SYNERGY™ H7493926016350Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 08714729840121), received between Nov 29, 2016 and Aug 2, 2021 — classified as 10 deaths, 21 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN HAD DIFFICULTY GETTING DOWN TO THE LESION WITH AN APEX AND NC BALLOON CATHETERS. SO, THE PHYSICIAN DECIDED TO USE A 6F GUIDELINER GUIDE EXTENSION CATHETER TO DELIVER THE DEVICES EASIER AND WAS ABLE TO DELIVER THE NC AND COMPLIANT BALLOONS. AFTER A PERCUTANEOUS OLD BALLOON ANGIOPLASTY WAS PERFORMED, A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, THE STENT COULD NOT BE DELIVERED TO THE CALCIFIED AREA AFTER PUSHING A COUPLE OF TIMES. THE STENT WAS PULLED OUT AND THE GUIDELINER WAS TRIED TO ADVANCE DOWN THE VESSEL WITH THE APEX BALLOON AND REACHED THE MID RCA. THE SYNERGY STENT WAS ADVANCED TO THE LESION AND IT WAS NOTICED THAT THERE WAS NO STENT ON THE STENT DELIVERY SYSTEM. THE STENT WAS FOUND VIA X-RAY TO BE IN THE GUIDE CATHETER ON THE STENT BALLOON SHAFT INSIDE THE AORTA. THE DEVICE WAS PULLED OUT OF THE PATIENT'S BODY AND COMPLETED THE PROCEDURE WITH A 3.0X16 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12263394 ↗
• InjuryJul 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY WHICH HAD A PREVIOUS OLD STENT. A 3.50 X 16MM SYNERGY II DRUG ELUTING STENT WAS INTRODUCED WITH THE HELP OF A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER BUT THE STENT WOULD NOT ADVANCE. UPON REMOVAL, THE STENT CAUGHT AND DISLODGED IN THE TOP OF THE EXTENSION CATHETER. A SMALL BALLOON WAS ADVANCED TO THE TIP AND INFLATED TO REMOVE THE DISLODGED STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109326 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 16 MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT OF CORONARY BLOCKAGE. HOWEVER, DURING THE ATTEMPT TO CROSS THE TIGHT LESION, THE SHAFT OF THE DEVICE FRACTURED. THE DEVICE FRAGMENTS WERE COMPLETELY RETRIEVED FROM THE GUIDE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SYNERGY II AND NOT SYNERGY XD AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485671 ↗
• InjuryJan 13, 2021Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 3.50 X 16 SYNERGY DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS STRIPPED FROM THE DELIVERY SYSTEM AND WAS LODGED IN THE RADIAL ARTERY. THE PROCEDURE WAS ABORTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY AND THAT THE LESION WAS PRE-DILATED WITH A BALLOON. IT WAS NOTED THAT THERE WERE MULTIPLE ATTEMPTS MADE TO POSITION THE STENT AT THE LESION SITE. DEVICE INTERACTION WITH A PREVIOUSLY DEPLOYED STENT WHICH CAUSED THE DISLODGEMENT WAS ALSO NOTED. IT WAS FURTHER REPORTED VIA MEDWATCH 2900390000-2021-8001 THAT THE PATIENT WAS BROUGHT EMERGENTLY FOR ST ELEVATION MYOCARDIAL INFARCTION REPERFUSION. THE PATIENT UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY, LEFT HEART CATHETERIZATION, LEFT VENTRICULOGRAM, AND PERCUTANEOUS CORONARY INTERVENTION (PCI). THE STENT WAS DISLODGED FROM THE BALLOON IN THE OSTIAL LEFT CIRCUMFLEX ARTERY. A VASCULAR SURGEON WAS CONSULTED BUT NO SURGICAL INTERVENTION WAS REQUIRED. THE STENT WAS LEFT IN THE DISTAL RADIAL ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11163730 ↗
• MalfunctionOct 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 16MM SYNERGY DRUG-ELUTING STENT WAS USED, HOWEVER, THE STENT CAME OFF THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10714183 ↗
• InjurySep 1, 2020Deflation Problem; Difficult to Remove; Defective Device; Deflation Problem; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT DIFFICULTY DEFLATING, REMOVAL DIFFICULTIES AND STENT PROFILE PROBLEM OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED AT 20 ATMOSPHERES. DURING DEFLATION THE BALLOON FELT STICKY AND TENSION WAS FELT WHILE PULLING THE BALLOON INTO THE GUIDE CATHETER. THE DEVICE WAS ABLE TO BE REMOVED; HOWEVER, THE MIDDLE OF THE STENT WAS NOT UNIFORMLY OPEN AND THE LESION WAS NOT ALLOWING IT TO FULLING EXPAND, THEY WERE UNABLE TO REACH THE AREA AGAIN TO FULLY EXPAND THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478285 ↗
