ABSORB GT1 1235300-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648213069), received between Oct 18, 2016 and Jul 20, 2018 — classified as 2 deaths, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult To Position” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• DeathApr 7, 2017Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT HAD A POSITIVE STRESS TEST AND A 3.0X28 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED TO TREAT A LESION IN THE TOTAL OCCLUDED, LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5X12 MM TREK BALLOON DILATATION CATHETER (BDC) AND A 2.75X12 MM NON-ABBOTT BDC. AFTER THE SCAFFOLD WAS IMPLANTED, AND POST-DILATATION WAS DONE WITH A 3.25X15 MM BDC. IMAGING SHOWED THROMBUS HAD FORMED APPROXIMATELY 20 MM DISTAL TO THE IMPLANTED SCAFFOLD. THE THROMBUS WAS TREATED WITH BALLOONING WITH AN UNSPECIFIED BDC, AND INTEGRILLIN WAS ADMINISTERED. THE PATIENT WAS STABLE. LATER THAT EVENING THE PATIENT HAD A HEMORRHAGIC STROKE. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL THAT SAME DAY AND INTEGRILLIN WAS DISCONTINUED. ON (B)(6) 2017 THE PATIENT EXPIRED. IT IS THE PHYSICIAN'S OPINION THAT DEATH WAS ATTRIBUTABLE TO THE A SIDE EFFECT OF THE INTEGRILLIN, HEMORAGIC STROKE AND NOT RELATED TO THE ABSORB GTI. THE CAUSE OF DEATH IS DUE TO BLEEDING FROM INTEGRILLIN. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Stroke/CVA; Thrombosis

  MAUDE report 6473968 ↗
• InjuryNov 17, 2016Difficult To Position

  IT WAS REPORTED THAT THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS PREDILATED WITH LASER ATHERECTOMY. AFTER POST DILATATION OF THE 3.0X28 ABSORB GT1 WAS PERFORMED, A PERFORATION WAS NOTED. THE 2.8X19 GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS INSERTED, BUT UNABLE TO ADVANCE PAST THE TORTUOUS AND CALCIFIED ANATOMY AND THE NEWLY IMPLANTED GT1. SUBSEQUENT TO THE DEVICE INTERACTION, THE PROXIMAL SHAFT OF THE GRAFTMASTER SDS SEPARATED. THE GUIDE CATHETER, GUIDE WIRE, AND SDS WERE REMOVED TOGETHER AS A UNIT. A NEW GRAFTMASTER SDS WAS INSERTED TO SUCCESSFULLY CROSS THE GT1 AND TREAT THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6110825 ↗
• MalfunctionNov 16, 2016Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A 90% ANGLE FROM THE LEFT MAIN TO THE LAD. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 20 MM NON-COMPLIANT BALLOON. THE 3.0 X 28 MM ABSORB GT1 DELIVERY CATHETER WAS ADVANCED, BUT IT COULDN'T BE ADVANCED ALL THE WAY TO THE LESION. THE DELIVERY CATHETER WAS REMOVED AND BACKLOADED INTO A 6F GUIDELINER AND ADVANCED IT AGAIN, BUT IT STILL WOULD NOT GO. RESISTANCE WAS MET WITH THE ANATOMY AND THE GUIDELINER. AN ATTEMPT WAS MADE TO PULL THE DELIVERY CATHETER BACK INTO THE GUIDELINER, BUT IT WOULDN'T GO IN ALL THE WAY. THE DEVICES WERE REMOVED TOGETHER FROM THE PATIENT. UPON EXAMINATION OF THE DEVICE, THE SCAFFOLD WAS DAMAGED FROM GETTING CAUGHT ON THE END OF THE GUIDELINER. A XIENCE STENT WAS IMPLANTED WITH A GOOD PATIENT OUTCOME. 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 6108136 ↗
• InjuryNov 14, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 ONE 3.0X28 AND ONE 3.0X23 ABSORB GT1 SCAFFOLD WERE IMPLANTED IN THE HEAVILY CALCIFIED, MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT HAD CHEST PAIN ON (B)(6) 2016 AND WAS FOUND TO HAVE IN-SCAFFOLD THROMBOSIS IN BOTH SCAFFOLDS. THE THROMBUS WAS TREATED WITH BALLOON DILATATION USING A NON-COMPLIANT BALLOON. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6100329 ↗
• 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 6065140 ↗
• InjuryOct 18, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED. AN ABSORB GT1 2.5 X 18 SCAFFOLD WAS DELIVERED DISTALLY WITH NO INCIDENCE. THEN, AN ABSORB GT1 3.0 X 28 MM SCAFFOLD WAS DEPLOYED PROXIMALLY TO THE FIRST SCAFFOLD WHEN A DISSECTION OCCURRED. A GRAFTMASTER 2.8 X 16 MM CORONARY STENT WAS USED AS TREATMENT TO COVER THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6038085 ↗