XIENCE ALPINE 1125350-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648199561), received between Sep 12, 2016 and Apr 21, 2021 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH GREATER THA 75% CALCIFIED STENOSIS. THE 3.5X33 MM XIENCE ALPINE STENT WAS IMPLANTED AND IT WAS LATER NOTED THAT THE DEVICE WAS 2 DAYS EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704333 ↗
• InjuryMar 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND A 3.5 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED IN A TORTUOUS LESION IN THE MID OBTUSE MARGINAL CORONARY ARTERY. POST PROCEDURE IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH ANGINA FOR A SECOND PERCUTANEOUS CORONARY INTERVENTION. IN-STENT RESTENOSIS OF THE STENT WAS IDENTIFIED; HOWEVER, DURING REVIEW OF THE STENT IMPLANT UNDER FLUOROSCOPY, A STENT FRACTURE WAS ALSO SUSPECTED. THE SUSPECTED FRACTURE WAS AT THE MIDDLE OF THE STENT IMPLANT, AT THE SITE OF THE RESTENOSIS. FOLLOWING DE-BULKING OF THE LESION WITH A LASER, A 3.5 X 15 MM XIENCE SIERRA STENT WAS DEPLOYED TO TREAT THE RESTENOSIS. POST DILATATION WAS PERFORMED WITH A 3.75 X 8 MM NC TREK BALLOON DILATATION CATHETER TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 8445707 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.50X33MM AND 3.50X38MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. NO TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7571665 ↗
• MalfunctionApr 20, 2018Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY AND FAILED TO CROSS THE LESION. ADDITIONALLY, THE PROXIMAL SHAFT SEPARATED; THEREFORE, BOTH PIECES WERE SIMPLY WITHDRAWN FROM THE ANATOMY. A 3.5 X 32 MM NON-ABBOTT STENT SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7447261 ↗
• MalfunctionDec 18, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH 95% STENOSIS AND MODERATE CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED WITH A 2.5 TREK BALLOON CATHETER. THE XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS ASSUMED TO BE DEPLOYED. A 4.0 X 15 MM NC TREK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION; HOWEVER, ANGIOGRAPHY REVEALED THAT NO STENT WAS IMPLANTED IN THE VESSEL. THE CARDIAC CATH LAB STAFF SEARCHED THE BACK TABLE FOR THE DISLODGED STENT AND IT WAS FOUND IN THE TRASH. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH. THE STENT WAS NOTED TO BE DAMAGED AND HAD AN ACCORDION SHAPE. REPORTEDLY, THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. ANOTHER XIENCE ALPINE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127763 ↗
• InjuryOct 7, 2017Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 3.5 X 33 MM XIENCE ALPINE STENT WAS USED. HOWEVER, IT MET INITIAL RESISTANCE WITH THE ANATOMY AND THE STENT DISLODGED FROM THE BALLOON IN THE LESION. THEREFORE, ANOTHER UNSPECIFIED STENT WAS IMPLANTED TO CRUSH AND EMBED THE ALPINE STENT IN THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6926557 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50X33 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR UNSPECIFIED CARDIOVASCULAR SYMPTOMS INCLUDING HYPOTENSION. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 6828821 ↗
• MalfunctionAug 14, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PLASTIC HOOP WITHOUT ISSUE. THE PROTECTIVE SHEATH WAS REMOVED FROM THE SDS WITHOUT ISSUE. WHEN THE SDS WAS READY TO BE LOADED ON THE GUIDE WIRE, IT WAS NOTED THAT THE STENT WAS NOT ON THE SDS. THE DISLODGED STENT WAS FOUND ON THE TABLE. THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6792557 ↗
• InjuryMay 12, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. DURING USE IN THE PATIENT ANATOMY, THE XIENCE ALPINE 3.5 X 33 MM STENT CAME OFF THE BALLOON AND HAD TO BE RETRIEVED IN THE PATIENT'S ARM USING A SNARE DEVICE. THERE WAS NO RESISTANCE NOTED PRIOR TO DISLODGEMENT. THERE WAS A DELAY IN THE PROCEDURE, HOWEVER IT WAS NOT CLINICALLY SIGNIFICANT AS THERE WERE NO ADVERSE PATIENT EFFECTS. ANOTHER XIENCE STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT HAD AN EXCELLENT FINAL OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6565210 ↗
• InjuryApr 28, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED AND TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY. THE 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS. DIFFICULTY WAS NOTED DURING WITHDRAWAL AND THE STENT DISLODGED. A SNARE DEVICE WAS ADVANCED AND THE DISLODGED STENT WAS PULLED INTO THE RADIAL ARTERY. THE STENT REMAINED IN THE RADIAL ARTERY AND THE PATIENT WAS SENT FOR A SURGICAL REMOVAL OF THE STENT. THE SURGICAL PROCEDURE WAS PERFORMED AND THE STENT WAS REMOVED. ADDITIONALLY, A CORONARY ARTERY BYPASS GRAFT PROCEDURE WAS PERFORMED TO TREAT THE TARGET LESION IN THE LAD. POST PROCEDURE, THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6532120 ↗
• InjuryFeb 21, 2017Failure to Advance

  IT WAS REPORTED THAT THE 3.5 X 33 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE HEAVILY TORTUOUS AND CALCIFIED 90% STENOSIS IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. A DISSECTION WAS NOTED IN THE VESSEL AFTER THE SDS WAS UNABLE TO CROSS THE LESION. A SHORTER, 3.5 X 23 XIENCE ALPINE SDS WAS ABLE TO CROSS THE LESION TO TREAT THE DISSECTION AND THE STENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED..

