ABSORB GT1 1235300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648213045), received between Aug 18, 2016 and Nov 7, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Difficult To Position” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AN ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED SOMETIME IN (B)(6) 2014 TO TREAT AN ANTERIOR MYOCARDIAL INFARCT IN THE RAMUS INTERVENTRICULARIS ANTERIOR (RIVA). SEVEN YEARS LATER, ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED WITH A MYOCARDIAL INFARCT DUE TO AN ANGIOGRAPHICALLY PROVEN VERY LATE THROMBOSIS OF THE BVS. OF NOTE, THE BVS WAS FULLY ABSORBED AND THE AREA ENDOTHELIALIZED, WITH ONLY SIGNS OF THE MARKERS VISIBLE. THE VESSEL WAS DILATED WITH AN UNSPECIFIED 2.5 X 15 MM BALLOON AND A NON-ABBOTT 3.5 X 23 MM STENT WAS IMPLANTED. PATIENT DID VERY WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 12756257 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2017, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (RCA) LESION. FOLLOWING PRE-DILATATION, A 3.0X18MM ABSORB GT1 SCAFFOLD (1235300-18, 6100461) WAS SUCCESSFULLY IMPLANTED IN THE DISTAL RCA. ON (B)(6) 2017, ANOTHER PCI WAS PERFORMED. FOLLOWING PRE-DILATATION, A 3.0X23MM ABSORB SCAFFOLD (1235300-23, 6101161) WAS SUCCESSFULLY IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. THERE WERE NO ADVERSE EVENTS AND THERE WAS NO DEVICE MALFUNCTION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR UNSTABLE ANGINA. IN-SCAFFOLD RESTENOSIS WAS OBSERVED IN THE 3.0X18MM ABSORB GT1 RCA SCAFFOLD. ANOTHER PCI WITH ATHERECTOMY AND BALLOON DILATATION WAS PERFORMED AS TREATMENT. PER PHYSICIAN, THE EVENT WAS NOT RELATED TO A DEVICE DEFICIENCY. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 10813960 ↗
• InjuryJun 22, 2020Material Deformation; Material Deformation

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2017, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (RCA) LESION. FOLLOWING PRE-DILATATION, A 3.0X18MM ABSORB GT1 SCAFFOLD (1235300-18, 6100461) WAS SUCCESSFULLY IMPLANTED IN THE DISTAL RCA. ON (B)(6) 2017, ANOTHER PCI WAS PERFORMED. FOLLOWING PRE-DILATATION, A 3.0X23MM ABSORB SCAFFOLD (1235300-23, 6101161) WAS SUCCESSFULLY IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. THERE WERE NO ADVERSE EVENTS AND THERE WAS NO DEVICE MALFUNCTION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED. A CORONARY ANGIOGRAM WAS PERFORMED AND SILENT MYOCARDIAL ISCHEMIA DIAGNOSED. THE DISTAL RCA, 3.0X18MM ABSORB SCAFFOLD, WAS OBSERVED WITH RESTENOSIS AND A FLARED STRUT. AS TREATMENT, AN ATHERECTOMY WAS PERFORMED. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO RESTENOSIS AND NO DEVICE ISSUE REGARDING THE 1ST DIAGONAL, 3.0X23MM ABSORB SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Ischemia; Stenosis

