Graftmaster 1012582-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 08717648176456), received between Aug 1, 2016 and Jun 25, 2026 — classified as 13 deaths, 51 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (27 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 77 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT OCCURRED AFTER STENTING WITH A NON-ABBOTT 3.5X26 MM DRUG ELUTING STENT. A NON-ABBOTT STENT WAS DEPLOYED AND SERIAL POST DILATATION WAS PERFORMED BUT THERE WAS CONTINUED BLEEDING. THE PATIENT BEGAN EXPERIENCING HYPOTENSION DESPITE FLUID BOLUSES. NOREPINEPHRINE WAS PROVIDED AND PERICARDIOCENTESIS WAS PERFORMED WITH ECHOCARDIOGRAPHY CONFIRMING A RAPIDLY DEPLOYING EFFUSION WITH RIGHT VENTRICLE COLLAPSE CONSISTENT WITH CARDIAC TAMPONADE. BEFORE PLACEMENT OF THE PERICARDIAL DRAIN, AN AGITATED SALINE STUDY WAS PERFORMED CONFIRMING LOCATION AND THE 3.5X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES. THIS STENT DID NOT SEAL THE PERFORATION SO A 4.0X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 15 ATMOSPHERES OVERLAPPING THE FIRST GRAFTMASTER. DESPITE MULTIPLE INFLATIONS THE BLEEDING CONTINUED AND INFLATION WAS PERFORMED WITH A 4.0 MM NC NON-ABBOTT BALLOON FOR 30 SECOND EPISODES. THERE WERE TWO EPISODES OF POLYMORPHIC VENTRICULAR TACHYCARDIA AND ELECTRICAL CARDIOVERSION WAS PERFORMED. THE PATIENT WAS STRUGGLING WITH DYSPNEA, DISCOMFORT AND NAUSEA. AFTER R

  Patient problems: Dyspnea; Nausea; Pain; Tachycardia

  MAUDE report 25627011 ↗
• InjuryFeb 9, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 4.0 X 19 MM GRAFTMASTER WAS IMPLANTED BUT DID NOT SEAL THE SIDE BRANCH. THERE WAS PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS DURING DEPLOYMENT OF THE 3.5 X 16 MM GRAFTMASTER. THIS STENT CLOSED OFF A SIDE BRANCH BUT SEALED THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 24292115 ↗
• InjurySep 24, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS REPORTED THAT THE 4.5X19 MM GRAFTMASTER WAS DEPLOYED FIRST. THIS DID NOT COMPLETELY SEAL THE PERFORATION AND THE 4.0X19 MM GRAFTMASTER WAS THEN IMPLANTED AND THE PERFORATION WAS THOUGHT TO HAVE BEEN SEALED. THE IMPELLA PUMP WAS PLACED DUE TO HIGH END DIASTOLIC PRESSURE (EDP). WHEN THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, THE 3.5X19 MM GRAFTMASTER WAS DEPLOYED. IN THE PHYSICIAN'S OPINION, NO GRAFTMASTER DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH AND THE PATIENT WAS DECLINING IN HEALTH (TOWARDS DEATH) PRIOR TO USE OF THE GRAFTMASTER DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137776 ↗
• InjuryJun 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 4.0X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED; HOWEVER, UNSURE IF THE PERFORATION WAS SEALED. A SECOND STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149255 ↗
• InjuryApr 11, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A PERFORATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. THE SDS WAS REMOVED WITHOUT ISSUE. ANOTHER GRAFTMASTER OF THE SAME SIZE WAS IMPLANTED TO SEAL THE PERFORATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086318 ↗
