XIENCE ALPINE 1125250-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648199219), received between Apr 4, 2016 and May 19, 2021 — classified as 11 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2017 THE 2.5X38 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) CORONARY ARTERY. ON (B)(6) 2017 THE 2.5X18 MM ABSORB GT1 WAS IMPLANTED IN THE RAMUS CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT HAD A MYOCARDIAL INFARCTION AND WAS FOUND TO HAVE STENOSIS NEAR THE XIENCE ALPINE STENT. THE STENOSIS WAS WITHIN 5 MM OF THE XIENCE ALPINE STENT. PERCUTANEOUS REVASCULARIZATION WAS PERFORMED AND A DRUG ELUTING STENT WAS IMPLANTED IN THE PLAD. THE CONDITION IS CONTINUING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Stenosis

  MAUDE report 9930963 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X38MM XIENCE ALPINE STENT WAS DEPLOYED; HOWEVER, THE PATIENT WAS RE-ADMITTED WITHIN 30 DAYS FOR UNKNOWN REASONS. ADDITIONAL STENTS WERE PLACED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7828529 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X 38 MM XIENCE ALPINE CORONARY STENT SYSTEM WAS IMPLANTED ON (B)(6) 2018. ON 04/01/2018 THE PATIENT WAS RE-ADMITTED WITH ENCEPHALOPATHY AND CARDIOVASCULAR SYMPTOMS. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7571899 ↗
• MalfunctionMay 22, 2018Difficult To Position; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED, 75% STENOSED CONCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5X15 MM NON-ABBOTT DEVICE. A 2.5X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED WITH A 6 FR NON-ABBOTT GUIDING CATHETER BEFORE PASSING THE INSERTION SITE OF THE VESSEL. THE SDS WAS REMOVED INDEPENDENTLY FROM THE PATIENT ANATOMY; HOWEVER, RESISTANCE WAS FELT WITH THE GUIDING CATHETER. THE PROXIMAL END STENT STRUTS WERE NOTED TO BE FLARED. A NEW SAME SIZE XIENCE ALPINE SDS WAS ADVANCED USING THE SAME NON-ABBOTT GUIDING CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7534907 ↗
• MalfunctionMay 22, 2018Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON CATHETER. THE 2.50X38MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH NO RESISTANCE. DURING ATTEMPTED INFLATION, THE BALLOON WOULD NOT HOLD PRESSURE AND A RUPTURE WAS SUSPECTED. THE SDS WAS REMOVED WITH THE STENT STILL INTACT ON THE BALLOON. ANOTHER 2.50X38MM XIENCE ALPINE SDS WAS ADVANCED HOWEVER FAILED TO CROSS DUE TO THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH TWO NON-ABBOTT STENTS. 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 7534371 ↗
• MalfunctionApr 30, 2018Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.5 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), SLIGHT RESISTANCE WAS FELT WHILE UNCOILING THE SDS AND WHEN REMOVING THE PROTECTIVE SHEATH. THE STENT WAS NOTED TO BE CRUSHED. ANOTHER UNSPECIFIED XIENCE ALPINE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473123 ↗
• MalfunctionFeb 21, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, 95% STENOSED, MID CIRCUMFLEX CORONARY ARTERY. A 2.50 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE LESION, MET RESISTANCE WITH THE ANATOMY AND WOULD NOT CROSS. UPON REMOVAL OF THE SDS FROM THE ANATOMY, THE PHYSICIAN OBSERVED THAT THE STENT WAS STILL ON THE BALLOON AND HE DID NOT SEE ANY SIGN OF THE STENT BEING UNSTABLE. AFTER THE SCRUB TECH RECEIVED THE SDS, IT WAS OBSERVED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND ON THE STERILE FIELD AND WAS OBSERVED TO BE UNDAMAGED. THE SCRUB TECH SPECULATED THAT THEY MAY HAVE INADVERTENTLY PULLED THE STENT OFF THE BALLOON WHILE HANDLING THE SDS AFTER REMOVAL FROM THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE IMPLANTATION OF TWO 2.50 X 18 MM XIENCE ALPINE STENTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287673 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BALLOON PRE-DILATATION OF THE 90% STENOSIS IN THE HEAVILY CALCIFIED, DISTAL LEFT CIRCUMFLEX CORONARY ARTERY, THE PATIENT EXPERIENCED ST ELEVATION. A 2.50X38 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED, REDUCING STENOSIS TO 0%. POST-DILATATION WAS NOT PERFORMED. ABOUT TWENTY MINUTES POST PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN WITH ST ELEVATION, AND WAS BROUGHT BACK TO THE CATH LAB. ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE AT 214 SECONDS WITH A TIMI 3 BLOOD FLOW. ADDITIONAL HEPARIN WAS ADMINISTERED. AN OCCLUSION/CLOT WAS UNABLE TO BE VISUALIZED; HOWEVER, THE PHYSICIAN SUSPECTED EITHER A CLOT OR UNSEEN CALCIUM BEHIND THE STENT MAY HAVE CAUSED THE ST ELEVATION. POST STENT BALLOON DILATATION WAS PERFORMED AND THE CHEST PAIN AND ST ELEVATIONS RESOLVED. AN INTRAVENOUS INFUSION OF INTEGRILIN WAS STARTED. IN THE OPINION OF THE PHYSICIAN, THE STENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT EVENT. THE PHYSICIAN BELIEVES THE EVENT WAS DUE TO INADEQUATE ANTI-COAGULATION AND RESIDUAL CALCIUM IN THE VESSEL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2017 AND WAS DOING GREAT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 7153391 ↗
• MalfunctionDec 21, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.50X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) DEVICE WAS NOT INSPECTED PRIOR TO ADVANCING IN THE PATIENT. THE XIENCE ALPINE SDS WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE NOTED, AND IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE SDS WAS REMOVED WITHOUT ISSUE AND THE STENT WAS LOCATED INSIDE THE PROTECTIVE SHEATH. A SAME SIZE XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140155 ↗
• MalfunctionDec 20, 2017Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. FOLLOWING PRE-DILATATION, A GUIDELINER WAS USED TO ASSIST A 2.50 X 38MM XIENCE ALPINE STENT DELIVERY SYSTEM, BUT WAS UNABLE TO CROSS DUE TO A HEAVILY CALCIFIED LESION. RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. A NON-ABBOTT STENT 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 7136467 ↗
• InjuryNov 1, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT A 2.5X38MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE HIGHLY TORTUOUS LEFT ANTERIOR DESCENDING, HEAVILY CALCIFIED LESION DUE TO ANATOMY. DURING SDS REMOVAL, RESISTANCE WAS MET AT THE GUIDE CATHETER AND THE STENT BUNCHED AND DISLODGED FROM THE DELIVERY SYSTEM. THE DISLODGED STENT REMAINED AT THE LAD LESION SITE AND A NON-COMPLIANT BALLOON CATHETER CRUSHED THE DISLODGED STENT AGAINST THE LAD LESION. ADDITIONALLY, ANOTHER STENT WAS IMPLANTED, CRUSHING THE DISLODGED STENT AGAINST THE VESSEL WALL. GOOD RESULTS WERE NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND IS IN STABLE CONDITION. REPORTEDLY, THE PATIENT EXPERIENCED NO CLINICAL SYMPTOMS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6995339 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE. AN ATHERECTOMY DEVICE, FOLLOWED BY A CUTTING BALLOON WAS USED TO PRETREAT TREAT THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). A 2.5 X 38 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID TO DISTAL RCA AND A 3.0 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL TO MID RCA. THE STENTS WERE DEPLOYED IN AN OVERLAPPING MANNER. POST DILATATION WAS PERFORMED. OPTICAL FREQUENCY DOMAIN IMAGING (OFDI) WAS PERFORMED AND NOTED THAT THE PROXIMAL EDGE OF THE 3.0 X 18 MM XIENCE ALPINE STENT WAS SLIGHTLY MALAPPOSED; HOWEVER, THIS WAS DEEMED ACCEPTABLE AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT BEGAN TO EXPERIENCE EXERTIONAL CHEST PAIN, AND ON (B)(6) 2017, EXPERIENCED CHEST PAIN AT REST. THE PATIENT WAS RE-HOSPITALIZED. CORONARY ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) NOTED IN-STENT THROMBOSIS, STARTING AT THE PROXIMAL EDGE OF THE 3.0 X 18 MM XIENCE ALPINE STENT, AND EXTENDING TO BOTH STENTS. INTERVENTION WAS PERFORMED, WITH THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY. CORONARY ANGIOGRAPHY PERFORMED ON (B)(6) 2017 NOTED NO ANOMALIES

