ABSORB GT1 1235250-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648212970), received between Aug 9, 2016 and May 10, 2017 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 18, 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 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2017 WAS TO TREAT A 67% STENOSED, NON-TORTUOUS, AND NON-CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT PRESENTED WITH HEART FAILURE AND UNSTABLE ANGINA. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED THROUGHOUT THE PROCEDURE. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5 MM. PRE-DILATATION WAS PERFORMED WITH A NC TREK BALLOON CATHETER AT NOMINAL PRESSURE. THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. A 2.5X23MM ABSORB GT1 SCAFFOLD WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH A NC TREK BALLOON DILATATION CATHETER. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. OCT CONFIRMED THAT THE SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL. THE PATIENT WAS COMPLIANT IN FOLLOWING THE DUAL ANTIPLATELET THERAPY (DAPT) OF CLOPIDOGREL AFTER THE PROCEDURE. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 WITH CHEST PAIN AND ELEVATED LEVELS OF TROPONIN. AN OCT WAS PERFORMED AND CONFIRMED RESTENOSIS IN THE PREVIOUSLY IMPLANTED SCAFFOLD. THE RESTENOSIS WAS TREATED WITH LASER ATHERECTOMY AND A 2.5X28MM XIENCE ALPINE STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Stenosis

  MAUDE report 6558756 ↗
• InjuryMar 14, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY DISEASED LESION WITH 95% STENOSIS DISTAL TO THE INTERNAL MAMMARY ARTERY. THE PATIENT CAME IN TO THE HOSPITAL ON (B)(6) 2016 WITH ANGINA. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED THROUGHOUT THE PROCEDURE. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5 MM. PRE-DILATATION WAS PERFORMED WITH AN UNKNOWN 2.5MM BALLOON DILATATION CATHETER AT 24 ATMOSPHERES (ATMS). THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. A 2.5X23MM ABSORB GT1 SCAFFOLD WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH AN UNKNOWN BALLOON AT 24 ATMS. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. IVUS CONFIRMED THAT THE SCAFFOLD WERE FULLY APPOSED TO THE VESSEL WALL. IT IS UNKNOWN IF THE PATIENT WAS COMPLIANT IN FOLLOWING THE DUAL ANTIPLATELET THERAPY (DAPT) AFTER THE PROCEDURE. ON (B)(6) 2017, THE PATIENT RETURNED WITH ANGINA AND RESTENOSIS WAS OBSERVED. THE RESTENOSIS OF 70% WAS TREATED WITH A 2.5X33MM METALLIC STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 6404603 ↗
• InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLANNED PROCEDURE ON (B)(6) 2016 WAS TO TREAT MILDLY CALCIFIED LESIONS IN THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING ARTERIES. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED FOR VESSEL SIZING AND BOTH VESSELS WERE DETERMINED TO BE 2.6 MM. PRE-DILATATION WAS PERFORMED IN BOTH LESIONS, REDUCING THE STENOSIS TO LESS THAN 40%. THE TWO 2.5 X 23 MM ABSORB GT1 SCAFFOLDS WERE IMPLANTED AND POST-DILATED WITH A NON-COMPLIANT BALLOON REDUCING THE STENOSIS TO LESS THAN 10%. OCT WAS USED TO CONFIRM GOOD VESSEL WALL APPOSITION. THE PATIENT WAS GIVEN BRILINTA DURING THE PROCEDURE, BUT BECAUSE IT WAS NOT COVERED BY INSURANCE, THE PATIENT WAS PRESCRIBED PLAVIX FOR DUAL ANTIPLATELET DRUG THERAPY (DAPT). THE PATIENT RETURNED ON (B)(6) 2016 WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THROMBOSIS WAS CONFIRMED IN BOTH SCAFFOLDS. THE THROMBOSIS WAS ASPIRATED FOLLOWED BY IMPLANTING 3.0 XIENCE ALPINE STENTS IN EACH OF THE SCAFFOLDS. THE FINAL PATIENT OUTCOME WAS GOOD. THE PATIENT CONFIRMED HE WAS COMPLIANT WITH DAPT AFTER THE INITIAL PROCEDURE. THE PHYSICIAN COMMENTED THAT THE THROMBOSIS MAY HAVE BEEN DUE TO SWITCHING THE MEDICATION FROM BRILINTA TO PLAVIX. NO ADDITIONAL INFOR

