Graftmaster 1012584-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176500), received between Oct 17, 2017 and Mar 5, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Difficult or Delayed Positioning; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A PERFORATION IN THE OSTIAL PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND DISTAL LEFT MAIN TRUNK (LMT) ARTERIES. THE 4.8X16M GRAFTMASTER COVERED STENT WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED; HOWEVER, POST DEPLOYMENT THE SHAFT SEPARATED DURING REMOVAL IN THE AORTA. THE SEPARATED BALLOON WAS SNARED FROM THE PATIENT, WHICH CAUSED A CLINICALLY SIGNIFICANT DELAY IN TREATING A NOTED RESIDUAL LEAK WHERE THE STENT WAS IMPLANTED. THE PATIENT WENT INTO SHOCK, RESPIRATORY FAILURE AND PERICARDIAL EFFUSION WAS NOTED WHICH REQUIRED PERICARDIOCENTESIS AND AN IMPELLA DEVICE. ANOTHER GRAFTMASTER STENT WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Foreign Body In Patient; Pericardial Effusion; Respiratory Failure

  MAUDE report 24524525 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A PERFORATION OCCURRED THEREFORE TWO 4.0X16MM GRAFTMASTER COVERED STENTS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24506714 ↗
• 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 11939766 ↗
• InjuryApr 26, 2021Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ANEURYSM IN THE DISTAL RIGHT CORONARY ARTERY (RCA). FOUR NON-ABBOTT ENDOVASCULAR COILS WERE IMPLANTED IN THE ANEURYSM. A NON-ABBOTT COVERED STENT WAS ADVANCED; HOWEVER, IT WAS UNABLE TO CROSS TO THE TARGET SITE AND WAS REMOVED. TWO OVERLAPPING GRAFTMASTER STENTS WERE IMPLANTED TO EXCLUDE THE ANEURYSM AND PROMOTE FLOW INTO THE RIGHT POSTERIOR DESCENDING ARTERY (PDA). ANGIOGRAPHY NOTED MINIMAL FLOW INTO THE ANEURYSM. POST DILATATION WAS PERFORMED TO SEAL THE RESIDUAL FLOW; HOWEVER, ONE GRAFTMASTER STENT EMBOLIZED INTO THE ANEURYSM. THERE WERE NO ATTEMPTS MADE TO REMOVE THE EMBOLIZED GRAFTMASTER; HOWEVER, AN ADDITIONAL COIL WAS PLACED MID VESSEL TO OCCLUDE FLOW INTO THE CORONARY ANEURYSM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 11728557 ↗
• InjuryOct 17, 2017Failure to Advance

  IT WAS REPORTED THAT THE 4.8 X 16 MM GRAFTMASTER STENT WAS USED TO SEAL A PERFORATION CAUSED BY ANOTHER DEVICE. AN ATTEMPT WAS MADE TO CROSS THE LESION HOWEVER, IT DID NOT CROSS THE ANATOMY. THE DEVICE WAS REPLACED WITH A 4 X 16 MM GRAFTMASTER STENT WHICH CROSSED SUCCESSFULLY. A SECOND GRAFTMASTER 2.8 X 16 MM DEVICE WAS ALSO USED IN THE PROCEDURE WITH NO COMPLICATIONS OR ADVERSE EVENTS, AND THE PERFORATION WAS SUCCESSFULLY SEALED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6956801 ↗