Graftmaster 1012581-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08717648176418), received between Sep 19, 2016 and Feb 11, 2025 — classified as 13 deaths, 32 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (17 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 53 reports, in the reporter's own words as published by the FDA.

• 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 21358299 ↗
• InjuryJan 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). TWO DRUG ELUTING STENTS (DES) WERE PLACED OVERLAPPING IN THE MID RCA. POST DEPLOYMENT INJECTION SHOWED A SEVERE PERFORATION. A BALLOON CATHETER WAS USED TO TAMPONADE THE AREA, THEN A 3.50X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 20 ATMOSPHERES; HOWEVER, THE PERFORATION WAS NOT SEALED DUE TO THE CALCIFICATION. ANOTHER BALLOON WAS INFLATED AT THE TARGET AREA AND SEALED THE PERFORATION. WHILE PERICARDIOCENTESIS AND EMERGENT CARDIAC WINDOW WERE BEING PERFORMED, THE LAST BALLOON WAS DEFLATED, ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS PERFORMED. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND DIED IN RECOVERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091998 ↗
• InjuryApr 23, 2024Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND DURING CORONARY ANGIOPLASTY A DESCRIBED SEVERE PERFORATION OCCURRED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WOULD REQUIRE AT LEAST THREE COVERED STENTS. ANATOMICAL HISTORY OF THE VESSEL INCLUDES A SIGNIFICANTLY SMALL DIAMETER, COMPLETE TOTAL OCCLUSION WITH PRE-DILATION PERFORMED WITH AN UNSPECIFIED 2.0X30 BALLOON DILATING CATHETER. THREE GRAFTMASTER COVERED STENTS (2.8X16MM, 2.8X26MM, 3.5X26MM) WERE SUCCESSFULLY IMPLANTED AND EACH SEALED THE SPECIFIC AREA IN THE LAD. HOWEVER, THE PERFORATION WAS STILL LARGER THAN EXPECTED AND A 3.5X26MM GRAFTMASTER WAS ADVANCED, INFLATED TO AN UNKNOWN PRESSURE, BUT WOULD NOT DEPLOY. UNDER FLUOROSCOPY, THE GRAFTMASTER WAS NOTED TO BE FRACTURED ON THE DELIVERY SYSTEM BUT NOT IN TWO PIECES. THE DELIVERY SYSTEM WITH THE STENT ATTACHED AND THE GUIDING CATHETER WERE REMOVED FROM THE ANATOMY INTACT AS A SINGLE UNIT UNDER FLUOROSCOPY WITH NO RESISTANCE. A 4.0X26MM GRAFTMASTER COVERED STENT WHICH WAS ATTEMPTED TO ADVANCE TO THE LESION SITE, BUT THE STENT SIZE WAS DEEMED TOO LARGE FOR THE SMALL VESSEL THUS FAILED TO CROSS DUE TO ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166272 ↗
• DeathApr 7, 2023Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THE 3.5X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED BUT DUE TO IMPROPER TECHNIQUE THE STENT WAS NOT IMPLANTED AND WAS LOST IN THE AORTA. THE PERFORATION WAS NOT SEALED. THE USE OF THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND DIED AFTER OTHER LIFE SAVING ATTEMPTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 16701309 ↗
• MalfunctionFeb 11, 2023Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ARTERIOVENOUS (AV) FISTULA THAT WAS ACTIVELY BLEEDING IN THE TIBIAL/PERONEAL ARTERY. THE 3.5X26MM GRAFTMASTER COVERED STENT WAS IMPLANTED TO TREAT A LARGE AV FISTULA / AV MALFORMATION WITH EARLY VENOUS FILLING WHICH WAS NOT SEALED. THE GRAFTMASTER 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 16359692 ↗
