmaster 1012580-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 08717648176357), received between Aug 1, 2016 and Apr 15, 2025 — classified as 30 deaths, 176 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (116 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 225 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE GRAFTMASTER COVERED STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, IVUS WAS PERFORMED AND THE STENT WAS OCCLUDED. BALLOON INFLATIONS WERE USED AS TREATMENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21839109 ↗
• MalfunctionApr 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A PERFORATION OCCURRED THEREFORE A 2.80X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED; HOWEVER, THERE WAS RESIDUAL LEAK. MEDICATION WAS GIVEN AS TREATMENT. THERE WERE 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 21805787 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  SUBSEQUENTLY, AFTER THE REPORT WAS FILED IT WAS NOTED THAT GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION NOR CARDIAC TAMPONADE. HE PERFORATION WAS NOTED ON THE ECHOGRAM AND UNSPECIFIED BALLOONS WERE USED IN AN ATTEMPT TO SEAL THE PERFORATION; HOWEVER, WERE UNSUCCESSFUL. CARDIAC TAMPONADE WAS NOTED. AN UNSPECIFIED REGULAR STENT (NOT COVERED STENT) WAS IMPLANTED IN AN ATTEMPT TO SEAL THE PERFORATION WAS ATTEMPTED, BUT ALSO FAILED TO SEAL. THEREFORE, THE GRAFTMASTER WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. IMAGINING SHOWED GRAFTMASTER SEALED THE PERFORATION. ONCE THE PERFORATION WAS SEALED, PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE BLOOD. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 21256550 ↗
• InjuryDec 26, 2024Failure to Advance; Failure to Advance

  SUBSEQUENTLY, AFTER THE PREVIOUS REPORT WAS FILED IT WAS NOTED THAT A 2.8X19MM GRAFTMASTER FAILED TO CROSS DUE TO ANATOMY AFTER MULTIPLE ATTEMPTS INCLUDING POST DILATATION AND THE USE OF UNSPECIFIED GUIDELINERS. THE PERFORATION WAS EVENTUALLY SEALED WITH MULTIPLE INFLATIONS WITH THE UNSPECIFIED PRE-DILATATION BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021500 ↗
• InjuryJun 24, 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 LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.80X19MM GRAFTMASTER STENT WAS IMPLANTED AND SEALED THE PERFORATION. HOWEVER THE PATIENT EXPERIENCED CHEST PAIN WITH DISTAL LAD INFARCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 19593929 ↗
• MalfunctionMay 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE CIRCUMFLEX. THE 2.80X19MM GRAFTMASTER STENT WAS SUCCESSFULLY DEPLOYED HOWEVER THE PERFORATION WAS NOT SEALED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254154 ↗
• MalfunctionApr 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE 2.80X19MM GRAFTMASTER STENT WAS USED AFTER THE EXPIRATION DATE. THE ACCOUNT CONFIRMED THE EXPIRATION DATE PRIOR TO USE; HOWEVER AS IT WAS AN EMERGENCY SITUATION, THE STENT WAS IMPLANTED ANYWAY. 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 19010369 ↗
• DeathMar 29, 2024Patient-Device Incompatibility; 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 19007794 ↗
• InjuryFeb 21, 2024Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; 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. 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 18749909 ↗
• InjuryFeb 21, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; 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 18748039 ↗
• InjuryFeb 6, 2024Off-Label Use; Failure to Advance; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERICARDIAL FISTULA IN THE RAMUS CORONARY ARTERY WITH ACTIVE BLEEDING. THE 2.8X19 MM GRAFTMASTER COVERED STENT COULD NOT CROSS THE LESION AS THE VESSEL WAS TOO SMALL. ANOTHER STENT WAS USED TO SEAL THE FISTULA. THERE WERE NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED AND WENT HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655789 ↗
• InjuryJan 23, 2024Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; 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 WHILE INSERTING 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 18567060 ↗
