XIENCE Sierra™ 1550250-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648227134), received between Aug 28, 2018 and May 3, 2024 — classified as 3 deaths, 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 2.5X33MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INSERTED INTO A 5FRENCH (F) GUIDE EXTENSION CATHETER WITH RESISTANCE WHEN THE STENT DISLODGED AND WAS UNABLE TO BE USED. THE DISLODGED STENT WAS REMOVED FROM INSIDE THE GUIDE EXTENSION CATHETER. ANOTHER 2.5X28MM XIENCE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243290 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 TWO XIENCE SIERRA DRUG ELUTING STENTS (2.50X33, 3.25X33MM) (DES) WERE IMPLANTED WITHOUT REPORTED ISSUE. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED DUE TO STENT THROMBOSIS AND CARDIAC FUNCTIONAL DISTURBANCES. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND DILATATION OF THE CORONARY ARTERY WAS PERFORMED. THE PATIENT WAS DISCHARGED TO HOME . NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12992051 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUS REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: ONLY THE 3.5X28MM XIENCE SIERRA STENT HAD RESTENOSED. THERE WAS NO RESTENOSIS IN OR WITHIN 5MM OF THE 2.5X33MM XIENCE SIERRA STENT.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 11803665 ↗
• MalfunctionDec 8, 2020Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY DUE TO THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS PATIENT ANATOMY. THERE WAS RESISTANCE MET WITH THE LESION DURING REMOVAL. AFTER THE FAILURE TO CROSS, THE TIP OF THE SDS WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10969425 ↗
• InjuryNov 30, 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 HAD A 2.50X33 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED DUE TO A CONGESTIVE HEART FAILURE. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 10923639 ↗
• InjuryOct 2, 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 ONE 2.5X33 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT WENT TO ANOTHER LOCAL HOSPITAL FOR STENT THROMBOSIS, SUPPOSEDLY DUE TO NOT TAKING POST-PROCEDURE ANTICOAGULANTS AT HOME. THE PATIENT HAD TO UNDERGO REPEAT HEART CATH PROCEDURE WHERE PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE CONDITION RESOLVED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 10620358 ↗
• InjurySep 15, 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 A ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A 2.5X33MM AND 3.0X38MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH AN ATRIAL FLUTTER AND OTHER CARDIOVASCULAR SYMPTOMS. PROCEDURE DESTRUCTION OF CONDUCTIVE MECHANISM WAS PROVIDED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Atrial Flutter

  MAUDE report 10536509 ↗
• InjuryMar 14, 2020Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NONE TORTUOUS, MILDLY CALCIFIED MID-RIGHT CORONARY ARTERY THAT WAS 80% STENOSED. THE 2.50X33MM XIENCE SIERRA BALLOON WOULD NOT INFLATE. EVENTUALLY, THE BALLOON PARTIALLY INFLATED. THE STENT WAS POST-DILATED WITH AN UNSPECIFIED BALLOON AND IT REMAINS IN THE LESION. IT WAS THEN NOTED THERE WAS A LEAK FROM A PINHOLE IN THE SHAFT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9833119 ↗
• InjuryFeb 12, 2020Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) TREATING A LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, MODERATELY CALCIFIED AND TIGHT LESION. TWO WIRES WERE PLACED, ONE IN THE LAD AND ONE IN THE INTERMEDIATE. PRE-DILATATION WAS PERFORMED AND A XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) ADVANCED. THE SDS FAILED TO CROSS THE LESION DUE TO ANATOMY. DURING SDS REMOVAL AND BEFORE REACHING THE GUIDE CATHETER SITE, RESISTANCE WAS MET DUE TO ANATOMY AND THE STENT DISLODGED AND EMBOLIZED INTO THE INTERMEDIATE CORONARY ARTERY. THE SDS AND GUIDE CATHETER WERE REMOVED AS A SINGLE UNIT AND THE DISLODGED/EMBOLIZED STENT REMAINED AT THE INTERMEDIATE CORONARY ARTERY. 3-4 HOURS WERE SPENT ATTEMPTING TO RE-WIRE THE LAD. ADDITIONAL CONTRAST AND RADIATION WAS PERFORMED FOR IMAGING. THE DISLODGED STENT WAS SNARED FROM THE CORONARY ARTERY. DURING REMOVAL AND ONCE AT THE GROIN SITE, THE STENT DISLODGED FROM THE SNARE AT THE RIGHT PROFUNDA. ANOTHER ACCESS SITE WAS CREATED AND THE STENT WAS SNARED AGAIN AND WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. THERE WAS A 3-4 DELAY, HOWEVER, THE PATIENT DID NOT HAVE ANY ASSOCIATED ADVERSE PATIENT EFFECTS. THERE WAS NO ADVERSE PATIENT SEQUE

