XIENCE ALPINE 1125400-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648199646), received between Mar 13, 2017 and Mar 13, 2019 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2018 WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS. A 4.0X28 MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WENT TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH, DIZZINESS, AND ARM PAIN THAT WERE DIAGNOSED AS ANGINA. ON (B)(4) 2019 PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO REVASCULARIZE THE RESTENOSIS IN THE RCA TARGET LESION. A NON-TARGET LESION WAS ALSO TREATED. THE CONDITION RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Dyspnea; Stenosis

  MAUDE report 8417988 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0X28MM XIENCE ALPINE STENT WAS DEPLOYED; HOWEVER, THE PATIENT WAS RE-ADMITTED WITHIN 30 DAYS FOR UNKNOWN REASONS. AN ADDITIONAL XIENCE STENT WAS PLACED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7829494 ↗
• MalfunctionAug 15, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY LESION WITHOUT ANY TORTUOSITY OR CALCIFICATION. A 4.0 X 28 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, WITHOUT RESISTANCE. ONCE AT THE LESION, THE BALLOON FAILED TO INFLATE; THEREFORE, IT WAS REMOVED WITHOUT REPORTED ISSUE AND ANOTHER 4.0 X 28 MM XIENCE ALPINE SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785618 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 A 4.0 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) AND IN (B)(6) 2016, 3 ALPINE STENTS (3.0 X 15 MM, 4.0 X 23 MM, 3.5 X 08) WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2017 THE PATIENT PRESENTED WITH CHEST PAIN AND RESTENOSIS WAS FOUND IN ONE OF THE PREVIOUSLY IMPLANTED STENTS. MEDICAL INTERVENTION WAS PERFORMED TO TREAT THE IN-STENT RESTENOSIS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 7113327 ↗
• InjuryMar 22, 2017Difficult or Delayed Positioning; Inflation Problem

  THE PROCEDURE WAS TO TREAT A 90 PERCENT STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED CONCENTRIC DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A 2.0X20MM NON-ABBOTT BALLOON, THROMBUS ASPIRATION WAS PERFORMED DUE TO THROMBUS ENTER THE PERIPHERAL VESSEL. A 4.0X28MM XIENCE ALPINE STENT WAS IMPLANTED AT THE LESION SITE AT 10 ATMOSPHERES FOR 20 SECONDS TWICE; HOWEVER, THE DISTAL PART OF THE STENT DIDN'T LOOK FULLY EXPANDED. AN INTRAVASCULAR ULTRASOUND CATHETER MEASURED THE DISTAL PART OF THE STENT AT 2.5MM. THE STENT DELIVERY CATHETER WAS RE-ADVANCED AND ADDITIONAL DILATATION WAS PERFORMED. THE DISTAL PART OF THE STENT WAS EXPANDED TO MATCH THE REST OF THE STENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE AN ATTEMPT TO INFLATE THE BALLOON OF THE DELIVERY CATHETER WAS MADE; HOWEVER, THE DISTAL PART OF THE BALLOON WOULD NOT FULLY EXPAND. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6425589 ↗
• InjuryMar 13, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A 4.0 X 28 MM XIENCE ALPINE STENT WAS DEPLOYED AT NOMINAL PRESSURE WHEN A PROXIMAL EDGE DISSECTION OCCURRED. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY AND ANOTHER XIENCE ALPINE WAS IMPLANTED PROXIMAL TO THE FIRST ALPINE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6401331 ↗