SYNERGY™ H7493926032300Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08714729840350), received between Nov 15, 2016 and Jul 14, 2022 — classified as 6 deaths, 10 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTICED THE STENT BUCKLED BACK ON ITSELF WHEN IT WAS INSERTED INTO THE GUIDE AND THE DEVICE FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15016183 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 32MM SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVING THE DEVICE FROM THE PACKAGING, THE STENT SHAFT BROKE IN HALF. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977872 ↗
• MalfunctionSep 1, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO PERFORM DOUBLE BARREL STENTING ON THE 90% STENOSED PROXIMAL LEFT ANTERIOR ARTERY (LAD), THE 95% STENOSED OSTIAL CIRCUMFLEX (CX), AND 90% STENOSED DISTAL LEFT MAIN (LM) LESIONS. THE VESSELS WERE MODERATELY CALCIFIED AND MILDLY TO MODERATELY TORTUOUS. THE LAD WAS SUCCESSFULLY WIRED WITH A NON-BOSTON SCIENTIFIC (BSC) WIRE AND THE CIRCUMFLEX WAS THEN WIRED WITH A RUNTHROUGH WIRE. THE LAD LESION WAS BALLOONED WITH A 2.0 X 20 COMPLIANT NON-BSC BALLOON. THE CIRCUMFLEX WAS THEN BALLOONED WITH A 2.5 X 15 COMPLIANT NON-BSC BALLOON. THE 3.0 X 28 SYNERGY WAS ADVANCED INTO THE LAD WITHOUT ISSUE. THE 3.0 X 32 SYNERGY WAS UNSUCCESSFUL IN CROSSING THE CIRCUMFLEX LESION. BOTH STENTS MET RESISTANCE WHEN BEING REMOVED FROM THE BODY. WHEN THE 3.0 X 28 SYNERGY WAS REMOVED IT APPEARED THE STENT WAS STILL ON THE BALLOON. WHEN THE 3.0 X 32 SYNERGY WAS REMOVED, IT WAS IDENTIFIED THAT THE STENT WAS NO LONGER ON THE BALLOON. THE STENT WAS LOCATED IN THE TOUHY. UPON FURTHER INSPECTION, THE 3.0 X 28 SYNERGY WAS NOT ON THE STENT DELIVERY SYSTEM. THE STENTS WERE BOTH CONFIRMED AND REMOVED FROM THE INSIDE OF THE TOUHY. A NEW 7F GUIDE CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406316 ↗
• MalfunctionMay 7, 2021Failure to Advance; Difficult to Advance; Material Deformation; Failure to Advance; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, RESISTANCE WAS FELT AND IT WAS NOTED THAT THE PROXIMAL END OF THE STENT WAS DAMAGED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795081 ↗
• DeathApr 15, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT HYPOTENSION, THROMBOSIS, AND DEATH OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE 85% STENOSED MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 75% STENOSED NON-CALCIFIED CIRCUMFLEX ARTERY (CX). AT THE BEGINNING OF THE PROCEDURE, THE PATIENT WAS HYPOTENSIVE. A VENTRICULAR SUPPORT DEVICE WAS USED AND PROCEDURE WAS CONTINUED. FOLLOWING ROTABLATION, THREE SYNERGY DRUG ELUTING STENTS, A 3.00 X 32, A 3.00 X 8, AND A 3.50 X 38 RESPECTIVELY WERE IMPLANTED, TWO IN THE LAD AND ONE IN THE CX. A NON-BOSTON SCIENTIFIC STENT WAS ALSO IMPLANTED IN THE CX. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABLE. WHEN THE VENTRICULAR SUPPORT DEVICE WAS REMOVED, THE PATIENT BECAME HYPOTENSIVE AGAIN. WHEN THE PHYSICIAN WENT BACK IN WITH THE GUIDE, IT WAS NOTED THAT ALL STENTS HAD STENT THROMBOSIS. BOTH THE LAD AND CX ARTERIES WERE CLOSED OFF AND THE PHYSICIAN WAS UNABLE TO REOPEN EITHER ONE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT THE PATIENT DID NOT SURVIVE. THE OFFICIAL CAUSE OF DEATH WAS CORONARY THROMBUS. NO AUTOPSY WAS PERFORMED.