• MalfunctionJul 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO PLACEMENT INSIDE THE VESSEL, IT WAS NOTED THAT THE STENT DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10283678 ↗
• MalfunctionJun 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND STENT NOT ABLE TO CROSS LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.50 X 16 SYNERGY II DRUG ELUTING BIODEGRADABLE STENT WAS ADVANCED FRO TREATMENT. HOWEVER, THE PHYSICIAN HAD DIFFICULTY DELIVERING THE STENT AS WELL AND NOTICED UPON REMOVAL OF THE DEVICE THAT IT HAD A FLARED STENT STRUT IN THE MID PORTION OF THE STENT. THE VESSEL WAS PREPPED WITH A NC BALLOON AND COMPLETED THE PROCEDURE WITH ANOTHER STENT OF THE SAME SIZE. ANOTHER PROCEDURE WAS PERFORMED ON A MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12 SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, PHYSICIAN HAD DIFFICULTY DELIVERING THE STENT AS WELL AND NOTICED UPON REMOVAL OF THE DEVICE THAT IT HAD A FLARED STENT STRUT IN THE MID PORTION OF THE STENT. PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED ON BOTH PROCEDURE. .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191079 ↗
• MalfunctionJun 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF FROM THE BALLOON INTO THE GUIDE. THE DEVICES WERE COMPLETELY REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105762 ↗
• MalfunctionMar 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A 3.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN IT WAS MIDWAY UP TO THE ARM, THE SHAFT BROKE. THE BROKEN PORTION WAS STILL OUTSIDE OF THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819275 ↗
• MalfunctionMar 4, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHILE PUSHING OVER THE WIRE, IT WAS NOTED THAT THE SHAFT BROKE APPROXIMATELY 12 INCHES FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9785969 ↗
• MalfunctionMar 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENT WITH ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN, PROXIMAL LEFT ANTERIOR DESCENDING AND PROXIMAL CIRCUMFLEX DISEASE WITH SOME CALCIFICATION. THE PHYSICIAN WAS ATTEMPTING TO STENT THE CIRCUMFLEX USING A 3.50 X 16 SYNERGY II DRUG-ELUTING STENT AFTER PRE-DILATING THE LESION. AS THE STENT WAS LOADED ON THE WORKHORSE WIRE, THE SHAFT OF THE STENT SNAPPED CLEANLY IN THE MIDDLE OF THE DEVICE. THE STENT NEVER ENTERED THE PATIENT AND ALL THE PIECES WERE REMOVED FROM THE TABLE BEFORE PROCEEDING ANY FURTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9776520 ↗
• MalfunctionJan 23, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION FAILURE AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, DUE TO DEFLATION ISSUES THE BALLOON FLARED/WINGED AND TELESCOPED WHICH DEFORMED THE TIP OF THE GUIDE CATHETER. THE PHYSICIAN HAD TO REMOVE ALL THE DEVICES AND PUT IN A NEW GUIDE CATHETER FOR POST-DILATATION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9623213 ↗
• InjuryDec 2, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE CALCIFIED LESION. THE STENT WAS DEPLOYED AND DURING REMOVAL, THE CATHETER SEPARATED LEAVING THE DISTAL ONE-FOURTH BEHIND, MOSTLY IN THE GUIDE CATHETER. ANOTHER BALLOON WAS ADVANCED INTO THE GUIDE AND INFLATED TO TRAP THE REMAINING PIECE OF THE STENT DELIVERY CATHETER. THE DEVICES WERE REMOVED TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395529 ↗
• InjuryNov 15, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND DURING REMOVAL, THE STENT SHEARED OFF IN THE LEFT MAIN. A 4.0X12MM NON-BSC STENT WAS USED TO CRUSH THE DETACHED STENT TO THE VESSEL WALL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Code Available

  MAUDE report 9328931 ↗
• MalfunctionNov 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 3.50X16MM SYNERGY LL DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9307386 ↗
• DeathOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DIED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESIONS WERE LOCATED IN THE VESSELS IN THE LEFT HEART. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED AND PLACED IN THE CIRCUMFLEX ARTERY (CX). ANGIOGRAPHY REVEALED THROMBUS PROXIMAL TO THE STENT LEADING INTO THE LEFT MAIN WHERE A 3.50 X 16 SYNERGY DES WAS THEN PLACED. THERE WAS MORE THROMBUS PRESENT DISTAL TO THE FIRST STENT IMPLANTED. ANOTHER 3.50 X 20 SYNERGY DES WAS IMPLANTED FOR TREATMENT. ALL ACTIVATED CLOTTING TIMES WERE REPORTED TO BE WITHIN THERAPEUTIC RANGE. HOWEVER, THE PATIENT'S VESSEL SHUT DOWN AND THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 9187949 ↗
• DeathOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT THE DIED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESIONS WERE LOCATED IN THE VESSELS IN THE LEFT HEART. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED AND PLACED IN THE CIRCUMFLEX ARTERY (CX). ANGIOGRAPHY REVEALED THROMBUS PROXIMAL TO THE STENT LEADING INTO THE LEFT MAIN WHERE A 3.50 X 16 SYNERGY DES WAS THEN PLACED. THERE WAS MORE THROMBUS PRESENT DISTAL TO THE FIRST STENT IMPLANTED. ANOTHER 3.50 X 20 SYNERGY DES WAS IMPLANTED FOR TREATMENT. ALL ACTIVATED CLOTTING TIMES WERE REPORTED TO BE WITHIN THERAPEUTIC RANGE. HOWEVER, THE PATIENT'S VESSEL SHUT DOWN AND THE PATIENT DIED.

  Patient problems: Death; Thrombosis

  MAUDE report 9187103 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED OVER A WIRE FOR TREATMENT; HOWEVER, THE SHAFT SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136549 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DEVICE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136508 ↗
• MalfunctionJul 26, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WAS STICKING OUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830401 ↗
• InjuryJul 4, 2019Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON AND DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. AFTER SUCCESSFUL ROTABLATION WITH A 1.5MM ROTAPRO AND PRE-DILATATION WITH A 3.00MM EMERGE BALLOON, A 3.50X16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE GOT STUCK IN THE CALCIFIED LESION AND COULD NOT BE ADVANCED OR RETRACTED. IN AN ATTEMPT TO REMOVE THE DEVICE, THE STENT STARTED TO STRIP OFF FROM THE BALLOON. THE PHYSICIAN THEN USED THE STENT DELIVERY BALLOON TO DEPLOY AS MUCH OF THE STENT AS POSSIBLE IN THE TARGET LESION. A SERIES OF INCREASING SIZES OF BALLOON WERE THEN USED TO FULLY EXPAND THE STENT. SUBSEQUENTLY, A SECOND STENT WAS DEPLOYED TO COVER THE ENTIRE AREA DUE TO THE ORIGINAL STENT BEING CRUMPLED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762618 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 3.50MM X 16MM SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. THE STENT SHAFT BROKE PRIOR TO ENTERING THE BODY. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748873 ↗
• MalfunctionJun 27, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) CLOSE TO THE OSTIUM. AFTER A 3.50X16MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED IN THE PROXIMAL RCA, THE PHYSICIAN DREW NEGATIVE PRESSURE ON THE BALLOON BUT THERE WAS NO CONTRAST WAS SEEN IN THE BALLOON UNDER FLUOROSCOPY. UPON REMOVAL, THE DEVICE WOULD NOT RETRACT BACK INTO THE GUIDE CATHETER. SUBSEQUENTLY, THE GUIDE CATHETER, BALLOON DELIVERY SYSTEM, AND WIRE WERE PULLED OUT AS A UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740349 ↗
• MalfunctionMay 31, 2019Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST AND THE SHAFT BROKE. A 3.50 X 16 SYNERGY BALLOON EXPANDABLE STENT WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE IN THE MILDLY TORTUOUS, MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE SYNERGY STENT WAS DELIVERED TO THE RCA. THE PHYSICIAN WAS ABLE TO FULLY DEPLOY THE STENT, BUT THE DELIVERY BALLOON BURST. DURING REMOVAL, THE DELIVERY SYSTEM WAS PULLED FULLY INTO THE GUIDE CATHETER BUT THE SHAFT BROKE AT THE GUIDEWIRE EXCHANGE PORT. EVERYTHING WAS REMOVED FROM THE PATIENT AS ONE UNIT. A NEW GUIDE CATHETER AND BALLOON WERE SELECTED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO COMPLICATIONS AND IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658507 ↗