XIENCE ALPINE 1125350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08717648199530), received between Aug 5, 2016 and Mar 26, 2020 — classified as 3 deaths, 22 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. THE PROCEDURE WAS TO TREAT A THROMBOSED LESION IN THE RIGHT CORONARY ARTERY. A 3.5X18MM XIENCE ALPINE STENT WAS IMPLANTED USING LOW PRESSURE DILATATION, PREVENTING DISTAL EMBOLIC PLAQUE FROM GOING FURTHER. ON (B)(6) 2018, DURING A FOLLOW-UP CONSULTATION, AN INTRAVASCULAR ULTRASOUND WAS PERFORMED AND 50% STENOSIS WAS CONFIRMED BUT NO TREATMENT CONDUCTED, AND IT WAS DETERMINED TO BE UNDER OBSERVATION. THE PHYSICIAN EXPLAINED THERE WAS NO PRODUCT PROBLEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9886172 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE 3.5X18 MM XIENCE ALPINE STENT WAS IMPLANTED AND A PERFORATION WAS NOTED. PROLONGED BALLOON INFLATION WAS PERFORMED, BUT DID NOT ACHIEVE HEMOSTASIS. THIS WAS FOLLOWED BY THE PLACEMENT OF THE 3.5X19 MM GRAFTMASTER IMPLANTED INSIDE THE XIENCE STENT; THIS SUCCESSFULLY TREATED THE PERFORATION AND STOPPED THE BLEEDING. THE CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED HOME TWO DAYS POST PROCEDURE. SIX MONTHS LATER, THE EFFORT ANGINA RETURNED; ANGIOGRAM FOUND A FOCAL RESTENOSIS ON THE DISTAL EDGE OF THE GRAFTMASTER. PCI WAS PERFORMED USING OCT AND ANGIOGRAM. OCT FOUND EXTREMELY FOCAL RESTENOSIS WITH HOMOGENEOUS NEOINTIMA. THERE WERE EXPOSED STRUTS IN THE MIDDLE AND PROXIMAL SEGMENT OF THE GRAFTMASTER STENT. THERE WAS NO THROMBUS FOUND. RESTENOSIS WAS TREATED WITH THE IMPLANTATION OF A 3.0X9 MM NON-ABBOTT, BIODEGRADABLE SIROLIMUS-ELUTING STENT. SIX MONTHS LATER, THE PATIENT HAD ANGINA AGAIN. THERE WAS STENOSIS IN THE NON-ABBOTT STENT. THIS WAS TREATED WITH BALLOON ANGIOPLASTY USING A 3.0X20 MM DRUG-COATED BALLOON.

  Patient problems: Angina; Perforation

  MAUDE report 9884910 ↗
• InjuryFeb 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, A 3.5X18M XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE MID RIGHT CORONARY ARTERY LESION (RCA). ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN AND DIAPHORESIS. ELEVATED TROPONIN WAS NOTED AND A NON-ST ELEVATED MYOCARDIAL INFARCTION WAS DIAGNOSED. PER IMAGING, STENT RESTENOSIS WITH RECOIL WERE OBSERVED. AS TREATMENT, ANGIOPLASTY WAS PERFORMED. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Diaphoresis; Myocardial Infarction; Stenosis

  MAUDE report 8345360 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5X18MM 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 7828566 ↗
• MalfunctionAug 28, 2018Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, ECCENTRIC AND HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY THAT WAS 99% STENOSED. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON DILATATION CATHETER. AN ATTEMPT WAS THEN MADE TO ADVANCE A 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS); HOWEVER, IT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. ADDITIONALLY, THERE WAS DIFFICULTY IN REMOVING THE DEVICE DUE TO THE ANATOMY AND THE DEVICE WAS REMOVED INDEPENDENTLY. THE SDS WAS THEN REPLACED WITH A 3.5 X 18 MM NON-ABBOTT SDS 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 Consequences Or Impact To Patient

