ABSORB GT1 1235250-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648212949), received between Oct 28, 2016 and Apr 22, 2020 — classified as 1 death, 1 injury.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• DeathOct 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANTATION OF TWO ABSORB SCAFFOLDS (3.0 X 28 MM AND 2.5 X 12 MM) IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY ON (B)(6) 2016, THE PATIENT EXPIRED IN THE INTENSIVE CARE UNIT TWO DAYS LATER ON (B)(6) 2016. NO ADDITIONAL INFORMATION CAN BE PROVIDED DUE TO HOSPITAL PRIVACY POLICY.

  Patient problems: Death

  MAUDE report 6065139 ↗