Graftmaster 1012582-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648176463), received between Sep 28, 2016 and Apr 22, 2024 — classified as 6 deaths, 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2024Failure to Advance; Failure to Advance

  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 19154990 ↗
• 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: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 16919375 ↗
• DeathSep 15, 2022Patient-Device Incompatibility; Activation Failure; Patient-Device Incompatibility; Activation Failure

  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: Cardiac Arrest; Hypoxia; Low Blood Pressure/ Hypotension; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 15428746 ↗
• InjuryDec 23, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FREE PERFORATION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 4.0X26MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED AND FAILED TO CROSS DUE TO THE BULKINESS OF THE STENT. A SECOND 4.0X16MM GRAFTMASTER COVERED STENT WAS DEPLOYED TO THE SAME TARGET LESION AT 12 ATMOSPHERES (ATMS) AND DID NOT SEAL THE PERFORATION. A THIRD 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078423 ↗
• InjurySep 23, 2021Off-Label Use; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Material Twisted/Bent; Material Split, Cut or Torn; Off-Label Use; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST ELEVATION MYOCARDIAL INFARCTION AND CARDIAC ARREST. MILD EXTRAVASATION WAS NOTED AROUND AN OLD COVERED STENT, WHICH WAS IMPLANTED ON (B)(6) 2017, GOING INTO A PRE-EXISTING PROXIMAL ANEURYSM IN THE SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL. A 4.0X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED FOR TREATMENT OF THE ANEURYSM, BUT AFTER A LOT OF MANIPULATING, FAILED TO REACH THE ANEURYSM. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE STENT WAS DISLOCATED AND THE DELIVERY SYSTEM WAS TORN AND STRETCHED. NEXT THE 4.5X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED FOR TREATMENT OF THE ANEURYSM, BUT FAILED TO REACH THE ANEURYSM. THERE WAS EVIDENCE OF WORSENING EXTRAVASATION INTO THE ANEURYSM. TRANSIENT NO FLOW WAS NOTED. BALLOON ANGIOPLASTY WAS PERFORMED FOR ONE MINUTE AND IMPROVED THE TRANSIENT NO FLOW. A NON-ABBOTT STENT WAS IMPLANTED, SUCCESSFULLY RESOLVING THE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 12523748 ↗
• InjuryJul 15, 2021Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: THE PERFORATION WAS PRESENT BEFORE ANY ARMADA CATHETER WAS USED. THERE WAS NO COMPLAINT, AND NO DEVICE RELATED ADVERSE EVENT AGAINST AN ARMADA DEVICE. IT IS UNKNOWN IF THE 2.8X19MM OR 4.0X26MM GRAFTMASTER STENTS HAD FAILED TO SEAL. THERE WAS NO NOTE REGARDING THIS ISSUE AND NO FURTHER INFORMATION AVAILABLE REGARDING THE GRAFTMASTER DEVICES. THE SURGERY WAS SUCCESSFUL, RESOLVING THE PERFORATION. PROLONGED HOSPITALIZATION WAS NOT REPORTED. REPORTEDLY, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177510 ↗
• InjuryMar 2, 2021Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LARGE ANEURYSM IN THE SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. ONE 4.0 X 26 MM GRAFTMASTER STENT WAS IMPLANTED AT THE DISTAL ARM OF THE ANEURYSM. DUE TO THE SIZE OF THE ANEURYSM, A SECOND 4.0 X 26 MM GRAFTMASTER STENT WAS IMPLANTED AT THE PROXIMAL ANEURYSM, OVERLAPPING THE FIRST. FILLING WAS NOTED AT THE DISTAL EDGE, SO A 4.0 X 19 MM GRAFTMASTER WAS ADVANCED THROUGH THE TWO PREVIOUSLY IMPLANTED STENTS. THE STENT WAS IMPLANTED AND POST DILATATION WAS PERFORMED. NO ADDITIONAL FILLING WAS NOTED. HAZINESS WAS NOTED AT THE PROXIMAL EDGE OF THE SECOND 4.0 X 26 MM GRAFTMASTER STENT, LIKELY DUE TO AN EDGE DISSECTION. A 3.5 X 12 MM NON-ABBOTT STENT WAS IMPLANTED AND THE DISSECTION WAS SEALED. POST PROCEDURE, THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS NOTED.

