ABSORB GT1 1235300-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648213052), received between Aug 17, 2016 and May 22, 2017 — classified as 9 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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.

• InjuryMay 22, 2017Improper or Incorrect Procedure or Method; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED MID LEFT CIRCUMFLEX ARTERY. IN (B)(6) 2017, THE PATIENT PRESENTED WITH A NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). THE VESSEL WAS CONFIRMED WITH OPTICAL COHERENCE TOMOGRAPHY (OCT) TO BE GREATER THAN 2.5MM. A THROMBECTOMY DEVICE WAS USED AN PRE-DILATATION WAS PERFORMED WITH A 2.5 X 12 MM NON-ABBOTT BALLOON CATHETER TO 16 ATMOSPHERES. A 3.0 X 23 MM ABSORB GT1 SCAFFOLD COULD NOT CROSS THROUGH THE MODERATE CALCIUM IN THE LCX. THE DEVICE WAS REMOVED AND RE-INSERTED THROUGH A GUIDELINER AND WAS IMPLANTED AT 16 ATMOSPHERES. POST DILATATION WAS PERFORMED WITH A 3.5 X 15 MM NON-ABBOTT NC BALLOON CATHETER INFLATED TO 17 AND 18 ATMOSPHERES AND A 3.75 X 12 MM NC BALLOON CATHETER TO 18 ATMOSPHERES. THE RESIDUAL STENOSIS WAS 0%. THE SCAFFOLD WAS CONFIRMED BY OCT TO BE FULLY APPOSED TO THE VESSEL WALL. ON 26 APRIL 2017, THE PATIENT RETURNED WITH A NSTEMI AND IN-SCAFFOLD THROMBOSIS WAS CONFIRMED WITH OCT.. A XIENCE ALPINE STENT WAS IMPLANTED TO TREAT THE THROMBOSIS. IT IS UNKNOWN IF THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6582185 ↗
• InjuryJan 19, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE ON (B)(6) 2017 WAS TO TREAT A LESION LOCATED IN THE MODERATELY CALCIFIED CIRCUMFLEX. A CUTTING BALLOON WAS ADVANCED; HOWEVER, WOULD NOT CROSS. A 2.5 X 20 NC TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION AND THE CUTTING BALLOON WAS READVANCED SUCCESSFULLY. THE 3.0 X 23 MM ABSORB GT1 SCAFFOLD WAS DEPLOYED IN THE LESION AND WAS POST-DILATED WITH A 3.0 X 20 MM NC TREK AT 16-18 ATMOSPHERES. INTRAVASCULAR ULTRASOUND CONFIRMED THE SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL AND THE LESION WAS CONFIRMED TO BE LESS THAN 10% RESIDUAL STENOSIS. PATIENT WAS PLACED ON BRILINTA AND ASPIRIN. ON (B)(6) 2017 THE PATIENT RETURNED TO THE HOSPITAL EXPERIENCING CHEST PAIN AND WAS REHOSPITALIZED. ANGIOGRAPHY REVEALED THROMBUS AT THE DISTAL END OF THE SCAFFOLD. A 2.0 X 20 MM TREK BALLOON WAS USED FOR PRE-DILATATION OF THE DISTAL END OF THE SCAFFOLD FOLLOWED BY THE DEPLOYMENT OF A 2.75 X 12 MM MULTI-LINK VISION STENT. POST-DILATATION WAS PERFORMED WITH A 3.0 X 12 MM TREK BALLOON AND THE FINAL OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6265411 ↗
• InjuryJan 4, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PROCEDURE ON (B)(6) 2016 WAS AT A DIFFERENT HOSPITAL. THE PATIENT PRESENTED WITH A NON ST ELEVATED MYOCARDIAL INFARCTION. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5 MM. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 15 MM NC TREK BALLOON CATHETER INFLATED TO 12 ATMOSPHERES FOR 20 SECONDS. THE RESIDUAL RESTENOSIS WAS LESS THAN 40%. A 3.0 X 23 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH A 3.75 X 15 MM NC TREK BALLOON INFLATED TO 18 ATMOSPHERES FOR 20 SECONDS. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. OPTICAL COHERENCE TOMOGRAPHY (OCT WAS PERFORMED AND THE SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL. ON (B)(6) 2016 THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION. THROMBOSIS WAS SUSPECTED, THERE WAS NO IMAGING PERFORMED, WHICH WAS TREATED WITH A 3.0 X 15 MM NC TREK BALLOON CATHETER. IT WAS CONFIRMED THAT THE PATIENT WAS NOT ON DUAL ANTIPLATELET THERAPY. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6221927 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A ST-ELEVATED MYOCARDIAL INFARCTION (STEMI). THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5 MM IN DIAMETER. PREDILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER WITH THE RESIDUAL STENOSIS REDUCED TO LESS THAN 40%. A 3.0 X 23 MM ABSORB GT1 SCAFFOLD WAS DEPLOYED AND POST-DILATATION WAS PERFORMED WITH A 3.5 X 12 NON-ABBOTT BALLOON CATHETER AT 12 ATMOSPHERES (ATM). THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 10%. THE ABSORB GT1 SCAFFOLD WAS NOT CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL BECAUSE IMAGING WITH INTRAVASCULAR ULTRASOUND OR OPTICAL COHERENCE TOMOGRAPHY WAS NOT AVAILABLE IN THE HOSPITAL. TWELVE HOURS AFTER THE PROCEDURE ST ELEVATION WAS NOTED AND SUBSEQUENTLY IN-SCAFFOLD THROMBOSIS WAS IDENTIFIED IN THE ABSORB GT1 SCAFFOLD. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. PATIENT IS DOING WELL. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT IN FOLLOWING THE DUAL ANTIPLATELET DRUG THERAPY (DAPT) CONSISTING OF CLOPIDOGREL AFTER THE INDEX PROCEDURE. THE PATIENTS MEDICATION WAS CHANGED FROM CLOPID