  MAUDE report 7822548 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A 2.25 X 12MM XIENCE ALPINE WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX ARTERY AND A 3.50 X 18MM XIENCE ALPINE WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. THE NEXT DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A RASH ON HER TORSO, TREATMENT WAS NOT PROVIDED AT THE TIME. ADDITIONALLY, TWO DAYS LATER, THE PATIENT STARTED EXPERIENCING BREATHING ISSUES (COULDN'T BREATHE PROPERLY), AND EXCESSIVE YAWNING. IN (B)(6) 2017, THE PATIENT WENT TO THE HOSPITAL TO GET CHECKED FOR THE SHORTNESS OF BREATH AND RASH ON HER TORSO. PATIENT WAS GIVEN TWO ADVIL TABLETS. PHYSICIAN NOTED NO COMPLICATIONS OR ADVERSE EFFECTS ON THE PATIENT. THE PATIENT LEFT THE SAME DAY. IN (B)(6) 2018, THE PATIENT VISITED THE HOSPITAL FOR ANOTHER CHECK-UP AND WAS GIVEN A STRESS TEST. PER THE PHYSICIAN, THE STRESS TEST RESULT WAS NORMAL. THE PATIENT LEFT THE SAME DAY. IN (B)(6) 2018, THE PATIENT OPTED FOR A NEW PHYSICIAN. THE RASH REMAINS THE SAME AND HAS NOT WORSENED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Fatigue; Hypersensitivity/Allergic reaction

  MAUDE report 7639754 ↗
• InjuryJun 15, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FIRST 3.5X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE PREDILATED, MID RIGHT CORONARY ARTERY (RCA) THAT HAD A STRANGE, TORTUOUS TAKE OFF IN THE PROXIMAL SEGMENT. AFTER THE SDS WAS REMOVED FROM THE ANATOMY, THE STENT STRUTS WERE FLARED. THE SECOND SAME SIZE XIENCE ALPINE SDS WAS INSERTED, BUT WAS ALSO UNABLE TO CROSS THE TARGET LESION AND DURING REMOVAL OF THE SDS, THE STENT DISLODGED FROM THE GUIDE CATHETER. ATTEMPTS TO REMOVE THE DISLODGED STENT VIA SNARE WERE MADE, BUT THESE WERE NOT SUCCESSFUL. A 3.5X12 NC BALLOON WAS INSERTED THROUGH THE DISLODGED STENT AND EXPANDED IN THE NON-TARGET PROXIMAL RCA. BALLOON ANGIOPLASTY WAS PERFORMED IN THE MID RCA. THE PROCEDURE WAS COMPLETED WITH ZERO STENTS IN THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7607890 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.5X18MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH MYELODYSPLASTIC SYNDROME AND OTHER CARDIOVASCULAR SYMPTOMS. UNKNOWN TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7575930 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 PATIENT PRESENTED WITH A HEART ATTACK AND THE LEFT ANTERIOR DESCENDING (LAD) WAS FOUND TO BE 80% BLOCKED AND THE LEFT CIRCUMFLEX WAS FOUND TO BE 70% BLOCKED. A 3.5 X 18 MM XIENCE ALPINE WAS IMPLANTED IN THE LAD AND A 2.5 X 15 MM XIENCE ALPINE WAS IMPLANTED IN THE RIGHT CIRCUMFLEX. THE PATIENT WAS PLACED ON A REGIMEN OF PLAVIX AND BABY ASPIRIN. ON (B)(6) 2018, THE PATIENT WAS TAKEN BACK TO THE CATH LAB AND THE STENT IN THE LAD WAS FOUND UNDER ANGIOGRAPHY TO BE 100% BLOCKED BY THROMBOSIS. AN UNSPECIFIED ROTATIONAL ATHERECTOMY SYSTEM WAS USED TO REOPEN THE STENT. THE PATIENT WAS DISCHARGED ON A REGIMEN OF PLAVIX AND BABY ASPIRIN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7324513 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING MYOCARDIAL INFARCTION. 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: Myocardial Infarction

  MAUDE report 7315247 ↗
• MalfunctionFeb 14, 2018Difficult to Insert; Unstable

  IT WAS REPORTED THAT DURING THE ATTEMPT TO INSERT THE 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) INTO THE GUIDE CATHETER EXTENSION, RESISTANCE WAS FELT WHICH CAUSED THE STENT TO MOVE ON THE BALLOON; HOWEVER, THE STENT IMPLANT WAS STILL ON THE BALLOON. THE SDS WAS REMOVED FROM THE GUIDE CATHETER AND REPLACED WITH A NEW SDS WHICH WAS USED SUCCESSFULLY FOR THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270727 ↗
• InjuryFeb 7, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND WAS INTUBATED DUE TO THROMBOSIS OF A PREVIOUSLY NON-ABBOTT IMPLANTED STENT IN AN OSTIUM VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT THE DISTAL END OF THE STENT GOT CAUGHT WITH THE PROXIMAL END OF THE PRE-EXISTING STENT IMPLANT AND THE XIENCE ALPINE STENT DISLODGED. A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT SUCCESSFULLY. DILATATION WAS PERFORMED AND A 3.0 X 28 MM XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7249389 ↗
• MalfunctionDec 21, 2017Difficult To Position