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 11676196 ↗
• InjuryOct 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT MAIN INTO THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32 SYNERGY DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT AND SUCCESSFULLY DEPLOYED. HOWEVER, AFTER INTRAVASCULAR ULTRASOUND WAS USED TOGETHER WITH AN ENHANCE STENT VISUALIZATION TOOL, IT WAS NOTED THAT THE STENT WAS FRACTURED. SUBSEQUENTLY, A SECOND LAYER OF STENT WAS IMPLANTED TO COVER THE FRACTURE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 10627969 ↗
• MalfunctionJul 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED, BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, THE STENT STRUTS WERE NOTED TO BE RAISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347061 ↗
• InjuryMay 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE STENT CAME OFF THE BALLOON AND WAS RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10057935 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STYLET OF THE STENT WAS BENT.

  Patient problems: No Patient Involvement

  MAUDE report 9967696 ↗
• MalfunctionFeb 11, 2020Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND GUIDEWIRE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT AND 300CM STRAIGHT TIP SAMURAI GUIDEWIRE WAS SELECTED FOR USE. DURING ADVANCEMENT, THE DELIVERY SYSTEM GOT STUCK ON THE GUIDEWIRE. DURING ATTEMPTS TO REMOVE THE DEVICE FROM THE WIRE, WHILE STILL OUTSIDE OF THE PATIENT, THE STENT GOT DAMAGED. THE PORTION OF THE WIRE STUCK WITH THE DELIVERY SYSTEM, WAS CUT OFF. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693695 ↗
• MalfunctionDec 2, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. A 3.00X32MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. PRE-DILATATION WAS PERFORMED AND THE DEVICE WAS ABLE TO CROSS THE LESION BUT WHEN THE PHYSICIAN PULLED THE DEVICE SLIGHTLY TO FULLY COVER THE LESION, THE DEVICE WAS PULLED TOO FAR AND COULD NOT BE ADVANCED FURTHER. PRE-DILATATION WAS AGAIN PERFORMED AND A NON-BSC EXTENSION CATHETER WAS USED TO AID IN CROSSING THE LESION. THE DEVICE WAS ABLE TO CROSS AND WAS INFLATED TO NOMINAL PRESSURE. THE BALLOON LOOKED GREAT ON X-RAY BUT WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT WAS STILL ON THE BALLOON, CRUNCHED BACK TO THE PROXIMAL END OF THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397714 ↗
• MalfunctionDec 2, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 3.00X32MM SYNERGY DRUG-ELUTING STENT WAS USED IN A PROCEDURE. HOWEVER, THE STENT WAS CONTAMINATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395733 ↗
• InjuryNov 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION. THE SMALL TARGET LESION WAS LOCATED IN THE TORTUOUS RIGHT CORONARY ARTERY (RCA). AFTER ADVANCING A GUIDEWIRE AND A GUIDE EXTENSION CATHETER, PRE-DILATION WAS PERFORMED. A 3.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, THE WHOLE SYSTEM WAS PUSHED OUT OF RCA, LEAVING THE STENT IN THE VESSEL. AFTER FAILING TO SNARE THE DISLODGED STENT, ANOTHER SYNERGY STENT WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE WALL. NO FURTHER COMPLICATIONS WERE REPORTED AND TIMI III FLOW WAS NOTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 9321463 ↗
• MalfunctionNov 12, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT GOT CAUGHT ON THE PREVIOUSLY UNKNOWN PLACED STENT AND IT FLARED THE STENT STRUT. THE STENT WAS PULLED OUT AND DEPLOYED ANOTHER 3.00X32MM STENT AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313067 ↗
• MalfunctionSep 6, 2019Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15AUG2019. IT WAS REPORTED THAT DEVICE DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00X32MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE PRODUCT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8970470 ↗
