Graftmaster 1012580-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 08717648176364), received between Sep 16, 2016 and Jan 7, 2026 — classified as 13 deaths, 53 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (46 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. A PERFORATION OCCURRED THEREFORE A 2.80X26MM RX GRAFTMASTER COVERED STENT WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND A TREK BALLOON CATHETER WAS USED 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 23989039 ↗
• InjuryAug 14, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.50X16MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO COVER A PERFORATION HOWEVER FAILED TO CROSS THE LESION. A 3.50X19MM AND 2.80X26MM RX GRAFTMASTER ALSO FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING A 4.0X16MM GRAFTMASTER. 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 22803641 ↗
• InjuryNov 8, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED TO BREAK UP THE CALCIFIED PLAQUE. HOWEVER, AFTER THE IVL, ANGIOGRAPHY REVEALED A DISTAL PERFORATION WHICH WAS ATTRIBUTED TO THE SHOCKWAVE TREATMENT. A GRAFTMASTER COVERED STENT WAS ADVANCED TO TREAT THE PERFORATION YET FAILED TO CROSS THE LESION DUE TO THE PATIENT'S ANATOMY. AN UNKNOWN SIZE STENT WAS IMPLANTED PROXIMAL IN THE TARGET LESION THEN TWO NON-ABBOTT STENTS WERE IMPLANTED DISTAL TO TREAT 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 20644096 ↗
• InjuryJun 26, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THIS WAS A NON-STEMI PATIENT WITH MULTIPLE VESSEL DISEASE, THE PATIENT WAS A HIGH RISK FOR SURGERY. THE DIAMONDBACK WAS USED FOR ATHERECTOMY IN THE LEFT ANTERIOR DESCENDING ARTERY, A PERFORATION OCCURRED. AN ATTEMPT WAS MADE TO BALLOON THE PERFORATION BUT THAT WAS UNSUCCESSFUL. A 2.80X26MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT IT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE STENT WAS NOT IMPLANTED, THE PERFORATION WAS NOT SEALED. THE PATIENT DIED WITHIN MINUTES ON (B)(6) 2024. PER THE PHYSICIAN, THE PERFORATION WAS CAUSED BY THE DIAMONDBACK. THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617647 ↗
• InjuryJun 5, 2024Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION OF A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. BALLOON TAMPONADE WAS INITIALLY STARTED FOR 5 MINUTES. THERE WAS PERSISTENT LEAKING IN THE PLAD AND THE 2.8X26MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 14 ATMOSPHERES (ATMS) WITH THE AID OF A 6FRENCH (F) GUIDELINER; HOWEVER, THERE WAS PERSISTENT BLEEDING. WITH GREAT DIFFICULTY, A COMPLIANT BALLOON WAS ADVANCED THROUGH THE GRAFTMASTER TO FURTHER POST DILATE THE STENT. SUSPECT ACTIVE BLEEDING WAS DUE TO LACK OF STENT APPOSITION DUE TO UNDER DEPLOYED STENTS FROM BEFORE. THEN USED ANOTHER 3.0MM NON-COMPLIANT BALLOON TO FURTHER POST DILATE THE GRAFTMASTER STENT AT HIGH PRESSURES. SUBSEQUENT ANGIOGRAPHY REVEALED RESOLUTION OF BLEEDING. DURING THIS TIME THE PATIENT WAS HAVING WORSENING CARDIOGENIC SHOCK AND PLACED AN IMPELLA CATHETER. THERE WERE NO FURTHER ATTEMPTS AT RECANALIZATION OF THIS HEAVILY STENTED ARTERY AND THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) IN CRITICAL CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469812 ↗
• InjuryNov 15, 2023Failure to Advance; Activation Failure; Failure to Advance; Activation Failure