  Patient problems: Intimal Dissection

  MAUDE report 6346086 ↗
• MalfunctionFeb 2, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 3.50 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. NO ISSUES WERE NOTED DURING UNPACKING, INSPECTION AND PREPARATION OF THE SDS. THE SDS WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED THREE TIMES. THE SDS WAS REMOVED FROM THE ANATOMY AND UNDER ANGIOGRAPHY NO STENT IMPLANT WAS OBSERVED IN THE LESION. IT WAS DISCOVERED THAT THE STENT IMPLANT HAD DISLODGED DURING PREPARATION AND WAS FOUND INSIDE THE PROTECTIVE SHEATH. ANOTHER 3.50 X 38 MM XIENCE ALPINE STENT IMPLANT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6298538 ↗
• MalfunctionNov 18, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM, THE STYLET WAS REMOVED, WITH THE STENT REMAINING ON THE STYLET. IT WAS NOT NOTED AT FIRST AND DEVICE PREPARATION CONTINUED. IT WAS THEN NOTED THAT THE STENT WAS NOT ON THE DELIVERY CATHETER AND WAS FOUND ON THE STYLET. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SAME SIZE XIENCE ALPINE WAS USED WITHOUT ISSUE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE DEVICE FROM THE DISPENSER HOOP AND NO DIFFICULTY REMOVING THE SHEATH OR STYLET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6115024 ↗
• InjuryNov 14, 2016Difficult to Remove; Unstable; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY (RCA). AN ABSORB SCAFFOLD WAS PLACED IN THE DISTAL RCA AND A 3.5 X 15 MM XIENCE ALPINE STENT WAS PLACED IN THE MID RCA. A 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED TO TREAT THE PROXIMAL RCA WHEN IT COULD NOT CROSS THROUGH A PREVIOUSLY PLACED STENT. AS THE DEVICE WAS BEING REMOVED, THE GUIDING CATHETER PUSHED FORWARD AND FLARED THE PROXIMAL END OF THE STENT IMPLANT AND THE STENT BECAME LOOSE. A SNARE DEVICE WAS ADVANCED TO SECURE THE STENT ON THE CATHETER; HOWEVER, WHEN IT GOT TO THE SHEATH AT THE ACCESS SITE, THE STENT DISLODGED. SEVERAL ATTEMPTS WITH THE SNARE DEVICE WERE MADE TO REMOVE THE DISLODGED STENT BUT IT COULD NOT BE REMOVED SO A SURGEON WAS CALLED IN AND A CUT DOWN WAS PERFORMED TO REMOVE THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6100738 ↗
• InjuryOct 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2015 A 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND A 2.5X28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE SECOND DIAGONAL OF THE LAD. ON (B)(6) 2015 THE PATIENT RETURNED WITH CHEST PAIN AND HIGH BLOOD PRESSURE. A 3.25X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE OBTUSE MARGINAL (OM) ARTERY AND A 3.5X33 MM XIENCE ALPINE WAS IMPLANTED IN THE PROXIMAL LAD ACROSS THE DISEASED SEGMENTS INTO THE PREVIOUSLY PLACED STENT. THE PATIENT HAS HAD SEVERAL ANGIOGRAMS PERFORMED DUE TO CONTINUED CHEST PAIN, ONE IN IN (B)(6) 2016, (DATE NOT SPECIFIED FOR (B)(6)) AND ON (B)(6) 2016, ANGIOGRAMS HAVE CONFIRMED ALL FOUR STENTS REMAIN PATENT. ROUTINE MEDICATION WAS GIVEN FOR ANGINA AND FOR HYPERTENSION. THE PATIENT IS CONCERNED THAT SHE IS POSSIBLY ALLERGIC TO THE STENTS WHICH COULD BE CAUSING THE CHEST PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction

  MAUDE report 6065124 ↗
• MalfunctionSep 29, 2016Stretched; Torn Material

  IT WAS REPORTED THAT THE 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGING AND THE PROTECTIVE SHEATH WAS REMOVED WITHOUT DIFFICULTY. IT WAS NOTED THAT THE ORANGE TIP OF THE STENT DELIVERY SYSTEM WAS DAMAGED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SECOND XIENCE ALPINE STENT DELIVERY SYSTEM WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. UPON RETURN, DEVICE ANALYSIS NOTED THAT THE TIP OF THE DEVICE WAS STRETCHED AND TORN. FOLLOW UP WITH THE SITE INDICATES THE DAMAGE NOTED IS THE REPORTED TIP DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5988800 ↗
• MalfunctionSep 12, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT NO RESISTANCE WAS FELT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE 3.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM; HOWEVER, AFTER REMOVAL IT WAS OBSERVED THAT THERE WAS NO STENT IMPLANT ON THE BALLOON. FURTHER INVESTIGATION FOUND THE STENT IMPLANT LOCATED INSIDE THE PROTECTIVE SHEATH. THE DEVICE COULD NOT BE USED ON THE PATIENT. ANOTHER SAME SIZE STENT DELIVERY SYSTEM WAS USED SUCCESSFULLY FOR THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5944832 ↗