XIENCE ALPINE 1145275-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648199967), received between Feb 21, 2019 and Mar 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 80% STENOSED LESION IN THE OBTUSE MARGINAL (OM). THE VESSEL WAS PRE-DILATATED WITH AN UNSPECIFIED NC TREK BALLOON DILATATION CATHETER (BDC), AND A 2.75X12MM XIENCE ALPINE DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION. ONCE AT THE LESION, THE DES WAS INFLATED ONE TIME TO 7 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE DES REMAINED IN PLACE AND THE STENT WAS PARTIALLY DEPLOYED IN THE TARGET LESION. A NEW NC TREK BDC WAS USED TO COMPLETE THE DEPLOYMENT OF THE STENT WHICH COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584707 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2017, THE PATIENT PRESENTED WITH ISCHEMIC CARDIOMYOPLASTY AND UNDERWENT A CORONARY STENTING PROCEDURE FOR A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 80-90% STENOSIS. A 2.50 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID LAD AND A 2.75 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL TO MID LAD WITHOUT ISSUE. ON (B)(6) 2019, THE PATIENT UNDERWENT FURTHER PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY (PTCA) FOR UNSPECIFIED SYMPTOMS. IN STENT RE-STENOSIS OF THE ALPINE STENTS WAS DIAGNOSED BY ANGIOGRAM. A 3.00 X 28 MM XIENCE SIERRA STENT AND A 3.00 X 23 MM XIENCE SIERRA STENT WERE DEPLOYED IN THE PROXIMAL TO MID LAD TO TREAT THE RE-STENOSIS. THE PATIENT WAS REPORTED TO BE WELL POST PROCEDURE AND WAS THEREFORE DISCHARGED; HOWEVER 5 DAYS LATER THE PATIENT DEVELOPED CHEST PAIN AND LOW BLOOD PRESSURE AND WAS RE-ADMITTED ((B)(6) 2019). ANGIOGRAM CONFIRMED IN STENT THROMBOSIS AND THE PATIENT WAS TREATED WITH MEDICATION AND ADDITIONAL BALLOON ANGIOPLASTY. A NON-ABBOTT HEART PUMP WAS USED DURING THE PROCEDURE. POST PROCEDURE THE STENTS WERE CONFIRMED TO BE PATENT AND THE PATIENT WAS REPORTED TO BE STABLE IN H

  Patient problems: Stenosis

  MAUDE report 8360237 ↗