XIENCE ALPINE 1125250-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648199189), received between Aug 12, 2016 and Jun 18, 2019 — classified as 2 deaths, 17 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE XIENCE ALPINE 2.5X23 MM STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY AND EXTENDED INTO THE FIRST DIAGONAL CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD ANGINA (CHEST PAIN). THE PATIENT WAS REPORTEDLY COMPLIANT WITH ALL MEDICATIONS. PERCUTANEOUS REVASCULARIZATION WAS PERFORMED ON (B)(6) 2019 TO TREAT THE OCCLUSION IN THE TARGET LESION. THE CONDITION RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Occlusion

  MAUDE report 8709167 ↗
• DeathFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEATH CERTIFICATE LISTS THE CAUSE OF DEATH AS CORONARY ARTERY DISEASE. IN THE OPINION OF THE PHYSICIAN, THIS EVENT IS NOT RELATED TO THE XIENCE ALPINE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 8298710 ↗
• MalfunctionNov 12, 2018Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MID RIGHT CORONARY ARTERY (RCA), THE 2.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WHEN ANATOMICAL RESISTANCE WAS NOTED. PRIOR TO REACHING THE TARGET LESION, UNDER FLUOROSCOPY, A GAP BETWEEN THE PROXIMAL EDGE OF THE STENT AND THE PROXIMAL MARKER WAS VISUALIZED, SO DEVICE REMOVAL WAS ATTEMPTED, BUT RESISTANCE WAS NOTED, SO THE SDS AND GUIDE CATHETER WERE REMOVED AS A SINGLE UNIT. AFTER REMOVAL FROM THE ANATOMY, THE STENT IMPLANT WAS NOTED TO BE BUNCHED/ACCORDION, WHICH WAS FELT TO BE THE CAUSE OF THE RESISTANCE DURING REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT GUIDE CATHETER AND XIENCE ALPINE STENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061859 ↗
• InjurySep 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OSTIAL CIRCUMFLEX ARTERY THAT WAS HEAVILY CALCIFIED. DURING ADVANCEMENT OF THE XIENCE ALPINE 2.5 X 23 MM STENT DELIVERY SYSTEM, THE STENT CAME OFF THE BALLOON. THERE WAS NO REPORTED RESISTANCE NOTED DURING ADVANCEMENT BEFORE THE DISLODGEMENT. THE STENT WAS WEDGED INTO THE CIRCUMFLEX AND LEFT MAIN AND WHEN A SNARE WAS USED IN ATTEMPT TO RETRIEVE THE STENT, IT MOVED INTO THE AORTA. IT IS CURRENTLY FREE-FLOATING IN THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT REMAINS IN THE HOSPITAL AS OF (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7914546 ↗
• InjurySep 5, 2018Adverse 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 UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF TWO XIENCE ALPINE STENTS - A 3.25 X 15 MM AND A 2.5 X 23 MM. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH IN-STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7844867 ↗
• MalfunctionAug 21, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED AFTER IT WAS EXPIRED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803853 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, TWO 2.5X12MM XIENCE ALPINE STENTS WERE IMPLANTED, ONE IN THE 2ND OBTUSE MARGINAL AND ONE IN THE 3RD OBTUSE MARGINAL CORONARY ARTERIES. A 2.5X23MM XIENCE ALPINE STENT WAS ALSO IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. REPORTEDLY, STENT PLACEMENT ANGIOGRAPHIC APPEARANCES WERE ACCEPTABLE. POST PROCEDURE AND PRIOR TO HOSPITAL DISCHARGE, THE PATIENT REPORTED ABDOMINAL CRAMPING AND TRIDIL INFUSION WAS PROVIDED. CHEST PAIN GRADE 9/10 WAS REPORTED AND AGGRASTAT INFUSION WAS INITIATED. ANOTHER ANGIOGRAM WAS PERFORMED. STENT THROMBOSIS WAS NOTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, 1ST DIAGONAL, MID CIRCUMFLEX, AND OSTIAL 2ND OBTUSE MARGINAL. ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AS TREATMENT WITH ADDITIONAL STENT PLACEMENT. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Thrombosis

