Graftmaster 1012584-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648176517), received between Apr 3, 2019 and Sep 5, 2020 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE SAPHENOUS VEIN GRAFT TO CIRCUMFLEX ARTERY. A 4.8X19MM RX GRAFTMASTER COVERED STENT WAS ADVANCED WITHOUT ISSUE BUT UNABLE TO DEPLOY AT ALL. THEN 4 RX GRAFTMASTERS (1 - 4X19MM, 1 - 3.5X19MM, AND 2 - 4.5X19MM) WERE DEPLOYED AT 15 ATMOSPHERES AND THE PERFORATION SEALED SUCCESSFULLY. ALL FIVE COVERED STENTS WERE REQUIRED TO SEAL THE LARGE PERFORATION. THE COVERED STENTS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE WERE NO DEVICE ISSUES WITH ANY OF THE FIVE COVERED STENTS AND THEY ALL WORKED AS INTENDED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10498075 ↗
• DeathFeb 17, 2020Off-Label Use; Failure to Advance; Off-Label Use; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PSEUDOANEURYSM OF THE PROPER HEPATIC ARTERY, WHICH WAS BLEEDING AND WAS CAUSED BY A TRAUMATIC INJURY. UNSPECIFIED TREATMENT WAS PERFORMED, BUT DID NOT SEAL THE BLEED. USING A GRAFTMASTER STENT WAS THE LAST OPTION, SO THE 4.8 X 19 MM GRAFTMASTER STENT SYSTEM WAS ADVANCED INTO THE ANATOMY, BUT WAS UNABLE TO CROSS TO THE TARGET LOCATION DUE TO THE PATIENT ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND NO ADDITIONAL TREATMENT WAS PERFORMED AT THAT TIME. PER PHYSICIAN, THE GRAFTMASTER STENT DID NOT CAUSE OR CONTRIBUTE TO WORSENING OF THE HEPATIC BLEED. ONE DAY LATER, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT THE HEPATIC ARTERY PSEUDOANEURYSM AND A NON-ABBOTT STENT WAS IMPLANTED SUCCESSFULLY SEALING THE PSEUDOANEURYSM. APPROXIMATELY TWO DAYS POST PROCEDURE, THE PATIENT DIED OF CAUSES RELATED TO THE HEPATIC BLEED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 9718133 ↗
• InjuryApr 3, 2019Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ACTIVELY BLEEDING PSEUDOANEURYSM IN THE LEFT HEPATIC ARTERY. A 4.8 X 19 MM AND A 4.0 X 19 MM GRAFTMASTER COVERED STENT WERE IMPLANTED AND SEALED THE PSEUDOANEURYSM. A SMALL NON-FLOW LIMITING DISSECTION WAS NOTED IN THE LEFT HEPATIC ARTERY DISTAL TO THE GRAFTMASTER COVERED STENT; HOWEVER, NO INTERVENTION WAS NECESSARY AT THE TIME OF THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8479721 ↗