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED. IT WAS NOTED THAT AFTER THE PERFORATION OF THE MID LAD WAS WAS OBSERVED RESULTING IN TAMPONADE. A PERICARDIAL DRAIN WAS PLACED EMERGENTLY. THE PATIENT REMAINED UNSTABLE WITH INTERMITTENT PULSELESS ELECTRICAL ACTIVITY (PEA) AND RECEIVED SHOCKS FOR VENTRICULAR FIBRILLATION IN ADDITION, TO ADVANCE CARDIOVASCULAR LIFE SUPPORT (ACLS) AND HIGH DOSE PRESSORS/INOTROPES. BALLOON TAMPONADE DID NOT SEAL THE PERFORATION AND BOTH GRAFTMASTERS COULD NOT BE DELIVERED DUE TO ANATOMY. OPEN CARDIAC SURGERY WAS ATTEMPTED; HOWEVER, PATIENT EXPIRED ON THE TABLE. PER THE PHYSICIAN'S OPINION BOTH GRAFTMASTERS DID NOT CAUSE OR CONTRIBUTE TO PATIENT'S DEATH AS THE PATIENT'S WAS ALREADY DECLINING TO DEATH, PRIOR TO THE ADVANCEMENTS OF THE GRAFTMASTERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Heart Problem

  MAUDE report 18141742 ↗
• DeathOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT THE OCCLUSION WAS DUE TO THROMBUS AND ANGIOPLASTY WAS PERFORMED; HOWEVER, THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Nausea; Obstruction/Occlusion; Pain; Thrombosis/Thrombus

  MAUDE report 18012661 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CRITICAL THREATENING LIMB ISCHEMIA OF THE RIGHT LOWER EXTREMITY. A 6FR 45 CM SHEATH AND A SUPRA CORE GUIDE WIRE WERE ADVANCED AND PARKED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE POSTERIOR TIBIAL ARTERY AND THE PERONEAL ARTERIES WERE BALLOONED BUT THERE WAS DIFFICULTY CROSSING TO THE POSTERIOR TIBIAL ARTERY. THEREFORE, A 5FR SHEATH WAS INTRODUCED AS WELL AS A STIFF NON-ABBOTT EXTRA SUPPORT GUIDEWIRE AND THE TARGET LESION WAS ACCESSED AND CONFIRMED WITH ANGIOGRAM. A 2.5 MM AND THEN A 3 MM BALLOON WAS INFLATED FOR ALMOST 10 MINUTES AND THERE WAS EXTRAVASATION OF CONTRAST. STENTING WAS PERFORMED IN THE RIGHT POPLITEAL AND RIGHT SUPERFICIAL FEMORAL ARTERIES WITH 7X120 MM, 7X100 MM AND 6X120 MM DRUG ELUTING STENTS FOLLOWED BY BALLOON ANGIOPLASTY WITH A 6X100 MM BALLOON. THE EXTRAVASATION IN THE POSTERIOR TIBIAL ARTERY WAS TREATED WITH A 2.8X19 MM, 2.8X26 MM, AND TWO 3.5X19 MM GRAFTMASTER COVERED STENTS. COMPLETE ANGIOGRAM SHOWED COMPLETE CESSATION OF THE EXTRAVASATION WITH GOOD FLOW TO THE LEVEL OF THE POSTERIOR TIBIAL ARTERY. THERE WAS CALF SWELLING AND THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO RELEASE THE COMPARTMENT SYNDROME. THE

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 17951450 ↗
• InjuryJun 1, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CARDIOMYOPATHY (ENLARGED HEART), EJECTION FRACTION 25%, THROAT CANCER AND FAILURE TO THRIVE. A 4.0X23MM XIENCE STENT WAS IMPLANTED WITHOUT ISSUE TO TREAT SIGNIFICANT STENOSIS AND CALCIFICATION IN THE PROXIMAL LAD. A GUIDEWIRE (GW) PERFORATION OCCURRED DUE TO A NON-ABBOTT GW. THE GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED FOR TREATMENT, BUT FAILED TO REACH THE PERFORATION DUE TO THE CALCIFICATION IN THE MID LAD. THE BLEEDING FROM THE PERFORATION WAS STOPPED USING FAT EMBOLIZATION. THE PATIENT WENT INTO CARDIAC ARREST FROM THE BLEEDING, WHICH CAUSED CARDIAC TAMPONADE. CPR WAS PERFORMED AND THE PATIENT WAS INTUBATED. PATIENT TRANSFERRED TO ICU AND ON THE SAME DAY THE PATIENT EXPIRED. THE PATIENT REPORTEDLY EXPIRED DUE TO THE PRE-EXISTING CONDITIONS. THE GRAFTMASTER COVERED STENT DID NOT CAUSE OR CONTRIBUTE THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039737 ↗
• InjuryMay 12, 2023Failure to Advance; Deformation Due to Compressive Stress; Failure to Advance; Deformation Due to Compressive Stress

