XIENCE Sierra™ 1550225-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648227028), received between Jun 27, 2018 and Jul 29, 2021 — classified as 2 deaths, 12 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Component Missing; Component Missing

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THERE WAS NO RESISTANCE REMOVING THE PROTECTIVE SHEATH FROM THE STENT DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246658 ↗
• InjuryApr 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST OBTUSE MARGINAL ARTERY. A 2.25X18MM XIENCE SIERRA WAS ADVANCED TO THE LESION WITHOUT RESISTANCE NOTED BUT BECAME DISLODGED. ANOTHER UNSPECIFIED STENT WAS USED TO CRUSH/EMBED THE DISLODGED STENT AGAINST THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11665217 ↗
• InjuryMar 8, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A PREVIOUSLY IMPLANTED STENT WAS ALSO PRESENT IN THE PROXIMAL LAD. THE 2.25X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS TO TREAT THE LESION DUE TO THE ANATOMY AND DURING REMOVAL THERE WAS RESISTANCE WITH THE LESION AND THE PREVIOUSLY IMPLANTED STENT. WHILE REMOVING THE SDS FROM THE ANATOMY, A DISSECTION WAS CAUSED. ANOTHER UNSPECIFIED STENT WAS ATTEMPTED TO BE DEPLOYED TO COVER THE DISSECTION BUT WAS UNSUCCESSFUL SO THE PATIENT WAS SENT TO SURGERY. THE FINAL PATIENT OUTCOME IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 11440562 ↗
• MalfunctionAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.25X18MM XIENCE SIERRA STENT DELIVERY SYSTEM, THE STENT DISLODGED DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZE XIENCE SIERRA 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 Patient Involvement

  MAUDE report 10368677 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10151149 ↗
• MalfunctionApr 8, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X18MM XIENCE SIERRA WAS ADVANCED AND ONCE AT THE LESION THE BALLOON COMPLETELY FAILED TO INFLATE AT THE FIRST INFLATION AT AN UNKNOWN PRESSURE. ANOTHER XIENCE SIERRA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9939663 ↗
• MalfunctionApr 7, 2020Leak/Splash; Difficult to Advance; Material Deformation; Leak/Splash; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY CALCIFIED DE NOVO MID LEFT CIRCUMFLEX ARTERY THAT WAS 90% STENOSED. A GUIDE WIRE WAS ABLE TO BE CROSSED TO THE LESION WITHOUT ISSUE. PRE-DILATATION WAS PERFORMED WITH A 2 MM BALLOON. A 2.25 X 18 XIENCE SIERRA WAS ADVANCED AND CROSSED THE LESION DESPITE SLIGHT RESISTANCE NOTED WITH THE ANATOMY. BALLOON INFLATION WAS ATTEMPTED; HOWEVER, IT WAS NOTED UNDER CINE THAT THE CONTRAST FLOWED OUT AROUND THE DISTAL END OF THE DELIVERY SYSTEM (SDS). THE SDS WAS REMOVED. THE DEVICE WAS REPLACED WITH THE SAME SIZE OF A NON-ABBOTT DRUG-ELUTING STENT TO CONTINUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS ALSO NOTED THAT THE STENT IMPLANT LOOKED FLARED AT THE PROXIMAL-DISTAL EDGE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933507 ↗
• InjuryMar 8, 2020Adverse 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 2.25X18MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803964 ↗
• InjuryMar 8, 2020Adverse 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 ATHEROSCLEROTIC HEART DISEASE. A 2.5X18MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH ATRIAL FIBRILLATION. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 9803931 ↗
• InjuryJan 10, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED DIAGONAL ARTERY. THE 2.25 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS. SEVERAL ATTEMPTS WERE MADE; HOWEVER, THE DEVICE WAS UNABLE TO CROSS AND THE DECISION WAS MADE TO REMOVE THE XIENCE SIERRA STENT DELIVERY SYSTEM. NO RESISTANCE WAS NOTED DURING REMOVAL, UNTIL THE STENT PORTION OF THE DEVICE WAS BEING REMOVED THROUGH THE CO-PILOT. THE XIENCE SIERRA STENT DELIVERY SYSTEM WAS UNABLE TO BE REMOVED, AND IT WAS SUSPECTED THAT THE CO-PILOT HAD NOT BEEN OPENED ALL THE WAY. THE STENT DELIVERY SYSTEM WAS CUT TO REMOVE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576707 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25X18MM XIENCE SIERRA WAS IMPLANTED IN THE CIRCUMFLEX CORONARY ARTERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH ELEVATED TROPONIN ENZYMES. IMAGING FOUND THAT THERE WAS NO FLOW DOWN THE CIRCUMFLEX ARTERY. THE CIRCUMFLEX ARTERY WAS OCCLUDED IN THE MID PORTION WHERE THE STENT HAD BEEN IMPLANTED. A BALLOON WAS ADVANCED TO REESTABLISH FLOW. NO ADDITIONAL TREATMENT WAS PERFORMED AS THE COLLATERAL CIRCULATION WAS SUFFICIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Occlusion

