XIENCE ALPINE 1145300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648200076), received between Jun 30, 2017 and Nov 9, 2017 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathNov 9, 2017Difficult or Delayed Positioning; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. ANGIOGRAPHY CONFIRMED TOTAL OCCLUSIONS IN THE CIRCUMFLEX (CX) AND LEFT ANTERIOR DESCENDING ARTERIES, AND 99% OCCLUSION IN THE RIGHT CORONARY ARTERY. THE 3.0X18MM OTW ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE MID CX AND DURING ATTEMPTED DEPLOYMENT, THE INDEFLATOR WOULD NOT HOLD PRESSURE AND THE BALLOON WOULD NOT FULLY INFLATE, THEREFORE THE STENT DID NOT FULLY DEPLOY. A BALLOON RUPTURE WAS SUSPECTED AS BLOOD ENTERED THE INDEFLATOR. THE SDS WAS REMOVED AND A 3.0X15MM NC TREK BALLOON CATHETER WAS USED TO DEPLOY THE STENT IN THE TARGET LESION WITH NO ISSUES. A BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE HE EXPIRED LATER THAT DAY. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS NOT REPORTED; HOWEVER, IT WAS NOT THOUGHT TO BE DEVICE RELATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 7016428 ↗
• MalfunctionSep 26, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A NON-ABBOTT GUIDE WIRE WAS ACROSS THE LESION. AN ATTEMPT WAS MADE TO ADVANCE THE 3.0 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) OVER THE GUIDE WIRE, OUTSIDE THE PATIENT, WHEN IT BECAME STUCK. AS THE SDS COULD NOT BE REMOVED FROM THE GUIDE WIRE BOTH DEVICES WERE REMOVED TOGETHER. A NEW GUIDE WIRE AND SDS WERE USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6896371 ↗
• MalfunctionJun 30, 2017Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.0 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE TO DEPLOY THE STENT; HOWEVER, A PINHOLE LEAK WAS SUSPECTED WHEN THEY BEGAN TO LOSE PRESSURE ON THE INFLATION DEVICE. THE BALLOON WAS INFLATED QUICKLY AND TO HIGHER PRESSURE, BUT BELOW RATED BURST PRESSURE, IN ORDER TO DEPLOY THE STENT; HOWEVER, A BALLOON RUPTURE OCCURRED. THE STENT WAS FULLY DEPLOYED AND WAS WELL APPOSED TO THE VESSEL WALL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6683230 ↗