SYNERGY™ H7493926038350Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 08714729840428), received between Nov 23, 2016 and Nov 4, 2021 — classified as 7 deaths, 17 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 38 SYNERGY II DRUG ELUTING CORONARY STENT WAS SELECTED FOR USED. HOWEVER, PRIOR OF ENTERING IT TO THE BODY THE STENT DELIVERY SYSTEM WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751597 ↗
• 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 11676199 ↗
• InjuryMar 16, 2021Deflation Problem; Difficult to Remove; Defective Device; Deflation Problem; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT DEFLATION FAILURE, REMOVAL DIFFICULTIES, AND STENT FORESHORTENING OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL AND PROXIMAL RIGHT CORONARY ARTERY. A 3.5 X 38 MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. THE STENT BALLOON WAS INFLATED AT 18 ATMOSPHERES FOR 20 SECONDS. HOWEVER, IT WAS OBSERVED THAT THE BALLOON BECAME STUCK AND WAS NOT ABLE TO DEFLATE FULLY. SUBSEQUENTLY, THE BALLOON WAS DEFLATED BY THE INDEFLATOR. DURING THE REMOVAL, THE DEFLATED BALLOON WAS PULLED ON THE STENT AND IT CAUSED FORESHORTENING. AN ADDITIONAL 3.5X12MM SYNERGY STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES AND THE PATIENT WAS STABLE THROUGHOUT THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497064 ↗
• MalfunctionFeb 10, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING ROTABLATION, A 3.50 X 38 SYNERGY STENT WAS DEPLOYED FOR TREATMENT. UPON WITHDRAWING THE STENT DELIVERY SYSTEM, THE SHAFT BROKE INSIDE THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED; HOWEVER, THE PROCEDURE WAS DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306753 ↗
• MalfunctionDec 14, 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. A 3.50 X 38 MM SYNERGY STENT DELIVERY SYSTEM WAS OPENED AND PREPPED CORRECTLY. UPON INSERTION, THE STENT FELL OFF FROM THE STENT DELIVERY SYSTEM BEFORE ENTERING THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW 3.50 X 38 MM SYNERGY. NO PATIENTS COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11005236 ↗
• MalfunctionJul 1, 2020Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN PULLING OUT THE STENT THROUGH A 7 FR NON-BSC GUIDE EXTENSION CATHETER, THE STENT WAS STUCK. THE DEVICES WERE PULLED OUT AND THE STENT WAS FOUND BENDED OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219873 ↗
• MalfunctionJun 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION EVEN AFTER REPEATED ATTEMPTS AND WAS DAMAGED. 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 10123165 ↗
• MalfunctionApr 14, 2020Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 38 SYNERGY II DES DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING PROCEDURE, THE STENT HAD A LIFTED STRUT AND IT BECAME CAUGHT ON THE GUIDEZILLA II CATHETER-GUIDE. BOTH THE STENT AND THE CATHETER-GUIDE WERE REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50 X 38 SYNERGY II DES DRUG-ELUTING STENT WITHOUT A CATHETER-GUIDE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE QUITE TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. IT WAS DIFFICULT TO PASS STENT OUT OF GUIDEZILLA II CATHETER-GUIDE, IT WAS DISRUPUTED WHEN IT WAS PULLED BACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957135 ↗
• MalfunctionMar 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 3.50 X 38 SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WIRE AND THE CATHETER WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9841405 ↗
• InjuryJan 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50X38MM SYNERGY II DRUG-ELUTING STENT (DES) WAS DEPLOYED FOR TREATMENT. HOWEVER, DURING AN INTRAVASCULAR ULTRASOUND, A FRACTURE WAS NOTED. THE LESION WAS BALLOONED AND A 35X12MM SYNERGY II DES WAS SUCCESSFULLY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Code Available