  MAUDE report 9317192 ↗
• MalfunctionNov 11, 2019Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGING FOR A 2.25X18MM XIENCE SIERRA STENT DELIVERY SYSTEM ON THE STERILE TABLE, IT WAS INSPECTED AND NOTED THAT THE DEVICE WAS EXPIRED ON 10/7/2019. HOWEVER, THE POUCH INDICATED A DIFFERENT DATE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE CHIPBOARD BOX WAS DISCARDED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9304507 ↗
• MalfunctionSep 26, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS CIRCUMFLEX CORONARY ARTERY. BEFORE THE PROCEDURE, A MINI TREK BDC WAS OPENED DURING PREP AND IT WAS NOTED THAT THE BALLOON WAS SEPARATED FROM THE SHAFT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A 3.5 X 23 MM XIENCE SIERRA WAS IMPLANTED WITHOUT ISSUE; HOWEVER, WIRE POSITION WAS LOST AS THE VESSEL CLOSED FOR AN UNKNOWN REASON. A NEW BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED AS WELL AS A WHISPER GUIDE WIRE AND THE WHISPER WAS THOUGHT TO BE IN THE TRUE LUMEN OF THE VESSEL. THE BMW WENT UNDER AND AROUND A COUPLE STRUTS OF THE PREVIOUSLY IMPLANTED XIENCE SIERRA STENT AND OVER THE WHISPER GUIDE WIRE. THE BMW WAS THEN JAILED WITH A 2.25 X 18 MM XIENCE SIERRA STENT. THE BMW WAS STUCK AND WAS NOT ABLE TO BE REMOVED. BALLOON ANGIOPLASTY WAS ATTEMPTED IN ORDER TO FREE THE GUIDE WIRE BUT IT WAS UNSUCCESSFUL. THE BMW THEN SEPARATED AND COILED INTO A BALL. THE TIP OF THE WHISPER GUIDE WIRE ALSO SEPARATED DUE TO THE BMW GUIDE WIRE WRAPPING AROUND IT. THE SEPARATED PORTIONS OF THE GUIDE WIRES BOTH REMAIN IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126640 ↗
• InjurySep 18, 2019Adverse 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) 2019, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE TO TREAT A LESION IN THE 1ST OBTUSE MARGINAL ARTERY. A 2.25 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT EXPERIENCED ANGINA. IN-STENT RESTENOSIS WAS NOTED AND A REVASCULARIZATION PROCEDURE WAS PERFORMED. THE ADVERSE PATIENT EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 9084734 ↗
• MalfunctionJun 18, 2019Improper 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 THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. A 2.25X18MM XIENCE SIERRA STENT WAS IMPLANTED AFTER ITS EXPIRATION DATE. THE DEVICE EXPIRED 05/03/2019. 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 8707596 ↗
• MalfunctionMay 6, 2019Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DIAGONAL ARTERY WITH HEAVY CALCIFICATION. A 2.25 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE TARGET LESION DUE TO THE HEAVY CALCIFICATION. THE SDS WAS RETRACTED WHEN RESISTANCE MET WITH THE CALCIFICATION. ALTHOUGH RESISTANCE WAS MET DURING REMOVAL, THE SDS WAS ABLE TO BE REMOVED WITHOUT ANY OTHER ISSUE. HOWEVER, AFTER THE SDS WAS REMOVED, LIFTED STRUTS WERE OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED STENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583789 ↗
• InjuryMay 6, 2019Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE STENT WAS IMPLANTED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. POST DILATATION WAS PERFORMED AND A DISSECTION OCCURRED IN THE LEFT MAIN CORONARY ARTERY. THE DISSECTION WAS TREATED WITH TWO OR THREE STENTS FROM THE LEFT MAIN TO THE LEFT CIRCUMFLEX CORONARY ARTERY. THE 2.25X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED TO GO DISTAL TO THE FIRST MID LAD STENT, BUT IT MET RESISTANCE WITH THE OTHER STENTS, SO THIS SDS WAS REMOVED FROM THE ANATOMY. ADDITIONAL POST DILATATION OF THE OTHER STENTS WAS PERFORMED AND THE XIENCE SIERRA SDS WAS RE-INSERTED, BUT THE STENT DISLODGED FROM THE SDS. IT IS SUSPECTED THAT THE XIENCE SIERRA HAD INTERACTED WITH ONE OF THE OTHER STENTS, CAUSING IT TO DISLODGE. AN ATTEMPT TO SNARE OUT THE DISLODGED STENT WAS UNSUCCESSFUL. ANOTHER STENT WAS IMPLANTED TO CRUSH THE DISLODGED XIENCE SIERRA STENT IN THE LEFT MAIN. THERE WAS NO ADDITIONAL CHEST PAIN AND NO ADDITIONAL MEDICATION WAS REQUIRED FOR THIS DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8582926 ↗
• InjuryApr 29, 2019Adverse 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 WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION, THROMBUS AND CARDIAC ARREST. A 2.25 X 18 MM XIENCE SIERRA STENT (8120341) AND A 2.5 X 28 MM XIENCE SIERRA STENT (8102441) WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. SLUGGISH FLOW WAS NOTED AFTER STENT DEPLOYMENT; HOWEVER, NO ADDITIONAL INTERVENTION WAS PERFORMED. ON (B)(6) 2019, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND WAS TAKEN BACK TO THE CATH LAB. CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE STENTED SEGMENT. A 2.5 X 33 MM XIENCE SIERRA STENT AND A 2.25 X 12 MM XIENCE SIERRA STENT (8090341) WERE IMPLANTED TO TREAT THE THROMBUS. POST DILATATION WAS PERFORMED USING AN UNSPECIFIED NC DILATATION CATHETER. A NON-FLOW LIMITING EDGE DISSECTION WAS NOTED AT THE 2.25 X 12 MM XIENCE SIERRA STENT. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE DISSECTION. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Thrombosis; Ventricular Tachycardia

