ABSORB GT1 1235350-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648213144), received between Aug 9, 2016 and May 17, 2017 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS TO TREAT A SEVERELY DISEASED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT PRESENTED WITH ANGINA AND WAS IN SINUS RHYTHM. THE PATIENT HAD A HISTORY OF INTERMITTENT ATRIAL FIBRILLATION AND WAS ON AN ANTI-ARRHYTHMIC MEDICATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED THROUGHOUT THE PROCEDURE. THE VESSEL WAS DETERMINED TO BE 3.5MM TO 3.75MM IN DIAMETER. RESTENOSIS WAS CONFIRMED IN THE LAD FROM TWO LAYERS OF PREVIOUSLY IMPLANTED STENTS (3.0MM AND 2.75MM) WHICH WERE UNDER DEPLOYED. PRE-DILATATION WAS PERFORMED WITH A 3.5X20MM NC BALLOON. THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. TWO 3.5X28MM ABSORB GT1 SCAFFOLDS WERE IMPLANTED AND POST-DILATED WITH 3.4MM AND 4.0MM BALLOONS. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. THE DISTAL END OF THE LAD WAS TOO SMALL FOR A STENT; HOWEVER, IT WAS DILATED WITH 2.0MM BALLOON CATHETER. ON (B)(6) 2017, THE PATIENT RETURNED WITH ANGINA AND ELEVATED LEVELS OF TROPONIN. THE PATIENT HAD A TROPONIN MEASUREMENT OF 2.8 ON ADMISSION THAT ELEVATED TO A 5. A TOTAL OCCLUSION (THROMBOSIS) WAS CONFIRMED BETWEEN THE TWO PREVIOUSLY IMPLANTED ABSORB GT1 SCAFFOLDS. A THR

  Patient problems: Angina; Atrial Fibrillation; Cardiac Enzyme Elevation; Thrombosis

  MAUDE report 6573269 ↗
• InjuryMay 17, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS TO TREAT A SEVERELY DISEASED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT PRESENTED WITH ANGINA AND WAS IN SINUS RHYTHM. THE PATIENT HAD A HISTORY OF INTERMITTENT ATRIAL FIBRILLATION AND WAS ON AN ANTI-ARRHYTHMIC MEDICATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED THROUGHOUT THE PROCEDURE. THE VESSEL WAS DETERMINED TO BE 3.5MM TO 3.75MM IN DIAMETER. RESTENOSIS WAS CONFIRMED IN THE LAD FROM TWO LAYERS OF PREVIOUSLY IMPLANTED STENTS (3.0MM AND 2.75MM) WHICH WERE UNDER DEPLOYED. PRE-DILATATION WAS PERFORMED WITH A 3.5X20MM NC BALLOON. THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. TWO 3.5X28MM ABSORB GT1 SCAFFOLDS WERE IMPLANTED AND POST-DILATED WITH 3.4MM AND 4.0MM BALLOONS. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. THE DISTAL END OF THE LAD WAS TOO SMALL FOR A STENT; HOWEVER, IT WAS DILATED WITH 2.0MM BALLOON CATHETER. ON (B)(6) 2017, THE PATIENT RETURNED WITH ANGINA AND ELEVATED LEVELS OF TROPONIN. THE PATIENT HAD A TROPONIN MEASUREMENT OF 2.8 ON ADMISSION THAT ELEVATED TO A 5. A TOTAL OCCLUSION (THROMBOSIS) WAS CONFIRMED BETWEEN THE TWO PREVIOUSLY IMPLANTED ABSORB GT1 SCAFFOLDS. A THR

  Patient problems: Angina; Atrial Fibrillation; Cardiac Enzyme Elevation; Thrombosis

  MAUDE report 6573268 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS TO TREAT A STENOSIS IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. PRIOR TO THE INITIAL PROCEDURE, THE PATIENT'S CLINICAL PRESENTATION WAS UNSTABLE ANGINA. PRE-DILATATION WAS PERFORMED WITH A 3 X 12 MM BALLOON. A 3.5 X 28 MM ABSORB GT1 SCAFFOLD WAS DEPLOYED WITH POST-DILATATION PERFORMED USING A 3.5 X 20 NON-COMPLIANT BALLOON TO 20 ATMOSPHERES WITH THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS LESS THAN 10%. IT WAS CONFIRMED THAT THE PATIENT HAD STOPPED DAPT 10 DAYS AFTER THE INDEX PROCEDURE. THE PATIENT WAS READMITTED ON (B)(6) 2017 AS HE WAS SYMPTOMATIC WITH CHEST PAIN WHEN THROMBOSIS WAS DIAGNOSED. THE THROMBOSIS WAS TREATED WITH A XIENCE STENT. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6528615 ↗
• InjuryFeb 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. PRE-DILATATION WAS PERFORMED WITH SEVERAL BALLOONS (1.5X8MM, 2.0X12MM, 2.5X18MM, 3.5X12MM). THE 3.5X28MM ABSORB GT1 SCAFFOLD WAS DEPLOYED AND POST-DILATED WITH A 3.5X12MM BALLOON. AFTER POST-DILATATION, AN EDGE DISSECTION WAS OBSERVED WHICH WAS TREATED BY IMPLANTING ANOTHER ABSORB SCAFFOLD. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6349848 ↗
• InjuryJan 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH AORTIC CORONARY STENOSIS AND UNDERWENT A CORONARY PROCEDURE TO TREAT TARGET LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). THE 3.5 X 28 MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED IN THE LAD AND A 2.25 X 15 MM XIENCE ALPINE WAS IMPLANTED IN THE RCA. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) WAS DIAGNOSED. ANGIOGRAPHY NOTED THROMBOSIS IN THE 3.5 X 28 MM ABSORB SCAFFOLD. THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE, WITH IMPLANTATION OF A 3.0 X 23 MM XIENCE ALPINE STENT AND A 3.0 X 12 MM XIENCE ALPINE STENT INSIDE THE ABSORB SCAFFOLD. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION AND THE EVENT RESOLVED. REPORTEDLY, THE PATIENT WAS NOT COMPLIANT WITH BRILINTA ADMINISTRATION, AS HE REPORTED THAT HE COULD NOT AFFORD THE PRESCRIPTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 6286896 ↗
• InjuryAug 9, 2016Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT. A 3.5 X 28 MM ABSORB GT1 SCAFFOLD WAS DEPLOYED AT 14 ATMOSPHERES; HOWEVER, ANGIOGRAPHY REVEALED A PERFORATION. TWO GRAFTMASTER COVERED STENTS (3.5 X 18 MM AND 3.5 X 26 MM) WERE SUCCESSFULLY USED TO SEAL THE PERFORATION. THE PATIENT HAD TO HAVE BLOOD TRANSFUSIONS, RECEIVED CARDIOPULMONARY RESUSCITATION (CPR) AND WAS PUT ON AN INTRA-AORTIC BALLOON PUMP. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Perforation

  MAUDE report 5857065 ↗