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6255034 ↗
• InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLANNED PROCEDURE ON (B)(6) 2016 WAS TO TREAT MILDLY CALCIFIED LESIONS IN THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING ARTERIES. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED FOR VESSEL SIZING AND BOTH VESSELS WERE DETERMINED TO BE 2.6 MM. PRE-DILATATION WAS PERFORMED IN BOTH LESIONS, REDUCING THE STENOSIS TO LESS THAN 40%. THE TWO 2.5 X 23 MM ABSORB GT1 SCAFFOLDS WERE IMPLANTED AND POST-DILATED WITH A NON-COMPLIANT BALLOON REDUCING THE STENOSIS TO LESS THAN 10%. OCT WAS USED TO CONFIRM GOOD VESSEL WALL APPOSITION. THE PATIENT WAS GIVEN BRILINTA DURING THE PROCEDURE, BUT BECAUSE IT WAS NOT COVERED BY INSURANCE, THE PATIENT WAS PRESCRIBED PLAVIX FOR DUAL ANTIPLATELET DRUG THERAPY (DAPT). THE PATIENT RETURNED ON (B)(6) 2016 WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THROMBOSIS WAS CONFIRMED IN BOTH SCAFFOLDS. THE THROMBOSIS WAS ASPIRATED FOLLOWED BY IMPLANTING 3.0 XIENCE ALPINE STENTS IN EACH OF THE SCAFFOLDS. THE FINAL PATIENT OUTCOME WAS GOOD. THE PATIENT CONFIRMED HE WAS COMPLIANT WITH DAPT AFTER THE INITIAL PROCEDURE. THE PHYSICIAN COMMENTED THAT THE THROMBOSIS MAY HAVE BEEN DUE TO SWITCHING THE MEDICATION FROM BRILINTA TO PLAVIX. NO ADDITIONAL INFOR

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6255032 ↗
• InjuryAug 19, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY TORTUOUS. PRE-DILATATION WAS PERFORMED WITH A 2.0 X 20MM NC TREK. AN ABSORB 2.5 X 23 MM BIORESORBABLE VASCULAR SCAFFOLD WAS DEPLOYED WHEN A PROXIMAL EDGE DISSECTION WAS NOTED. A XIENCE ALPINE 3.0 X 38 MM STENT WAS USED TO COVER THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 5890344 ↗
• InjuryAug 9, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT THE OBTUSE MARGINAL ARTERY OFF THE CIRCUMFLEX ARTERY. THE PATIENT WAS REFERRED TO THE HOSPITAL FROM A DIFFERENT HOSPITAL FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 MM UNKNOWN BALLOON CATHETER. A 2.5 X 23 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED AT 12 ATMOSPHERES. POST-DILATATION WAS PERFORMED WITH A 2.5 X 15 MM UNKNOWN NC BALLOON CATHETER TO 20 ATMOSPHERES. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. OPTICAL COHERENCE TOMOGRAPHY (OTC) WAS PERFORMED PRE IMPLANT BUT NOT POST IMPLANT. IT IS UNKNOWN OF IF THE SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL. THE PATIENT WAS PUT ON PLAVIX AND ASPIRIN. ON 7/28/16, THE PATIENT PRESENTED AT A DIFFERENT HOSPITAL WITH CHEST PAIN AND ST ELEVATED ELECTROCARDIOGRAM (EKG). ANGIOGRAPHY CONFIRMED IN-SCAFFOLD THROMBOSIS WHICH WAS TREATED WITH 2 NON-ABBOTT STENTS. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY UP TO THE TIME HE WAS RE-ADMITTED. THE PATIENT REMAINED ON PLAVIX AND ASPIRIN. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 5860129 ↗