SYNERGY™ H7493926032250Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08714729840336), received between Nov 15, 2016 and Nov 2, 2020 — classified as 2 deaths, 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2020Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-OCT-2020. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. A LEFT HEART CATHETERIZATION WAS BEING PERFORMED. DURING INSERTION OF A 2.50 X 32MM SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE DEVICE WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10771785 ↗
• MalfunctionApr 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE AVERAGELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. AFTER A STAGED ROTABLATOR, THE LESION WAS DILATED WITH AN EMERGE BALLOON CATHETER WITHOUT ISSUES, BUT UPON REMOVAL FROM THE PATIENT'S BODY THE SHAFT THEN SNAPPED 1/3 FROM THE HUB INSIDE THE 8FR GUIDE CATHETER. THE WIRE WAS PULLED BACK INTO THE GUIDE CATHETER AND SNARED THE BROKEN SHAFT WITHOUT REMOVING THE GUIDE CATHETER. THE LESION THEN DILATED WITH A DIFFERENT BALLOON CATHETER. A 2.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS AND SO ANOTHER BALLOON WAS USED TO PRE-DILATE THE LESION. THE 2.50 X 32 STENT WAS ADVANCED FOR THE SECOND TIME BUT THE SHAFT BROKE AT THE MID PORTION OF THE CATHETER WHILE ADVANCING INTO THE GUIDE. THE STENT WAS PULLED OUT FROM THE GUIDE CATHETER WITHOUT REMOVING THE DEVICE FROM IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE ALL THROUGHOUT THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915287 ↗
• MalfunctionMar 14, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND DAMAGE WAS NOTED ON THE ACTUAL STENT STRUTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832943 ↗
• MalfunctionDec 19, 2019Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE LESION WAS PREDILATED WITH TWO NON BSC BALLOON CATHETER. THEN THIS 2.50X32MM SYNERGY DRUG ELUTING STENT WAS SELECTED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE SHAFT BECAME BENT AND BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9495069 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50X32MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED DURING UNPACKING. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9416086 ↗
• InjuryJul 26, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHAFT BREAK AND STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50X32MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE DURING ADVANCING AND UPON PULLING THE DEVICE OUT FROM THE GUIDE, IT WAS NOTICED THAT THE STENT WAS NO LONGER ON THE BALLOON. THE STENT WAS NEVER FOUND AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BREAK OCCURRED "HALFWAY" FROM THE HUB. IT IS UNKNOWN EXACTLY WHEN THE STENT DISLODGED. THE STENT WAS NOT PULLED INTO THE GUIDE CATHETER. THE GUIDE CATHETER WAS CHECKED FOR THE DISLODGED STENT BUT IT WAS NOT THERE. A SCAN WAS DONE ON THE PATIENT TO FIND THE DETACHED STENT BUT WAS UNABLE TO BE LOCATED. NO FURTHER INTERVENTION WAS PERFORMED TO LOCATE THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831070 ↗
• InjuryJul 1, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS AND ST-SEGMENT ELEVATION OCCURRED. THE PATIENT WAS GIVEN ASPIRIN, PLAVIX 300MG, TENECTEPLASE (TNKASE), HEPARIN BOLUS AND DRIP ADDITIONAL HEPARIN GIVEN IN CENTRAL VENOUS LINE. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND MID CIRCUMFLEX ARTERY. SUBSEQUENTLY, TWO SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED IN THE TARGET LESIONS 95 AND 112 MINUTES AFTER TNKASE. HOWEVER, ELECTROCARDIOGRAM SHOWED ST-SEGMENT ELEVATION 5 HOURS AFTER STENT PLACEMENT. THE PATIENT WAS SENT BACK TO LAB AND IT WAS NOTED THAT BOTH STENTS WERE OCCLUDED. THE CLOT WAS REMOVED, STENTS WERE PLACED AND PATIENT WAS GIVEN AN INTEGRILIN AND BRILINTA. EJECTION FRACTION (EF) IS 20-25% AND NO FURTHER CHEST PAIN WAS EXPERIENCED PRIOR TO DISCHARGE. FOLLOW-UP CLINIC VISIT STATED THAT PATIENT IS WEARING A LIFEVEST. IT WAS FURTHER REPORTED THAT THE PATIENT ALSO EXPERIENCED CHEST PAIN POST STENT PLACEMENT.