  MAUDE report 9633327 ↗
• DeathJan 9, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH # (B)(4) THAT THE PATIENT DIED. PRIOR TO THE PROCEDURE THE PATIENT WAS AT A REHAB FACILITY WERE SHE WAS EXPERIENCING NAUSEA AND VOMITING, WHICH LATER ON DEVELOPED HEAVINESS OF ARMS AND CHEST. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. DURING CARDIAC CATHETERIZATION, A 3.50 X 38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). POST-DEPLOYMENT, THE WIRE WAS ABLE TO BE REMOVED; HOWEVER, THE DELIVERY BALLOON WAS STUCK IN THE IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED STENT IN THE PROXIMAL LAD WHICH LIKELY UNDER EXPANDED. A NEW WIRE WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT PASS THE BALLOON WHICH WAS IN THE LAD. THE PHYSICIAN PULLED THE DELIVERY BALLOON HARD AND THE SHAFT BROKE WITH BALLOON STILL STUCK IN THE LAD STENT. THE PATIENT HAD A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND A LONG SAMURAI WIRE WAS USED AND FORMED A SNARE THROUGH THE GUIDE CATHETER TO RETRIEVED THE STUCK BALLOON AND ITS SHAFT. NO FRAGMENTS WERE LEFT INSIDE THE BODY AFTERWARDS. HOWEVER, THE PATIENT CODED AND WAS UNABLE TO BE RESUSCITATED. THE PATIENT DIED. SUSPECTED CAUSE OF DEATH WAS MYOCARDIAL INFARCT

  Patient problems: Death

  MAUDE report 9569316 ↗
• MalfunctionDec 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11DEC2019. IT WAS REPORTED THAT DEVICE INTERACTION OCCURRED. A 3.50X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS THAT THE STENT INTERACTED WITH A 7FR NON-BSC RAPID EXCHANGE GUIDE CATHETER. A NEW STENT WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491762 ↗
• DeathDec 12, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED WITH PREVIOUSLY PLACED STENTS, POSSIBLY MULTIPLE LAYERS. FOLLOWING PREDILATATION, A 3.5X12MM STENT WAS PLACED. THERE WAS NO EXCESSIVE RESISTANCE FELT WITH EITHER DEVICE AND THERE WERE NO ISSUES DEPLOYING THE STENT. A 3.50X38MM SYNERGY II DRUG-ELUTING STENT WAS THEN PLACED AT THE PROXIMAL END OF THE OLD STENTS. THERE WAS A NARROWING OF THE VESSEL, AT THE PROXIMAL END WITH THE MULTIPLE LAYERS OF THE OLD STENT THAT WAS NOT ABLE TO BE EXPANDED BY PRE DILATATION OR STENT EXPANSION. AFTER THE 3.50X38MM SYNERGY STENT WAS DEPLOYED, THE BALLOON WAS NOT ABLE TO BE REMOVED FROM THE STENTED AREA. THE BALLOON LOOKED FULLY DEFLATED ON FLUOROSCOPY. VACUUM WAS PULLED TWICE WITH THE INDEFLATOR AND THEN WITH A 20CC SYRINGE. THE BALLOON WAS INFLATED TO BURSTING IN AN ATTEMPT TO BE ABLE TO REMOVE THE BALLOON. THE PHYSICIAN STRUGGLED TO REMOVE THE DEVICE FOR 15 MINUTES BEFORE THE SHAFT BROKE AND HAD TO SNARED. THE PHYSICIANS THOUGHT THAT THE MOST LIKELY CAUSE OF THE STUCK BALLOON WAS THE REDUCED LUMEN DIAMETER AND POTENTIALLY FRACTURED OR MALLOPPOSED STRUTS FROM THE PREVIOUSLY PLACED, OLDER, STENTS CATCHING THE BALLOON AS IT WAS BEING WITHDRA

  Patient problems: Death

  MAUDE report 9459408 ↗
• DeathDec 12, 2019Break; Difficult to Remove; Physical Resistance/Sticking

