XIENCE ALPINE 1145225-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648199813), received between Nov 27, 2017 and Nov 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2017Overheating of Device; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS RIGHT CORONARY ARTERY. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE LESION. A 2.25 X 23 OTW XIENCE ALPINE WAS BEING ADVANCED OVER THE GUIDE WIRE WITHOUT RESISTANCE; HOWEVER, THE GUIDE WIRE BACKED OUT SLIGHTLY SO THE PHYSICIAN TRIED TO ADVANCE THE GUIDE WIRE WHEN THERE WAS RESISTANCE WITH THE CATHETER. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER, BUT AT THE GUIDING CATHETER TIP, THERE WAS RESISTANCE AGAIN WITH THE GUIDE WIRE SO THE DEVICES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE GUIDE WIRE TIP HAD SEPARATED AND THE COILS HAD STRETCHED AND SOME OF THEM WERE ENTWINED WITH THE STENT STRUTS. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE SO IT IS UNKNOWN IF THE COILS ARE STILL ENTWINED WITH THE STENT. THERE WAS NO PART OF THE GUIDE WIRE LEFT IN THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE WIRE AND STENT DELIVERY SYSTEM. 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 7060243 ↗