ABSORB GT1 1235300-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648213021), received between Aug 17, 2016 and Apr 22, 2017 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 6513896 ↗
• InjuryFeb 15, 2017Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6) 2016 WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. THE VESSEL WAS DETERMINED TO BE 3.0MM IN DIAMETER PER ANGIOGRAPHY. PREDILATATION WAS PERFORMED WITH A 3.0 X 12 MM NC TREK BALLOON CATHETER; HOWEVER, RESIDUAL STENOSIS WAS GREATER THAN 40%. A 3.0 X 12 MM ABSORB SCAFFOLD WAS IMPLANTED AND POST-DILATATION WAS PERFORMED WITH A 3.0 X 12 MM NC TREK BALLOON. NO IMAGES WERE TAKEN TO DETERMINE WHETHER THE ABSORB SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL. THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2016 WITH CHEST PAIN AND WAS ADMITTED. ANGIOGRAPHY SHOWED AN ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND THROMOBSIS/FULLY OCCLUDED SCAFFOLD IN THE PROXIMAL LAD ARTERY. A 3.5 X 15 MM XIENCE ALPINE WAS IMPLANTED AND FLOW WAS RESTORED; PATIENT DOING FINE. THE PATIENT WAS CONFIRMED TO HAVE BEEN COMPLIANT WITH THEIR DUAL ANTI-PLATELET THERAPY (DAPT) CONSISTING OF PLAVIX AFTER THE PROCEDURE. THERE HAVE BEEN NO CHANGES TO THE PATIENT'S DAPT. REPORTEDLY, REVIEW OF THE PROCEDURE CINE BY THE ACCOUNT REP IDENTIFIED THAT THE ABSORB SCAFFOLD WAS NOT WELL APPOSED TO THE VESSEL WALL. N

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 6332862 ↗
• DeathFeb 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT AN 80% STENOSIS IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. THE PATIENT PRESENTED WITH NON- ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). VESSEL SIZING WAS EVALUATED USING AN OPTICAL COHERENCE TOMOGRAPHY (OCT) AND WAS DETERMINED TO BE GREATER THAN 2.5 MM. A 3.0 X 8 MM NC TREK BALLOON WAS USED FOR PRE-DILATATION, REDUCING THE STENOSIS TO 40%. A 3.0 X 12 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH A 3.0 X 12 MM TREK WITH THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS LESS THAN 10%. OCT CONFIRMED THAT THE SCAFFOLD WAS FULLY OPPOSED TO THE VESSEL WALL. IT WAS REPORTED THAT PATIENT VISITED A VA HOSPITAL ON AN UNKNOWN DATE BETWEEN (B)(6) 2016 AND THE PHYSICIAN REQUESTED THE PATIENT TO BE TAKEN OFF OF ALL PREVIOUSLY PRESCRIBED BLOOD THINNING MEDICATIONS DUE TO CHRONIC NOSE BLEEDS. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIAC ARREST AND THROMBOSIS WAS FOUND. THE THROMBOSIS WAS ASPIRATED AND BALLOON ANGIOPLASTY WAS PERFORMED, ACHIEVING A TIMI 3 FLOW. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED IN THE HOSPITAL W

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6312865 ↗
• InjuryFeb 7, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY. AFTER PRE-DILATATION WITH A 7X40MM BALLOON THE 6.5X80MM SUPERA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT DEPLOYED IN THE LESION [ANEURYSM]; HOWEVER, DURING RETRACTION OF THE SDS THE TIP/NOSECONE CAUGHT ON A STENT STRUT AND THE DELIVERY SYSTEM COULD NOT BE REMOVED. ACCESS WAS GAINED FROM THE LEFT GROIN ANTEGRADE AND A 7X40 MM BALLOON WAS INFLATED DISTALLY TO ANCHOR THE STENT, WHICH ALLOWED THE SDS TO BE RETRACTED FROM THE STENT WITHOUT ISSUE. THE STENT WAS SUCCESSFULLY FULLY DEPLOYED AT THE TARGET ANEURYSM SITE. THE PROCEDURE CONTINUED ON WITH COILING OF THE ARTERY TO COMPLETE TREATMENT OF THE ANEURYSM. THE PROCEDURE WAS NOTED AS BEING PROLONGED; HOWEVER, THIS WAS NOT CLINICALLY SIGNIFICANT AND THE FINAL RESULT WAS GOOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309344 ↗