  MAUDE report 7794830 ↗
• MalfunctionJun 19, 2018Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, PROXIMAL CIRCUMFLEX. AFTER FAILING TO CROSS THE LESION WITH THE STENT DELIVERY SYSTEM (SDS), THE DELIVERY SYSTEM WAS RETRACTED BACK INTO THE GUIDE CATHETER WITH DIFFICULTY. AFTER REMOVAL OF THE SDS IT WAS OBSERVED THAT A STRUT IN THE MIDDLE OF THE STENT IMPLANT WAS RAISED. A NEW SDS WAS USED TO COMPLETE THE CASE SUCCESSFULLY. 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 7615824 ↗
• InjuryJun 18, 2018Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE 2.5X23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS INTENDED TO BE ADVANCED TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, BUT THE SDS MET RESISTANCE WITH CALCIUM IN THE LEFT MAIN CORONARY ARTERY AND WAS UNABLE TO CROSS. THE SDS WAS REMOVED FROM THE ANATOMY, BUT THE XIENCE STENT DISLODGED FROM THE SDS AND WAS REMOVED VIA SNARE. DURING REMOVAL OF THE DISLODGED STENT, THE STENT BECAME ELONGATED AND MANGLED. THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609795 ↗
• InjuryMay 14, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LONG LESION WITH FIBROTIC CALCIFICATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.5 X 38 MM XIENCE ALPINE STENT WAS DEPLOYED SUCCESSFULLY IN THE MID-SECTION OF THE LAD. THE 2.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED FOR DISTAL PLACEMENT, BUT COULD NOT CROSS THE 2.5 X 38 MM XIENCE ALPINE STENT IMPLANT. WHEN THE 2.5 X 23 MM XIENCE ALPINE SDS WAS PULLED BACK, THE STENT GOT CAUGHT WITH THE IMPLANTED STENT AND DISLODGED PROXIMAL TO THE IMPLANTED STENT. A 2.75 X 12 MM NC TREK BALLOON WAS USED TO COMPRESS THE DISLODGED STENT AGAINST THE VESSEL WALL AND A 2.75 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED OVER THE COMPRESSED STENT WHICH WAS AN INTENDED SITE PLANNED FOR STENTING. A 2.5 X 12 MM XIENCE ALPINE WAS ADVANCED AND IMPLANTED IN THE DISTAL LAD SUCCESSFULLY TO COMPLETE THE PROCEDURE. AT THE END OF THE PROCEDURE, THE VESSEL HAD GREAT RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7511997 ↗
• MalfunctionApr 11, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE, FLUOROSCOPY WAS PERFORMED AS A 2.50 X 23 XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED, AND IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE DEVICE WAS REMOVED AND IT WAS RECONFIRMED THAT THE STENT WAS NOT PRESENT ON THE DEVICE. ANOTHER XIENCE ALPINE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AFTERWARDS, IT WAS NOTED THAT THE STENT WAS IN THE TRASH. IT IS UNKNOWN HOW THE STENT GOT THERE, BUT IT IS SUSPECTED THAT THE STENT DISLODGED DURING PREPARATION OF THE DEVICE. 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 7423329 ↗
• MalfunctionMar 6, 2018Difficult To Position; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT ANTERIOR DESCENDING ARTERY THAT DID NOT HAVE ANY TORTUOSITY NOR CALCIFICATION. THE RADIAL APPROACH WAS TAKEN AND A 2.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS USED. HOWEVER, THE SDS DID NOT HAVE PROPER SUPPORT FROM AN UNSPECIFIED GUIDING CATHETER, AND THE PROXIMAL PART OF THE STENT BECAME CAUGHT ON THE TIP OF THE GUIDING CATHETER. THEREFORE, THE SDS WAS PULLED BACK AND THE STENT STRUT WAS NOTED TO BE FLARED. THE SDS WAS THEN REMOVED AS A SINGLE UNIT WITH THE GUIDING CATHETER. THE FEMORAL APPROACH WAS THEN TAKEN WITH AN UNSPECIFIED STENT DELIVERY SYSTEM WHICH WAS BETTER SUPPORTED WITH A DIFFERENT UNSPECIFIED GUIDING CATHETER 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 7319139 ↗
• InjuryMar 1, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.5 X 23 MM AND 2.5 X 28 MM) WERE DEPLOYED SUCCESSFULLY ON (B)(6) 2017. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR OTHER CARDIOVASCULAR SYMPTOMS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION TOOK PLACE 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 7307215 ↗
• DeathJan 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS A HIGH RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, WITH ADDITIONAL DISEASE NOTED IN THE CIRCUMFLEX AND RIGHT CORONARY ARTERY, WHICH WAS TOTALLY OCCLUDED. AN IMPELLA DEVICE WAS PLACED, THEN PRE-DILATATION WAS PERFORMED. A 2.5X23MM ALPINE STENT WAS DEPLOYED IN THE MID TO PROXIMAL LAD AND ANOTHER 2.5X23MM ALPINE STENT WAS DEPLOYED IN THE LEFT MAIN (LM). INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THEN POST-DILATATION WAS PERFORMED ON BOTH ALPINE STENTS WITH A 2.75 BALLOON. THE STENTS WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL AND THE PROCEDURE WAS COMPLETED AT THIS TIME. HOWEVER, AFTER SEVERAL MINUTES, THE PATIENT EXPERIENCED BRADYCARDIA, CODED AND THEN EXPIRED. THE PHYSICIAN DOES NOT BELIEVE THERE WAS IN-STENT THROMBOSIS DUE TO THE LACK OF ST ELEVATION. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Cardiac Arrest; Death