  Patient problems: Angina; Thrombosis

  MAUDE report 6828727 ↗
• InjuryMay 18, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED, CONCENTRIC, DE NOVO, 70% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER PERFORMING THROMBUS ASPIRATION AND ADVANCING A BASKET GUIDE WIRE, THE XIENCE ALPINE 2.50 X 38 MM WAS DEPLOYED AT 10 ATMOSPHERES. THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED TWICE AT 10 ATMOSPHERES. AN ATTEMPT WAS MADE TO REMOVE THE SDS FROM THE DEPLOYED STENT BUT THE SDS COULD NOT BE REMOVED. THE SDS WAS INFLATED AGAIN AT 12 ATMOSPHERES AND IT WAS DEFLATED BUT THE SDS COULD NOT BE REMOVED FROM THE DEPLOYED STENT. ON ANGIOGRAPHY THE SDS BALLOON WAS CONFIRMED TO HAVE BEEN DEFLATED; MEANING NO CONTRAST MEDIA WAS CONFIRMED TO BE PRESENT INSIDE THE BALLOON. THE DEPLOYED STENT WAS WELL APPOSED TO THE VESSEL WALL. IN AN ATTEMPT TO HELP REMOVE THE SDS FROM THE DEPLOYED STENT, A GUIDE WIRE WAS ADVANCED THROUGH THE DEPLOYED STENT AND THEN THE SDS WAS REMOVED FROM THE STENT SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6575774 ↗
• MalfunctionApr 10, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN OPENING A CHIPBOARD BOX LABELED AS A 2.5X38MM SIZE, LOT NUMBER 6091941,RX XIENCE ALPINE DRUG-ELUTING STENT (DES) SYSTEM, IT WAS DISCOVERED THAT THE INNER FOIL POUCH WAS LABELED AS A 2.5X28MM SIZE WITH LOT NUMBER 6090641. THE INNER FOIL POUCH REMAINED SEALED AND WAS NOT OPENED. THE SITE HAD CONFIRMED THAT THE OUTER CHIPBOARD BOX WAS SEALED PRIOR TO OPENING. THERE WAS NO PATIENT INVOLVEMENT AND THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A CLINICALLY SIGNIFICANT DELAY. ANOTHER 2.5X38MM RX XIENCE ALPINE DES WAS OPENED AND USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6476603 ↗
• MalfunctionMar 13, 2017Crack; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC DE NOVO LESION (DIAMETER 2.5 MM X LENGTH 33 MM) LOCATED FROM MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION THAT WAS 75% STENOSED. A 2.5 X 38 MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND CROSSED; HOWEVER DURING STENT DEPLOYMENT, AIR WAS OBSERVED TO BE PULLED INTO THE INDEFLATOR. IT WAS REPORTED THAT THE LEAK ORIGINATED FROM THE HUB AND THE HUB WAS CONFIRMED TO BE CRACKED. AIR ASPIRATION (DEVICE PREP) WAS PERFORMED OUTSIDE THE ANATOMY AND AGAIN INSIDE THE ANATOMY PRIOR TO STENT DEPLOYMENT. THE PHYSICIAN STATED THAT THE DEVICE MIGHT HAVE BEEN OVER TIGHTENED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6401449 ↗
• InjuryJan 31, 2017Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THROUGH A VOLUNTARY EVENT REPORT, MW5068736 WHICH STATES, BLOCKAGE IN UPPER GROUND AND CORONARY BLOCKAGE. SERIOUS INJURY AND HOSPITALIZATION. EVENT DATE (B)(6) 2015 [IMPLANT DATE]. THE FOLLOWING ADDITIONAL INFORMATION WAS ALSO RECEIVED: THE PATIENT WAS OBSERVED AT THE HOSPITAL ON (B)(6) 2017 FOR CHEST PAIN. THE MEDICAL THERAPY WAS ALREADY OPTIMIZED. A CORONARY ANGIOGRAM WAS NOT PERFORMED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. THE PATIENT DID NOT HAVE ANOTHER HEART ATTACK. THE PATIENT IS UNABLE TO WORK BECAUSE OF THE HEART CONDITION. REGARDING THE MW REPORT, THE CHEST PAIN AND SHORTNESS OF BREATH BEGAN ONE MONTH AFTER THE STENT PROCEDURE. THE UPPER GROUND IN THE MW REFERS TO THE BLOCKAGE IN THE GROIN STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Myocardial Infarction; Stenosis; Weakness

