XIENCE Sierra™ 1550350-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648227455), received between Aug 29, 2018 and Jul 8, 2022 — classified as 15 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 25, 2020Class IITerminated

   Incorrect expiration date

   Z-2370-2020 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

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.

• InjuryJul 8, 2022Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X33MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME BELOW NOMINAL PRESSURE WHEN A RUPTURE OCCURRED. THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL AND REQUIRED ADDITIONAL DILATATION TO BE FULLY IMPLANTED, THEREFORE ANOTHER 3.5MM BALLOON WAS USED TO POST-DILATE THE STENT AND SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS COMMENTED THAT THE CALCIFIED PART IN THE LESION OR A STENT THAT HAD ALREADY BEEN DEPLOYED AT THE PROXIMAL PART TO THE LESION, PROBABLY CAUSED THE RUPTURE, BUT THAT IT CANNOT BE CONCLUDED. 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 14958186 ↗
• MalfunctionDec 2, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 90% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.50X33 XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND UPON BEING PULLED BACK INTO THE GUIDING CATHETER WITH RESISTANCE, THE STENT BECAME FLARED. THE DEVICE WAS EVENTUALLY PULLED BACK BUT COULD NO LONGER BE USED. PRE-DILATATION WAS PERFORMED AND THEN ANOTHER SAME SIZE XIENCE SIERRA SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917878 ↗
• InjuryOct 7, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. A 3.50X33 MM SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCING; HOWEVER, THE STENT DID NOT CROSS THE TARGET LESION DUE TO RESISTANCE WITH THE ANATOMY. THEREFORE, THE SDS WAS RETRACTED BACK TO BE REMOVED; HOWEVER, THE STENT BECAME STUCK WITH THE ANATOMY AND THE STENT CAME OFF THE BALLOON. THE SDS WAS REMOVED FROM THE PATIENT AND THE STENT WAS OBSERVED IN THE MICROCATHETER. AN UNSPECIFIED BALLOON WAS ADVANCED TO SECURE THE STENT, AND THEN THE MICROCATHETER WAS REMOVED WITH THE STENT. THE TARGET LESION WAS SUCCESSFULLY COMPLETED WITH A NEW SIERRA STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 12590555 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5X33MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT HAD PREVIOUSLY PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING CHRONIC ISCHEMIC HEART DISEASE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia

  MAUDE report 11401779 ↗
• InjuryDec 30, 2020Deflation Problem; Inflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT MAIN CORONARY ARTERY. A 3.50X33MM XIENCE SIERRA WAS NOTED TO BE SLOW DURING INFLATION; HOWEVER, STENT WAS DEPLOYED AT 18 ATMOSPHERES. THE XIENCE SIERRA WOULD NOT FULLY DEFLATE AFTER ATTEMPTS TO FLUSH THE CONTRAST OUT OF THE BALLOON WITH SALINE, PULLED NEGATIVE MULTIPLE TIMES AND FINALLY RESORTED TO USING THE PHILLIPS LASER TO POP AND DEFLATE THE BALLOON. IT WAS NOTED THE DEVICE WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11095202 ↗
• MalfunctionDec 17, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.50X33MM XIENCE SIERRA, THE HOOP COIL WAS REMOVED AS WAS THE PROTECTIVE SHEATH. AFTER REMOVAL, IT WAS NOTED THAT THE STENT IMPLANT WAS NOT ON THE BALLOON, HOWEVER, CRIMP MARKS WERE VISIBLE. NO RESISTANCE REPORTED DURING REMOVAL OF THE HOOP OR PROTECTIVE SHEATH. THE STENT IMPLANT WAS NEVER FOUND. THE DEVICE WAS NOT USED AND ANOTHER 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 11028545 ↗
• InjurySep 14, 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) 2020 TWO XIENCE SIERRA STENTS (SIZES 3.5X33 AND 3.5X38) WERE IMPLANTED IN THE PROXIMAL AND MID RIGHT CORONARY (RCA) ARTERY. ON (B)(6) 2020 THE PATIENT HAD CHEST PAIN/HEAVINESS. ANGIOGRAM PERFORMED ON (B)(6) 2020 SHOWED IN-STENT RESTENOSIS IN BOTH THE RCA STUDY STENTS ALONG WITH STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE RAMUS ARTERY. A TRIPLE CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED ON (B)(6) 2020. THE PATIENT CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 10528080 ↗
• MalfunctionSep 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A 3.5X33MM XIENCE SIERRA WAS ADVANCED TO THE LESION, INFLATED ONCE AND DEPLOYED AT 10 ATMOSPHERES. ONCE THE DELIVERY SYSTEM WAS REMOVED OUT OF THE ANATOMY, THE INDEFLATOR WAS NOTED WITH BLOOD. THE SIERRA STENT-BALLOON WAS DRIPPING. VIA TROUBLESHOOTING, THE STENT-BALLOON WAS INJECTED WITH SALINE AND SALINE AND BLOOD WERE NOTED DRIPPING AGAIN. 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 10503082 ↗
• MalfunctionJul 16, 2020Difficult to Insert; Contamination /Decontamination Problem; Difficult to Insert; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNSPECIFIED GUIDE WIRE WAS UNABLE TO BE LOADED ONTO A 3.5X33MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) BECAUSE THERE WAS A PLASTIC PIECE IN THE TIP OF THE CATHETER. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SAME SIZE XIENCE SIERRA SDS 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 10286501 ↗
• MalfunctionJun 9, 2020Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL RIGHT CORONARY ARTERY. A 3.50X33MM XIENCE SIERRA FAILED TO CROSS DUE TO ANATOMY, AND DURING REMOVAL RESISTANCE WAS MET WITH THE GUIDELINER. THE STENT IMPLANT BECAME DISLODGED AND LANDED AT THE TIP OF THE GUIDELINER. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. NOTHING REMAINED IN THE ANATOMY. A NON-ABBOTT STENT 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 Consequences Or Impact To Patient