  Patient problems: Chest Pain; ST Segment Elevation; Thrombosis

  MAUDE report 8749202 ↗
• MalfunctionJan 16, 2019Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED CORONARY ARTERY. A 2.50 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254694 ↗
• MalfunctionNov 15, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE STENT WAS NOT VISIBLE UNDER FLUOROSCOPY. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE DEVICE WAS NOT VISIBLE UNDER THE X-RAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. DEVICE EVALUATED BY MFR: SYNERGY II US MR 2.50 X 32MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION (VISUAL AND VIA SCOPE) OF THE CRIMPED STENT FOUND NO ISSUES WITH THE STENT. THERE WERE NO SIGNS OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED AND WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON WAS REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE HYPOTUBE KINKS. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES. AN EXAMINATION (VISUAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074658 ↗
• DeathOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT A DEATH HAD OCCURRED. IN (B)(6) 2017, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 X 32 MM STUDY STENT. FOLLOWING POST-DILATATION THERE WAS 1% RESIDUAL STENOSIS AND THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018 THE SUBJECT PRESENTED TO EMERGENCY DEPARTMENT WITH THE COMPLAINT OF CHEST PAIN. PER MEDICAL PERSONNEL, THE SUBJECT WAS HYPERTENSIVE AND FELT NAUSEOUS WHICH WAS TREATED WITH ZOFRAN AND ASPIRIN FOLLOWING WHICH SOME IMPROVEMENT WAS NOTED. THE SUBJECT FOUND SOMNOLENT AND EVALUATION WAS RECOMMENDED. A CAT SCAN OF THE HEAD WAS PERFORMED AND REVEALED A PROMINENT INTRAPARENCHYMAL HEMATOMA IN THE RIGHT EXTERNAL CAPSULE. THERE WAS EXTENSIVE SUBARACHNOID HEMORRHAGE IN THE FRONTAL, PARIETAL AND TEMPORAL AS WELL AS LEFT FRONTAL AND TEMPORAL REGIONS. SUBARACHNOID HEMORRHAGE FILLS THE BASILAR CISTERNS AND SYLVAIN FISSURES AND EXTENDED ALONG THE CLIVUS INFERIORLY ADJACENT TO THE BRAINSTEM AND SU

  Patient problems: Cardiopulmonary Arrest; Death

  MAUDE report 7992241 ↗
• MalfunctionOct 1, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A BMW WIRE ATTEMPTED TO CROSS A 2.50 X 32MM SYNERGY US MR STENT THROUGH THE LEFT MAIN INTO THE OSITIAL CIRCUMFLEX (CX), HOWEVER, THE STENT WAS UNABLE TO ADVANCE DUE TO AN UNKNOWN STENT HANGING OUT OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). WHEN THE SYNERGY STENT WAS REMOVED, IT WAS NOTICED THAT THE STENT HAD DAMAGE TO THE STRUTS. A 2.5 X 12 EMERGE BALLOON WAS ADVANCED INTO THE OSITAL CIRCUMFLEX (CX) AND WAS INFLATED. A NEW SECOND STENT WAS CROSSED INTO THE LESION AND WAS DEPLOYED WITHOUT INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923664 ↗
• MalfunctionJun 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND STUCK ON THE STENT. A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO LOAD PRODUCT ONTO WIRE, IT WAS NOTED THAT THERE WAS SOMETHING WRONG WITH THE STENT. IT FELT LIKE THE STENT WAS CAUGHT WITH SOME FIBER/GAUZE. THE DEVICE WAS NEVER USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7578475 ↗
• MalfunctionMar 29, 2018Break; Break