  Patient problems: Embolism

  MAUDE report 9701375 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT AFTER THE 2.5X33 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY, A POSSIBLE PROXIMAL DISSECTION ON THE STENT EDGE WAS NOTED ON THE ANGIOGRAM. A SECOND XIENCE SIERRA STENT, SIZE 3.0X12, WAS IMPLANTED TO TREAT THE DISSECTION. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 9606747 ↗
• MalfunctionNov 11, 2019Inflation Problem; Leak/Splash; Material Deformation; Inflation Problem; Leak/Splash; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MILD CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). A 2.5 X 33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE BALLOON INFLATION WAS PERFORMED BUT THE BALLOON DID NOT INFLATE. THE INDEFLATOR WAS PRESSURIZED TO THE RATED BURST PRESSURE, BUT THERE WAS NO INCREASE IN THE PRESSURE GAUGE AND THE BALLOON DID NOT INFLATE. THEREFORE, THE SDS WAS REMOVED AND THE OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT BLOOD WAS INSIDE THE SDS. ADDITIONALLY, IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT IMPLANT WAS SEVERELY DAMAGED. A NEW NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305545 ↗
• InjuryOct 28, 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 2.5X33 XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND ANOTHER SAME SIZE XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LAD. ON (B)(6) 2019 THE PATIENT HAD ACUTE CHEST PAIN THAT MAY ALSO HAVE BEEN A MUSCULOSKELETAL STRAIN. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND TREATED WITH MEDICATION. THE CONDITION RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9245756 ↗
• DeathSep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A STAGED PERCUTANEOUS CORONARY INTERVENTION DUE TO A NON-ST ELEVATED MYOCARDIAL INFARCTION. THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE LESION WAS PREPPED WITH ATHERECTOMY AND BALLOON ANGIOPLASTY. A 2.25 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED DISTALLY, AND A 2.5 X 33 MM XIENCE SIERRA STENT WAS IMPLANTED PROXIMALLY; HOWEVER, FOLLOWING DEPLOYMENT OF THE 2.5 X 33 MM XIENCE SIERRA STENT, A PERFORATION WAS NOTED. UNSUCCESSFUL ATTEMPTS WERE MADE TO SEAL THE PERFORATION WITH BALLOON TAMPONADE AND THE PATIENT¿S BLOOD PRESSURE STARTED DROPPING, SO A 2.8 X 19 MM GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED, BUT THE SHAFT KINKED AND THE DEVICE WAS REMOVED WITHOUT ISSUE. A SECOND 2.8 X 19 MM GRAFTMASTER STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE PERICARDIAL EFFUSION. FOLLOWING A NON-ABBOTT TEMPORARY VENTRICULAR ASSIST DEVICE WAS PLACED AND BLOOD CLOTS WERE NOTED IN THE PROXIMAL LAD, IN THE GRAFTMASTER (DUE TO UNDERSIZING) AND LIKELY IN THE PROXIMAL 2.5 X 33 MM XIENCE SIERRA STENT. ASPIRATION OF THE CL

  Patient problems: Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion; Thrombosis