• MalfunctionMar 17, 2022Off-Label Use; Failure to Advance; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC OCCLUSION IN THE MID RIGHT CORONARY ARTERY. THE 3.50X26MM GRAFTMASTER RX FAILED TO CROSS THE LESION. THEREFORE, THE OCCLUSION WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THE PATIENT PRESENTED FOR AN ATHERECTOMY PROCEDURE USING A NON-ABBOTT DEVICE FOLLOWED BY PLACEMENT OF FOUR OVERLAPPING XIENCE SIERRA STENTS (2.75X33, 2.75X15, 3.0X38 AND 3.5X33MM). ALL WERE INFLATED TO 18 ATMOSPHERES FOR 20 SECONDS. AN EDGE DISSECTION WAS NOTED AND THE GRAFTMASTER WAS ATTEMPTED TO TREAT THE DISSECTION; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795628 ↗
• MalfunctionJan 17, 2022Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY IN ATTEMPT TO OCCLUDE THE SIDE BRANCH FOR STEAL SYNDROME. A NON-ABBOTT GUIDE WIRE WAS USED TO TRAVERSE INTO THE SIDE BRANCH OF THE LIMA GRAFT. SELECTIVE ANGIOGRAPHY WAS PERFORMED OF THE LIMA GRAFT TO THE LAD CORONARY ARTERY AND A DISSECTION OF THE OSTIAL PROXIMAL LIMA GRAFT INTO THE SIDE BRANCH WAS NOTED. THE DECISION WAS MADE TO PLACE THE 3.5X26 MM GRAFTMASTER COVERED STENT AT NOMINAL PRESSURE, BUT THERE WAS A SLIGHT RESIDUAL REMNANT THUS A SECOND GRAFTMASTER 3.5X16 MM WAS IMPLANTED AT NOMINAL PRESSURE TO OVERLAP THE 1ST GRAFTMASTER AND POST DILATATION WAS PERFORMED WITH A 3.5 MM NON-COMPLIANT BALLOON. THERE WAS GOOD RESULT BUT THERE WAS AN EDGE DISSECTION NOTED WHICH WAS A SPIRAL WITHOUT EXTRAVASATION OF DYE AND WAS NON FLOW LIMITING. IT WAS DECIDED NOT TO TREAT THIS DISSECTION AS THE PATIENT WAS HEMODYNAMICALLY STABLE. THERE WERE NO EKG CHANGES AND THE PATIENT REMAINED IN NORMAL SINUS RHYTHM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266404 ↗
• MalfunctionDec 15, 2021Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION. THE 3.50X26MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER BEFORE EXITING THE GUIDE, THE PROXIMAL SHAFT KINKED AND SEPARATED. THE SDS WAS SIMPLY REMOVED FROM THE GUIDE WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE HOWEVER THE PATIENT EXPIRED. PER THE PHYSICIAN, THE PATIENT DEATH WAS NOT RELATED TO THE GRAFTMASTER DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13013279 ↗
• MalfunctionOct 26, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE MID LEFT ANTERIOR ARTERY. AN EXPIRED 3.5X26MM GRAFTMASTER RX COVERED STENT WAS DEPLOYED AT 12 ATMOSPHERES AND SEALED THE PERFORATION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697945 ↗
• InjurySep 10, 2021Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT MAIN CORONARY ARTERY. THE 3.5X26 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED TO TREAT THE PERFORATION BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE GRAFTMASTER COVERED STENT WAS READVANCED WITH A NON-ABBOTT GUIDE SUPPORT CATHETER BUT COULD NOT BE ADVANCED THROUGH THE GUIDE SUPPORT CATHETER SO THE GRAFTMASTER WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT BALLOON WAS USED AND THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM SHOWED NO EVIDENCE OF PERICARDIAL EFFUSION OR CARDIAC TAMPONADE. ADDITIONAL DILATATION WAS PERFORMED AND A NON-ABBOTT COVERED STENT WAS USED TO SEAL THE PERFORATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE FAILURE TO CROSS. THE PATIENT RECOVERED WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453590 ↗