  Patient problems: Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 6216061 ↗
• InjuryDec 2, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ELECTIVE PROCEDURE ON (B)(6) 2016 WAS FOLLOWING A STRESS TEST THAT REVEALED A FOCAL CALCIFICATION IN THE LEFT DESCENDING CORONARY (LAD) ARTERY. THE CALCIFIED LESION WAS PROXIMAL TO MID LAD WITH 75% STENOSIS. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO DETERMINE VESSEL SIZE (3.25MM TAPERING TO 3.0MM). SEVERAL PASSES WITH AN ATHERECTOMY CATHETER WERE MADE, FOLLOWED BY PRE-DILATATION WITH A 2.5 MM NC TREK BALLOON, REDUCING THE STENOSIS TO LESS THAN 40%. THE 3.0X23 MM ABSORB GTI SCAFFOLD WAS IMPLANTED AT 8 ATMOSPHERES AND POST-DILATED WITH A 3.0 MM NC TREK BALLOON. IVUS SHOWED PROXIMAL UNDER EXPANSION SO ADDITIONAL POST-DILATATION WAS DONE WITH A 3.5 MM NC TREK BALLOON. IVUS SHOWED SATISFACTORY APPOSITION AND EXPANSION. GREAT ANGIOGRAPHIC RESULTS; RESIDUAL STENOSIS WAS LESS THAN 10%. ON (B)(6) 2016, THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY SHOWED THE SCAFFOLD WAS OCCLUDED WITH THROMBUS. A 3.0X28 MM XIENCE STENT WAS IMPLANTED FOR TREATMENT OF THE THROMBUS. THE PATIENT IS DOING WELL. IT WAS CONFIRMED THAT THE PATIENT HAD NOT BEEN COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) (HAD NOT TAKEN ASPIRIN SINCE THE PROCEDURE). THE

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6142957 ↗
• 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 6100334 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MILD CALCIFICATION AND NO TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.0 X 23 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED AT 16 ATMOSPHERES (ATM) SUCCESSFULLY; HOWEVER, A PERFORATION OCCURRED WHICH REQUIRED A GRAFTMASTER TO TREAT THE PERFORATION. REPORTEDLY, THE PATIENT OUTCOME IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 5988823 ↗
• 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 5973440 ↗
• 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 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 5883033 ↗