ABSORB GT1 1235250-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648212987), received between Sep 23, 2016 and Jan 5, 2017 — classified as 9 injuries.

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 16, 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.

• InjuryJan 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHRONIC STABLE ANGINA. THE INDEX PROCEDURE ON (B)(6) 2016 WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AT THE JUNCTION OF THE LAD BIFURCATION AND DIAGONAL. NO DISEASE IN THE DIAGONAL. QUANTITATIVE CORONARY ANGIOGRAPHY DETERMINED THE VESSEL DIAMETER TO BE 2.75MM. PREDILATATION WAS PERFORMED USING A SEMI-COMPLIANT BALLOON AT HIGH PRESSURE WITH RESIDUAL STENOSIS REDUCED TO LESS THAN 20%. A 2.5X28MM ABSORB GT1 WAS IMPLANTED; HOWEVER, THERE WAS NO FLOW THROUGH THE DIAGONAL. A GUIDE WIRE WAS ADVANCED TO DILATE THE DIAGONAL WHICH GOT THE FLOW BACK BUT NEEDED A SMALL STENT IN PLACE DISTAL TO THE ABSORB GT1 IN THE LAD. THE SCAFFOLD AND STENT SHOULD NOT BE IN CONTACT; THEREFORE, THEY WERE NOT OVERLAPPED. AFTER SUCCEEDING WITH THE DIAGONAL STENTING, THE LAD AT THE ABSORB GT1 SITE THROMBOSED LOCALLY IN THE SCAFFOLD. A 2.75X15MM NC NON-ABBOTT BALLOON CATHETER WAS USED TO REINFLATE THE SCAFFOLD AT 18 ATMOSPHERES AND IT WAS A SUCCESS ANGIOGRAPHICALLY. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. THE CARDIOLOGIST BELIEVES THAT HE SHOULD HAVE MONITORED THE ACT LEVEL MORE CLOSELY AS IT WAS BELOW 200 AND

  Patient problems: Occlusion; Thrombosis

  MAUDE report 6227449 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT THE DISTAL AND PROXIMAL RIGHT CORONARY ARTERY. TWO 2.5 X 28 MM ABSORB GT1 SCAFFOLDS WERE DEPLOYED. AS POST-DILATATION WAS DONE IN THE MID SECTION OF THE DISTALLY DEPLOYED SCAFFOLD A PERFORATION OCCURRED. ANOTHER NON-COMPLIANT (NC) BALLOON WAS USED TO POST-DILATE THE MID PART WITH GOOD RESULTS. WHILE REMOVING THE NC BALLOON CATHETER A DISSECTION OCCURRED IN THE PROXIMALLY DEPLOYED SCAFFOLD. A 2.75 X 18 MM XIENCE V STENT WAS IMPLANTED TO COVER THE DISSECTION. THE FINAL OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6216636 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT THE DISTAL AND PROXIMAL RIGHT CORONARY ARTERY. TWO 2.5 X 28 MM ABSORB GT1 SCAFFOLDS WERE DEPLOYED. AS POST-DILATATION WAS DONE IN THE MID SECTION OF THE DISTALLY DEPLOYED SCAFFOLD A PERFORATION OCCURRED. ANOTHER NON-COMPLIANT (NC) BALLOON WAS USED TO POST-DILATE THE MID PART WITH GOOD RESULTS. WHILE REMOVING THE NC BALLOON CATHETER A DISSECTION OCCURRED IN THE PROXIMALLY DEPLOYED SCAFFOLD. A 2.75 X 18 MM XIENCE V STENT WAS IMPLANTED TO COVER THE DISSECTION. THE FINAL OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6216628 ↗
• InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2016 WAS TO TREAT A PROXIMAL/OSTIAL AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS TURNED DOWN FOR CORONARY ARTERY BYPASS SURGERY. IT IS UNKNOWN WHAT DEVICE WAS USED FOR PRE-DILATATION; HOWEVER, THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. A 3.0 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL OSTIAL LAD AND A 2.5 X 28 MM ABSORB SCAFFOLD WAS IMPLANTED IN THE MID LAD. POST DILATATION WAS PERFORMED WITH A 2.75 BALLOON CATHETER, THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THE FINAL VESSEL SIZE WAS 2.2 MM AT THE DISTAL EDGE AND THEN STEPPED DOWN TO 1.9 MM. OCT ALSO CONFIRMED THE STENT AND SCAFFOLD WERE FULLY APPOSED TO THE VESSEL WALL. ON (B)(6) 2016 THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION AND ELECTROCARDIOGRAM SHOWED ANTEROLATERAL WALL ISCHEMIA. ADDITIONALLY, THROMBOSIS WAS CONFIRMED IN THE MID-PORTION OF THE ABSORB SCAFFOLD. A GUIDE WIRE WAS ADVANCED AND A 2.5 X 15 MM NON-ABBOTT BALLOON CATHETER WAS USED TO DILATE THE LESION. A 2.75 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID-PORTION OF THE ABSORB TO THE DISTAL EDGE O