• InjuryNov 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A 2.75 X 12 MM NC TREK BALLOON CATHETER WAS USED FOR PRE-DILATATION AND PRESSURIZED TWICE TO 12 AND THEN 16 ATMOSPHERES. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THERE WAS RESIDUAL CALCIFICATION REMAINING. A 3.0 X 12 MM ABSORB GT1 SCAFFOLD WAS DEPLOYED AT 16 ATMOSPHERES WHEN A PERFORATION OCCURRED. THE PERFORATION WAS TREATED WITH A BALLOON CATHETER INFLATED TO 16 ATMOSPHERES. THE PATIENT WAS ADMINISTERED PROTAMINE. THE PATIENT IS IN STABLE CONDITION IN THE INTENSIVE CARE UNIT (ICU). THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6126107 ↗
• InjuryNov 23, 2016Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE 3.0X12 ABSORB GT1 SCAFFOLD WAS DEPLOYED AT 14 ATMOSPHERES IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A WAIST WAS NOTED IN THE MIDPORTION OF THE GT1 TREATED WITH POST DILATATION WITH A 3.5X9 MM NON-ABBOTT BALLOON DILATATION CATHETER. THIS RESULTED IN PERICARDIAL STAINING, CONSISTENT WITH A VESSEL PERFORATION IN THE MID LAD. THE PATIENT HAD CHEST DISCOMFORT AND ST DEPRESSION. A 3.5X15MM GRAFTMASTER COVERED STENT WAS PLACED ACROSS THE LESION, DEPLOYED AT 16 ATM WITH GOOD RESULT. THE CHEST DISCOMFORT AND ST DEPRESSION RESOLVED AFTER THE PERFORATION WAS SEALED WITH THE GRAFTMASTER. NO FURTHER STAINING WAS NOTED AND THE PATIENTS BLOOD PRESSURE REMAINED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6124348 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) ON (B)(6) 2016. INTRAVASCULAR ULTRASOUND WAS PERFORMED PRIOR TO IMPLANTATION OF THREE ABSORB GT1 SCAFFOLDS, A 3.0 X 12 MM IN THE MID CIRCUMFLEX (CX) AND TWO 2.5 X 28 MM OVERLAPPING IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE CIRCUMFLEX WAS PRE-DILATED WITH A 3.0 X 12 MM NC TREK BALLOON AND POST-DILATATION WAS DONE WITH A 3.5 X 12 MM NC TREK. THE MID LAD WAS PRE-DILATED WITH A 2.5 X 20 MM NC TREK BALLOON AND POST-DILATATION WAS DONE SUCCESSFULLY WITH A 3.0 X 15 MM NC TREK BALLOON. THE PATIENT PRESENTED WITH CHEST PAIN IN THE EMERGENCY ROOM ON (B)(6) 2016 AND ANGIOGRAPHY REVEALED 100% THROMBUS IN ALL OF THE SCAFFOLDS. REPORTEDLY, THE PATIENT HAD NOT BEEN DUAL ANTIPLATELET THERAPY (DAPT) COMPLIANT SINCE THE SCAFFOLDS HAD BEEN IMPLANTED. A BALLOON PUMP WAS USED AND THROMBUS ASPIRATION WAS DONE; HOWEVER, THERE WAS TOO MUCH THROMBUS; THEREFORE, THE PATIENT WAS THEN SENT FOR CORONARY ARTERY BYPASS GRAFT (CABG). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6042604 ↗
• InjuryAug 17, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT A PATIENT DUE TO ABNORMAL STRESS TEST. THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WHICH WAS HEAVILY CALCIFIED AND THERE WAS DIFFICULTY GETTING A GUIDE WIRE DOWN. PRE-DILATATION WAS PERFORMED WITH A 2.0 SEMI-COMPLIANT BALLOON AND AGAIN WITH A 3.0 NON-COMPLIANT (NC) BALLOON. THE 3.0 X 23 MM AND 3.0 X 12 MM ABSORB GT1 SCAFFOLDS WERE IMPLANTED OVERLAPPING AND POST-DILATED TWICE WITH A 3.5 NC TREK (16 AND 18 ATMOSPHERES). OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS ATTEMPTED 3 TIMES, BUT NEVER GOT A COMPLETE VIEW OF THE SCAFFOLDS DISTAL TO PROXIMAL. FINAL ANGIOGRAPHY SHOWED LESS THAN 10% RESIDUAL STENOSIS. ON (B)(6) 2016, THE PATIENT PRESENTED TO THE HOSPITAL WITH AN ST-ELEVATED MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE SCAFFOLDS. TWO ADDITIONAL DRUG ELUTING STENTS WERE IMPLANTED FOR TREATMENT WITH A GOOD FINAL PATIENT OUTCOME. IT WAS CONFIRMED THAT THE PATIENT WAS NOT COMPLIANT WITH THE DUAL ANTI-PLATELET THERAPY (DAPT) AFTER THE INDEX PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 5883196 ↗