ABSORB GT1 1235350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648213120), received between Nov 23, 2016 and Nov 3, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 22, 2017Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE TEMPERATURE MONITORS (TAG ALERTS) ON TWO ABSORB GT1 SCAFFOLDS, A 3.0 X 12 MM AND A 3.5 X 18 MM, TRIGGERED DUE TO IMPROPER STORAGE AT THE ACCOUNT; HOWEVER, THE DEVICES WERE USED ANYWAY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6513920 ↗
• InjuryDec 15, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH NO TORTUOSITY AND NO CALCIFICATION IN THE MID RIGHT CORONARY ARTERY (RCA). THE 3.5 X 18 MM ABSORB GT1 WAS DEPLOYED AT THE TARGET LESION SUCCESSFULLY WITH GOOD RESULTS. POST DILATATION WAS PERFORMED USING A 4.0 X 12 MM NC TREK TO 18 ATMOSPHERES; HOWEVER, A PERFORATION OCCURRED. A 4.0 X 16 MM GRAFTMASTER WAS USED TO SUCCESSFULLY SEAL THE PERFORATION. THE PATIENT OUTCOME WAS GOOD. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6176080 ↗
• InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS. THE LESION WAS PREDILATED USING A 3.5X15MM NON-ABBOTT BALLOON CATHETER. A 3.5X18MM ABSORB GT1 RX SCAFFOLD DELIVERY SYSTEM (SDS) WAS IMPLANTED WITHOUT ISSUE. POST DILATATION WAS PERFORMED USING AN UNSPECIFIED 3.75X15 NON-COMPLIANT (NC) BALLOON CATHETER THAT WAS INFLATED TO NOMINAL PRESSURE. DURING THE PROCEDURE THE PHYSICIAN WAS WORKING ON A DIFFERENT LESION. THE PATIENT BECAME SYMPTOMATIC WITH A BLOOD PRESSURE DROP AND TROUBLE BREATHING. THE PATIENT WAS INTUBATED TO HELP WITH BREATHING AND GIVEN HEPARIN TO PROPERLY COAGULATE. THE PHYSICIAN NOTED THE AREA AROUND THE SCAFFOLD WAS CLOUDY DUE TO THROMBOSIS. AN UNSPECIFIED NC BALLOON CATHETER WAS USED TO SUCCESSFULLY TREAT THE THROMBOSIS. THE PATIENT IS STILL HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Respiratory Failure; Thrombosis

  MAUDE report 6167907 ↗
• InjuryNov 23, 2016Adverse Event Without Identified Device or Use Problem

  A REVIEW OF THE CINE BY AN ABBOTT VASCULAR PHYSICIAN NOTED A DISSECTION AT THE PROXIMAL EDGE OF THE ABSORB GT1 SCAFFOLD.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6124681 ↗