  MAUDE report 10179822 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2019. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2019 AND A 2.75 X 26 MM DRUG ELUTING STENT WAS IMPLANTED TO TREAT IN-STENT RESTENOSIS. THE PATIENT CONDITION RESOLVED ON (B)(6) 2019 AND THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 8458671 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 3.0X18 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2018 AT THE ONE YEAR FOLLOW-UP VISIT, CORONARY ANGIOGRAM WAS PERFORMED WHICH FOUND ASYMPTOMATIC ISCHEMIA. A DE NOVO LESION WAS FOUND IN THE PROXIMAL LAD, PROXIMAL TO THE MID LAD SCAFFOLD. ON (B)(6) 2018 PERCUTANEOUS CORONARY INTERVENTION WAS SUCCESSFULLY PERFORMED IN THE LAD. OCT (OPTICAL COHERENCE TOMOGRAPHY) FOUND STENOSIS IN THE PROXIMAL SEGMENT OF THE MID LAD SCAFFOLD. THE DISTAL LAD ALSO HAD 50% STENOSIS. BALLOON ANGIOPLASTY WAS PERFORMED WITH A DRUG COATED BALLOON DILATATION IN THE STENOSIS AND ON THE PROXIMAL AND DISTAL ENDS OF THE SCAFFOLD. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Stenosis

  MAUDE report 7844494 ↗
• InjuryJul 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF A 3.0 X 18 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.25 X 23MM XIENCE ALPINE STENT IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS PRESCRIBED DUAL ANTI-PLATELET THERAPY (DAPT) OF ASPIRIN AND CLOPIDOGREL AND WAS DISCHARGED TO HOME. ON (B)(6)2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBOSIS IN BOTH THE ABSORB BVS AND IN THE XIENCE STENT. THE PATIENT REPORTED BEING NON-COMPLIANT WITH DAPT. THROMBECTOMY WAS PERFORMED. TWO ADDITIONAL XIENCE ALPINE STENTS WERE IMPLANTED; ONE IN THE ABSORB SCAFFOLD IN THE LAD AND ONE IN THE XIENCE ALPINE STENT IN THE RCA. THE CLOPIDOGREL WAS CHANGED TO TICAGRELOR AND THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. ON (B)(6)2017, THE PATIENT WAS RE-HOSPITALIZED AGAIN, WITH ANGINA, AND THROMBOSIS WAS NOTED IN BOTH LOCATIONS (LAD AND RCA). THE PATIENT WAS ADMITTED IN CARDIOGENIC SHOCK WITH BLOOD PRESSURE OF 80/59. AN INTRA-AORTIC BALLOON PUMP AND A TEMPORARY PACEMAKER WERE PLACED AND THE BLOOD PRESSURE INCREASED TO THE 150-160 RA

  Patient problems: Angina; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 6734926 ↗
• InjuryApr 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT A STENOSIS IN THE POSTERIOR DESCENDING CORONARY ARTERY. PRIOR TO THE INITIAL PROCEDURE, THE PATIENT'S CLINICAL PRESENTATION WAS UNSTABLE ANGINA. FOR THE INDEX PROCEDURE, IT IS UNKNOWN HOW THE LESION WAS PREPPED HOWEVER AFTER IMPLANTATION OF THE ABSORB GT1 3.0 X 18 MM SCAFFOLD, POST-DILATATION WAS PERFORMED WITH AN NC TREK 3 X 12 MM BALLOON DILATATION CATHETER WITH FINAL ANGIOGRAPHIC RESIDUAL STENOSIS LESS THAN 10%. THE PATIENT WAS READMITTED ON (B)(6) 2017 PRESENTING WITH CHEST PAIN WHEN THROMBOSIS WAS DIAGNOSED. THE THROMBOSIS WAS TREATED WITH A 2.25 X 14 NON-ABBOTT STENT. THE PATIENT OUTCOME WAS GOOD. IT IS UNKNOWN IF PATIENT WAS COMPLIANT WITH DUAL ANTI PLATELET THERAPY (DAPT) AFTER THE INITIAL PROCEDURE OR IF THERE HAVE BEEN ANY CHANGES TO THE PATIENT'S MEDICATIONS FOLLOWING THE DIAGNOSIS OF THROMBUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6513740 ↗
• InjuryMar 7, 2017Difficult To Position