• InjuryFeb 17, 2021Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5X19MM RX GRAFTMASTER AND A 3.5X26MM RX GRAFTMASTER COVERED STENT DELIVERY SYSTEMS FAILED TO CROSS DUE TO MEETING RESISTANCE WITH AN UNSPECIFIED PREVIOUSLY DEPLOYED STENT. THE PERFORATION WAS SUCCESSFULLY TREATED WITH PROLONGED BALLOON INFLATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338443 ↗
• InjuryJan 7, 2021Off-Label Use; Failure to Advance; Material Deformation; Off-Label Use; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND WITH A MID-LEFT ANTERIOR DESCENDING (LAD) PSEUDOANEURYSM, STATUS POST A RECENT PERCUTANEOUS CORONARY INTERVENTION (PCI) ON THE LAD AND DIAGONAL PERFORMED ON (B)(6) 2020. THE PSEUDOANEURYSM WAS AT THE SAME SITE THE NON-ABBOTT ROTABLATOR HAD BECOME STUCK DURING THE PREVIOUS PCI. SEVERAL ADDITIONAL CORONARY LESIONS AND STENOSED CORONARY GRAFTS WERE OBSERVED AND ANOTHER PCI WAS PERFORMED ON (B)(6) 2020. A 3.5X26MM GRAFTMASTER (GM) STENT DELIVERY SYSTEM WAS UNABLE TO ADVANCE TO THE MID LAD PSEUDOANEURYSM SITE DUE TO ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND RAISED STENT STRUTS WERE OBSERVED. THE DEVICE WAS DISCARDED. IN REPLACEMENT, A GUIDELINER WAS PLACED AND A 3.5X16MM GRAFTMASTER STENT (1012581-16, 9032941) WAS DEPLOYED AT NOMINAL PRESSURES WITHOUT A DEVICE ISSUE. A TINY LEAK WAS SEEN FROM THE PSEUDOANEURYSM SITE. POST-DILATATION AND BALLOON DILATATION WAS PERFORMED ON THE PSEUDOANEURYSM, SEALING THE PSEUDOANEURYSM. REPORTEDLY, THE PSEUDOANEURYSM WAS LARGER THAN THE 3.5X26MM GRAFTMASTER STENT AND THERE WAS NO STENT LEAKING. BALLOON DILATATION HAD SEALED THE ENTIRE PSEUDOANEURYSM. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11131956 ↗
• InjuryNov 25, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION (MI), AND THE PATIENT HAD CODED. A 4X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES (ATMS) BUT FAILED TO SEAL THE PERFORATION. THEN, A 3.5X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMS BUT FAILED TO SEAL THE PERFORATION. THEN, A 3.5X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 20 ATMS BUT FAILED TO SEAL THE PERFORATION. AN UNSPECIFIED STENT WAS ATTEMPTED, BUT THE PATIENT EXPIRED ON (B)(6) 2020 DUE TO THE MI AND PERFORATION. IN THE OPINION OF THE PHYSICIAN, THE USE OF THESE GRAFTMASTERS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH IN ANY WAY. THE PATIENT'S HEALTH WAS DECLINING TOWARD DEATH (MI AND PERFORATION) PRIOR TO ANY GRAFTMASTER USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906138 ↗