  MAUDE report 8561588 ↗
• DeathMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED MID CIRCUMFLEX ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.25X15MM MINI TREK BALLOON DILATATION CATHETER. THEN A 2.25X18MM XIENCE SIERRA STENT WAS IMPLANTED AT THE LESION. THERE WERE NO DEVICE ISSUES NOTED WITH THE XIENCE SIERRA. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO USE A DRAGONFLY CATHETER TO PERFORM AN OPTICAL COHERENCE TOMOGRAPHY PROCEDURE, BUT A GOOD QUALITY PULL BACK COULD NOT BE ATTAINED. THE DRAGONFLY CATHETER WAS THEN RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED VIA UNKNOWN METHODS. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY. THE NEXT DAY, THE PATIENT DIED; HOWEVER, THE CAUSE OF DEATH IS UNKNOWN. AN AUTOPSY WAS NOT PERFORMED. THE PHYSICIAN MENTIONED THAT THE PATIENT HAD EXPERIENCED ST- ELEVATION MYOCARDIAL INFARCTION TWO WEEKS BEFORE THE PROCEDURE. PER THE PHYSICIAN, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH IN ANY WAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 8401311 ↗
• DeathDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED OBTUSE MARGINAL BRANCH, THE DIAGONAL BRANCH AND THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE OBTUSE MARGINAL BRANCH, A 2.25 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DIAGONAL BRANCH AND A 2.5 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITHOUT ANY ISSUES. HOWEVER, THE PATIENT COMPLAINED OF DISCOMFORT AND THEN BECAME HYPOTENSIVE AND EXPERIENCED CARDIAC ARREST. THEREFORE, CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED AND THE PATIENT WAS INTUBATED. IT WAS NOTED THAT THERE WAS NO FLOW IN THE VESSELS THAT WERE STENTED DUE TO THROMBUS. THEREFORE, BALLOON ANGIOPLASTY WAS PERFORMED IN THE PROXIMAL CIRCUMFLEX, DIAGONAL AND LAD ARTERIES. ASPIRATION WAS PERFORMED TO REMOVE THE THROMBUS AND A 2.5 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL LAD. CPR CONTINUED; HOWEVER, THE PATIENT EXPIRED THAT SAME DAY ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Arrest; Low Blood Pressure/ Hypotension; Respiratory Failure; Thrombosis

  MAUDE report 8197815 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A 2.25X18MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH A GASTRO INTESTINAL (GI) HEMORRHAGE. THE TREATMENT PERFORMED AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8161639 ↗
• MalfunctionJul 16, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED BOTH OF THE 2.25X18MM RX XIENCE SIERRA STENT DELIVERY SYSTEMS (SDS) WERE PREPPED PRIOR TO REMOVAL OF THE PROTECTIVE SHEATH. AFTER REMOVAL OF THE SHEATH, THE STENT WAS NOTED TO BE MISLOCATED ON BOTH OF THE SDS. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7692499 ↗
• MalfunctionJul 16, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED BOTH OF THE 2.25X18MM RX XIENCE SIERRA STENT DELIVERY SYSTEMS (SDS) WERE PREPPED PRIOR TO REMOVAL OF THE PROTECTIVE SHEATH. AFTER REMOVAL OF THE SHEATH, THE STENT WAS NOTED TO BE MISLOCATED ON BOTH OF THE SDS. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7692477 ↗
• InjuryJun 27, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE 2.75X33 XIENCE SIERRA STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). THE 2.25X18 XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INSERTED TO TREAT THE HEAVILY TORTUOUS, DISTAL RCA, BUT IT MET RESISTANCE WITH THE MID RCA STENT. WHEN RESISTANCE WAS MET, THE DOCTOR STOPPED AND REMOVED THE SDS FROM THE ANATOMY. THE MID RCA STENT WAS POST DILATED WITH A 3.0 MM DIAMETER BALLOON. THE 2.25X18 SDS WAS RE-INSERTED, BUT MET RESISTANCE WITH THE MID RCA STENT. THIS TIME, THE SDS WAS STUCK IN THE 2.75X33 STENT AND WAS UNABLE TO BE REMOVED. THE 2.25X18 STENT WAS IMPLANTED INSIDE THE 2.75X33 STENT. THERE WERE NO FURTHER ATTEMPTS TO TREAT THE DISTAL RCA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7641828 ↗