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT A TARGET LESION IN THE DIAGONAL ARTERY. PRE-DILATATION WAS PERFORMED AT THE TARGET LESION AND THE 3.0 X 18 MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED WITHOUT DIFFICULTY. POST DILATATION WAS PERFORMED AND A PERFORATION WAS NOTED DISTAL TO THE SCAFFOLDED AREA. A 2.8 X 16 MM GRAFTMASTER STENT WAS ADVANCED TO THE PERFORATION SITE, USING A NON-ABBOTT GUIDE CATHETER EXTENSION FOR SUPPORT. DUE TO THE PATIENT ANATOMY, THE USE OF THE GUIDE CATHETER EXTENSION AND ADVANCEMENT DISTALLY THROUGH THE IMPLANTED ABSORB, RESISTANCE WAS MET AND POSITIONING WAS DIFFICULT; THEREFORE, THE 2.8 X 16 MM GRAFTMASTER DID NOT FULLY COVER THE PERFORATION BUT SEALED THE AREA WHERE IT WAS IMPLANTED. A SECOND 2.8 X 19 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS ADVANCED AND WAS ABLE TO COVER THE REMAINING PERFORATION. DURING USE OF THE NON-ABBOTT GUIDE CATHETER EXTENSION, AS THE GUIDE CATHETER EXTENSION WAS ENGAGED IN THE LEFT ANTERIOR DESCENDING ARTERY, A DISSECTION OCCURRED (CAUSED BY THE GUIDE CATHETER EXTENSION). A 3.0 X 15 MM XIENCE ALPINE WAS ADVANCED TO THE DISSECTION AND DEPLOYED. POST-DILATATION WAS PERFORMED USING A 4.0 X 15

  Patient problems: Perforation

  MAUDE report 6386402 ↗
• InjuryMar 7, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE ON (B)(6) 2017 WAS TO TREAT IN-STENT RE-STENOSIS OF TWO PREVIOUSLY PLACED DRUG ELUTING STENTS LOCATED IN THE MID CIRCUMFLEX THE SAME LESION HAD TWICE RE-STENOSED. THE PATIENT PRESENTED WITH CHEST PAIN ON (B)(6) 2017 AND AN ABSORB GT1 BVS 3.0 X 18 MM SCAFFOLD WAS IMPLANTED AS TREATMENT. IT WAS CONFIRMED THAT VESSEL SIZING WAS NOT DONE HOWEVER, VISUALLY, THE VESSEL WAS DETERMINED TO BE >2.5MM. THE LESION WAS PREPPED WITH A 3 X 12 NC TREK BALLOON DILATATION CATHETER (BDC) THEN A 3.5 X 12 NC TREK BDC TO 12 ATMOSPHERES. IT IS UNKNOWN IF THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40% AFTER PRE-DILATATION. POST-DILATATION WAS PERFORMED WITH A 3.5 X 12 NC TREK BDC WITH THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS LESS THAN 10%. IT COULD NOT BE CONFIRMED THAT THE PATIENT WAS COMPLIANT IN FOLLOWING THE DUAL ANTIPLATELET DRUG THERAPY (DAPT) AFTER THE INITIAL PROCEDURE ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT RETURNED WITH CHEST PAIN AND SCAFFOLD THROMBOSIS WAS DISCOVERED. THE THROMBOSIS WAS TREATED BY IMPLANTING A XIENCE ALPINE STENT. THE PATIENT OUTCOME WAS GOOD. THERE HAVE BEEN NO CHANGES TO THE PATIENT'S MEDICATIONS FOLLOWING THE DIAGNOSIS OF T