  IT WAS REPORTED THE RX ALPINE STENT DELIVERY SYSTEM (SDS) COULD NOT BE ADVANCED OVER THE 300 ALL STAR GUIDE WIRE. THE DEVICE WAS SET ASIDE AND A NEW ALPINE WAS USED WITH THE SAME GUIDE WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE INNER MEMBER OF THE SHAFT WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139069 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HYPERTENSIVE HEART DISEASE WITH HEART FAILURE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 7077417 ↗
• DeathNov 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 3.5 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON( B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED FOR ACUTE RESPIRATORY FAILURE AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Respiratory Failure

  MAUDE report 7071044 ↗
• MalfunctionNov 13, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT IMPLANT DISLODGED FROM THE 3.5 X 18 MM XIENCE ALPINE BALLOON AND WAS LOCATED IN THE PROTECTIVE SHEATH. NO RESISTANCE WAS FELT DURING REMOVAL OF THE SHEATH. THE DEVICE COULD NOT BE USED ON THE PATIENT. A NEW XIENCE ALPINE 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 7026183 ↗
• DeathNov 3, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS ADMINISTERED ASPIRIN 300 MG WHILE BEING TRANSFERRED TO THE HOSPITAL BY AMBULANCE AND EFFIENT WAS ADMINISTERED JUST PRIOR TO THE PROCEDURE. THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A THROMBOTIC OCCLUSION THAT WAS 99% STENOSED. THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY AND WAS ASPIRATED. PRE-DILATATION WAS PERFORMED AND A 3.5 X 18MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL LAD. SOME OF THE THROMBOSIS MIGRATED TO THE PERIPHERAL PART OF THE VESSEL AND THERE WAS SOME THROMBOSIS REMAINING PROXIMAL TO THE DEPLOYED 3.5 X 18 XIENCE ALPINE STENT. THUS, A 3.5 X 12MM XIENCE ALPINE STENT WAS DEPLOYED PROXIMAL TO THE OTHER STENT. THE STENTS WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. THROMBOSIS STARTED TO FORM AGAIN AND THE VESSEL WAS OCCLUDED. THROMBOSIS ALSO FORMED IN THE LEFT CIRCUMFLEX (CX). THEREFORE, THROMBUS ASPIRATION WAS PERFORMED REPETITIVELY, BUT THE OCCLUSION CONTINUED. ALGATROBAN WAS ADMINISTERED BUT THE PATIENTS CONDITION DETERIORATED AND THE PATIENT DIED DUE TO CARDIAC ARREST AS A RESULT OF THE THRO