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919373 ↗
• InjuryMay 8, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.8X26MM GRAFTMASTER WAS ATTEMPTED TO ADVANCE; HOWEVER, MET RESISTANCE WITH THE HEAVY CALCIFICATION AND FAILED TO CROSS. IT WAS NOTED THE STENT STRUTS BECAME FLARED. THREE ADDITIONAL (2.8X16MM, 2.8X16MM, 3.5X16) GRAFTMASTER COVERED STENT DELIVERY SYSTEMS (SDS) WERE ADVANCED, BUT ALL BECAME KINKED AT THE PROXIMAL SHAFT DURING ADVANCEMENT DUE TO RESISTANCE WITH THE ANATOMY. ALL THREE GFRAFTMASTER SDS SEPARATED AT THE PROXIMAL SHAFT DURING REMOVAL. THE PATIENT WAS TRANSFERRED TO OUTSIDE FACILITY FOR CORONARY ARTERY BYPASS GRAFT (CABG) EMERGENT; HOWEVER, WAS DENIED. THEREFORE, THE PATIENT RETURNED AND THE PERFORATION WAS COILED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886371 ↗
• MalfunctionOct 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRE-DILATATIONS WERE PERFORMED THROUGH THE ENTIRE STENTED VESSEL OF THE LAD. ADDITIONAL DILATATION WAS PERFORMED IN THE DISTAL SEGMENT OF THE STENTS. FOLLOWING THIS, THE BALLOON RUPTURED AND THERE WAS LOCALIZED EXTRAVASATION OF CONTRAST. THE PHYSICIAN FELT THAT THERE MIGHT BE A POSSIBLE PERFORATION. THE 2.8X26MM GRAFTMASTER STENT FAILED TO CROSS PAST THE MID SEGMENT OF THE LAD AND COULD NOT BE DEPLOYED IN THE MORE DISTAL SEGMENT. SIMILARLY, THE GRAFTMASTER COULD NOT BE WITHDRAWN INTO THE GUIDE CATHETER THEREFORE IT WAS DEPLOYED IN THE PROXIMAL LAD AT THE LEVEL OF THE PREVIOUS STENOSIS AND IN-STENT RESTENOSIS. FINAL ANGIOGRAM REVEALED A FULLY PATENT VESSEL WITH TIMI III DISTAL FLOW AFTER THE PROCEDURE WAS COMPLETED WITH A STENT IMPLANTED. THE PHYSICIAN NOTED THAT IT WAS JUST A LOCAL EXTRAVASATION OF CONTRAST DUE TO THE BALLOON RUPTURE. IT WAS CONFIRMED THERE WAS NO PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE FAILURE TO CROSS. THE PATIENT LEFT THE HOSPITAL IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650903 ↗
• InjuryOct 19, 2022Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION AND HYPOTENSION. THE FIRST (3X28MM) AND SECOND (3X18MM) SKYPOINT STENTS WERE IMPLANTED WITHOUT ISSUE. THE 3RD (2.5X18MM) SKYPOINT WAS ADVANCED TO THE DIAGONAL ARTERY (DX) AND IMPLANTED WITHOUT ISSUE. HOWEVER, AFTER IMPLANTING THE 3RD (2.5X18MM) SKYPOINT IN THE DX, IT WAS THEN NOTED THAT THERE WAS A PERFORATION CAUSED BY THE FIRST (3X28MM) SKYPOINT STENT IN THE LAD. A 2.8X26MM RX GRAFTMASTER (GM) STENT WAS DECIDED TO BE USED TO TREAT THE PERFORATION. THE GM STENT WAS ADVANCED BUT FAILED TO CROSS INITIALLY DUE TO THE FLARED STENT STRUTS OF THE IMPLANTED (2.5X18MM) SKYPOINT IN THE DX, BUT ULTIMATELY CROSSED IN A SECOND ATTEMPT (GM STENT WAS REMOVED AND REINSERTED). ONCE THE GM STENT WAS IMPLANTED, THE PERFORATION WAS SEALED SUCCESSFULLY. BUT THEN THERE WAS ACUTE THROMBUS THAT PRESENTED IN THE GM STENT. PATIENT EXPERIENCED CHEST PAIN. THE THROMBUS WAS TREATED WITH 2 ADDITIONAL (2.5X12MM AND 3X12MM) SKYPOINT STENTS AND MEDICATION FOR THE CHEST PAIN. PATIENT WAS FINE AFTERWARDS, THERE WERE NO OTHER ISSUES PRESENTED. NO ADDITIONAL INFORMATION WA