• InjuryMar 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT MAIN TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE 4.0X19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED IN THE OSTIAL LAD, A 3.5X19 MM GRAFTMASTER WAS IMPLANTED IN THE LEFT MAIN CORONARY ARTERY AND A 2.8X19 MM GRAFTMASTER WAS IMPLANTED IN THE PROXIMAL LAD. REPORTEDLY, THE DEVICES WERE IMPLANTED WITHOUT ISSUE BUT THE PERFORATION WAS NOT SEALED. THE PATIENT DEVELOPED MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND THE PATIENT WAS SHOCKED AND MEDICATION GIVEN. HOWEVER, THE PATIENT REPORTEDLY EXPIRED DUE TO VENTRICULAR FIBRILLATION AND UNCONTROLLED PERFORATION. IN THE PHYSICIAN'S OPINION, THE PATIENTS HEALTH WAS DECLINING TOWARDS DEATH PRIOR TO USE OF THE GRAFTMASTER DEVICES AND THE GRAFTMASTER DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. ALTHOUGH REQUESTED, VERY FEW DETAILS WERE RECEIVED THEREFORE THE RELATIONSHIP, IF ANY, OF THE GRAFTMASTER DEVICES TO THE REPORTED PATIENT EFFECTS ARE UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 19006831 ↗
• InjuryJan 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE RIGHT CORONARY ARTERY (RCA). BALLOON TAMPONADE WAS PERFORMED USING A 4.0X12 NON-COMPLIANT BALLOON FOR 10 MINUTES AND IMPROVED THE APPEARANCE BUT BLEEDING DUE TO THE PERFORATION CONTINUED. THE 3.5X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED OVERLAPPING ANOTHER 4.0X19MM GRAFTMASTER COVERED STENT DUE TO A LARGE PERFORATION AND ONE COVERED STENT WAS NOT LONG ENOUGH TO FULLY SEAL THE PERFORATION. HOWEVER, THERE WAS STILL ONGOING BLEEDING FROM THE PERFORATION SO AN ADDITIONAL GRAFTMASTER COVERED STENT, 4.0X19MM, WAS IMPLANTED IN THE MIDDLE. THE COVERED STENTS WERE ABLE TO SEAL THE PERFORATION. THE USE OF THE GRAFTMASTER DID NOT CAUSE ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485539 ↗
• MalfunctionNov 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE GRAFTMASTER COVERED STENTS, 2.8X19MM, 4.0X19MM AND 3.5X16MM, WERE ALL IMPLANTED, HOWEVER, DID NOT SEAL THE PERFORATION. THE PERFORATION WAS DISCOVERED TO BE LARGER THAN INITIALLY ANTICIPATED/ VISUALIZED ANGIOGRAPHICALLY AND THE GRAFTMASTER STENTS WERE THE CORRECT SIZE IMPLANT USED (LENGTH OR DIAMETER) FOR THE SIZE OF THE PERFORATION. HOWEVER, POSSIBLY THE MAIN REASON THE PERFORATION DID NOT COMPLETELY SEAL WAS DUE TO THE HEAVY CALCIFICATION AND THE STENTS HAD POOR WALL APPOSITION. THE USE OF THE GRAFTMASTER DID NOT CAUSE ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THE PERFORATION EVENTUALLY SEALED ON IT'S OWN AFTER 1 DAY. THE PATIENT REQUIRED A PERICARDIAL DRAIN WHICH WAS EVENTUALLY REMOVED AND WAS NOT INTENDED TO TREAT THE PERFORATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155381 ↗
• InjuryNov 15, 2023Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. THE 4.0X19MM GRAFTMASTER COVERED STENT WAS ADVANCED WITHOUT RESISTANCE AND WAS ABLE TO REACH 20 ATMOSPHERES (ATMS) BUT WOULD NOT HOLD THE PRESSURE. THE STENT WAS DEPLOYED WITH A COUPLE OF INFLATIONS AT 20 ATMS, HOWEVER, ADDITIONAL NON-COMPLIANT BALLOONS WERE USED TO POST DILATE THE STENT TO ACHIEVE OPTIMAL RESULTS. THE USE OF THE GRAFTMASTER CAUSED OR CONTRIBUTED TO COMPLICATIONS OR ADVERSE EVENT. HOWEVER, THE GRAFTMASTER DELIVERY SYSTEM WAS TESTED OUTSIDE OF THE BODY AND THE BALLOON DID HOLD THE PRESSURE AND WAS WORKING FINE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142331 ↗
• MalfunctionApr 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.0X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT A PRESSURE OF 18 ATMOSPHERES (ATMS) AND SEALED THE PERFORATION. HOWEVER, THE GRAFTMASTER STENT IMPLANTED EXPIRED ON (B)(6) 2023 AND THIS WAS NOT DETECTED BY THE PHYSICIAN. THE USE OF 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 16834125 ↗