• MalfunctionNov 19, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PERFORATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION. AN UNSPECIFIED 6F SHEATH AND NON-ABBOTT GUIDE CATHETER WERE USED WITH A NON-ABBOTT GUIDE WIRE AND A NON-ABBOTT ATHERECTOMY CATHETER. UNSPECIFIED 2.5X12MM AND 3X12MM NC BALLOONS WERE USED FOR PRE-DILATATION, AND A 2.5X38MM NON-ABBOTT STENT WAS USED BUT FAILED TO CROSS. AFTER FURTHER DILATATION USING THE 3X12 NC BALLOON, A PERFORATION WAS NOTED, SO THE SAME BALLOON WAS USED AS TREATMENT. THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC, SO PERICARDIOCENTESIS WAS PERFORMED. THE GRAFTMASTER WAS QUICKLY PREPPED AND INSERTED. IT WAS DURING THE FAILURE TO CROSS ATTEMPTS THAT THEY REALIZED THE PERFORATION WAS ALREADY SEALED FROM THE PREVIOUS BALLOON TREATMENT. THE GRAFTMASTER WAS REMOVED WITHOUT ISSUE. THE PATIENT WAS THEN SENT TO SURGERY AS THROMBUS, UNRELATED TO THE GRAFTMASTER, WAS NOTED BUT WITH GOOD FLOW, AND THERE WERE OTHER PROCEDURAL COMPLICATIONS. AN UNSPECIFIED INTRA-AORTIC BALLOON PUMP WAS USED WITH AN 8F SHEATH. IN THE OPINION OF THE PHYSICIAN, THE USE OF THIS GRAFTMASTER DID NOT CAUSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10868909 ↗
• DeathSep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION WAS NOTED IN THE RIGHT CORONARY ARTERY. THE 3.50 X 26 MM GRAFTMASTER COVERED STENT WAS IMPLANTED WITHOUT ISSUE AND SUCCESSFULLY SEALED THE PERFORATION. THE NEXT MORNING THE PATIENT DIED. IT WAS STATED THAT THE GRAFTMASTER HELPED STABILIZE THE PATIENT FROM THE CORONARY PERFORATION; HOWEVER, IT COVERED THE RIGHT VENTRICULAR (RV) BRANCH THAT COULD HAVE CONTRIBUTED TO THE RV FAILURE. THE DIRECT CAUSE OF DEATH IS CORONARY PERFORATION AND SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Heart Failure

  MAUDE report 10491977 ↗
• InjuryAug 25, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, A 3.5 X 23MM XIENCE SIERRA STENT WAS ADVANCED BUT FAILED TO REACH THE LESION. ANGIOGRAPHY SHOWED A SIGNIFICANT PERFORATION. PATIENT BECAME HYPOTENSIVE AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND A TEMPORARY PACEMAKER WAS PLACED, SUCCESSFULLY REVIVING THE PATIENT. A 3.5X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED BUT FAILED TO REACH THE PERFORATION AND WAS REMOVED WITHOUT ISSUE. TWO ADDITIONAL GRAFTMASTER STENTS (3.5X19MM, 3.5X16MM) WERE ADVANCED AND SUCCESSFULLY SEALED THE PERFORATION; HOWEVER, A DISTAL EDGE DISSECTION WAS NOTED. A 3X12MM XIENCE SIERRA STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE DISSECTION. ADDITIONALLY, DURING THIS PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD SEVERE AORTIC STENOSIS AND WAS PLACED ON AN INTRA-ARTERIAL BALLOON PUMP. AORTIC BALLOON VALVOPLASTY WAS PERFORMED, WITH GOOD RESULTS. POST PROCEDURE, THE PATIENT REMAINED IN CRITICAL CONDITION WITH A POOR PROGNOSIS. LATER THAT EVENING, THE PATIENT DIED FROM PULSELESS ELECTRICAL ACTIVITY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451761 ↗
• InjuryJul 9, 2020Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation; Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A PROPER HEPATIC ARTERY BLEEDING PSEUDOANEURYSM WITH HEMATOBILIA AND A TRANSPLANTED LIVER. AN ARTERIAL THROMBOSIS FROM THE COMMON HEPATIC ARTERY FOR PERSISTENT THROMBUS WITHIN THE PROPER HEPATIC ARTERIAL UNSPECIFIED STENT, THROUGHOUT THE DISTAL PROPER HEPATIC ARTERY, AND PERSISTENT OCCLUSION OF THE RIGHT HEPATIC ARTERY. COIL EMBOLIZATION WAS PERFORMED WITHIN THE GASTRODUODENAL ARTERY (GDA) AND MICROCATHETER ADVANCED. A 2.8X19MM GRAFTMASTER (GM) STENT (1012580-19, 8051141--EXPIRED) WAS IMPLANTED. NO FURTHER EXTRAVASATION WAS OBSERVED. POST-PROCEDURE IMAGING WAS PERFORMED AND THE 2.8X19MM GM STENT HAD OCCLUDED WITH THROMBUS. IT IS UNKNOWN IF THIS THROMBUS WAS PER-EXISTING. MEDICATION WERE PROVIDED AND ANOTHER CATHETERIZATION WAS PERFORMED THAT SAME DAY TO INFUSE PERCUTANEOUS THROMBOLYTICS OVERNIGHT. ON (B)(6) 2020, THE PATIENT PRESENTED WITH PROPER HEPATIC ARTERY HEMORRHAGE FROM THE SAME SITE, UNKNOWN IF THE 2.8X19MM GM STENT HAD FAILED TO SEAL. THE RIGHT HEPATIC ARTERY STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY AND ANGIOPLASTY WAS PERFORMED THROUGHOUT THE OCCLUDED GM STENT. A 3.5X26MM GRAFTMASTER (1012581-26, 8031641

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10255758 ↗
• MalfunctionMar 13, 2020Improper 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 A 3.5X26MM GRAFTMASTER COVERED STENT WAS USED TO TREAT A FREE PERFORATION THAT OCCURRED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY ON (B)(6) 2020. THE STENT SUCCESSFULLY COVERED THE PERFORATION; HOWEVER, THE STENT WAS USED AFTER THE EXPIRATION DATE OF (B)(6) 2019. AS PER THE PHYSICIAN, THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9828965 ↗
• DeathDec 6, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT ATHERECTOMY WAS PERFORMED AND CAUSED A FREE PERFORATION WITH EXTRAVASATION IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 2.8X26MM GRAFTMASTER RX COVERED STENT SYSTEM (CSS) FAILED TO CROSS DUE TO THE ANATOMY AND THE SHAFT KINKED AND SEPARATED. THE SEPARATED SHAFT WAS SIMPLY WITHDRAWN. A 2.8X16MM, 4.0X19MM, AND 3.5X26MM GRAFTMASTER RX CSS ALSO FAILED TO CROSS DUE TO THE ANATOMY. A 3.5X16MM GRAFTMASTER RX CSS WAS ADVANCED AND THE STENT WAS DEPLOYED AT 12 ATMOSPHERES; HOWEVER, THE PERFORATION WAS NOT SEALED. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE, WHICH WAS TREATED WITH PERICARDIOCENTESIS; HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade

  MAUDE report 9433132 ↗
• InjuryNov 13, 2019Failure to Advance; Failure to Advance

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: THE FIRST 3.5X26MM GRAFTMASTER (GM) STENT DELIVERY SYSTEM (SDS) HAD FAILED TO CROSS A LESION DUE TO ANATOMY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317019 ↗
• InjuryOct 9, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance; Off-Label Use; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE RIGHT VERTEBRAL ARTERY. A 3.50X26MM RX GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS DUE TO ANATOMY. THE LESION WAS THEN DILATED WITH A 2.5X15MM UNSPECIFIED BALLOON AND THE DEVICE WAS REINSERTED BUT STILL FAILED TO CROSS DUE TO ANATOMY. THERE WAS AN EXCHANGE OF WIRES AND A WIGGLE WIRE WAS USED. THE LESION WAS THEN DILATED WITH A 3.0MM UNSPECIFIED BALLOON AND THE DEVICE WAS ABLE TO CROSS SUCCESSFULLY. THE COVERED STENT WAS DEPLOYED AT 14 ATMOSPHERES, BUT THE PERFORATION WAS NOT SEALED AS THERE WAS A SMALL REGION OF EXTRAVASATION OF CONTRAST NOTED. THE STENT WAS THEN POST-DILATED WITH A 4.0X15MM UNSPECIFIED BALLOON WITH MULTIPLE INFLATIONS UP TO 14 ATMOSPHERES. REPEAT ANGIOGRAPHY SHOWED THE STENT WIDELY PATENT AND NO EXTRAVASATION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173168 ↗