  IT WAS FURTHER REPORTED THAT THE COMPLAINT DEVICE WAS A 3.00 X 32MM SYNERGY II DRUG-ELUTING STENT AND NOT A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT AS PREVIOUSLY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382042 ↗
• DeathSep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2017-09375. (B)(6) STUDY. IT WAS REPORTED THAT CONGESTIVE HEART FAILURE, ACUTE CORONARY SYNDROME AND DEATH OCCURRED. IN (B)(6) 2016, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL BRANCH WITH 90% STENOSIS AND WAS 38 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 2.25 X 32 MM AND 2.25 X 16 MM STUDY STENTS. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS. SEVEN DAYS LATER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ELEVEN DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHIEF COMPLAINT OF CHEST PAIN WHICH LASTED FOR 15 MINUTES AND WAS ASSOCIATED WITH DYSPNEA. THE PATIENT WAS ADVISED TO USE NITRO PASTE AND TO CONTINUE THE USE OF ASPIRIN, CLOPIDOGREL AND A BETA-BLOCKER. ELECTROCARDIOGRAM (EKG) PERFORMED IN THE EMERGENCY ROOM SHOWED SINUS RHYTHM WITH A RIGHT BUNDLE BRANCH BLOCK AND WAS NOTED TO BE IN ATRIAL FIBRILLATION. CHEST X-RAY PERFORMED ON THE SAME DAY SHOWED, CARDIOMEGALY WITH PULMONARY EDEMA CONCERNING FOR CONGESTIVE HEART FAILURE. BIBASILAR AIRSPACE DISEASE AND BILATERAL PLEURAL COLLECTION WHICH WAS MOST LIKELY

  Patient problems: Arrhythmia; Cardiac Enzyme Elevation; Chest Pain; Congestive Heart Failure; Death; Dyspnea; Macular Edema; Pericardial Effusion

  MAUDE report 6887026 ↗
• InjuryJul 12, 2017Fracture; Fracture

  IT WAS REPORTED VIA FACILITY MEDWATCH# 5070388 THAT STENT FRACTURE OCCURRED. IN (B)(6) 2016, A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. HOWEVER IN (B)(6) 2017, DURING CARDIAC CATHETERIZATION, IT WAS NOTED THAT THE PREVIOUSLY DEPLOYED STENT HAD 360 DEGREES FRACTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6707514 ↗
• MalfunctionMay 31, 2017Bent; Bent

  SAME CASE AS MDR ID# 2134265-2017-05473. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). A GUIDE CATHETER WAS POSITIONED, THEN A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS DISRUPTED AND FLARED. SUBSEQUENTLY, A 2.50 X 16 SYNERGY II WAS ADVANCED BUT ALSO FAILED TO CROSS THE LESION AND THE PROXIMAL EDGE OF THE STENT WAS ALSO DISRUPTED AND FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6602316 ↗
• InjuryMay 9, 2017Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VEIN GRAFT TO THE CIRCUMFLEX ARTERY. A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THEY WENT TO DIAL UP THE INFLATION DEVICE, THE STENT DID NOT INFLATE. THE PHYSICIAN PULLED ON THE SHAFT A LITTLE BIT BACKWARDS AND REALIZED THAT THE STENT DID NOT MOVE. THE PHYSICIAN KEPT ON PULLING THE DEVICE AND THE SHAFT BROKE IN HALF. A GUIDE WIRE WAS THEN USED TO GRAB THE BROKEN HALF OF THE DEVICE AND PULLED IT INTO THE NON-BSC GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 32 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555401 ↗
• MalfunctionApr 18, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVE ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED CIRCUMFLEX (CX) ARTERY TO THE LEFT MAIN (LM) ARTERY. AFTER A NON BSC GUIDEWIRE HAS CROSSED THE LESION, A 2.5 X 20 EMERGE¿ BALLOON CATHETER WAS ADVANCED AND PRE-DILATED THE LESION WITH GOOD RESULT. SUBSEQUENTLY, A 2.50 X 32 SYNERGY II STENT WAS ADVANCED BUT JUST AT THE BIFURCATION OF THE CX TO LM THERE APPEARED TO BE A LOT OF CALCIUM THAT WAS NOT VISIBLE ON THE ANGIOGRAPHY. THE STENT FAILED TO CROSS THE LESION AND DURING REMOVAL OF THE DEVICE, RESISTANCE WAS FELT. THE PHYSICIAN CONTINUED TO PULL AND WHEN THE DEVICE PASSED THROUGH THE TUOHY IT WAS DISCOVERED THAT THE STENT HAD MOVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH 3 NON-BSC STENTS WHICH ALSO HAD TROUBLE CROSSING BUT ENDED UP IMPLANTED WITH GOOD RESULTS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6500146 ↗
• InjuryApr 17, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED VIA FACILITY MEDWATCH# MW5068367 THAT CLOT FORMATION OCCURRED. AFTER THE PATIENT WAS GIVEN PRE-PROCEDURE ANTI-COAGULANT, A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED TO TREAT A LESION. HOWEVER, DURING THE PROCEDURE, CLOT FORMATION WAS NOTED AT THE STENT SITE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis

  MAUDE report 6497570 ↗
• MalfunctionApr 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 32MM SYNERGY II STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, UPON REMOVING THE STENT PROTECTIVE COVER, THE STENT GOT STUCK AND FELL OFF OF THE DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6484542 ↗
• MalfunctionApr 4, 2017Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 32 SYNERGY II STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, UPON REMOVING STYLET OUT OF THE DISTAL POSITION OF THE STENT, THE STENT WAS COMPLETELY REMOVED AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6459181 ↗
• MalfunctionMar 23, 2017Bent; Device Dislodged or Dislocated; Bent; Device Dislodged or Dislocated

  SAME CASE AS MDR ID: 2134265-2017-02369. IT WAS REPORTED THAT STENT DAMAGED AND STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.00MM X 20MM NC EMERGE® BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED AT 20 ATMOSPHERES. THE DEVICE WAS REMOVED AND THE PHYSICIAN NOTICED THAT THE BALLOON HAD COMPLETELY CAME OFF FROM THE DELIVERY SYSTEM AND REMAINED IN THE BODY. SUBSEQUENTLY, A STENT WAS ADVANCED AND WAS DEPLOYED TO COVER THE DETACHED BALLOON. AFTER THAT, A 2.50 X 32MM SYNERGY II STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE CAUGHT ON THE PREVIOUSLY DEPLOYED STENT AND THE STENT APPEARED TO BE UNRAVELED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTED THAT THE STENT CAME OFF ON THE BACK TABLE OUTSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427013 ↗
• MalfunctionMar 9, 2017Bent; Bent

  SAME CASE AS MDR ID 2134265-2017-01849 AND 2134265-2017-01851. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS CHRONICALLY TOTALLY OCCLUDED (CTO). A 2.50 X 24, 2.50 X 32 AND 2.50 X 38 SYNERGY II STENT WERE ADVANCED THROUGH A NON-BSC GUIDE EXTENSION CATHETER AND THEN FAILED TO CROSS THE LESION. THE STENTS WERE DAMAGED WHILE PULLING BACK INTO THE GUIDE EXTENSION CATHETER FOR REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390999 ↗
• MalfunctionJan 20, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OUTSIDE THE PATIENT OCCURRED. A 2.50MMX32MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT CAME OFF THE BALLOON WHEN IT WAS TAKEN OUT FROM THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6267600 ↗
• MalfunctionDec 17, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 2.50 X 32 SYNERGY II STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, WHILE REMOVING THE STENT PROTECTOR, THE STENT CAME OFF FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6184182 ↗