SYNERGY™ H7493926028400Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729840312), received between Nov 21, 2016 and Jul 5, 2022 — classified as 10 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT OBSTRUCTION AND HEART FAILURE OCCURRED. ON (B)(6) 2020, TWO 4.00 X 28 SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). LESS THAN A MONTH AGO, THE PATIENT WAS VERY SICK AND VISITED THE HOSPITAL TO CHECK ON THE STENTS. IT WAS NOTED THAT BOTH STENTS HAD COLLAPSED AND THE PATIENT WAS IN FULL CONGESTIVE HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 14917379 ↗
• InjuryJul 5, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT OBSTRUCTION AND HEART FAILURE OCCURRED. ON (B)(6) 2020, TWO 4.00 X 28 SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). LESS THAN A MONTH AGO, THE PATIENT WAS VERY SICK AND VISITED THE HOSPITAL TO CHECK ON THE STENTS. IT WAS NOTED THAT BOTH STENTS HAD COLLAPSED AND THE PATIENT WAS IN FULL CONGESTIVE HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 14917359 ↗
• MalfunctionJan 15, 2021Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-JAN-2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 4.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11178846 ↗
• MalfunctionJan 6, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 28MM SYNERGY DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STRUT FLARED PREVENTING THE DEVICE FROM CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11122857 ↗
• InjuryOct 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN(LM)/LEFT ANTERIOR DESCENDING ARTERY. THIS WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) CASE, HOWEVER THE LM WAS KNOWN TO HAVE LOW ORIGIN IN ROOT. IN EFFORTS TO PROTECT LM, 6F FL4, 6F GUIDEZILLA, A NON-BSC GUIDEWIRE AND A 4.0 X 28 SYNERGY DRUG-ELUTING STENT (UNDEPLOYED) WERE PLACED IN LM BEFORE A TRANSCATHETER AORTIC VALVE DEPLOYMENT. THE STENT WAS STILL LOADED ON BALLOON AND WAS NEVER ATTEMPTED TO BE DEPLOYED. THE STENT STRIPPED OFF THE BALLOON AND IN BETWEEN THE AORTIC ROOT AND THE TAVR VALVE AT 6-8MM INTO THE LM. THE LM WAS WIRED WITH A SEPARATE GUIDE CATHETER, GUIDEWIRE AND THE 4.0 X 12MM SYNERGY STENT WAS DEPLOYED. POST-DILATATION WAS PERFORMED WITH A 5.5MM NC BALLOON CATHETER. THE 4.0 X 12 SYNERGY STENT WAS DEPLOYED TO CRUSH THE 4.0 X 28 SYNERGY STENT AGAINST THE ARTERY WALL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10646693 ↗
• MalfunctionSep 29, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-SEP-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 4.00X28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10601781 ↗
• MalfunctionJun 9, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT WAS DAMAGED UPON REMOVAL. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND CALCIFIED PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY. A 4.00X28 AND 4.00X16 SYNERGY DRUG ELUTING STENT WERE USED FOR TREATMENT TOGETHER WITH THE GUIDEZILLA GUIDE EXTENSION CATHETER. DURING THE PROCEDURE, TWO SYNERGY STENTS WERE DEPLOYED IN THE VESSEL AND A NON-BSC STENT WAS USED DISTAL TO THE TWO SYNERGY. SUBSEQUENTLY, THE 4.00X28 STENT WAS PLACED INTO THE VESSEL BUT COULD NOT ADVANCE TO THE DISTAL LESION. THE STENT WAS REMOVED FROM THE BODY AND IT WAS NOTED TO BE UNRAVELED. THEN, A 4.0X16 STENT WAS ADVANCED IN THE GUIDEZILLA HOWEVER IT COULD NOT PASS THE TRANSITION PART OF THE GUIDEZILLA. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT WAS STUCK IN THE SHAFT OF THE CO-PILOT TUOHY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135394 ↗
• MalfunctionMar 23, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00X28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO REACH THE DESIRED PLACEMENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE OVER THE WIRE IN ORDER TO PRE-DILATE FURTHER AND MET SLIGHT RESISTANCE PULLING IT BACK INTO THE GUIDE. UPON REMOVAL, THE STENT WAS NO LONGER ON THE BALLOON/DEPLOYMENT SYSTEM. THE STENT WAS FOUND TO BE ON THE GUIDE CATHETER. ALL DEVICES WERE SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE CATHETER, GUIDE WIRE, AND STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS UNHARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865590 ↗
