XIENCE ALPINERecalls & reported problems across all models
Abbott Vascular Inc. · 72 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 898
- Deaths reported
- 33
- Injuries reported
- 595
- Recalls
- 0
We found 72 models of XIENCE ALPINE by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 898 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2016 and Mar 28, 2024 — classified as 33 deaths, 595 injuries, 269 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (192 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported XIENCE ALPINE problems
Device problems
- Adverse Event Without Identified Device or Use Problem455
- Device Dislodged or Dislocated192
- Difficult to Remove149
- Failure to Advance137
- Improper or Incorrect Procedure or Method88
- Material Deformation63
- Difficult To Position38
- Material Rupture25
Patient problems
- No Consequences Or Impact To Patient266
- Angina178
- Thrombosis80
- No Patient Involvement72
- Myocardial Infarction70
- No Code Available66
- Foreign Body In Patient34
- Vessel Or Plaque, Device Embedded In28
XIENCE ALPINE models
72 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIENCE ALPINE 1125350-18Coronary drug-eluting stent3 deaths42 reports
- XIENCE ALPINE 1125350-23Coronary drug-eluting stent40 reports
- XIENCE ALPINE 1125300-15Coronary drug-eluting stent1 death36 reports
- XIENCE ALPINE 1125300-18Coronary drug-eluting stent1 death33 reports
- XIENCE ALPINE 1125250-23Coronary drug-eluting stent2 deaths32 reports
- XIENCE ALPINE 1125250-18Coronary drug-eluting stent28 reports
- XIENCE ALPINE 1125350-12Coronary drug-eluting stent1 death28 reports
- XIENCE ALPINE 1125250-15Coronary drug-eluting stent3 deaths27 reports
- XIENCE ALPINE 1125350-38Coronary drug-eluting stent1 death27 reports
- XIENCE ALPINE 1125300-23Coronary drug-eluting stent2 deaths26 reports
- XIENCE ALPINE 1125250-12Coronary drug-eluting stent25 reports
- XIENCE ALPINE 1125300-28Coronary drug-eluting stent25 reports
- XIENCE ALPINE 1125225-12Coronary drug-eluting stent23 reports
- XIENCE ALPINE 1125225-15Coronary drug-eluting stent23 reports
- XIENCE ALPINE 1125350-15Coronary drug-eluting stent23 reports
- XIENCE ALPINE 1125400-15Coronary drug-eluting stent1 death23 reports
- XIENCE ALPINE 1125250-38Coronary drug-eluting stent22 reports
- XIENCE ALPINE 1125275-23Coronary drug-eluting stent2 deaths19 reports
- XIENCE ALPINE 1125225-18Coronary drug-eluting stent1 death18 reports
- XIENCE ALPINE 1125300-12Coronary drug-eluting stent1 death18 reports
- XIENCE ALPINE 1125325-15Coronary drug-eluting stent1 death18 reports
- XIENCE ALPINE 1125275-15Coronary drug-eluting stent17 reports
- XIENCE ALPINE 1125350-33Coronary drug-eluting stent17 reports
- XIENCE ALPINE 1125225-28Coronary drug-eluting stent2 deaths16 reports
- XIENCE ALPINE 1125250-28Coronary drug-eluting stent16 reports
- XIENCE ALPINE 1125275-28Coronary drug-eluting stent16 reports
- XIENCE ALPINE 1125300-38Coronary drug-eluting stent16 reports
- XIENCE ALPINE 1125400-12Coronary drug-eluting stent2 deaths16 reports
- XIENCE ALPINE 1125325-18Coronary drug-eluting stent2 deaths15 reports
- XIENCE ALPINE 1125225-23Coronary drug-eluting stent14 reports
- XIENCE ALPINE 1125350-28Coronary drug-eluting stent14 reports
- XIENCE ALPINE 1125275-12Coronary drug-eluting stent2 deaths13 reports
- XIENCE ALPINE 1125400-18Coronary drug-eluting stent13 reports
- XIENCE ALPINE 1125300-33Coronary drug-eluting stent12 reports
- XIENCE ALPINE 1125275-18Coronary drug-eluting stent11 reports