• InjuryFeb 21, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE OSTIAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 4.0X19MM GRAFTMASTER COVERED STENT HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THE PROXIMAL SHAFT BROKE INTO 2 PIECES OUTSIDE THE ANATOMY. THERE WAS NO RESISTANCE DURING WITHDRAWAL. ANOTHER GRAFTMASTER WAS USED TO SEAL THE PERFORATION. THE GRAFTMASTER DID NOT CAUSE ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410064 ↗
• MalfunctionDec 18, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE SAPHENOUS VEIN GRAFT TO RIGHT CORONARY ARTERY (SVG TO RCA). THE 4.0X19MM GRAFTMASTER COVERED STENT WAS SUCCESSFULLY IMPLANTED AT A PRESSURE OF 16 ATMOSPHERES (ATMS), HOWEVER, THE DEVICE WAS EXPIRED AND IT WAS NOTED AFTER THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001526 ↗
• InjuryOct 25, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 4.0X19MM GRAFTMASTER RX COVERED STENT FAILED TO CROSS DUE TO ANATOMY. A 4.0X26MM GRAFTMASTER RX WAS DEPLOYED AT 10 ATMOSPHERES (ATMS) WITH NO ISSUE; HOWEVER, THE PERFORATION WAS LARGER THAN EXPECTED AND THIS WAS CONFIRMED VIA ANGIOGRAM. THEREFORE, AN ADDITIONAL 4.0X26MM GRAFTMASTER RX WAS DEPLOYED AT 15 ATMS RIGHT NEXT TO THE OTHER COVERED STENT. BOTH GRAFTMASTERS SUCCESSFULLY SEALED THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670528 ↗
• DeathOct 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL BRANCH (OM). INITIALLY A RUN-THROUGH WIRE WAS PASSED INTO THE OM; HOWEVER, AN UNSPECIFIED INTRAVASCULAR ULTRASOUND (IVUS) PROBE DID NOT CROSS THROUGH THE SAPHENOUS VEIN AS SIGNIFICANT CALCIFICATION WAS NOTED AND DOUBLE LAYERS OF UNSPECIFIED STENTS NOTED. A NON-ABBOTT BALLOON WAS ATTEMPTED TO BE ADVANCED, BUT ALSO FAILED TO CROSS; THEREFORE, THE DECISION WAS MADE TO PROCEED WITH LASER TREATMENT. THREE TO FOUR PASSES AT 80S TO 80 WERE PERFORMED AND A 3.5X2MM NON-COMPLIANT BALLOON WAS ATTEMPTED TO ADVANCE; HOWEVER, FAILED. SHOCKWAVE BALLOON WAS USED ALL AT 80 PULSES WERE GIVEN AT THE SITE AND AT THE END IT EXPANDED; HOWEVER, ANGIOGRAM REVEALED A PERFORATION OF THE VESSEL AT THE SITE OF THE SHOCKWAVE THERAPY. THE PERFORATION WAS ATTEMPTED TO BE TREATED WITH BALLOON DILATATION, BUT FAILED AND A 4.0X19MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 16 ATMOSPHERES (ATM). POST DILATATION WITH A 4.0MM NON-COMPLIANT BALLOON WAS PERFORMED AT 24 ATMS; HOWEVER, THE PERFORATION DID NOT SEAL. SURGERY WAS CONSULTED; HOWEVER, IT WAS NOTED TO BE EXTREMELY HIGH RISK AND SHOULD TRY CONSERVATIVE THERAPY ONLY. B

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia; Thrombosis/Thrombus

  MAUDE report 15670459 ↗
• InjuryJul 27, 2022Improper 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 THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH OCCLUSION AND 3 AREAS OF HIGH GRADE STENOSIS. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED TO CROSS THE LESIONS IN THE RIGHT CORONARY ARTERY AND INTO THE POSTEROLATERAL BRANCH. A 4.0X38 MM XIENCE SKYPOINT STENT WAS POSITIONED OVER THE FIRST 2 STENOSES AND DEPLOYED AT 18 ATMOSPHERES (ATM). THERE WAS WAIST SEEN IN THE MIDDLE OF THE STENT AND ANGIOGRAM POST STENT DEPLOYMENT SHOWED A PERFORATION AT THE DISTAL EDGE OF THE STENT. THE STENT BALLOON WAS ADVANCED AND INFLATED TO 4 ATM FOR ABOUT 5 MINUTES. THE LEAK WAS DECREASED BUT STILL PRESENT SO ANOTHER INFLATION WAS PERFORMED FOR 5 MINUTES. THE BMW GUIDE WIRE WAS THEN MOVED IN A PARALLEL FASHION TO THE VEIN GRAFT. AT THIS TIME THERE WAS MINIMAL EXTRAVASATION OF DYE AT THE PERFORATION SITE SO THE DISTAL PORTION OF THE LESION WAS TREATED WITH A 3.5X18 MM XIENCE SKYPOINT STENT DEPLOYED AT 12 ATM. POST DILATATION WAS PERFORMED WITH A 4.0X12 MM BALLOON AND THE BALLOON WAS THEN USED FOR THE PERFORATION SITE FOR 8 MINUTES. ANGIOGRAM FOLLOWING THIS SHOWED EXTRAVASATION OF CONTRAST AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED PERSISTENT PERICARDIAL EFFUSION. THE

  Patient problems: Perforation of Vessels

  MAUDE report 15114336 ↗
• InjuryJul 14, 2022Patient-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 A PERFORATION OCCURRED DURING AN INTERVENTION TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.5X19MM GRAFTMASTER COVERED STENT WAS ADVANCED AND IMPLANTED, BUT FAILED TO SEAL THE PERFORATION. NEXT A 4X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED, BUT THE PERFORATION REMAINED UNSEALED. IT IS UNKNOWN IF THE PERFORATION WAS EVER SEALED; HOWEVER, SOMETIME AFTER THE FULL INTERVENTION, THE PATIENT EXPERIENCED PULSELESS ELECTRICAL ACTIVITY (PEA ARREST) AND COULD NOT BE RESUSCITATED. THE PATIENT DIED. PER THE PHYSICIAN, THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15021862 ↗
• InjuryJun 27, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED, IN GUARDED CONDITION, FOR TREATMENT OF A COMPLEX LESION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (CX) ARTERY. THE DECISION WAS MADE TO USE A MINI CRUSH TECHNIQUE. A 4.0 X 22 MM NON-ABBOTT STENT WAS DEPLOYED IN THE CX, WITH APPROXIMATELY 2-3 MM IN THE LEFT MAIN. AFTER DEPLOYMENT AND BEFORE THE STENT WAS CRUSHED, ANGIOGRAM DEMONSTRATED A PERFORATION. THE PATIENT BECAME HYPOTENSIVE AND HAD COMPLAINTS OF CHEST DISCOMFORT. MEDICATION WAS ADMINISTERED AND A DILATATION CATHETER BALLOON WAS INFLATED TO TAMPONADE THE PERFORATION. THE 4.0 X 19 MM GRAFTMASTER STENT WAS DEPLOYED, APPROXIMATELY 2-3 MM BEYOND THE PROXIMAL MARGIN OF THE PREVIOUSLY IMPLANTED STENT, AND THE PERFORATION WAS SEALED. INTRAVASCULAR ULTRASOUND OF THE LEFT MAIN TO THE CX DEMONSTRATED THE GRAFTMASTER STENT TO BE WELL DEPLOYED AND THAT THE NON-ABBOTT STENT WAS THE ONLY PART THAT WAS COVERING THE ORIGIN OF THE LAD. THE DECISION WAS MADE TO CONTINUE THE CRUSHING TECHNIQUE; HOWEVER, ANGIOGRAM DEMONSTRATED RECURRENT PERFORATION AND THE PATIENT STATUS DECLINED. DILATATION CATHETER BALLOONS WERE ADVANCED AND INFLATED TO TAMPONADE THE PERFORATION. DOPPLER ULTRASOUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837052 ↗
• InjuryApr 14, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 4.00X19 MM GRAFTMASTER COVERED STENT WAS INSERTED INTO THE GUIDING CATHETER AND WAS ATTEMPTED TO BE ADVANCED; HOWEVER, IT COULD NOT CROSS TO TREAT THE AREA DUE TO AN UNKNOWN REASON. THE PERFORATION WAS SEALED WITH A BALLOON. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113757 ↗
• InjuryApr 7, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE OBTUSE MARGINAL CORONARY ARTERY. A 4.00X19 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT CROSS THE LESION. A 4.00X16 MM GRAFTMASTER COVERED STENT WAS THEN ADVANCED AND IMPLANTED AT 12 ATMOSPHERES FOR 20 SECONDS AND THE PERFORATION WAS SEALED. REPORTEDLY, THE USE OF 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 14044372 ↗