• MalfunctionFeb 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS. WHEN THE STENT WAS PULLED BACK, IT WAS NOTED THAT THE STENT DISLODGED FROM THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9672527 ↗
• MalfunctionJan 8, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22DEC2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 4.00 X 28 MM SYNERGY II STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9563998 ↗
• MalfunctionNov 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDWATCH REPORT NUMBER: (B)(4). IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X28MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE BALLOON DID NOT INFLATE. THE STENT CAME OFF FROM THE DELIVERY SYSTEM AND GOT CAUGHT WITH THE WIRE IN THE PERIPHERAL VESSEL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9350261 ↗
• InjuryOct 15, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND DEVICE BREAK OCCURRED. THE PATIENT PRESENTED WITH MULTIPLE LAYERS OF STENTS ALREADY WITH SIGNIFICANT IN-STENT RESTENOSIS OF THE ENTIRE VERY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. THE VESSEL WAS PREPPED WITH PRE-DILATATIONS, CUTTING BALLOONS, AND ROTABLATOR. STENTS WERE PLACED FROM THE DISTAL END AND A GUIDE DISSECTION WAS NOTED IN THE OSTIUM. A 4.00 X 28MM SYNERGY DRUG-ELUTING STENT WAS PLACED IN THE PROXIMAL/OSTIUM WITH NO ISSUES. THE STENT BALLOON WAS PULLED BACK TO POST DILATE THE OSTIUM TO 5MM. THE BALLOON EXPANDED AND DEFLATED JUST FINE. WHEN THE DOCTOR TRIED TO REMOVE THE BALLOON FROM THE PATIENT, THE BALLOON WOULD NOT MOVE. THE BALLOON WAS INFLATED AGAIN AND IT WENT UP AND BACK DOWN FINE, BUT IT STILL WOULD NOT MOVE. THE BALLOON WAS EXPANDED AND DEFLATED ONCE MORE, BUT THIS TIME WHEN AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, THE BALLOON SNAPPED OFF THE SHAFT AND THE SHAFT CAME OUT OF THE BODY LEAVING THE BALLOON IN THE VESSEL. AN ATTEMPT WAS MADE TO SNARE THE BALLOON BUT WHEN IT FAILED, THE PATIENT WAS BROUGHT TO SURGERY FOR ANOTHER PHYSICIAN TO ASSESS. BECAUSE THE BALLOON COULD NOT BE SNARED AND THE PATIENT WAS NOT A SURG

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9191978 ↗
• MalfunctionSep 27, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 28 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING ADVANCING, THE DEVICE WAS PUSHED HARDER AND THE CATHETER KINKED AND BROKE OUTSIDE OF THE GUIDE AND OUTSIDE OF THE BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130535 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 28 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, WHEN THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED, THE DISTAL SHAFT BROKE AND ONLY THE PROXIMAL PORTION CAME OUT. THEREFORE, THE NON-BSC WIRE WAS RETRACTED AND THE DISTAL PORTION OF THE BALLOON DELIVERY SYSTEM CAME OUT WITH IT INTO THE NON-BSC GUIDE CATHETER AND THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811599 ↗
• MalfunctionJul 9, 2019Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JUN2019. IT WAS REPORTED THAT DEVICE INTERACTION WERE ENCOUNTERED. A 4.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT GOT STUCK IN A 6F GUIDE EXTENSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772997 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. A 4.00MM X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. THE PHYSICIAN TOOK IT OUT OF THE PATIENT'S BODY AND THEN ADVANCED IT AGAIN FOR THE SECOND TIME. UPON ADVANCING, THE PHYSICIAN NOTICED THAT THE CATHETER OF THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716232 ↗
• MalfunctionMar 7, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND STENT DISLODGEMENT OCCURRED. A 4.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT GOT SMASHED AND BECAME STUCK IN THE BODY. THE STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S REPORTED TO BE OKAY.