• 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 18455724 ↗
• InjuryNov 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. A STENT WAS PLACED IN THE MID LAD AND ONE DISTAL OVERLAPPING 1ST STENT. A NON-COMPLIANT BALLOON WAS PLACED AND INFLATED AT THE OVERLAP, HOWEVER, THE MID LAD PERFORATED. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS ADVANCED TO THE LESION, HOWEVER, COMPLETELY FAILED TO INFLATE AND WAS REMOVED. ANOTHER 2.8X19MM GRAFTMASTER COVERED STENT WAS ADVANCED BUT FAILED TO CROSS THE PROXIMAL STENT TO THE PERFORATION SITE AND DID NOT WORSE THE PERFORATION. THE PATIENT WAS SENT TO SURGERY WHERE EMERGENT PERICARDIOCENTESIS AND SINGLE VESSEL BYPASS WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELAE. IN THE PHYSICIAN'S OPINION, THE GRAFTMASTER CAUSED OR CONTRIBUTED TO THE PERICARDIOCENTESIS AND BYPASS SURGERY THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187106 ↗
• InjuryNov 21, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. A STENT WAS PLACED IN THE MID LAD AND ONE DISTAL OVERLAPPING 1ST STENT. A NON-COMPLIANT BALLOON WAS PLACED AND INFLATED AT THE OVERLAP, HOWEVER, THE MID LAD PERFORATED. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS ADVANCED TO THE LESION, HOWEVER, COMPLETELY FAILED TO INFLATE AND WAS REMOVED. ANOTHER 2.8X19MM GRAFTMASTER COVERED STENT WAS ADVANCED BUT FAILED TO CROSS THE PROXIMAL STENT TO THE PERFORATION SITE BUT DID NOT WORSE THE PERFORATION. THE PATIENT WAS SENT TO SURGERY WHERE EMERGENT PERICARDIOCENTESIS AND SINGLE VESSEL BYPASS WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELAE. IN THE PHYSICIAN'S OPINION, THE GRAFTMASTER CAUSED OR CONTRIBUTED TO THE PERICARDIOCENTESIS AND BYPASS SURGERY THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182876 ↗
• 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 18155305 ↗
• InjuryNov 15, 2023Failure to Advance; Activation Failure; Failure to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD). THE 2.80X19MM GRAFTMASTER WAS ATTEMPTED TO BE RELEASED BUT FAILED TO DEPLOY; THEREFORE, ANOTHER 2.80X26 MM GRAFTMASTER STENT WAS USED IN AN ATTEMPTED TO SEAL THE PERFORATION BUT THE SAME ISSUE OCCURRED. THE PATIENT WAS SENT TO CARDIAC SURGERY; HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141744 ↗
• InjuryNov 14, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WITH 100% STENOSIS. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS ADVANCED BUT FAILED TO CROSS DUE TO THE ANATOMY. THE PERFORATION WAS NOT SEALED WITH ANOTHER DEVICE. AFTER FURTHER IMAGES, THE PHYSICIAN RECOGNIZED THAT IT WAS A SMALL BRANCH AND THE CONTRAST STAINING RESOLVED. THE USE OF THE GRAFTMASTER COVERED STENT DID NOT CAUSE CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135907 ↗
• InjuryJul 24, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE ANASTOMOSIS FROM THE SAPHENOUS VEIN GRAFTS (SVGS) TO THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 6.0 FR NON-ABBOTT GUIDE WIRE WAS USED TO ENGAGE THE CORONARY ARTERY AND CONFIRMED THE LESION. THEN, A NON-ABBOTT WIRE WAS PLACED AND A 2.5X15MM UNSPECIFIED BALLOON WAS USED TO PRE DILATE THE LESION AND A NON-ABBOTT INTRAVASCULAR LITHOTRIPSY (IVL) WAS USED PRIOR STENTING. AFTER 60 PULSES AND IN THE SIXTH DILATATION INFLATED TO 6 ATMOSPHERES, THE ANGIOGRAPHY REVEALED A PERFORATION IN THE LAD. A 2.8X19MM GRAFTMASTER WAS ATTEMPTED TO BE PLACED; HOWEVER, AFTER SEVERAL ATTEMPTS FAILED TO CROSS SINCE THE NON-ABBOTT WIRE AND NON-ABBOTT CATHETER EXTENSION DID NOT PROVIDE SUFFICIENT SUPPORT. THE AREA CLOTTED AND A 2.0X12MM NON-ABBOTT BALLOON AND A WHISPER WIRE REPLACED THE OTHER ONES; HOWEVER, THEY STILL COULD NOT CROSS. THE PATIENT BECAME PROGRESSIVELY UNSTABLE AND HAD HYPOTENSION WHICH WAS TREATED WITH FLUIDS AND MEDICATION. PERICARDIOCENTESIS WAS PERFORMED DUE TO A PERICARDIAL EFFUSION AND THE PATIENT WAS SENT FOR CORONARY ARTERY BYPASS GRAFTING (CABG) IN ORDER TO SEAL THE PERFORATION AS WELL AS A SURGICAL AORTIC VALVE