• InjurySep 19, 2019Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THERE WAS A LARGE VESSEL PERFORATION IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WHICH OCCURRED AFTER ATHERECTOMY WAS PERFORMED. THE DOCTOR KNEW HE WOULD NEED SEVERAL GRAFTMASTERS TO TREAT THE PERFORATION. THE GRAFTMASTERS DID NOT WORSEN THE PERFORATION, BUT IT WAS DIFFICULT TO LOCATE WHERE THE PERFORATION WAS LEAKING FROM. THE PERFORATION WAS NOT COMPLETELY SEALED BY THE FOUR GRAFTMASTERS, SO A FIFTH STENT WAS INSERTED TO BE PLACED PROXIMAL TO THE FIRST FOUR STENTS, BUT IT WAS NOT ABLE TO REACH THE VESSEL. THE UNDEPLOYED GRAFTMASTER WAS REMOVED WITH DIFFICULTY AS A UNIT WITH THE GUIDE WIRE AND GUIDING CATHETER. THE UNDEPLOYED GRAFTMASTER WAS NOTED TO HAVE FRAYED STENT STRUTS ON THE DISTAL END. ANOTHER GRAFTMASTER WAS INSERTED AND WAS SUCCESSFULLY DEPLOYED. THE PERFORATION WAS SEALED WITH THE 5TH GRAFTMASTER. THERE WERE NO ADVERSE EVENTS RELATED TO THE GRAFTMASTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088502 ↗
• InjuryAug 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE RADIAL ARTERY. A 2.8 X 26 MM AND A 3.5 X 26 MM GRAFTMASTER COVERED STENT WERE IMPLANTED; HOWEVER, BOTH FAILED TO SEAL THE PERFORATION. THEREFORE, POST-DILATATION WAS PERFORMED WITH A 3.5 X 20 MM NON-ABBOTT BALLOON CATHETER AS MEDICAL INTERVENTION TO SEAL IT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890803 ↗
• InjuryJun 4, 2019Break; Off-Label Use; Failure to Advance; Break; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A KNOWN RUPTURED ANEURYSM BETWEEN STENTS LOCATED FROM THE SAPHENOUS VEIN GRAFT TO THE DIAGONAL CORONARY ARTERY. THE 3.50X26 MM GRAFTMASTER COULD NOT PASS TO THE LESION DUE TO RESISTANCE WITH THE PROXIMALLY, PREVIOUSLY IMPLANTED STENT AND BROKE IN THE DISTAL SHAFT. THERE WAS NO RESIDUAL DEBRIS AND THE GRAFTMASTER WAS ABLE TO BE REMOVED WITHOUT COMPLICATION. A 3.50X19 MM GRAFTMASTER WAS THEN PLACED AS WELL AS A 4.00X19 MM GRAFTMASTER AND BOTH WERE ABLE TO COVER THE ANEURYSM WITH SOME EDGE LEAK NOTED ON ANGIOGRAPHY POST PROCEDURE. TWO GRAFTMASTER STENTS WERE NEEDED AS THE LENGTH OF THE ANEURYSM REQUIRED THE LENGTH OF BOTH STENTS. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED WITH PLANS TO CHECK IN 3-5 DAYS THAT THE ANEURYSM IS STABLE. THE PHYSICIAN NOTED THAT IT IS PRESUMED THE LEAK WILL STILL BE PRESENT BUT OF STABLE SIZE. THE USE OF THE GRAFTMASTER DEVICES DID NOT CAUSE OR CONTRIBUTE TO ANY COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668369 ↗
• InjuryJun 4, 2019Unintended System Motion; Off-Label Use; Improper or Incorrect Procedure or Method; Unintended System Motion; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE RIGHT PERONEAL ARTERY. A 3.0 X 100 MM ARMADA 18 BALLOON CATHETER WAS USED, AND A 3.5 X 26 MM GRAFTMASTER COVERED STENT WAS IMPLANTED. HOWEVER, IT WAS NOTED THAT THE COVERED STENT WAS IMPLANTED OUTSIDE THE PERFORATION [MOVEMENT]; THEREFORE, A 3.5 X 19 MM AND 3.5 X 16 MM GRAFTMASTER COVERED STENT WERE 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 Consequences Or Impact To Patient

  MAUDE report 8667786 ↗