ABSORB GT1Recalls & reported problems across all models

We found 11 models of ABSORB GT1 by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2016 and Nov 7, 2021 — classified as 4 deaths, 71 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ABSORB GT1 problems

ABSORB GT1 models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ABSORB GT1 1235300-18

  Absorbable coronary drug-eluting stent
  13 reports
• ABSORB GT1 1235250-28

  Absorbable coronary drug-eluting stent
  9 reports
• ABSORB GT1 1235300-23

  Absorbable coronary drug-eluting stent
  9 reports
• ABSORB GT1 1235300-28

  Absorbable coronary drug-eluting stent
  2 deaths9 reports
• ABSORB GT1 1235300-12

  Absorbable coronary drug-eluting stent
  1 death8 reports
• ABSORB GT1 1235350-18

  Absorbable coronary drug-eluting stent
  7 reports
• ABSORB GT1 1235250-18

  Absorbable coronary drug-eluting stent
  6 reports
• ABSORB GT1 1235250-23

  Absorbable coronary drug-eluting stent
  6 reports
• ABSORB GT1 1235350-28

  Absorbable coronary drug-eluting stent
  6 reports
• ABSORB GT1 1235350-23

  Absorbable coronary drug-eluting stent
  4 reports
• ABSORB GT1 1235250-12

  Absorbable coronary drug-eluting stent
  1 death2 reports

Recent ABSORB GT1 adverse event reports

The 15 most recent reports across all models, 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 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED ON (B)(6) 2017, TREATING A TARGET LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. A 3.5 X 18 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED. ON (B)(6) 2021, IN-SCAFFOLD RESTENOSIS WAS NOTED IN THE IMPLANTED ABSORB GT1 BVS. THE PATIENT WAS RE-HOSPITALIZED AND A REVASCULARIZATION PROCEDURE WAS PERFORMED. THE EVENT RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12747257 ↗
• 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 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL/FINAL MDR REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2020 FOR FOLLOW UP CORONARY ANGIOGRAPHY. THE PATIENT EXPERIENCED NO SYMPTOMS AND CORONARY ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2020. THE RESTENOSIS IN THE DISTAL CIRCUMFLEX WAS NOTED TO BE 90%; HOWEVER, NO INTERVENTION WAS PERFORMED AT THAT TIME. ON (B)(6) 2021, CORONARY INTERVENTION WAS PERFORMED. PRE-DILATATION WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER AND 2.25 X 20 MM NON-ABBOTT STENT WAS IMPLANTED. THE PATIENT WAS DISCHARGED TO HOPE ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9988790 ↗
• InjuryMar 24, 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, THE PATIENT UNDERWENT A CORONARY PROCEDURE PERFORMED TO TREAT A LESION IN THE DISTAL CIRCUMFLEX ARTERY. A 2.5 X 18 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED. ON (B)(6) 2020, A NEW AREA OF STENOSIS, WITHIN 5 MM FROM THE PREVIOUSLY IMPLANTED ABSORB SCAFFOLD, WAS NOTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED AND A REVASCULARIZATION PROCEDURE WAS PERFORMED, RESOLVING THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9875793 ↗
• 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 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED ON (B)(6) 2017 TO TREAT A NARROW LESION WITH ECCENTRIC STENOSIS AND MODERATE CALCIFICATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. A 3.0 X 28 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED AND POST-DILATED WITH A 3.5 X 20 MM NON-COMPLIANT BALLOON. USING QUANTITATIVE CORONARY ANGIOGRAPHY (QCA), THE SCAFFOLD WAS CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND ANGIOGRAPHY NOTED THROMBOSIS IN THE ABSORB SCAFFOLD. A 2.5 X 20 MM TREK BALLOON AND A 3.0 X 20 NC TREK BALLOON WERE USED TO TREAT THE THROMBOSIS WITH OPTIMAL RESULTS. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7706787 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 3.5X18 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2018 SCAFFOLD THROMBOSIS WAS SEEN IN THE ABSORB GT1 ON OCT [OPTICAL COHERENCE TOMOGRAPHY], IVUS [INTRAVASCULAR ULTRASOUND], AND ANGIOGRAM. THE PATIENT HAD CHEST PAIN WITH THE THROMBOSIS WHICH WAS DIAGNOSED DURING A REGULAR HOSPITAL VISIT. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE THROMBUS. THE CONDITION RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7535030 ↗
• InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem

  VOLUNTARY MEDWATCH REPORT (MW5075563) WAS RECEIVED AND STATES: IN 2017, I HAD THE ABBOTT GT1 BVS ABSORB STENT PLACED IN MY HEART, AFTER 9 MONTHS THE STENT FAILED. I STARTED GETTING CHEST PAIN AND SHORTNESS OF BREATH. I HAD TO BE RESTENTED ON 2018. ADDITIONAL INFORMATION RECEIVED: IN ADDITION TO EXPERIENCING CHEST PAIN AND SHORTNESS OF BREATH, THE PATIENT FAILED A STRESS TEST AND WAS HOSPITALIZED. A COMPUTED AXIAL TOMOGRAPHY (CAT) SCAN AND AN ANGIOGRAPHY WERE PERFORMED, REVEALING A 95% OCCLUSION OF THE SCAFFOLD. A 3.0 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED AS TREATMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 7383115 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, FOLLOWING PRE-DILATATION WITH A 2.75MM TREK DILATATION CATHETER, A 3.0X28MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. POST DILATATION WAS PERFORMED USING A 3.25X20MM TREK CATHETER. ON (B)(6) 2018, RESTENOSIS WAS NOTED AT THE BVS SITE AND THE PATIENT EXPERIENCED ASSOCIATED ANGINA, CLASS 3. ANOTHER PERCUTANEOUS PROCEDURE WAS PERFORMED AS TREATMENT. A NON-ABBOTT STENT WAS IMPLANTED AS TREATMENT AT THE BVS RESTENOSED SITE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 7232391 ↗
• InjuryAug 7, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, TWO ABSORB SCAFFOLDS, SIZES 2.5X18 AND 3.0X28, WERE IMPLANTED, USING VISUAL ASSESSMENT, IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY . ON (B)(6) 2017, THE PATIENT PRESENTED WITH CHEST PAIN AND EKG CHANGES. THE TWO SCAFFOLDS WERE NOTED TO BE THROMBOSED AT THE SITE OF OVERLAP. A NON-ABBOTT STENT WAS IMPLANTED AS TREATMENT AND THE CONDITION RESOLVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6771141 ↗
• InjuryAug 7, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2016, TWO ABSORB SCAFFOLDS, SIZES 2.5X18 AND 3.0X28, WERE IMPLANTED, USING VISUAL ASSESSMENT, IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY . ON (B)(6)2017, THE PATIENT PRESENTED WITH CHEST PAIN AND EKG CHANGES. THE TWO SCAFFOLDS WERE NOTED TO BE THROMBOSED AT THE SITE OF OVERLAP. A NON-ABBOTT STENT WAS IMPLANTED AS TREATMENT AND THE CONDITION RESOLVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6771137 ↗
• 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 ↗

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