  MAUDE report 7175244 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED DE NOVO LESION IN THE LEFT MAIN ARTERY. A 3.0X12MM XIENCE XPEDITION STENT WAS DEPLOYED; HOWEVER, A DISSECTION WAS OBSERVED. A 3.5X15MM XIENCE V STENT WAS SUCCESSFULLY USED TO COVER THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7169930 ↗
• MalfunctionDec 12, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DIAGONAL ARTERY. A 2.50X23MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION; HOWEVER, FAILED TO CROSS DUE TO HEAVY CALCIFICATION. AS THE SDS WAS BEING RETRIEVED, GUIDE WIRE SUPPORT WAS LOST DUE TO THE CALCIFICATION AND THE SDS WAS PULLED BACK TO THE TIP OF THE GUIDE CATHETER. THE TIP OF THE GUIDE CATHETER BECAME KINKED CAUSING THE STENT TO DISLODGE WITHIN THE GUIDE CATHETER. EVERYTHING WAS REMOVED AS A UNIT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY. 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 7110384 ↗
• MalfunctionOct 30, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION, AN ATTEMPT WAS MADE TO CONNECT AN INFLATION DEVICE TO THE HUB OF A 2.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM; HOWEVER, IT COULD NOT BE THREADED ONTO THE HUB OF THE CATHETER. AN ATTEMPT WITH ANOTHER DEVICE WAS ALSO MADE TO THREAD ONTO THE HUB BUT IT ALSO COULD NOT BE THREADED ON THE CATHETER HUB. ANOTHER XIENCE ALPINE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED A CRACK AND LEAK IN THE HUB OF THE STENT DELIVERY SYSTEM.

  Patient problems: No Patient Involvement

  MAUDE report 6986989 ↗
• InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE MORNING HOURS EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION. A 2.5 X 23 MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE FIRST DIAGONAL ARTERY WITHOUT REPORTED ISSUE; HOWEVER, LATER IN THE DAY, THE PATIENT REPORTED CHEST PAIN AND WAS RETURNED TO THE CATHETERIZATION LAB. IN-STENT STENOSIS WAS NOTED ALONG WITH ST SEGMENT ELEVATION, WHICH WAS DIAGNOSED AS A MYOCARDIAL INFARCTION (STEMI). ADDITIONAL POST DILATATION WAS PERFORMED WITH A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 6985551 ↗
• InjuryOct 19, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED IN THE CIRCUMFLEX. A 2.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED TO THE LAD WHEN IT COULD NOT CROSS THROUGH HEAVY CALCIFICATION. WHEN REMOVING THE DEVICE, WHILE IN THE LEFT MAIN ARTERY, THE STENT CAUGHT ON SEVERE CALCIFICATION AND THE STENT IMPLANT DISLODGED. THE STENT MIGRATED TO THE INTERNAL ILIAC WHERE IS WAS REMOVED WITH A SNARE DEVICE. THE PROCEDURE ENDED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963437 ↗
• InjuryOct 7, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 70% STENOSED, LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND A LESION IN THE MILDLY TORTUOUS, NON-CALCIFIED, 70% STENOSED, DIAGONAL CORONARY ARTERY UTILIZING THE KISSING STENT METHOD. A 2.50 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE LESION IN THE LAD. THE SDS WAS ADVANCED TO THE LESION, POSITIONED, ALTHOUGH IT WAS NOT DEPLOYED AT THAT TIME. A 2.5 X 33 MM XIENCE ALPINE SDS WAS SELECTED TO TREAT THE LESION IN THE DIAGONAL CORONARY ARTERY. THE SDS WAS ADVANCED TOWARD THE LESION, MET RESISTANCE WITH THE GUIDING CATHETER AND WOULD NOT NEGOTIATE THE CURVE INTO THE DIAGONAL. DURING REMOVAL OF THE SDS FROM THE ANATOMY, THE STENT DISLODGED FROM THE BALLOON AND WAS FOUND INSIDE THE GUIDING CATHETER. IT WAS DECIDED TO GO AHEAD AND DEPLOY THE FIRST STENT IN THE LAD. WHEN THEY WENT TO REPOSITION THE STENT PRIOR TO DEPLOYMENT IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE BALLOON AND STENT WERE NOT MOVING AS THE DELIVERY SYSTEM WAS MOVED. IT WAS DETERMINED THAT THE BALLOON AND STENT HAD SEPARATED FROM THE DELIVERY SYSTEM. THE SDS WAS REMOVED FROM THE ANATOMY. N