  MAUDE report 8978065 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50X33MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH ATHEROSCLEROSIS BEFORE THE PROCEDURE. ON (B)(6) 2019 THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HYPOTENSION. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8958036 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE SIERRA STENTS (2.5 X 33 MM, 3.0 X 12 MM, AND 3.0 X 18 MM) WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 AND (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH A PERIAPICAL ABSCESS, CHEST PAIN, AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8701937 ↗
• DeathApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2019, WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI). CORONARY INTERVENTION WAS PERFORMED, AND TWO XIENCE SIERRA STENTS (2.5X33MM, 3.0X38MM) WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, IN AN OVERLAPPING FASHION. A 2.5X33MM XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL (OM1) ARTERY. POST DILATATION WAS PERFORMED PER FACILITY PROTOCOL, AT BOTH LESIONS. THE ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE 225 ON THE FIRST MEASUREMENT, AND 290 ON THE SECOND. ASPIRIN AND BRILINTA WERE ADMINISTERED. TWO DAYS POST PROCEDURE, THE PATIENT HAD COMPLAINTS OF WORSENING CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBUS IN THE LAD AND OM1. BALLOON ANGIOPLASTY WAS PERFORMED. ALTHOUGH POOR FLOW WAS NOTED, THE VESSELS WERE OPENED. THE ACT WAS NOTED TO BE 400. AN INTEGRILIN DRIP WAS STARTED. ON (B)(6) 2019, THE PATIENT HAD COMPLAINTS OF JAW PAIN AND DIED. CAUSE OF DEATH WAS RELATED TO WEAKENED CONDITION FROM THE ADMITTING STEMI, STENT THROMBOSIS, AND PULMONARY EMBOLUS. PER PHYSICIAN, THE PULMONARY EMBOLUS WAS NOT RELATED TO THE IMPLANTED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Death; Ischemia; Thrombosis

  MAUDE report 8562491 ↗
• DeathApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2019, WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI). CORONARY INTERVENTION WAS PERFORMED, AND TWO XIENCE SIERRA STENTS (2.5X33MM, 3.0X38MM) WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, IN AN OVERLAPPING FASHION. A 2.5X33MM XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL (OM1) ARTERY. POST DILATATION WAS PERFORMED PER FACILITY PROTOCOL, AT BOTH LESIONS. THE ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE 225 ON THE FIRST MEASUREMENT, AND 290 ON THE SECOND. ASPIRIN AND BRILINTA WERE ADMINISTERED. TWO DAYS POST PROCEDURE, THE PATIENT HAD COMPLAINTS OF WORSENING CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBUS IN THE LAD AND OM1. BALLOON ANGIOPLASTY WAS PERFORMED. ALTHOUGH POOR FLOW WAS NOTED, THE VESSELS WERE OPENED. THE ACT WAS NOTED TO BE 400. AN INTEGRILIN DRIP WAS STARTED. ON (B)(6) 2019, THE PATIENT HAD COMPLAINTS OF JAW PAIN AND DIED. CAUSE OF DEATH WAS RELATED TO WEAKENED CONDITION FROM THE ADMITTING STEMI, STENT THROMBOSIS, AND PULMONARY EMBOLUS. PER PHYSICIAN, THE PULMONARY EMBOLUS WAS NOT RELATED TO THE IMPLANTED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Death; Ischemia; Thrombosis