- XIENCE ALPINE 1125325-12Coronary drug-eluting stent10 reports
- XIENCE ALPINE 1125325-23Coronary drug-eluting stent1 death9 reports
- XIENCE ALPINE 1125400-38Coronary drug-eluting stent9 reports
- XIENCE ALPINE 1125250-08Coronary drug-eluting stent7 reports
- XIENCE ALPINE 1125250-33Coronary drug-eluting stent7 reports
- XIENCE ALPINE 1125300-08Coronary drug-eluting stent1 death7 reports
- XIENCE ALPINE 1125325-28Coronary drug-eluting stent7 reports
- XIENCE ALPINE 1125400-23Coronary drug-eluting stent7 reports
- XIENCE ALPINE 1125275-33Coronary drug-eluting stent1 death6 reports
- XIENCE ALPINE 1125400-28Coronary drug-eluting stent6 reports
- XIENCE ALPINE 1125225-08Coronary drug-eluting stent5 reports
- XIENCE ALPINE 1125325-38Coronary drug-eluting stent5 reports
- XIENCE ALPINE 1125350-08Coronary drug-eluting stent5 reports
- XIENCE ALPINE 1125400-08Coronary drug-eluting stent5 reports
- XIENCE ALPINE 1125275-38Coronary drug-eluting stent4 reports
- XIENCE ALPINE 1125400-33Coronary drug-eluting stent4 reports
- XIENCE ALPINE 1145300-18Coronary drug-eluting stent1 death3 reports
- XIENCE ALPINE 1145300-38Coronary drug-eluting stent3 reports
- XIENCE ALPINE 1145350-23Coronary drug-eluting stent3 reports
- XIENCE ALPINE 1145350-38Coronary drug-eluting stent3 reports
- XIENCE ALPINE 1125275-08Coronary drug-eluting stent2 reports
- XIENCE ALPINE 1145275-12Coronary drug-eluting stent2 reports
- XIENCE ALPINE 1145350-28Coronary drug-eluting stent2 reports
- XIENCE ALPINE 1145400-08Coronary drug-eluting stent1 death2 reports
- XIENCE ALPINE 1125325-33Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145225-23Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145250-08Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145250-15Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145250-18Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145250-23Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145250-28Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145275-18Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145300-08Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145300-15Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145325-28Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145400-18Coronary drug-eluting stent1 report
- XIENCE ALPINE 1145400-38Coronary drug-eluting stent1 report
Recent XIENCE ALPINE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2024Off-Label Use; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Off-Label Use; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 3.5X38MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED TO THE LESION WHEN IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE DEVICE WAS REMOVED. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH AND WAS NOTED TO BE STRETCHED; HOWEVER, THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. IMPROPER OR INCORRECT PROCEDURE OF NOT INSPECTING DEVICE UPON USE OCCURRED. ANOTHER SAME SIZE XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 18990041 ↗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 ↗InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH UNSTABLE ANGINA; THEREFORE A 3.50X23MM XIENCE ALPINE STENT WAS IMPLANTED IN THE 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE TO ANGINA AND ANGIOGRAPHY CONFIRMED THE PREVIOUSLY IMPLANTED STENT HAD BECOME 90% RESTENOSED. THEREFORE THE LESION WAS RETREATED WITH BALLOON DILATATION, ROTATIONAL ATHERECTOMY SYSTEM AND STENT IMPLANTATION. IN ADDITION THE PATIENT WAS GIVEN ASPIRIN AND PLAVIX. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 15954937 ↗MalfunctionOct 5, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TIBIAL ARTERY. ATHERECTOMY WAS PERFORMED SO THE VESSEL WAS FREE OF CALCIFICATION AND TORTUOSITY. THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED BUT IT COULD NOT CROSS THE LESION FOR AN UNKNOWN REASON. THE SDS WAS STUCK TO THE GUIDE WIRE DURING REMOVAL SO THEY WERE REMOVED TOGETHER AND A NEW XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. 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 15544903 ↗InjuryJun 30, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT A NON-ABBOTT STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY, BUT PROTRUDED INTO THE LEFT MAIN ARTERY. ONE MONTH LATER, DURING IMPLANTATION OF A 3.0X38MM XIENCE ALPINE STENT IN THE LEFT MAIN ARTERY TO THE ANTERIOR DESCENDING CORONARY ARTERY, IT WAS NOTED THAT THE WALL APPOSITION WAS POOR AROUND THE AREA OF THE PREVIOUSLY IMPLANTED NON-ABBOTT STENT. AT THE AREA OF MALAPPOSITION, THROMBUS WAS NOTED. TREATMENT IS UNKNOWN. FOR COMPLETE REPORTED INFORMATION, PLEASE SEE THE ATTACHED ARTICLE, TITLED ¿NAPKIN RING FORMATION IN CULOTTE STENTING USING CURRENT-GENERATION DRUG-ELUTING STENTS IN LEFT MAIN CORONARY ARTERY BIFURCATION."
Patient problems: Thrombosis/Thrombus
MAUDE report 14881840 ↗InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: AFTER STENT IMPLANTATION, THE PATIENT WAS TAKING A LOW DOSE OF ASPIRIN AND BRILINTA. MEDICATION WAS INCREASED FOR TREATMENT OF ANGINA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 12913645 ↗MalfunctionOct 11, 2021Leak/Splash; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Leak/Splash; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn
IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT DE NOVO OSTIAL LEFT MAIN. A XIENCE ALPINE 4.0X8 DRUG ELUTING STENT (DES) WAS INSERTED. HOWEVER, WHEN FLUSHING THE DEVICE, A HOLE IN THE SIDE OF THE CATHETER SHAFT WAS OBSERVED. IT WAS NOTED THE DEVICE WAS ATTEMPTED TO BE PREPARED WHILE IN THE ANATOMY. DUE TO THIS, THE STENT WAS REMOVED AND REPLACED WITH A SAME SIZE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605924 ↗InjuryJul 9, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI). DUE TO THE PRESENCE OF THROMBUS, ASPIRATION WAS PERFORMED AND THEN TWO XIENCE ALPINE STENTS (3.5X23MM, 3.0X33MM) WERE IMPLANTED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. REPORTEDLY, THE OVERLAPPED SECTION WAS NOT WELL APPOSED TO THE VESSEL WALL, AND POST DILATATION WAS ATTEMPTED BUT UNABLE TO BE PERFORMED DUE TO THE SLOW BLOOD FLOW, RESULTING IN SOME ISCHEMIA AND TIMI FLOW ONLY 2.5. DUAL ANTIPLATELET THERAPY WAS GIVEN. ON (B)(6) 2019, DAPT WAS DISCONTINUED BUT THE PATIENT CONTINUED TO TAKE ASPIRIN. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO AN AMI. THE 3.5X23MM XIENCE ALPINE STENT WAS NOTED TO BE 100% OCCLUDED WITH THROMBUS. THE THROMBUS WAS ASPIRATED. A NON-ABBOTT STENT WAS IMPLANTED FOLLOWED BY POST DILATATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED CONFIRMING GOOD WALL APPOSITION OF ALL 3 STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Ischemia