  Patient problems: Angina; Thrombosis

  MAUDE report 6385564 ↗
• InjuryNov 10, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF AN UNSPECIFIED XIENCE STENT IN THE CIRCUMFLEX ARTERY AND TWO 3.0 X 18 MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2016, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ANGINA AND THROMBUS WAS NOTED WITHIN THE ABSORB BVS. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND THE SCAFFOLD WAS NOTED TO BE WELL APPOSED TO THE VESSEL WALL. BALLOON ANGIOPLASTY WAS PERFORMED USING AN NC TREK DILATATION CATHETER. THERE WAS SOME CONCERN THAT THE PATIENT WAS EITHER NON-COMPLIANT WITH PLAVIX THERAPY OR WAS RESISTANT TO PLAVIX; THEREFORE, THE PATIENT'S MEDICATION WAS CHANGED TO BRILINTA. POST PROCEDURE, THE PATIENT IS DOING WELL AND THE THROMBUS IS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6094086 ↗
• InjuryNov 10, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF AN UNSPECIFIED XIENCE STENT IN THE CIRCUMFLEX ARTERY AND TWO 3.0 X 18 MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2016, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ANGINA AND THROMBUS WAS NOTED WITHIN THE ABSORB BVS. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND THE SCAFFOLD WAS NOTED TO BE WELL APPOSED TO THE VESSEL WALL. BALLOON ANGIOPLASTY WAS PERFORMED USING AN NC TREK DILATATION CATHETER. THERE WAS SOME CONCERN THAT THE PATIENT WAS EITHER NON-COMPLIANT WITH PLAVIX THERAPY OR WAS RESISTANT TO PLAVIX; THEREFORE, THE PATIENT'S MEDICATION WAS CHANGED TO BRILINTA. POST PROCEDURE, THE PATIENT IS DOING WELL AND THE THROMBUS IS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6094085 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT AN 80% STENOSIS IN THE FIRST OBTUSE MARGINAL OF THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY WITH NO CALCIFICATION NOTED. PRIOR TO THE INITIAL PROCEDURE, THE PATIENT'S CLINICAL PRESENTATION WAS UNSTABLE ANGINA. PRE-DILATATION WAS PERFORMED WITH A NON-COMPLIANT, NON-ABBOTT 3 X 12 BALLOON AT 12 ATMOSPHERES, WITH NO RESIDUAL STENOSIS AND NO EVIDENCE OF DISSECTION. A 3.0 X 18 MM ABSORB GT1 SCAFFOLD WAS DEPLOYED. THERE WAS NO REPORTED POST-PROCEDURE CHEST PAIN. THE PATIENT WAS READMITTED ON (B)(6) 2016 WITH CHEST PAIN WHEN THROMBOSIS WAS DIAGNOSED. IT WAS CONFIRMED THAT THE PATIENT HAD BEEN COMPLIANT IN FOLLOWING THE DUAL ANTIPLATELET DRUG THERAPY. THE PATIENT WAS TREATED BY PLACING TWO ADDITIONAL XIENCE ALPINE STENTS, ONE DISTAL AND ONE IN ANOTHER LESION PROXIMALLY AND THE PAIN RESOLVED. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED DURING THE SECOND PROCEDURE AND NO INDEX IMAGING WAS PERFORMED. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. THERE HAVE BEEN NO CHANGES TO THE PATIENT'S MEDICATION. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 5989107 ↗
• InjuryAug 18, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION. THE PATIENT WAS NOT ON ROUTINE ANTIPLATELET MEDICATIONS BEFORE THE PROCEDURE HAD NO LOADING DOSE ANTI-PLATELET THERAPY. FOLLOWING PRE-DILATATION, A 3.0X18MM ABSORB SCAFFOLD WAS IMPLANTED AND POST DILATATION WAS PERFORMED WITHOUT ISSUE. THE SCAFFOLD WAS WELL-APPOSED TO THE VESSEL WALL. THE PATIENT WAS DISCHARGED FROM THE CATHETERIZATION LAB AND BACK ON THE HOSPITAL FLOOR WHEN HE STARTED TO EXPERIENCE CHEST PAIN WITHIN AN HOUR. THE PATIENT WAS TRANSFERRED BACK TO THE CATH LAB AND A SCAFFOLD THROMBOSIS WAS DISCOVERED. THE THROMBOSIS WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION.

  Patient problems: Angina; Thrombosis

  MAUDE report 5887488 ↗