  Patient problems: Vascular Dissection

  MAUDE report 11402616 ↗
• InjuryFeb 9, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 4X26MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO THE ANATOMY. AFTER REMOVAL, IT WAS NOTED THAT THE STENT HAD DAMAGED STENT STRUTS. A 4X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED SUCCESSFULLY AND SEALED THE PERFORATION WITH NO ISSUE. IN THE OPINION OF THE PHYSICIAN, THE USE OF THESE GRAFTMASTERS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS IN ANY WAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302720 ↗
• DeathJul 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, AN ATHERECTOMY WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WHEN A PERFORATION OCCURRED. BALLOON ANGIOPLASTY WAS PERFORMED AND DRUG-ELUTING STENTS WERE SUCCESSFULLY IMPLANTED. THE PERFORATION CONTINUED AND AS ADDITIONAL TREATMENT, A NON-ABBOTT COVERED STENT WAS IMPLANTED. THE PERFORATION CONTINUED AND A 4.0X26MM GRAFTMASTER STENT (1012582-26, 9071641) WAS SUCCESSFULLY IMPLANTED. THE PERFORATION HOWEVER, HAD NOT SEALED. THERE WAS NO DEVICE MALFUNCTION NOTED, HOWEVER, THE CAUSE OF CONTINUED BLEEDING/PERFORATION WAS UNKNOWN. REPORTEDLY, IT IS UNKNOWN IF THERE WAS ANY DEVICE LEAKING. THE PATIENT WAS TAKEN TO SURGERY AND OPEN HEART SURGICAL REPAIR WAS PERFORMED. THE BLEEDING HAD CONTINUED AND A PERICARDIOCENTESIS WAS PERFORMED. ON (B)(6) 2020, THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10233624 ↗
• InjuryMay 8, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE SAPHENOUS VEIN GRAFT THAT WAS NOTED AFTER STENTING WITH A 3.5X38 MM NON-ABBOTT STENT. THE 4.0X26 MM GRAFTMASTER COVERED STENT WAS ADVANCED OVER THE WIRE AND INTO THE PROXIMAL VEIN GRAFT; HOWEVER, THERE WAS SIGNIFICANT RESISTANCE AND THE STENT COULD NOT CROSS TO TREAT THE PERFORATION. DURING REMOVAL THERE WAS RESISTANCE WHEN PULLING THE GRASTMASTER INTO THE GUIDING CATHETER. DURING THIS TIME, DOPAMINE INFUSION WAS STARTED, A PERIOCARDIOCENTESIS TRAY WAS OPENED AND ECHOCARDIOGRAM PERFORMED SUGGESTED THERE WAS NOT SIGNIFICANT EFFUSION. NEXT, A 3.5X20 MM NON-ABBOTT STENT WAS INSERTED INTO THE VEIN GRAFT AND INFLATED, AND ANGIOGRAM SHOWED PERSISTENT ACTIVE EXTRAVASATION OF DYE. THE BALLOON WAS REMOVED AND A 6FR GUIDELINER WAS INSERTED TO ASSIST WITH DELIVERY OF THE 4.0X19 MM GRAFTMASTER; HOWEVER, IT WAS NOT ABLE TO CROSS TO TREAT THE PERFORATION. THE PATIENT WAS SENT TO SURGERY AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 10038978 ↗
• DeathMar 25, 2020Difficult to Advance; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL STATED THE REPORTED DEVICE MALFUNCTIONS WERE REPORTED ON THE WRONG DEVICE: THE UPDATED INFORMATION STATED THE 4.0X19MM GRAFTMASTER FAILED TO LOAD ONTO THE GUIDE WIRE AND THE 4.0X26MM GRAFTMASTER WAS IMPLANTED BUT FAILED TO SEAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Death

