ABSORB GT1 1235350-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648213137), received between Jan 11, 2017 and Apr 11, 2017 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2017Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED, DE NOVO LESION IN THE MILDLY TORTUOUS CIRCUMFLEX (CX) CORONARY ARTERY. A 3.5X23MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM WAS ADVANCED AND DEPLOYED WITHOUT DIFFICULTY AT 10 ATMOSPHERES WHEN A DISTAL EDGE DISSECTION WAS OBSERVED. THE ABSORB GT1 DELIVERY SYSTEM WAS WITHDRAWN WITHOUT DIFFICULTY. AN ATTEMPT WAS MADE TO ADVANCE A 3.0X12MM ABSORB GT1 BVS SYSTEM THROUGH THE DEPLOYED 3.5X23MM ABSORB GT1 SCAFFOLD, HOWEVER, IT WAS UNABLE TO CROSS THROUGH THIS SCAFFOLD AND WAS WITHDRAWN WITHOUT RESISTANCE. NO DAMAGE WAS CAUSED TO EITHER ABSORB SCAFFOLD. A 3.0X12 XIENCE ALPINE STENT CROSSED AND WAS DEPLOYED, SUCCESSFULLY TREATING THE DISSECTION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6481084 ↗
• InjuryMar 24, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL CIRCUMFLEX ARTERY INTO THE FIRST MARGINAL. THE PATIENT CAME IN TO THE HOSPITAL ON (B)(6) 2017 FOR A ROUTINE CHECK-UP. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED THROUGHOUT THE PROCEDURE. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5 MM. A ROTOBLADER WAS USED AND MULTIPLE UNSPECIFIED BALLOONS WERE USED FOR PRE-DILATATION. THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. A 3.5 X 23 MM ABSORB SCAFFOLD WAS IMPLANTED; HOWEVER, THE CENTER OF THE SCAFFOLD RECOILED, SO A 4.0 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED OVER THE SCAFFOLD FOR A BAIL-OUT AND IT ALSO RECOILED. POST-DILATATION WAS PERFORMED WITH A NC TREK BALLOON CATHETER. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS 40-50%. OCT CONFIRMED THAT THE SCAFFOLD AND STENT WERE FULLY APPOSED TO THE VESSEL WALL. ON (B)(6) 2017, THE PATIENT RETURNED WITH CHEST DISCOMFORT AND THROMBOSIS WAS OBSERVED IN BOTH THE SCAFFOLD AND THE STENT AND INTO THE MARGINAL ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED TO REGAIN FLOW TO THE ARTERIES. THE PATIENT HAD BEEN ON PLAVIX AND ASPIRIN AND THE DUAL ANTIPLATELET THERAPY (DAPT) MEDICATION WAS CHANGED TO BRILINTA. THE PATIENT IS STABLE. NO ADDIT

  Patient problems: Angina; Thrombosis

  MAUDE report 6432168 ↗
• MalfunctionFeb 2, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING UNPACKAGING, WHEN PULLING A 3.5X23 ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM FROM ITS DISPENSER HOOP PACKAGING WITHOUT DIFFICULTY, THE DISTAL SHAFT SEPARATED AT THE PROXIMAL TO DISTAL JUNCTION AREA. THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. A NEW ABSORB WAS UNPACKAGED WITHOUT ISSUE AND WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6296639 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT PRESENTED WITH A TACHYCARDIA INDUCED CARDIOMYOPATHY AND THE LEFT VENTRICULAR (LV) FUNCTION WAS 20. PRE-DILATATION WAS PERFORMED WITH A 3.25 X 15 MM NC TREK AND A 3.5 X 15 NC TREK BALLOON CATHETERS TO 16 ATMOSPHERES. A 3.5 X 23 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED AT 12 ATMOSPHERES (ATMS) FOR 20 SECONDS. OPTICAL COHERENCE TOMOGRAPHY WAS PERFORMED AND THE SCAFFOLD WAS FULLY APPOSED TO THE VESSEL WALL. POST-DILATATION WAS PERFORMED WITH A 3.5 X 15 MM NC TREK TO 20 ATMS, A 3.75 X 15 MM NC TREK TO 24 ATMS AND THEN A 4.0 X 12 MM NC TREK AT 20 ATMS WHEN A PERFORATION OCCURRED. THE PERFORATION WAS TREATED WITH A 3.75 X 15 MM UNSPECIFIED BALLOON CATHETER AT 9 ATMS FOR 4 1/2 MINUTES. THE BLOOD FLOW WAS STILL SLOW, SO A 3.5 X 28 MM XIENCE ALPINE WAS IMPLANTED IN THE OSTIAL LESION OF THE LAD AND WAS POST-DILATED WITH A 3.75 X 20 MM NC TREK BALLOON CATHETER TO 15 ATMOSPHERES AND THE DISTAL FLOW INCREASED. A PERICARDIOCENTESIS WAS PERFORMED DUE TO THE PERFORATION. A BALLOON PUMP WAS PUT IN THE PATIENT DUE TO THE LOW LV FUNCTION. THE PATIENT WAS ADMITTE

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 6244393 ↗