MAUDE report 12147353 ↗InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI). DUE TO THE PRESENCE OF THROMBUS, ASPIRATION WAS PERFORMED AND THEN TWO XIENCE ALPINE STENTS (3.5X23MM, 3.0X33MM) WERE IMPLANTED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. REPORTEDLY, THE OVERLAPPED SECTION WAS NOT WELL APPOSED TO THE VESSEL WALL, AND POST DILATATION WAS ATTEMPTED BUT UNABLE TO BE PERFORMED DUE TO THE SLOW BLOOD FLOW, RESULTING IN SOME ISCHEMIA AND TIMI FLOW ONLY 2.5. DUAL ANTIPLATELET THERAPY (DAPT) WAS GIVEN. ON (B)(6) 2019, DAPT WAS DISCONTINUED BUT THE PATIENT CONTINUED TO TAKE ASPIRIN. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO AN AMI. THE 3.5X23MM XIENCE ALPINE STENT WAS NOTED TO BE 100% OCCLUDED WITH THROMBUS. THE THROMBUS WAS ASPIRATED. A NON-ABBOTT STENT WAS IMPLANTED FOLLOWED BY POST DILATATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED CONFIRMING GOOD WALL APPOSITION OF ALL 3 STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Thrombosis/Thrombus
MAUDE report 12147352 ↗MalfunctionMay 19, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER THE STENT SYSTEM WAS PREPARED, IT MAY NOT HAVE BEEN CHECKED FOR DAMAGE PRIOR TO ENTERING THE PATIENT ANATOMY. DURING THE POSTERIOR TIBIAL ARTERY INTERVENTION, THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND THE BALLOON INFLATED, BUT THE STENT WAS NOT ON THE BALLOON. THE PATIENT ANATOMY WAS CHECKED, AND NO STENT WAS PRESENT IN THE PATIENT. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11852779 ↗MalfunctionApr 23, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT A 3.0X15MM XIENCE ALPINE STENT WAS DEPLOYED WITHOUT ISSUES; HOWEVER, DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) RESISTANCE WITH THE GUIDE WIRE WAS FELT. THE SDS AND GUIDE WIRE HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS NOTED THAT THE STENT WAS STATIONARY ON THE BALLOON AND WAS NOT DEPLOYED AS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11717870 ↗InjuryApr 22, 2021Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). TWO XIENCE ALPINE STENT SYSTEMS WERE USED. WITH EACH STENT DELIVERY SYSTEM, THE BALLOON WAS INFLATED AND THE STENT WAS DEPLOYED. EACH BALLOON LOST PRESSURE AND DEFLATED ALMOST IMMEDIATELY. A BALLOON RUPTURE WAS SUSPECTED IN EACH DEVICE. THE STENT DELIVERY SYSTEMS WERE REMOVED WITHOUT RESISTANCE AND THE STENTS REMAINED AT THE TARGET LESION. POST DILATATION WAS PERFORMED WITH EACH STENT, AS IT COULD NOT BE DETERMINED IF THE STENTS WERE FULLY APPOSED TO THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712009 ↗InjuryApr 22, 2021Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). TWO XIENCE ALPINE STENT SYSTEMS WERE USED. WITH EACH STENT DELIVERY SYSTEM, THE BALLOON WAS INFLATED AND THE STENT WAS DEPLOYED. EACH BALLOON LOST PRESSURE AND DEFLATED ALMOST IMMEDIATELY. A BALLOON RUPTURE WAS SUSPECTED IN EACH DEVICE. THE STENT DELIVERY SYSTEMS WERE REMOVED WITHOUT RESISTANCE AND THE STENTS REMAINED AT THE TARGET LESION. POST DILATATION WAS PERFORMED WITH EACH STENT, AS IT COULD NOT BE DETERMINED IF THE STENTS WERE FULLY APPOSED TO THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11711989 ↗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 ↗MalfunctionApr 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING PREPARATION, IT WAS NOTED THAT THE STENT IMPLANT OF THE 3.50X38MM XIENCE ALPINE HAD MOVED, STILL REMAINING ON THE DELIVERY SYSTEM. THERE WAS NO RESISTANCE WHEN REMOVING THE DEVICE FROM THE DISPENSER HOOP COIL, OR WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO DAMAGE NOTED TO THE CHIPBOARD BOX OR DISPENSER HOOP COIL. ANOTHER XIENCE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11704162 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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