  MAUDE report 9879526 ↗
• InjuryFeb 11, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X19MM GRAFTMASTER RX COVERED STENT SYSTEM WAS ADVANCED; HOWEVER, THE STENT DISLODGED. AN UNSPECIFIED DRUG-ELUTING STENT WAS USED TO CRUSH THE DISLODGED STENT INTO THE PROXIMAL RCA. AN ATTEMPT TO ADVANCE A 4.0X26MM GRAFTMASTER RX COVERED STENT SYSTEM WAS MADE, BUT IT DID NOT CROSS. IT WAS NOT REPORTED HOW THE PERFORATION WAS TREATED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695980 ↗
• MalfunctionFeb 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT. DURING USE OF AN UNSPECIFIED DEVICE, A PERFORATION OCCURRED. THE 4.0 X 26 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGING FOR DEVICE PREPARATION; HOWEVER, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE CONTINUED. AN UNSPECIFIED EMBOLIC PROTECTION FILTER WAS PLACED. THE 4.0 X 16 MM GRAFTMASTER STENT WAS THEN ADVANCED INTO THE PATIENT ANATOMY. THE STENT WAS DEPLOYED WITHOUT ISSUE, SEALING THE PERFORATION. HOWEVER, DURING REMOVAL OF THE FILTER, THE RETRIEVAL CATHETER INTERACTED WITH THE IMPLANTED GRAFTMASTER STENT, MOVING THE STENT OUT OF POSITION, SO THAT IT NO LONGER FULLY COVERED THE PERFORATION. AN ADDITIONAL GRAFTMASTER STENT, A 4.5 X 26 MM, WAS THEN DEPLOYED, SEALING THE PERFORATION AND ANCHORING THE 4.0 X 16 MM GRAFTMASTER STENT. THE PERFORATION WAS SEALED AND THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9663132 ↗
• DeathNov 7, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST AFTER THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY WAS TREATED PERCUTANEOUSLY. THE 4.0X26 MM GRAFTMASTER STENT WAS IMPLANTED IN THE MLAD CORONARY ARTERY TO TREAT A VESSEL PERFORATION IN THE MLAD. THE GRAFTMASTER WAS DEPLOYED DURING CARDIOPULMONARY RESUSCITATION (CPR) WHICH MADE IT A CHALLENGE BECAUSE OF THE ACTIVITIES OF CPR AND MOVEMENT. AFTER THE GRAFTMASTER WAS DEPLOYED, PROLONGED BALLOON INFLATION WAS PERFORMED ALONG WITH PERICARDIOCENTESIS. THE GRAFTMASTER DID NOT SEAL THE PERFORATION. THE PATIENT HAD A COMPLETE LOSS OF BLOOD PRESSURE AND WAS UNABLE TO BE RESUSCITATED. THE PATIENT'S CARDIAC RHYTHMS PROGRESSED FROM PULSELESS ELECTRICAL ACTIVITY TO VENTRICULAR TACHYCARDIA TO VENTRICULAR FIBRILLATION. THE PATIENT EXPIRED IN THE CATH LAB DESPITE THE RESUSCITATION ATTEMPTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 9293100 ↗
• InjuryAug 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY, THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION. A 4.00 X 26 MM GRAFTMASTER COVERED STENT DELIVERY SYSTEM (SDS) WAS DEPLOYED; HOWEVER, THE PERFORATION WAS NOT COMPLETELY SEALED. A 3.50 X 16 MM GRAFTMASTER STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO RESISTANCE WITH A 6F UNSPECIFIED SHEATH. TWO FURTHER GRAFTMASTER STENTS (3.50 X 16 MM AND A 2.80 X 16 MM) WERE DEPLOYED BUT THE PERFORATION STILL DID NOT FULLY SEAL. ULTIMATELY A 2.80 X 16 MM GRAFTMASTER COVERED STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER EXTRAVASATION WAS STILL NOTED. THE PATIENT LEFT THEATER ON AN EXTRACORPOREAL MEMBRANE OXYGENATION [ECMO] SYSTEM. ANTICOAGULATION WAS REVERSED AND THE DISSECTION WAS NOTED TO HAVE SELF SEALED. THE PATIENT WAS EXTUBATED AND WAS INITIALLY REPORTED TO BE STABLE. THE PATIENT DECLINED FURTHER MEDICAL INTERVENTION AND REPORTEDLY EXPIRED FROM HEART FAILURE 4 DAYS POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884026 ↗
• DeathJul 12, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE PROXIMAL RIGHT CORONARY ARTERY. A 4.0 X 26 MM GRAFTMASTER COVERED STENT WAS IMPLANTED; HOWEVER, IT FAILED TO SEAL IT. THE PATIENT THEN EXPERIENCED CARDIAC ARREST AND EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; No Consequences Or Impact To Patient