  Patient problems: No Code Available

  MAUDE report 8401830 ↗
• MalfunctionFeb 11, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURED. A 4.00 X 28 SYNERGY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER THE STENT WAS DEPLOYED AND DURING THE REMOVAL OF STENT DELIVERY SYSTEM THE BALLOON SEPARATED FROM THE STENT SHAFT. THE PHYSICIAN WAS ABLE TO REMOVE THE GUIDE CATHETER AND ALL THE COMPONENTS OF THE STENT DELIVERY SYSTEM CAME OUT WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327764 ↗
• InjuryJan 22, 2019Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT SHAFT BREAK AND STENT INADEQUATE APPOSITION OCCURED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER AN UNKNOWN STENT WAS DEPLOYED IN THE PROXIMAL RCA, IT WAS DECIDED TO PLACE ANOTHER STENT DISTALLY. A 4.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO THE DISTAL LESION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERE, THE STENT DELIVERY BALLOON STARTED TO DEFLATE IMMEDIATELY. THE STENT WAS NOT FULLY DEPLOYED. WHEN THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED, THE SHAFT CAME OUT WITHOUT THE BALLOON. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE REMAINING BALLOON AND STENT FOR TWO HOURS, BUT AS UNSUCCESSFUL AND THE PATIENT WAS SENT TO SURGERY FOR RETRIEVAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8268913 ↗
• MalfunctionOct 29, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X28MM SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT A PORTION OF THE FRONT END OF THE STENT WAS PUSHED UP. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00X28 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017396 ↗
• InjuryAug 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED CIRCUMFLEX ARTERY. A GUIDEWIRE AND GUIDE CATHETER WERE IN PLACE WITH A 4.00 X 28 SYNERGY II STENT. THE DEVICE WERE "KICKED OUT" OF THE VESSEL AND IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. X-RAY REVEALED THAT THE STENT HAD REMAINED IN THE CIRCUMFLEX ARTERY. SNARING WAS ATTEMPTED TO RETRIEVE THE DISLODGED STENT BUT FAILED. SUBSEQUENTLY, A DIFFERENT STENT WAS USED TO TRAP THE DISLODGED STENT TO THE VESSEL WALL. AN OPTICAL COHERENCE TOMOGRAPHY WAS PERFORMED TO MAKE SURE THAT THE STENT WAS COMPLETELY SECURED AGAINST THE WALL. NO PATIENT COMPLICATIONS WERE REPORTED THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7758769 ↗
• MalfunctionJul 16, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL TO THE VEIN GRAFT OF THE CIRCUMFLEX. AFTER DEPLOYING A 4.0X20 MM SYNERGY STENT IN THE OSTIUM OF THE VEIN GRAFT, THE PHYSICIAN DECIDED TO A TREAT A DISTAL LESION. THE VEIN GRAFT WAS RE-ENGAGED AND A NON-BSC WIRE WAS ADVANCED. A 4.00X28 MM SYNERGY II STENT WAS THEN ADVANCED TO TREAT THE TARGET LESION. HOWEVER, THE STENT CAUGHT UP WITH THE PREVIOUSLY DEPLOYED STENT AND WAS DAMAGED. THE DEVICE WAS REMOVED TOGETHER WITH GUIDE CATHETER, GUIDE WIRE AND GUIDEZILLA. 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 7690402 ↗
• MalfunctionApr 27, 2018Bent; Bent

  SAME CASE AS MDR ID: 2134265-2018-03568. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED OSTIAL RIGHT CORONARY ARTERY. A 4.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED THROUGH A 6F GUIDEZILLA¿ II GUIDE EXTENSION CATHETER. HOWEVER, IT WAS NOTED THAT THE STENT PENETRATED THE CALCIUM AND THE DISTAL EDGE OF THE STENT WAS DINGED UP. WHEN THE DEVICE WAS REMOVED, THE PROXIMAL END GOT CAUGHT ON THE GUIDEZILLA II GUIDE EXTENSION CATHETER AND THE STENT WAS QUASHED OR SQUEEZED. THE PHYSICIAN REMOVED THE ENTIRE SYSTEM OUT AND THEN RE-ENGAGED AND COMPLETED THE PROCEDURE WITH A 4.00 X 12MM 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 7470653 ↗
• MalfunctionApr 13, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00 X 28MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429373 ↗
• MalfunctionMar 22, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 28 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, AS THE DEVICE WAS ATTEMPTED TO INSERT INTO THE GUIDE CATHETER INTO A SYSTEM, THE SHAFT BENT AND EVENTUALLY BROKE INTO TWO PIECES. USAGE OF THE DEVICE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT HAD A POSITIVE OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362013 ↗