  MAUDE report 10135772 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION AND TWO (3.5X33MM AND 3.0X12MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND PLEURODYNIA. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10121482 ↗
• MalfunctionMar 20, 2020Stretched; Failure to Advance; Material Deformation; Stretched; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS BIFURCATION AT THE DISTAL LEFT MAIN (LM) AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.50X33MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. THE SDS WAS REMOVED WITHOUT RESISTANCE. OUTSIDE OF THE PATIENT, THE PROXIMAL END OF THE STENT WAS NOTED TO BE LIFTED. A NEW XIENCE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS NOTED THE INNER AND OUTER MEMBER SHAFTS WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860954 ↗
• MalfunctionMar 19, 2020Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT A 3.5X33MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS LABELED WITH A SHELF LIFE OF THREE YEARS WHEN IT SHOULD HAVE BEEN LABELED WITH A SHELF LIFE OF ONE YEAR. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9856203 ↗
• MalfunctionMar 12, 2020Stretched; Device Dislodged or Dislocated; Material Deformation; Stretched; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AFTER REMOVAL FROM THE DISPENSER COIL AND DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE XIENCE SIERRA STENT DELIVERY SYSTEM, WITH NO RESISTANCE REPORTED, THE STENT BECAME STRETCHED AND DISLODGED FROM THE BALLOON. THE DEVICE WAS NOT USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9826574 ↗
• MalfunctionMar 11, 2020Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD TORTUOSITY AND MILD CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. THE SDS WAS PRESSURIZED TO NOMINAL PRESSURE, BUT THE STENT DID NOT DEPLOY. THERE WAS NO STENT ON THE BALLOON. THE DISLODGED STENT WAS FOUND ON THE BACK TABLE WHERE THE SDS HAD BEEN PREPARED FOR USE. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. ANOTHER SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONALLY, A SUS VOLUNTARY EVENT REPORT (MW5092968) WAS RECEIVED REPORTING: XIENCE SIERRA STENT WAS TO BE UTILIZED FOR PCI OF RCA. STENT WAS PREPPED IN THE USUAL FASHION AND DEVICE WAS PLACED INTO THE PT IN NORMAL FASHION. AFTER BALLOON INFLATION AND ATTEMPTED STENT DEPLOYMENT IT WAS DETERMINED THAT THE STENT WAS NO PRESENT IN THE ARTERY AS EXPECTED. UPON FURTHER INVESTIGATION, THE STENT WAS FOUND HAVING NEVER BEEN INSERTED INTO THE PT. IT WAS APPARENT THAT THE STENT HAD BEEN DISLODGED FROM TEH DELIVERY BALLOON AND WAS FOUND ON THE STE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818840 ↗
• 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A 3.5X33MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH CONGESTIVE HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 9803941 ↗
• 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 3.5X33MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 AND (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED DUE TO UNSTABLE ANGINA AND A NSTEMI WAS DIAGNOSED. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 9803851 ↗
• MalfunctionDec 26, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. TWO XIENCE SIERRA STENTS WERE IMPLANTED WITH NO ISSUE. A 3.50X33MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND FAILED TO CROSS THE LESION. IT WAS NOTED THE STENT DISLODGED FROM THE BALLOON. THE SDS WITH THE STENT, WERE REMOVED WITH SLIGHT RESISTANCE. NO INTERVENTION WAS NEEDED. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT SDS. 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 9520479 ↗