  Patient problems: Ischemia; Myocardial Infarction; Thrombosis

  MAUDE report 6168350 ↗
• InjuryNov 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED 2.5MM BALLOON DILATATION CATHETER. THE 2.5X28 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS DEPLOYED WITHOUT ISSUE. POST-DILATATION WAS PERFORMED WITH 3.0X15 MM AND 2.5X20 MM NC BALLOONS. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) CATHETER WAS ADVANCED IN THE PATIENT ANATOMY CONFIRMING THE SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL AT WHICH TIME THROMBUS WAS NOTED IN THE BVS. THE THROMBUS WAS TREATED BY INCREASING MEDICATION. THE PATIENT IS STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 6106374 ↗
• 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 SCAFFOLDS, A 3.0 X 12 MM ABSORB SCAFFOLD IN THE MID CIRCUMFLEX (CX) AND TWO 2.5 X 28 MM ABSORB SCAFFOLDS 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 DAPT COMPLIANT SINCE THE ABSORBS 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 6042602 ↗
• 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 6042600 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 , 3 ABSORB SCAFFOLDS WERE SUCCESSFULLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, WITHOUT ISSUE. SUBSEQUENTLY, THE SAME DAY THE PATIENT HAD CHEST PAIN; HOWEVER, REPEAT ANGIOGRAPHY SHOWED NO STENT THROMBOSIS AND THE SCAFFOLDS WERE WIDELY PATENT. THE PATIENT WAS DISCHARGED. ON (B)(6) 2016, THE PATIENT PRESENTED WITH CHEST PAIN, DIAPHORESIS AND HAD AN ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS HOSPITALIZED AND ANGIOGRAPHY SHOWED THROMBOSIS IN THE DISTAL SCAFFOLDS; HOWEVER, THE PROXIMAL MOST PART OF THE VESSEL WAS OPEN. A 38 MM XIENCE ALPINE STENT WAS USED AS TREATMENT WITH A GOOD OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Diaphoresis; Myocardial Infarction; Thrombosis

  MAUDE report 5973441 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 , 3 ABSORB SCAFFOLDS WERE SUCCESSFULLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, WITHOUT ISSUE. SUBSEQUENTLY, THE SAME DAY THE PATIENT HAD CHEST PAIN; HOWEVER, REPEAT ANGIOGRAPHY SHOWED NO STENT THROMBOSIS AND THE SCAFFOLDS WERE WIDELY PATENT. THE PATIENT WAS DISCHARGED. ON (B)(6) 2016, THE PATIENT PRESENTED WITH CHEST PAIN, DIAPHORESIS AND HAD AN ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS HOSPITALIZED AND ANGIOGRAPHY SHOWED THROMBOSIS IN THE DISTAL SCAFFOLDS; HOWEVER, THE PROXIMAL MOST PART OF THE VESSEL WAS OPEN. A 38 MM XIENCE ALPINE STENT WAS USED AS TREATMENT WITH A GOOD OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Diaphoresis; Myocardial Infarction; Thrombosis

  MAUDE report 5973439 ↗