  Patient problems: Cardiac Arrest; Death; Thrombosis

  MAUDE report 6999750 ↗
• InjuryOct 23, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. WHEN THE XIENCE ALPINE 3.50 X 18 MM STENT DELIVERY SYSTEM WAS ADVANCED TOWARDS THE LESION, THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS REMOVED FROM THE VESSEL WITH A SNARE DEVICE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE FINAL PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6970220 ↗
• InjuryOct 18, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT AN OCCLUDED LESION WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE TARGET LESION AND PRE-DILATATION WAS PERFORMED. A 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS THE TARGET LESION. DURING THE REMOVAL OF THE SDS, THE STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN COMMENTED THAT THERE WAS NOTHING UNUSUAL FELT DURING RETRACTION OF THE SDS. SEVERAL ATTEMPTS WERE MADE TO SNARE THE DISLODGED STENT BUT THIS WAS UNSUCCESSFUL. USING 1.5 AND 20 BALLOONS, THE STENT WAS ABLE TO BE PARTIALLY DEPLOYED IN THE MID RCA, WHICH WAS CALCIFIED THROUGHOUT. THE PATIENT WAS HEMODYNAMICALLY STABLE AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR CORONARY ARTERY BYPASS GRAFTING (CABG) LATER THAT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6959721 ↗
• MalfunctionOct 9, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE WHEN THE PROTECTIVE SHEATH OF THE XIENCE ALPINE 3.5 X 18 MM STENT DELIVERY SYSTEM (SDS) WAS REMOVED, THE STENT WAS NOT ON THE BALLOON. THE STENT DISLODGED IN THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE REPORTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE TUBING OR DURING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6929589 ↗
• InjurySep 20, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY VIA RADIAL ACCESS. A 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED TO THE LESION WHEN THERE WAS RESISTANCE WITH THE ANATOMY. AS THE DEVICE WAS BEING REMOVED THERE WAS RESISTANCE WITH THE GUIDELINER AND THE STENT IMPLANT DISLODGED. THE STENT WAS REMOVED WITH A SNARE DEVICE THROUGH THE WRIST. A NEW ACCESS SITE WAS MADE AT THE GROIN AND A 3.5 X 16 MM NON-ABBOTT STENT WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE SNARING OF THE STENT AND HAVING TO OBTAIN A NEW ACCESS SITE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6880276 ↗
• MalfunctionAug 29, 2017Crack; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN INDEFLATOR WAS ATTACHED AND THE HUB OF THE XIENCE ALPINE 3.50 X 18 MM STENT DELIVERY SYSTEM WAS NOTED TO BE CRACKED; CONTRAST WAS LEAKING AT THE CONNECTION POINT. THE SAME INDEFLATOR WAS USED WITH THE SECOND DELIVERY SYSTEM AND THE XIENCE ALPINE WAS PREPARED FOR USE PER THE INSTRUCTIONS FOR USE WITH NO ISSUES NOTED. THE DEVICE WAS REPLACED WITH ANOTHER SAME SIZE NON-ABBOTT STENT DELIVERY SYSTEM TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6828692 ↗
• MalfunctionAug 4, 2017Difficult to Remove; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM, DURING REMOVAL OF THE PROTECTIVE SHEATH THERE WAS RESISTANCE, AND THE STENT IMPLANT DISLODGED INSIDE THE SHEATH. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Patient Involvement

  MAUDE report 6768046 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE THE PATIENT UNDERWENT WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. THREE XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017: 3.5 X 28 MM, 3.0 X 38 MM AND 3.5 X 18 MM. APPROXIMATELY 2-3 DAYS POST STENTING PROCEDURE, THE PATIENT BEGAN EXPERIENCING HIVES, RASHES, ITCHING AND BRUISING (FROM SCRATCHING) ALL OVER HER BODY AND WAS RE-HOSPITALIZED ON (B)(6) 2017 DUE TO HER SYMPTOMS. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2017. SHE HAS SEEN 4 SPECIALISTS (CARDIOLOGIST, INTERNIST, DERMATOLOGIST AND ALLERGIST), AND IT WAS THOUGHT THAT THE ADVERSE REACTION IS LIKELY DUE TO THE DRUG (EVEROLIMUS) ON THESE STENTS. THE PATIENT HAS NO MEDICAL HISTORY OF ALLERGIES. SHE UNDERWENT A STENTING PROCEDURE APPROXIMATELY 8 YEARS AGO, WITH IMPLANTATION OF ONE STENT; THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTERWARDS. THE DOSAGE OF HER MEDICATIONS HAVE BEEN INCREASED. SHE WAS PRESCRIBED EPIFOAM AND VISTARIL, AS WELL AS PREDNISONE. HER PHYSICIAN ORIGINALLY PRESCRIBED PLAVIX; THIS WAS CHANGED TO BRILINTA. THE BRILINITA WAS THEN CHANGED TO EFFIENT, WHICH CONTINUES. BEFORE THE THREE XIENCE ALPINE IMPLANTS, THE PATIENT WAS TAKING BABY ASPIRIN BUT THIS WAS

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 6699151 ↗
• MalfunctionJun 12, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, MILDLY CALCIFIED, DISTAL CIRCUMFLEX (CX) CORONARY ARTERY. A 3.50 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. FOLLOWING REMOVAL OF THE STENT PROTECTIVE SHEATH, THE SDS WAS HANDED TO THE PHYSICIAN AND HE NOTED PRIOR TO ADVANCING THE SDS INTO THE ANATOMY THAT THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS FOUND ON THE PREP TABLE NEAR THE PROTECTIVE SHEATH. THE SDS WAS NOT USED IN THE PROCEDURE. A NEW XIENCE ALPINE SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6635156 ↗