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 15636349 ↗
• InjurySep 15, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428675 ↗
• DeathNov 22, 2021Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FREE PERFORATION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 4.0X16MM RX GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED AND IT WAS NOTED THAT THE FIRST STENT WOULD NOT PASS TO THE PERFORATION DUE TO THE BULKINESS OF THE STENT. A SECOND 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. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT A 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 ATMS AND DID

  Patient problems: Cardiac Arrest; Cardiogenic Shock

  MAUDE report 12856073 ↗
• DeathNov 22, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A PERFORATION OCCURRED DURING USE OF AN UNSPECIFIED DEVICE. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE 3.5 X 19 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY; HOWEVER, DUE TO THE PATIENT ANATOMY AND CPR, THE DEVICE WAS UNABLE TO CROSS AND WAS REMOVED. THE 2.8 X 26 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS THEN ADVANCED INTO THE PATIENT ANATOMY; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS. THE PATIENT CONDITION CONTINUED TO DECLINE AND A CLINICALLY SIGNIFICANT DELAY WAS REPORTED RELATED TO THE FAILURE TO CROSS OF BOTH DEVICES. A DILATATION CATHETER WAS ADVANCED TO THE TARGET SITE AND INFLATED, SEALING THE PERFORATION; HOWEVER, THE PATIENT DIED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Failure of Implant; Perforation

  MAUDE report 12855810 ↗
• InjuryOct 28, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN DECLINING HEALTH WITH A FREE PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.8X26MM GRAFTMASTER COVERED STENT WAS ADVANCED BUT DUE TO THE CALCIFIED AND DIFFICULT ANATOMY, AND INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, THE GRAFTMASTER COVERED STENT DISLODGED FROM THE DELIVERY SYSTEM AND WAS EMBEDDED IN THE CORONARY ARTERY. SUBSEQUENTLY, THE PREVIOUSLY PLACED STENTS WERE RE-DILATED WITH A LARGER BALLOON AT HIGHER PRESSURES, AND A GUIDELINER WAS USED TO SUCCESSFULLY DELIVER A 3.5X26MM GRAFTMASTER COVERED STENT WHICH SEALED THE PERFORATION. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE OF MULTIPLE ORGAN SYSTEM FAILURE DUE TO DECLINING HEALTH. PER THE PHYSICIAN, THE GRAFTMASTER STENTS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DECLINING HEALTH OR DEATH. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12712376 ↗
• InjurySep 14, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED FOR A PERCUTANEOUS CORONARY INTERVENTION ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A NON-ABBOTT GUIDE WIRE PASSED WITH SOME DIFFICULTY DUE TO THE TIGHT STENOSIS. NON-ABBOTT CATHETERS WERE UNABLE TO CROSS THE LESION. AN UNSPECIFIED BALLOON CATHETER HAD ALSO FAILED TO CROSS. IT WAS THEN DECIDED TO PERFORM LASER ATHERECTOMY. ATHERECTOMY WAS PERFORMED. THE NON-ABBOTT CATHETER WAS REINSERTED AND CROSSED. ROTABLATION WAS PERFORMED AND A CONTAINED PERFORATION WAS NOTED FOLLOWING. BALLOON ANGIOPLASTY WAS PERFORMED AND A 2.8X26MM GRAFTMASTER STENT DELIVERY SYSTEM HAD FAILED TO CROSS THE SEVERELY CALCIFIED LESION TO TREAT THE PERFORATION. IN REPLACEMENT, TWO XIENCE STENTS WERE USED WITHOUT ISSUES REPORTED, SEALING THE ENTIRE PERFORATION. ANGIOGRAPHY SHOWED 0% RESIDUAL STENOSIS AND A SEALED PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471384 ↗
• InjuryJul 30, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE 2.8X26 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS INSERTED TO TREAT THE PERFORATION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, BUT THE SDS WAS UNABLE TO CROSS. THIS SDS WAS REMOVED AND REPLACED WITH THE 2.8X19 MM GRAFTMASTER SDS, WHICH SUCCESSFULLY CROSSED AND WAS IMPLANTED TO TREAT 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 12256724 ↗
• InjuryJul 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A SMALL PERFORATION OCCURRED DURING THE PROCEDURE. THE 2.8X26 MM GRAFTMASTER STENT WAS IMPLANTED, BUT THE LEAK CONTINUED. THE SECOND 2.8X26 MM GRAFTMASTER STENT WAS IMPLANTED, BUT THE LEAK PERSISTED. COILS WERE IMPLANTED AND SUCCESSFULLY SEALED THE PERFORATION. THERE WERE NO ISSUES WITH THE GRAFTMASTER BESIDES THE PERFORATION NOT BEING SEALED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207107 ↗
• InjuryJul 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A SMALL PERFORATION OCCURRED DURING THE PROCEDURE. THE 2.8X26 MM GRAFTMASTER STENT WAS IMPLANTED, BUT THE LEAK CONTINUED. THE SECOND 2.8X26 MM GRAFTMASTER STENT WAS IMPLANTED, BUT THE LEAK PERSISTED. COILS WERE IMPLANTED AND SUCCESSFULLY SEALED THE PERFORATION. THERE WERE NO ISSUES WITH THE GRAFTMASTER BESIDES THE PERFORATION NOT BEING SEALED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206949 ↗
• InjuryJul 15, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS USED TO TREAT A PERFORATION CAUSED BY AN UNSPECIFIED DEVICE. THE GRAFTMASTER SDS WAS ADVANCED INTO THE PATIENT ANATOMY; HOWEVER, DIFFICULTY WAS MET DUE TO THE PATIENT ANATOMY AND THE DELIVERABILITY OF THE DEVICE. THE 2.8 X 16 MM GRAFTMASTER COULD NOT BE ADVANCED COMPLETELY ACROSS THE PERFORATION. THE STENT WAS DEPLOYED; HOWEVER, THE PERFORATION WAS ONLY PARTIALLY SEALED. A SECOND GRAFTMASTER SDS, A 2.8 X 26 MM, WAS ADVANCED; HOWEVER, THIS DEVICE WAS UNABLE TO CROSS DUE TO THE PATIENT ANATOMY AND THE DELIVERABILITY OF THE DEVICE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. ADDITIONAL BALLOON DILATATION WAS PERFORMED TO SEAL THE PERFORATION. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178543 ↗
• InjuryMar 31, 2021Failure to Advance; Failure to Advance