  MAUDE report 8562489 ↗
• InjuryApr 15, 2019Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD THE 2.50.33 MM XIENCE SIERRA STENT IMPLANTED AT 20 ATMOSPHERES (ATM) IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT WAS STILL IN THE HOSPITAL DUE TO OTHER HEALTH ISSUES ON (B)(6) 2019 WHEN IT WAS NOTED THERE WAS AN ACUTE CLOSURE OF THE XIENCE SIERRA STENT IN THE LAD. THE PATIENT WAS EXPERIENCING CHEST PAIN, SO THE FILMS FROM (B)(6) 2019 WERE REVIEWED AND IT WAS NOTED THE SIERRA STENT WAS DOGBONED AND SEVERELY UNDER-DEPLOYED IN MULTIPLE AREAS. THROMBUS WAS NOTED THROUGHOUT THE ENTIRE STENT. THROMBECTOMY WAS PERFORMED FOLLOWED BY MULTIPLE BALLOON INFLATIONS WITH A HIGH PRESSURE BALLOON TO SUCCESSFULLY APPOSE THE STENT. THE PATIENT IS STABLE AND DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8515649 ↗
• MalfunctionMar 13, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, TREATING A TARGET LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, AFTER STENT DEPLOYMENT, THE BALLOON WAS SLOW TO DEFLATE. THE PHYSICIAN PHONED THE TERRITORY MANAGER, WHO INSTRUCTED THE PHYSICIAN TO INFLATE THE BALLOON AND THEN SLOWLY DEFLATE. THE BALLOON WAS ABLE TO BE REMOVED WITHOUT PATIENT EFFECT. 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 8418873 ↗
• MalfunctionNov 9, 2018Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED UNSPECIFIED CORONARY LESION. DURING ATTEMPTED DEPLOYMENT OF A 2.50X33MM XIENCE SIERRA, THE BALLOON RUPTURED AT AN UNKNOWN ATMOSPHERE AND THE STENT SLIGHTLY PARTIALLY DEPLOYED, STILL REMAINING ON THE DELIVERY SYSTEM. THE DEVICE WAS SIMPLY REMOVED AS A SINGLE UNIT. ANOTHER XIENCE DEVICE 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 8057096 ↗
• InjuryOct 22, 2018Difficult 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 AN OCCLUDED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY TORTUOSITY AND NO CALCIFICATION. THE VESSEL DIAMETER WAS 5MM. A 4.00 X 38 MM XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED. THE STENT WAS NOT POST-DILATED, BUT WAS NOTED TO BE UNDERSIZED FOR THE LESION. POST DEPLOYMENT, THE VESSEL DISTAL TO THE STENT COULD BE VISUALIZED AND FURTHER OCCLUSION WAS NOTED. THEREFORE, A 2.50 X 33 MM XIENCE SIERRA SDS WAS ATTEMPTED TO BE ADVANCED DISTALLY; HOWEVER, MET RESISTANCE AND BECAME STUCK WITH THE DEPLOYED 4.00 X 38 MM STENT. DIFFICULTY REMOVING THE 2.50 X 33 MM XIENCE SIERRA SDS WAS FELT AND FORCE WAS APPLIED. THE STENT DISLODGED. A SNARE DEVICE WAS USED UNSUCCESSFULLY TO TRY AND RETRIEVE THE STENT. AS THE LESION DISTAL TO THE DEPLOYED STENT REMAINED OCCLUDED, FURTHER ATTEMPTS AT SNARING THE DISLODGED STENT WERE NOT MADE AND THE PATIENT UNDERWENT BYPASS SURGERY FOR THE RCA. THE DISLODGED STENT WAS REMOVED DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORTED DAMAGE TO THE DEPLOYED STENT AND THIS WAS NOT EXPLANTED. THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7993390 ↗
• MalfunctionAug 28, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATIENT WITH AN ACUTE MYOCARDIAL INFARCTION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED WITH DIFFUSE DISEASE. THE XIENCE SIERRA 2.50 X 33 MM STENT WAS SUCCESSFULLY DEPLOYED AT 16 ATMOSPHERES. THE BALLOON OF THE STENT DELIVERY SYSTEM (SDS) WAS THOUGHT TO BE FULLY DEFLATED, BUT THERE WAS RESISTANCE DURING REMOVAL OF THE (SDS). THE BALLOON WAS RE-INFLATED AND DEFLATED PULLING NEGATIVE PRESSURE BUT STILL ENCOUNTERED RESISTANCE DURING REMOVAL. ON THE THIRD ATTEMPT, THE SDS WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE ANATOMY. AN NC TREK RX 3.0 X 12 MM BALLOON DILATATION CATHETER WAS USED FOR POST DILATATION. ALTHOUGH IT TOOK SOME EXTRA TIME TO REMOVE THE SDS, IT WAS NOT CLINICALLY SIGNIFICANT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824792 ↗