ABSORB GT1 1235250-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648212963), received between Sep 24, 2016 and Mar 24, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 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.

• 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 ↗
• 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 ↗
• InjuryJan 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2016, A 2.5X18MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS SUCCESSFULLY IMPLANTED WITH POST-DILATATION, IN THE POSTERIOR DESCENDING ARTERY (PDA). THE PATIENT WAS DISCHARGED WITH A PRESCRIPTION FOR BRILINTA, BUT DID NOT FILL THE PRESCRIPTION. REPORTEDLY, THE PATIENT HAD PLAVIX AT HOME, SO THEY TOOK THE PLAVIX INSTEAD OF THE BRILINTA. AT THE END OF (B)(6) 2016, THE PATIENT RAN OUT OF PLAVIX AND WAS NOT ON DUAL ANTIPLATELET THERAPY (DAPT) FOR ABOUT ONE WEEK PRIOR TO (B)(6) 2017, WHEN THE PATIENT REPORTED HAVING CHEST PAIN. ON (B)(6) 2017, ANGIOGRAPHY WAS PERFORMED AND THROMBUS WAS NOTED IN THE BVS. THE BVS WAS NOTED TO BE WELL APPOSED TO THE VESSEL WALL. BALLOONING WAS PERFORMED AND 3 XIENCE ALPINE STENTS WERE IMPLANTED, RESOLVING THE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6258898 ↗
• InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) ON (B)(6) 2016. THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT CIRCUMFLEX ARTERY WITH MILD TORTUOSITY AND CHRONIC TOTAL OCCLUSION. A 2.5X15MM NON-ABBOTT BALLOON CATHETER WAS INFLATED TO NOMINAL PRESSURE TO PREDILATE THE LESION. A 2.5X18MM ABSORB GT1 SCAFFOLD DELIVERY SYSTEM (SDS) WAS IMPLANTED WITHOUT ISSUE. A 2.75X15MM NON-ABBOTT BALLOON CATHETER WAS INFLATED TO NOMINAL PRESSURE TO POST DILATE THE SCAFFOLD. TWENTY SIX HOURS LATER AND WHILE STILL IN THE HOSPITAL, THE PATIENT EXPERIENCED CHEST PRESSURE, ST ELEVATIONS AND AN INCREASE IN TROPONIN. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED TO CONFIRM THAT THE AREA AROUND THE SCAFFOLD WAS CLOUDY DUE TO THROMBOSIS. A NON-COMPLIANT BALLOON CATHETER WAS USED TO SUCCESSFULLY TREAT THE THROMBOSIS IN THE SCAFFOLD. THE PROCEDURE WAS ENDED. FOLLOWING THE CASE THE PATIENT WAS ADMINISTERED A HEPARIN DRIP FOR 24 HOURS IN ADDITION TO ASPIRIN AND EFFIENT. THE PATIENT WAS DISCHARGED FOUR DAYS LATER ON NOVEMBER 29, 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6167892 ↗
• InjuryNov 22, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE ON (B)(6) 2016 WAS TO A LESION IN THE MID DIAGONAL ARTERY WITH MILD CALCIFICATION. THE PATIENT PRESENTED WITH ANGINA. PRE-DILATATION WAS DONE WITH A 2.5 NON-COMPLIANT (NC) BALLOON, REDUCING THE STENOSIS TO LESS THAN 40%. THE ABSORB GT1 2.5 X 18 MM SCAFFOLD WAS DEPLOYED AND POST-DILATED WITH A 2.5 X 20 MM BALLOON. FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED BOTH PRE AND POST DEPLOYMENT. THE PATIENT WAS PRESCRIBED DUAL ANTIPLATELET THERAPY (DAPT) OF ASPIRIN AND PLAVIX. THE PATIENT RETURNED ON (B)(6) 2016 DUE TO CHEST PAIN AT WHICH TIME SCAFFOLD THROMBOSIS WAS DIAGNOSED. THE THROMBOSIS WAS TREATED WITH BALLOON ANGIOPLASTY USING AN NC BALLOON WITH A GOOD FINAL PATIENT OUTCOME. IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN TAKEN OFF ASPIRIN AND PUT ON WARFARIN. THE PATIENT REMAINS ON PLAVIX. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6122883 ↗
• InjurySep 24, 2016Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A MILDLY CALCIFIED LESION IN THE HEAVILY TORTUOUS MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY, A 2.5MM X 18MM ABSORB GT1 SCAFFOLD DELIVERY SYSTEM WAS ADVANCED WITH EASE TO THE TARGET LESION. WHEN DEPLOYING THE GT1 SCAFFOLD WITHOUT ISSUE AT 18 ATMOSPHERES, A DISTAL EDGE PERFORATION OCCURRED. THE PERFORATION WAS SUCCESSFULLY SEALED VIA PROLONGED INFLATIONS WITH AN UNSPECIFIED 2.25MM BALLOON. THERE WERE NO DEVICE ISSUES, NO ADVERSE PATIENT SEQUELAE, AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 5976007 ↗