  THE PATIENT PRESENTED WITH A FREE PERFORATION IN THE 1ST DIAGONAL. A 2.5X12MM UNSPECIFIED BALLOON STENT WAS DEPLOYED AND SUBSEQUENT ANGIOGRAM REVEALED A PERFORATION NEAR THE DISTAL STENT EDGE. THE UNSPECIFIED STENT BALLOON WAS ADVANCED BACK INTO THE VESSEL AND INFLATED. ANGIOGRAM WAS PERFORMED WITH BALLOON INFLATED AND NO ADDITIONAL DYE EXTRAVASATION WAS PRESENT. THE BALLOON WAS LEFT INFLATED WHEN A 2.80X26MM RX GRAFTMASTER WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS THROUGH THE PROXIMAL CALCIUM IN THE LEFT ANTERIOR DESCENDING ARTERY. ANOTHER PROLONGED INFLATION WAS PERFORMED AND THERE WAS NO FURTHER DYE EXTRAVASATION THEREFORE, PERFORATION WAS SEALED. PATIENT HAD STABLE BLOOD FLOW AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS NEGATIVE FOR PERICARDIAL EFFUSION. NO FURTHER ATTEMPT WAS MADE TO REWIRE AS THE PHYSICIAN DID NOT WANT TO REOPEN THE PERFORATION. PATIENT HAD NO CHEST PAIN AND WAS MONITORED OVERNIGHT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599831 ↗
• InjuryNov 19, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. A GRAFTMASTER COVERED STENT SYSTEM WAS ADVANCED BUT FAILED TO REACH THE PERFORATION DUE TO THE CALCIFIED ANATOMY. A DIFFERENT COVERED CORONARY STENT WAS USED TO SEAL THE PERFORATION. THE PATIENT ULTIMATELY DID WELL. USE OF THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO ANY COMPLICATIONS OR ADVERSE PATIENT EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871789 ↗
• InjuryApr 8, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PRE-EXISTING PERFORATION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X26MM GRAFTMASTER STENT DELIVERY SYSTEM FAILED TO CROSS A NON-ABBOTT STENT. THE PERFORATION WAS SEALED WITH BYPASS SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934012 ↗