  Patient problems: Foreign Body In Patient

  MAUDE report 6927435 ↗
• MalfunctionAug 18, 2017Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING PRE-DILATATION WITH A COUPLE OF BALLOON CATHETERS, A 3.0X15MM XIENCE PROX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE LAD; HOWEVER, THE SDS FAILED TO CROSS DUE TO THE ANATOMY. THE STENT BECAME STUCK IN A CURVE OF THE LAD AND THE STENT COULD NOT BE MOVED. IT WAS ASSUMED THAT THERE WAS A HIGH GRADE OF STENOSIS SO THE STENT WAS DEPLOYED WITH A GOOD RESULT. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS IMPLANTED. THERE WAS RESIDUAL STENOSIS IN THE NON-ABBOTT STENT; THEREFORE, ANOTHER STENT WAS PLACED IN BETWEEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH POST-DILATATION AND THE PATIENT OUTCOME WAS GOOD. 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 6804839 ↗
• MalfunctionJul 19, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE TORTUOSITY AND CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 2.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS TO THE LESION DUE TO THE ANATOMY. THE SDS WAS REMOVED, AND RESISTANCE WAS NOTED WITH THE GUIDING CATHETER. AFTER REMOVAL, IT WAS FOUND THAT THE STENT STRUT HAD BECOME FLARED. A NEW 2.5 X 23 MM XIENCE ALPINE SDS WAS USED TO 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 6725155 ↗
• InjuryJun 6, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY. AFTER PRE-DILATING THE LESION A 2.5 X 23 MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT THE SDS FAILED TO CROSS DUE TO A DIFFICULT VESSEL TURN AND HEAVY CALCIFICATION AT THE OSTIAL CX, PRIOR TO REACHING THE LESION. FORCE WAS APPLIED AND THE STENT DISLODGED AT THE LEFT MAIN (LM) TO PROXIMAL CX AREA. AFTER REMOVING ALL DEVICES AS A SINGLE UNIT, THE DISLODGED STENT WAS ABLE TO BE PULLED BACK TO THE LEFT MAIN USING A SNARE DEVICE, BUT WAS UNABLE TO BE RETRIEVED. THE DISLODGED STENT WAS THEN CRUSHED AGAINST THE VESSEL WALL OF THE LM AND CX OSTIUM USING A BALLOON, FOLLOWED BY DEPLOYMENT OF AN ADDITIONAL UNSPECIFIED STENT TO SECURE THE CRUSHED STENT. TREATMENT OF THE TARGET LESION WAS ABANDONED WITH FUTURE PLANS FOR TREATMENT, AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION AS A PRECAUTION. THERE WERE NO ADVERSE PATIENT SEQUELAE. AS OF (B)(6) 2017, THE PATIENT WAS DOING WELL AND DUE TO BE DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6616347 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X23 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING CONGESTIVE HEART FAILURE. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 6483551 ↗
• MalfunctionMar 13, 2017Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE RETURN DEVICE ANALYSIS REVEALED THAT THE XIENCE ALPINE STENT DELIVERY SYSTEM WAS RETURNED FROZEN ON AN ABBOTT .014 WIGGLE GUIDE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6401425 ↗