  MAUDE report 6291648 ↗
• InjuryJan 31, 2017Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2017, THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (STEMI). PRE-DILATATION WAS PERFORMED WITH A 2.5 X 28 AND A 3.0 X 15 MM UNSPECIFIED BALLOON CATHETER. A 2.5 X 38 MM AND A 3.0 X 15 MM XIENCE ALPINE STENTS WERE DEPLOYED. POST-DILATATION WAS PERFORMED WITH A 3.25 X 35 MM NC BALLOON CATHETER. FINAL ANGIOGRAPHY CONFIRMED THE STENTS WERE FULLY APPOSED TO THE VESSEL. THERE WAS SOME RESISTANCE REMOVING THE NON-ABBOTT GUIDE WIRE FROM THE ANATOMY AT THE COMPLETION OF THE PROCEDURE. THE PATIENT WAS PUT ON DUAL ANTI-PLATELET THERAPY. ON (B)(6) 2017, THE PATIENT RETURNED TO THE CATH LAB WITH CHEST PAIN AND ANGIOGRAPHY CONFIRMED THERE WAS IN-STENT THROMBOSIS IN THE ENTIRE LENGTH OF THE XIENCE ALPINE STENTS. IT WAS BELIEVED THAT WHEN THERE WAS RESISTANCE REMOVING THE GUIDE WIRE THAT IT DAMAGED THE DISTAL END OF THE DISTAL STENT. THERE WAS DIFFICULTY ADVANCING THROUGH THE THROMBUS SO A 1.5 X 10 MM AND THEN A 2.0 MM BALLOON WERE USED FOR DILATATION AND A 2.25 X 28 MM XIENCE ALPINE AND A 2.5 X 18 MM XIENCE ALPINE STENT WERE SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. PATI

  Patient problems: Angina; Thrombosis

  MAUDE report 6289631 ↗
• InjuryNov 18, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 10/06/2016, THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH ANGINA. THE CORONARY PROCEDURE WAS PERFORMED TO TREAT A 99% STENOSIS IN THE PROXIMAL LEFT ANTERIOR CX ARTERY. PRE-DILATATION WAS PERFORMED WITH A 1.5 X 6 MM AND 2.0 X 13 MM BALLOON DILATATION CATHETERS (BDC). THE LESION WAS MEASURED USING INTRAVASCULAR ULTRASOUND (IVUS) AND A 2.5 X 38 MM XIENCE ALPINE STENT WAS IMPLANTED AT 14 ATMOSPHERES. IVUS REVEALED IN-STENT PROTRUSION, WHICH WAS TREATED WITH A 3.0 X 13 MM BDC. IVUS WAS RE-ADVANCED TO THE LESION AND ALTHOUGH THERE WAS A SLIGHT PROTRUSION REMAINING, BLOOD FLOW HAD BEEN IMPROVED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER TREATMENT. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2016, THE PATIENT PRESENTED WITH CHEST PAIN, WHICH SUBSIDED IN THE SAME DAY. ON (B)(6) 2016, THE PATIENT WAS RE-HOSPITALIZED FOR ANOTHER PROCEDURE TO TREAT A DIFFERENT LESION IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2016. ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS IN THE PROXIMAL PORTION OF THE 2.5 X 38 MM XIENCE ALPINE STENT IMPLANT, WHICH WAS TREATED WITH A 3.25 X 15 MM TREK BDC. ALTHOUGH THE PATIENT STILL REMAINS IN THE HOSPITAL, THE PATIENT COND

  Patient problems: Angina; Thrombosis

  MAUDE report 6114747 ↗
• MalfunctionOct 27, 2016Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH HEAVY TORTUOSITY AND MILD CALCIUM IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5 X 38 MM XIENCE ALPINE WAS ADVANCED; HOWEVER, THE SHAFT BROKE DURING THE UNSUCCESSFUL ATTEMPT TO CROSS THE LESION. ANOTHER 2.5 X 38 MM XIENCE CROSSED THE LESION SUCCESSFULLY. THE 2.5 X 20 MM TREK BALLOON CATHETER WAS ADVANCED, BUT COULD NOT CROSS THE LESION AND THE SHAFT BROKE AS WELL. A 2.5 X 20 MM TREK WAS ABLE TO CROSS THE LESION TO COMPLETE THE PROCEDURE. THE DEVICES WERE ABLE TO BE WITHDRAWN FROM THE PATIENT ANATOMY AS THE SHAFTS BROKE OUTSIDE THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6061526 ↗
• InjuryAug 12, 2016Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THREE XIENCE ALPINE STENT DELIVERY SYSTEMS (2.5 X 38 MM, AND TWO 2.25 X 18 MM) COULD NOT CROSS THE LESION DUE TO THE ANATOMY; HOWEVER, A DISSECTION OCCURRED WHICH WAS TREATED WITH A NON-ABBOTT DRUG ELUTING STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 5873661 ↗
• MalfunctionApr 4, 2016Break

  STENT SHEARED OFF OF STENT CATHETER WHILE BEING BROUGHT BACK INTO GUIDING CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5553779 ↗