• MalfunctionNov 15, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 99 % STENOSED LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9331796 ↗
• InjuryNov 14, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.5X33MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. AN ATTEMPT TO REMOVE THE SDS WAS MADE, BUT RESISTANCE WITH THE GUIDELINER WAS FELT AND THE STENT DISLODGED AT THE DISTAL END OF THE GUIDELINER. A SECOND BALANCE WIRE WAS ADVANCED PAST THE DISLODGED STENT AND WRAPPED AROUND THE ORIGINAL GUIDEWIRE. AS A UNIT, THE GUIDELINER, STENT, AND WIRES WERE PULLED BACK INTO THE GUIDE CATHETER. THE GUIDE CATHETER ALONG WITH THE RETRIEVED EQUIPMENT WAS THEN REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.25X33MM XIENCE SIERRA STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324889 ↗
• MalfunctionAug 28, 2019Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. IT WAS NOTED THAT A PREVIOUSLY UNSPECIFIED STENT IN THE LAD, WAS IMPLANTED THREE DAYS PRIOR. THE PATIENT PRESENTED TO THE HOSPITAL WITH ANGINA. A 3.5 X 33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE DUE TO THE HEAVY CALCIFICATION. MINIMAL FORCE WAS APPLIED AND PRIOR TO CROSSING THE TARGET LESION, THE PROXIMAL SHAFT BECAME SEPARATED, BUT REMAINED HELD TOGETHER ON THE GUIDE WIRE. THE SDS WAS REMOVED WITH THE UNSPECIFIED GUIDE WIRE AS A SINGLE UNIT. TWO ADDITIONAL DEVICES FAILED TO CROSS AND THE PROCEDURE WAS ABORTED WITHOUT THE TARGET LESION BEING TREATED. 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 8942537 ↗
• MalfunctionAug 14, 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 75% STENOSED, HEAVILY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. A 3.5 X 33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WITH THE ANATOMY WAS FELT WHEN REMOVING THE SDS. AFTER REMOVAL OF THE SDS IT WAS NOTED THAT THE STENT STRUT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED XIENCE STENT. 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 8895576 ↗
• MalfunctionAug 12, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 3.50X33MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING WITHDRAWAL, THE SDS CAUGHT THE EDGE OF AN UNSPECIFIED GUIDING CATHETER. WITH FORCE, THE SDS WAS REMOVED FROM THE ANATOMY INDEPENDENTLY FROM THE GUIDING CATHETER. OUTSIDE OF THE ANATOMY IT WAS NOTED THAT THE STENT STRUTS WERE MANGLED AND LIFTED OFF THE BALLOON. A NEW 3.25X33 XIENCE SIERRA SDS 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 Consequences Or Impact To Patient

  MAUDE report 8883965 ↗
• InjuryJul 29, 2019Inflation Problem; Material Rupture; Device Dislodged or Dislocated; Inflation Problem; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT OF THE 3.5X33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) CAME PARTIALLY OFF THE SDS WHILE HALFWAY OUT OF THE GUIDE CATHETER. REPORTEDLY, NO RESISTANCE WAS NOTED. THE PHYSICIAN TRIED TO INFLATE THE BALLOON ONCE THE STENT WAS IN PLACE BUT THE DEVICE WOULD NOT HOLD PRESSURE AND THE BALLOON FAILED TO INFLATE. THE STENT WAS RETRIEVED BY USING A NON-ABBOTT GUIDE CATHETER EXTENSION AND A BALLOON TO TRAP THE STENT AND PULL EVERYTHING OUT. ANOTHER, SAME SIZE XIENCE SIERRA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839364 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 3.5 X 33 MM XIENCE SIERRA STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR ANOXIC BRAIN DAMAGE AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 8405626 ↗