  AN ELDERLY FEMALE PATIENT WITH HISTORY OF HYPERTENSION (HTN), CHEST PAIN, RECENT TRAFFIC ACCIDENT WITH T12 COMPRESSION FRACTURE AND RIGHT (R) SIDED RIB FRACTURES PRESENTS TO THE HOSPITAL. WHILE HAVING A CARDIAC CATHETERIZATION, THE STENT DEPLOYED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. UNABLE TO REMOVE DELIVERY BALLOON/ CATHETER. WHILE ATTEMPTING TO REMOVE, BALLOON TIP FRACTURED. ATTEMPTS MADE TO SNARE AND REMOVE BALLOON. PT CODED. BALLOON EVENTUALLY RETRIEVED. UNABLE TO RESUSCITATE PATIENT EXPIRED. PROCEDURE: CARDIAC CATH. "WE WERE ABLE TO TAKE THE WIRE OUT BUT NOT THE BALLOON WHICH WAS STUCK IN THE SEVER INSTANT RESTENOSIS OF THE PROXIMAL LEFT ANTERIOR (LA) STENT WHICH IS LIKELY UNDER EXPANDED. I TRIED TO USE ANOTHER CORONARY WIRE BUT COULD NOT PASS BY THE BALLOON WHICH WAS IN THE LAD. WE PULLED THE BALLOON HARD AND SHAFT BROKE WITH BALLOON STILL STUCK IN THE LAD STENT. PATIENT HAD A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND WE TOOK LONG SUMARIAI WIRE AND FORMED A SNARE THROUGH GUIDE CATHETER TO RETRIEVE THE STUCK BALLOON AND ITS SHAFT. THERE WAS NO RESIDUAL MATERIAL WERE LEFT IN PLACE AFTERWARDS."

  Patient problems: Cardiopulmonary Arrest; Death

  MAUDE report 9457971 ↗
• MalfunctionDec 9, 2019Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. WHILE A 3.50 X 38 SYNERGY DRUG ELUTING STENT WAS BEING ADVANCED, THE SHAFT BROKE IN HALF. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9441456 ↗
• InjuryDec 2, 2019Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY, STENT DAMAGE AND DISLODGEMENT OCCURRED. THE 70-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER PREPPING THE LESION WITH ROTAPRO ATHERECTOMY AND WITH INTRAVASCULAR ULTRASOUND, DILATATION WAS PERFORMED WITH 3.0X15 NC EMERGE BALLOON CATHETERS. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE MID LAD. HOWEVER, DURING DEPLOYMENT, THE PROXIMAL 10MM OF THE STENT DID NOT EXPAND. MULTIPLE DILATATIONS AT 22 ATMOSPHERES WERE DONE BUT THE ISSUE WAS NOT RESOLVED. THE DEVICE WAS THEN FORCED TO BE RETRACTED RESULTING IN A SEVERE DEFORMATION OF THE STENT. ANOTHER 3.00 X 38 SYNERGY DES WAS ADVANCED TO TREAT THE PROXIMAL LAD BUT THE PROXIMAL 10MM OF THE STENT DID NOT EXPAND AS WELL. AFTER MULTIPLE LONG DURATION OF INFLATIONS AT 22 ATMOSPHERES, THE STENT WAS ABLE TO BE FULLY EXPANDED WITH GOOD RESULT. A 3.50 X 38MM SYNERGY DES WAS ALSO ADVANCED TO TREAT THE PROXIMAL LAD. HOWEVER, THE PROXIMAL 10MM OF THE STENT DID NOT EXPAND DESPITE MULTIPLE INFLATIONS AT 22 ATMOSPHERES. THE DEVICE WAS FORCEFULLY RETRACTED INTO THE GUIDE CATHER BUT COULD NOT

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9397506 ↗
• MalfunctionNov 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS DAMAGED ON THE BALLOON. THE DEVICE WAS NEVER ENTERED INTO THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9271721 ↗
• InjuryOct 24, 2019Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED AND PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND LEFT MAIN ARTERY. A 4.0X20MM NC BALLOON CATHETER WAS USED TO POST-DILATE THE STENT AND A NON-BSC HEART PUMP DEVICE WAS ALSO PLACED. ANGIOGRAPHY SHOWS THAT THE STENT WAS PATENT. A FEW DAYS LATER, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND WAS RUSHED TO THE CATH LAB. THE STENTS THAT WERE PLACED WERE OPEN. THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT AND CONTINUED TO HAVE SOME ISSUES. AN ECHOCARDIOGRAM WAS THEN PERFORMED WHICH REVEALED THAT THE 20MM OF THE SYNERGY STENT WAS HANGING INTO THE AORTA. THE STENT WAS SNARED SUCCESSFULLY. THE PATIENT ALREADY HAD LOW EJECTION FRACTION AND A LEFT VENTRICULAR ASSIST DEVICE WAS GIVEN. THE PHYSICIAN NOTED THAT THE ARTERY WAS STILL OPEN AND THERE WAS NO FURTHER PLAN TO DO ADDITIONAL STENTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS BEING MONITORED.

