Graftmaster 1012584-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176524), received between Sep 29, 2016 and Jan 6, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A PERFORATION IN THE MID RIGHT CORONARY ARTERY. THE 4.80X26 MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 16 ATMOSPHERE AND THE PERFORATION WAS SEALED. AN ATRIAL WALL HEMATOMA WAS ALSO NOTED; HOWEVER IT IS UNKNOWN IF THE GRAFTMASTER CAUSED OR CONTRIBUTED TO THE HEMATOMA. NO DEVICE ISSUES WITH THE GRAFTMASTER COVERED STENT WERE NOTED; HOWEVER, POST DEPLOYMENT OF THE GRAFTMASTER COVERED STENT THERE WAS ATRIAL FIBRILLATION. CARDIOVERSION WAS ATTEMPTED TWICE AND WAS UNSUCCESSFUL. AMIODARONE WAS ADMINISTERED AND THERE WAS SPONTANEOUS CONVERSION TO NORMAL SINUS RHYTHM ON (B)(6) 2020 IN THE EVENING. ON (B)(6) 2020, A CHEST CT SCAN WAS PERFORMED, SHOWING NO PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Hematoma

  MAUDE report 11128150 ↗
• InjuryFeb 15, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HIGH CERVICAL INTERNAL CAROTID ARTERY WITH FLOW LIMITING STENOSIS AND BRAIN HYPOPERFUSION WITH ASSOCIATED LARGER GROWING PSEUDOANEURYSM. THE 4.80X26 GRAFTMASTER STENT WAS DEPLOYED AT 12 ATMOSPHERES. THE PSEUDOANEURYSM WAS EXCLUDED AND NORMAL LUMINAL DIAMETER WAS RESTORED AND BRAIN PERFUSION WAS IMPROVED. THE PATIENT WAS DISCHARGED HOME WITH MEDICATION. THERE WAS NO ADVERSE PATIENT SEQUELA. ADDITIONAL INFORMATION RECEIVED NOTED THAT AFTER IMPLANTATION OF THE GRAFTMASTER STENT, AN INDENTATION OF THE CAROTID WAS NOTED A FEW CM ABOVE THE STENT. THIS HAS NO RESPONDED TO THE ADMINISTRATION OF INTRAVENOUS NITROGLYCERIN. THERE IS PERSISTENT STENOSIS FOR A FEW CM ABOVE THE NEWLY PLACED STENT. A PRECISE SELF EXPANDABLE 5 X 30 MM STENT WAS THEN ADVANCED OVER THE WIRE AND DISTAL TO THE COVERED STENT TO COVER THE STENOTIC SEGMENT. FOLLOW UP ANGIOGRAPHY REVEALS RESTORATION OF THE NORMAL LUMINAL DIAMETER OF THE ARTERY AND COMPLETE EXCLUSION OF THE PSEUDOANEURYSM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7274474 ↗
• InjuryDec 5, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GRAFTMASTER 4.8 X 26 MM COVERED STENT WAS SUCCESSFULLY DEPLOYED AT 16 ATMOSPHERES TO TREAT AN ANEURYSM LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL COMPLETELY SEALING THE ANEURYSM. HOWEVER, THIS RESULTED IN A PERFORATION OF THE SAPHENOUS VEIN GRAFT AT THE INFLOW OF THE INITIAL STENT AS A COMPLICATION WHICH WAS SEALED SUCCESSFULLY WITH ANOTHER GRAFTMASTER 4.8 X 26 MM COVERED STENT. THE SECOND DEVICE WAS ABLE TO SUCCESSFULLY OVERLAP THE INITIAL STENT AND SEAL THE PERFORATION. INTRAVASCULAR ULTRASOUND OF THE SAPHENOUS VEIN GRAFT, POST STENT DEPLOYMENT, REVEALED EXCELLENT STENT EXPANSION, WELL APPOSED TO THE VESSEL WALL. PATIENT TOLERATED PROCEDURE WELL WITH NO COMPLICATIONS. THE PATIENT WILL UNDERGO A REPEAT COMPUTERIZED TOMOGRAPHY CORONARY ANGIOGRAPHY IN 3-6 MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 7085212 ↗
• InjuryAug 28, 2017Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE OSTIAL RIGHT CORONARY ARTERY FROM THE USE OF AN UNSPECIFIED DEVICE. A 4.8 X 26 MM GRAFTMASTER WAS INSERTED INTO THE ANATOMY, BUT COULD NOT CROSS THE LESION AND WAS NOT IMPLANTED. IT WAS REMOVED WITHOUT ISSUE AND A 5.0 X 26 MM GRAFTMASTER WAS SUCCESSFULLY IMPLANTED IN THE PERFORATION, SEALING IT WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6825947 ↗
• InjurySep 29, 2016Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT HAS A FENESTRATED ABDOMINAL AORTIC STENT GRAFT THAT WAS PREVIOUSLY PLACED IN THE PAST. JOSTENTS WERE PLACED ON (B)(6) 2011 IN BOTH RENAL ARTERIES FROM THE GRAFT AND IN THE CELIAC AND SUPERIOR MESENTERIC ARTERY. A COMPUTED TOMOGRAPHY SCAN IN 2012 SHOWED THAT THE ABDOMINAL AORTIC STENT GRAFT WAS PATENT. THE NATIVE ABDOMINAL AORTIC ANEURYSM WAS AGAIN OBSERVED AND IT DECREASED IN SIZE, MEASURING 6.9X6.3 CM. ON (B)(6) 2016, THE PATIENT WAS ADMITTED SECONDARY TO SUBSTERNAL CHEST PAIN. REPORTEDLY, IT APPEARS THAT THE JOSTENT THAT WAS PLACED IN THE LEFT RENAL ARTERY HAS EITHER DEVELOPED A STRUT FRACTURE OR HAS DEVELOPED MIGRATION OUTSIDE OF THE GRAFT WHERE IT WAS INITIALLY FLARED AS IT WAS IMPLANTED. THAT STENT NEEDS TO BE REVISED. BECAUSE OF ITS SIZE, THE ONLY AVAILABLE DEVICE WOULD BE AN ADDITIONAL JOSTENT. THE PATIENT HAS HAD SIGNIFICANT ENLARGEMENT OF THE ABDOMINAL AORTIC ANEURYSM AS A RESULT OF THIS TYPE 3 ENDOLEAK. ON (B)(6) 2016, A 4.8X26 MM GRAFTMASTER STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY IN AN ATTEMPT TO TREAT THE ENDOLEAK; HOWEVER, THE STENT GRAFT DID NOT SEAL THE ENDOLEAK. POST-DILATATION WAS PERFORMED; HOWEVER, ENDOLEAK WAS STILL PRESENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5988727 ↗