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 17378734 ↗
• MalfunctionJul 22, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSIS IN THE DISTAL ANASTOMOSIS OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL AS WELL AS THE NATIVE DIAGONAL VESSEL THROUGH THE GRAFT. AFTER PRE-DILATATION, A 2.0X10MM NON-ABBOTT CUTTING BALLOON DILATATION WAS PERFORMED, WHICH RESULTED IN A SIGNIFICANT VESSEL PERFORATION. THE PERFORATION WAS TAMPONADED WITH AN 8-MINUTE INFLATION USING A 2.0X30MM BALLOON; HOWEVER THE PATIENT AGAIN DEVELOPED RECURRENT CHEST PAIN; THEREFORE THE VESSEL WAS AGAIN TAMPONADED WITH THE 2.0X30MM BALLOON WHILE PREPPING A 2.8X19 MM GRAFTMASTER (GM) COVERED STENT. IT WAS REALIZED THAT THE STENT WAS TOO LARGE FOR THE VESSEL, BUT IT WAS TO BE INFLATED AT VERY LOW PRESSURE. HOWEVER, THE GRAFTMASTER WOULD NOT GO THROUGH THE NON-ABBOTT SUPPORT CATHETER WHICH WAS BEING USED FOR EXTRA SUPPORT. IN THE PROCESS OF TRYING TO REMOVE THE SUPPORT CATHETER AND PREPARE ANOTHER GRAFTMASTER, THE ENTIRE GUIDE CLOTTED OFF AND THE PATIENT'S CHEST PAIN HAD IMPROVED DRAMATICALLY. A STAT ECHOCARDIOGRAM SHOWED NO SIGNIFICANT PERICARDIAL EFFUSION. SO, AT THIS POINT, IT WAS THOUGHT THAT THE GRAFT TO DIAGONAL WOULD LIKELY CLOT OFF, THEREFORE, NO ADDITIONAL INTERVENTION WAS PERF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375412 ↗
• InjuryJul 17, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE TRIPLE VESSEL DISEASE AND THE PROCEDURE WAS TO TREAT A PERFORATION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.80X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS THE LESION. A BALLOON WAS USED WITH EXTENDED INFLATION TO SEAL THE PERFORATION. THE PATIENT WAS TRANSFERRED TO A TERTIARY FACILITY AND DIED 24 HOURS LATER DUE TO CARDIOGENIC SHOCK AND RIGHT VENTRICULAR (RV) FAILURE. THE PATIENT'S HEALTH WAS DECLINING TOWARDS DEATH PRIOR TO THE USE OF THE GRAFTMASTER. THE USE OF THE GRAFTMASTER STENT DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENT. PER THE PHYSICIAN, THE USE OF THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336322 ↗
• InjuryJun 5, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION AT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.8X19MM GRAFTMASTER FAILED TO CROSS DUE TO INTERACTION WAS A PREVIOUSLY IMPLANTED STENT. A SMALLER SIZED UNSPECIFIED BALLOON WAS USED TO SEAL THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060965 ↗
• InjuryApr 28, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE PATIENT PRESENTED WITH AN ACTIVE PERFORATION AND DECLINING HEALTH. A 2.80X19MM GRAFTMASTER COVERED STENT WAS ADVANCED, HOWEVER IT FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT AND COULD NOT REACH THE TARGET LESION. A 2.80X16MM GRAFTMASTER COVERED STENT WAS THEN ADVANCED, HOWEVER IT ALSO FAILED TO CROSS THE IMPLANTED STENT AND COULD NOT BE IMPLANTED. THE PERFORATION WAS NOT SEALED, AND THE PATIENT EXPIRED ON (B)(6) 2023. IT WAS NOTED THAT THE GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE TO ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833657 ↗
• InjuryApr 18, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 10% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. A LARGE PERFORATION WAS NOTED IN THE VESSEL. A 2.80X19MM GRAFTMASTER (GM) COVERED STENT WAS ADVANCED BUT FAILED TO CROSS THE STENT STRUTS OF A PREVIOUSLY IMPLANTED STENT. THE DEVICE WAS REMOVED WITHOUT ISSUE. THREE GRAFTMASTER COVERED STENTS (2.80X16MM, 4.00X16MM, 4.00X19MM) WERE ADVANCED TO THE PERFORATION, IMPLANTED AND SUCCESSFULLY SEALED THE PERFORATION WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762375 ↗
• InjuryMar 13, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE 2.8X19MM GRAFTMASTER COVERED STENT WAS USED TO TREAT A PERFORATION IN THE MILDLY CALCIFIED AND TORTUOUS OBTUSE MARGINAL ARTERY. THE GRAFTMASTER WAS ADVANCED TO THE TARGET SITE; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS. THE GRAFTMASTER WAS REMOVED WITHOUT ISSUE AND THE PERFORATION WAS SEALED WITH BALLOON DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529943 ↗