  MAUDE report 8787053 ↗
• InjuryMay 14, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE RIGHT CORONARY ARTERY (RCA), FROM USE OF AN UNSPECIFIED DEVICE. THE GRAFTMASTER STENT FAILED TO SEAL THE PERFORATION. SURGICAL INTERVENTION WAS PERFORMED TO RESOLVE THE PERFORATION. THERE WAS NO REPORTED COMPLICATION OR ADVERSE EVENT RELATED TO THE USE OF THE GRAFTMASTER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7511959 ↗
• InjuryApr 13, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE PATIENT WITH AN ACUTE, ONGOING MYOCARDIAL INFARCTION WHOSE HEALTH WAS DECLINING PRIOR TO USE OF THE GRAFTMASTER STENT. THREE GRAFTMASTERS, (SIZES 3.5 X 16, 4.0 X 19, AND 4.0 X 26 MM) WERE IMPLANTED TO TREAT THE CORONARY PERFORATION IN THE RIGHT CORONARY ARTERY (RCA), BUT THESE WERE NOT LARGE ENOUGH TO SEAL THE PERFORATION. THE PERFORATION WAS DISCOVERED TO BE LARGER THAN INITIALLY ANTICIPATED/ VISUALIZED ANGIOGRAPHICALLY, BUT A LARGER GRAFTMASTER SIZE WAS NOT AVAILABLE. THE PERFORATION WAS UNABLE TO BE SEALED. THE PATIENT EXPIRED FROM SUSPECTED CARDIAC TAMPONADE. IN THE OPINION OF THE PHYSICIAN, USE OF THE GRAFTMASTERS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 7429684 ↗
• InjurySep 26, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE SAPHENOUS VEIN GRAFT TO THE 1ST DIAGONAL ARTERY. A PERFORATION OCCURRED. THE 2.8 X 16 MM GRAFTMASTER STENT, THE 2.8 X 19 MM GRAFTMASTER STENT AND THE 4.0 X 26 MM GRAFTMASTER STENT WERE IMPLANTED IN OVERLAPPING FASHION. IT WAS NOTED THAT THE PERFORATION DID NOT SEAL. IT WAS THOUGHT THAT THE PERFORATION MAY HAVE BEEN LARGER THAN INITIALLY ANTICIPATED; HOWEVER, IT IS NOT KNOWN WHY THE PERFORATION WAS NOT SEALED. A COIL WAS PLACED TO SEAL THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6894618 ↗
• MalfunctionDec 20, 2016Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2016, A 4.0X26 RX GRAFTMASTER COVERED STENT THAT HAD EXPIRED ON 07/31/2016, WAS DEPLOYED AT 9 ATMOSPHERES AND SEALED THE PERFORATION. USE OF THE GRAFTMASTER DEVICE DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE HAVE BEEN NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6192052 ↗
• DeathNov 21, 2016Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT PRESENTED WITH CHEST PAIN, ELEVATED TROPONIN LEVEL, A DECLINING HEALTH STATUS, AND A FREE PERFORATION WITH EXTRAVASATION IN AN ANGULATED SAPHENOUS VEIN GRAFT TO AN UNSPECIFIED CORONARY ARTERY. ON (B)(6) 2016, AN ATTEMPT WAS MADE TO TREAT THE PERFORATION USING A 4.0X26 RX GRAFTMASTER COVERED STENT SYSTEM, HOWEVER, THIS DEVICE FAILED TO CROSS TO THE PERFORATION DUE TO THE ANGULATED VESSEL GRAFT AND PREVIOUSLY IMPLANTED STENT. THE GRAFTMASTER WAS WITHDRAWN AND THE PERFORATION WAS TREATED WITH BALLOON TAMPONADE, BUT THE PERFORATION STILL WOULD NOT SEAL. SUBSEQUENT HYPOTENSION REQUIRED MEDICATION INTUBATION. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM TO PERFORM CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY AND SEAL OFF THE PERFORATED VESSEL, BUT THE PATIENT WENT INTO CARDIOGENIC SHOCK, THEN CARDIAC ARREST IN THE OR AFTER ANESTHESIA ADMINISTRATION, BUT PRIOR TO PERFORMING ANY SURGICAL INTERVENTION. THE PATIENT WAS PLACED ON LIFE SUPPORT WITH CARDIOPULMONARY RESUSCITATION (CPR) AND MEDICATION. PER FAMILY DISCUSSION, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED THE SAME DAY DUE TO THE RESULTANT CARDIOGENIC SHOCK AND CARDIAC ARREST THAT OC

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Death; Low Blood Pressure/ Hypotension; Respiratory Failure

  MAUDE report 6117674 ↗
• MalfunctionSep 28, 2016Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 4.0X26 MM GRAFTMASTER STENT WAS IMPLANTED TO TREAT A PERFORATION IN THE MID SEGMENT OF THE SAPHANEOUS VEIN GRAFT TO RIGHT CORONARY ARTERY. THE PERFORATION WAS SUCCESSFULLY SEALED WITHOUT ANY ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMAITON WAS PROVIDED. THE GRAFTMASTER STENT WAS NOTED TO HAVE BEEN USED AFTER THE EXPIRATION DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5984236 ↗