• MalfunctionJul 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00X32MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT CATHETER BROKE ABOUT 35CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY THROUGH A GUIDEZILLA EXTENSION GUIDE CATHETER. 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 8764429 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK HAD OCCURRED. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED DURING A PROCEDURE. AS THE DEVICE WAS BEING REMOVED FROM THE HEMOSTASIS VALVE, THE SHAFT BROKE APPROXIMATELY 30 CM FROM THE HUB OF THE DEVICE. BOTH PORTIONS OF THE DEVICE WERE RETRIEVED WITHOUT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687477 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A RIGHT CORONARY ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8550888 ↗
• MalfunctionApr 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED. THE DEVICE WAS NEVER INTRODUCED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8481193 ↗
• MalfunctionMar 31, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGED OCCURED. A 3.00MM X 32MM SYNERGY DRUG-ELUTING WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STRUTS WERE DAMAGED. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8468061 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION WITH A 2.0X15 NC EMERGE BALLOON CATHETER AND A 2.5X10 NON-BSC SCORING BALLOON CATHETER, A 3.00 X 32 SYNERGY STENT WAS ADVANCED AND IMPLANTED WITHOUT POST-DILATATION. THE PATIENT WAS GIVEN 60S PROTAMINE AND THE PROCEDURE WAS COMPLETED. HOWEVER, FORTY MINUTES POST-PROCEDURE, THE PATIENT CAME BACK WITH ACUTE STENT THROMBOSIS. SOME OF THE CLOT WAS REMOVED AND IN-STENT DILATATION WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis

  MAUDE report 8383442 ↗
• MalfunctionFeb 12, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURED. DURING A PERCUTANEOUS CORONARY INTERVENTION(PCI), A 3.00 X 32MM SYNERGY II DES WAS SELECTED FOR TREATMENT. HOWEVER THAT STENT WAS UNABLE TO CROSS THE LESION AND WAS DAMAGED INSIDE THE VESSEL. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331414 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY(LAD). TWO STENTS WERE PLACED IN THE LAD, A 2.75X38MM SYNERGY IN MID LAD, OVERLAPPED PROXIMALLY WITH 3.0X32MM SYNERGY II DRUG-ELUTING STENT. PATIENT WAS NOTED TO BE FINE POST PROCEDURE. HOWEVER, SEVERAL HOURS LATER, THE PATIENT WAS SYMPTOMATIC AND HAD TO BE RE-CATHED WHICH REVEALED THROMBUS IN THE LAD STENTS. THE PHYSICIAN PREFORMED A THROMBECTOMY TREATMENT PROCEDURE, ADMINISTERED DOSE OF AGGRASTAT ALONG WITH MORE BALLOONING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 8285390 ↗
• MalfunctionDec 19, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 32 SYNERGY STENT WAS SELECTED FOR USE. HOWEVER, UPON ADVANCING, THE PHYSICIAN CRIMPED THE HYPOTUBE AND THE SHAFT BROKE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A SHORTER SYNERGY STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179537 ↗
• MalfunctionDec 6, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. A SYNERGY II DES STENT WAS SELECTED FOR A CHRONIC TOTAL OCCLUSION (CTO) INTERVENTION. DURING THE PROCEDURE, AFTER PRE-DILATATION, A 2.5X38MM SYNERGY STENT WAS PLACED IN THE OSTIAL TO MID SEGMENT (OM1). FOLLOWING THIS DEPLOYMENT, MULTIPLE BALLOONS (1.0MM, 2.0MM, AND 3.0MM) WERE INFLATED IN THE PROXIMAL CIRCUMFLEX IN PREPARATION FOR STENT DELIVERY. A 6F GUIDELINER WAS INSERTED TO ASSIST IN THE DELIVERY OF THE 3.0X32 SYNERGY STENT. THE 3.0X32 SYNERGY STENT WAS INSERTED AND UNABLE TO FULLY ADVANCE ACROSS THE LESION. WHEN THE DEVICE WAS PULLED BACK BY THE PHYSICIAN, IT WAS NOTED THAT THE DISTAL 5MM OF THE STENT HAD BEEN TRIPPED BEYOND THE STENT BALLOON. A 3.0X20 EMERGE STENT WAS INSERTED INTO THE GUIDE CATHETER TO TRAP THE STENT AND REMOVE IT. THIS WAS NOT SUCCESSFUL. THE PHYSICIAN PULLED ON THE STENT DELIVERY SYSTEM AGAIN AND WAS ABLE TO REMOVE THE STENT AND DELIVERY SYSTEM ENTIRELY TOGETHER. NO FURTHER STENT WAS ATTEMPTED TO BE DELIVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139211 ↗