  Patient problems: Ventricular Tachycardia

  MAUDE report 9236623 ↗
• InjurySep 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND VESSEL OCCLUSION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY. A 3.50 X 38 MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT GOT CAUGHT IN THE LEFT MAIN AND STARTED TO UNRAVEL. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS ADVANCED OVER THE STENT AND WAS ABLE TO BE REMOVED SUCCESSFULLY. BLOOD FLOW WAS MOMENTARILY LOST IN THE LEFT MAIN BUT IT WAS ABLE TO BE RESTORED WITH THE IMPLANTATION OF ANOTHER SYNERGY DRUG-ELUTING STENT. THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Stenosis

  MAUDE report 8955508 ↗
• MalfunctionAug 2, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION SLOW AND DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER CROSSING A NON-BSC GUIDE WIRE, PRE-DILATATION WAS PERFORMED WITH A 3X30MM EMERGE BALLOON. A 3.50X38MM SYNERGY STENT WAS THEN DEPLOYED. HOWEVER, IT WAS NOTED THAT THE BALLOON DEFLATION WAS SLOW BUT WAS ABLE TO WITHDRAW THE BALLOON SYSTEM AFTER ABOUT 20 SECONDS. SUBSEQUENTLY, A 3.50X28MM SYNERGY STENT WAS THEN DEPLOYED, OVERLAPPING THE FIRST STENT ABOUT 3-4 MM. HOWEVER, BALLOON DEFLATION WAS SLOW AND ONCE IT DEFLATED, THE STENT SYSTEM COULD NOT BE REMOVED. THE TECH PULLED NEGATIVE, A COUPLE TIMES ON THE BALLOON SYSTEM AND THEN WENT TO TUG ON IT THE GUIDE DID COME INTO THE OSTIUM OF THE VESSEL A LITTLE BIT BUT EVENTUALLY IT WAS ABLE TO BE REMOVED. POST-DILATATION WAS PERFORMED WITH A 3.5 X 30 NON-BSC BALLOON AND THEN SWITCHED TO A 3.5X15 NC EMERGE BALLOON WAS ATTEMPTED BUT FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENTS. THE DEVICE WAS REMOVED AND A 3.5X15MM EMERGE BALLOON WAS ABLE TO DILATE THE PROXIMAL AREA OF 3.5X25 STENT. FURTHER DILATATION WAS PERFORMED WITH A NEW 4.0X15MM NC EMERGE BALLOON AND THE PROCEDURE WAS COMPLETED WITH GOOD FLOW AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854752 ↗
• MalfunctionJul 17, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27JUN2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.50 X 38MM SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR DILATION HOWEVER THE STENT WAS NOT ABLE TO CROSS THE LAD LESION DUE TO HIGHLY CALCIFIED ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE AND HYPOTUBE DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800641 ↗
• MalfunctionJul 5, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-JUN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.50 X 38 SYNERGY II US MR STENT WAS SELECTED FOR USE. DURING PERCUTANEOUS CORONARY INTERVENTION, IT WAS NOTED THAT THE SYNERGY US MR STENT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764625 ↗
• MalfunctionJul 3, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, DURING REMOVAL, THE BALLOON WAS STUCK INSIDE THE STENT. THE BALLOON WAS EVENTUALLY REMOVED COMPLETING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759172 ↗
• InjuryJul 1, 2019Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON DEFLATION FAILURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL OF THE RIGHT LEG BELOW THE KNEE. A 3.50 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INFLATION, THE BALLOON DID NOT BLOW UP. HIGHER PRESSURE WAS APPLIED UNTIL THE BALLOON WAS INFLATED. WHEN THE STENT WAS EXPANDED, THE BALLOON WOULD NOT DEFLATE. THE DEVICE WAS ATTEMPTED TO PULL BUT THE SHAFT BROKE ABOUT 40MM BACK FROM THE TOP OF THE BALLOON. THE BALLOON WAS POPPED AND WAS REMOVED FROM THE PATIENT'S BODY WITH A SNARE IN A PARTIALLY INFLATED STATE. THE PROCEDURE ENDED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748683 ↗
• MalfunctionJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, THE STENT CAME OFF THE BALLOON PRIOR INSERTION INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8735791 ↗