• InjuryNov 12, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.0X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS TO TREAT THE PERFORATION. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE USE OF THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS FOR THE PATIENT. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807302 ↗
• InjuryNov 12, 2021Failure to Advance; Failure to Advance

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803803 ↗
• InjuryNov 9, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID RIGHT CORONARY ARTERY. THE 4.0X19MM GRAFTMASTER RX WAS DEPLOYED AT 16 ATMOSPHERES (ATM); HOWEVER, FAILED TO SEAL THE PERFORATION. ADDITIONALLY, POST DILATATION WITH A 4.5MM NON-COMPLIANT BALLOON WAS PERFORMED AT 20 ATM, BUT DEVICE STILL DID NOT SEAL. ANOTHER 3.5X19MM GRAFTMASTER RX WAS DEPLOYED AT 16 ATM AND SUCCESSFULLY SEALED THE PERFORATION. STANDARD POST-DILATATION WAS PERFORMED WITH A 4.5X12 NON-COMPLIANT BALLOON AT 16 ATM. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778773 ↗
• InjuryOct 26, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FREE PERFORATION WITH EXTRAVASATION IN THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERIES. A 4.5X19MM AND 4X19MM RX GRAFTMASTER COVERED STENTS WERE DEPLOYED AT 16 ATMOSPHERES (ATM) AND 15 ATM, BUT FAILED TO SEAL THE PERFORATION. TYPE OF MEDICAL INTERVENTION WAS NOT SPECIFIED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, THE ACCOUNT CONFIRMED THAT THE 4X19MM RX GRAFTMASTER WAS FIRST IMPLANTED BUT FAILED TO SEAL THE PERFORATION. THERE WERE NO DEPLOYMENT ISSUES WITH THE STENT AND IT DID NOT EXACERBATE THE PERFORATION. THEN A 4.5X19MM RX GRAFTMASTER STENT WAS DEPLOYED AND ULTIMATELY SEALED THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700076 ↗
• InjuryOct 1, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY DISEASE. A NON-ABBOTT STENT (ONYX, 4.5X15MM) WAS IMPLANTED WHEN A PERFORATION OCCURRED. A 4.0X19MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) HAD FAILED TO CROSS DUE TO THE PREVIOUSLY IMPLANTED, ONYX STENT. THE SDS WAS REMOVED WITHOUT ISSUE REPORTED. FOLLOWING, A 3.5X19MM GRAFTMASTER WAS IMPLANTED AT THE PERFORATION SITE AND WITHIN ONYX STENT, SEALING THE PERFORATION. THE PERFORATION WAS SEALED SUCCESSFULLY. THE PATIENT WAS PLACED ON A CORONARY BYPASS AND EXPERIENCED A MAJOR LOSS OF BLOOD. PER PHYSICIAN, THE MAJOR BLEEDING EVENT WAS UNRELATED TO THE PERFORATION. THE PATIENT EXPIRED THAT DAY DUE TO THE BLEEDING EVENT. PER PHYSICIAN, THE PERFORATION HAD SEALED, AND THE SUBSEQUENT ADVERSE EVENTS HAD NOTHING TO DO WITH THE GRAFTMASTER DEVICES. THERE WAS NO DEVICE MALFUNCTION OF THE IMPLANTED STENT. THE MAJOR BLEEDING EVENT, AND SUBSEQUENT PATIENT DEATH, WERE UNRELATED TO THE GRAFTMASTER DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565104 ↗
• MalfunctionAug 6, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE, A PERFORATION OCCURRED DURING USE OF AN UNSPECIFIED DEVICE. AS THIS WAS AN URGENT USE, THE 4.0 X 19 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS GRABBED AND THE STENT WAS IMPLANTED. AFTER DEPLOYMENT, THE DEVICE WAS NOTED TO BE EXPIRED. THE GRAFTMASTER STENT SUCCESSFULLY SEALED THE PERFORATION WITHOUT ADVERSE PATIENT EFFECTS OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288849 ↗