SYNERGY™ H7493926020400Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729840190), received between Nov 15, 2016 and Oct 12, 2021 — classified as 2 deaths, 9 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED FOR TREATMENT. THE BALLOON OF THE STENT DELIVERY SYSTEM (SDS) WAS INFLATED AT 11 ATMOSPHERES AND WAS DEFLATED. HOWEVER, DURING REMOVAL, IT WAS NOTED THAT THE SDS WOULD NOT RETRACT INTO THE GUIDE CATHETER DESPITE MULTIPLE INFLATION AND DEFLATION OF THE BALLOON. THE FULLY DEFLATED BALLOON DELIVERY SYSTEM AND GUIDE CATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE CATHETER AND WIRE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616522 ↗
• MalfunctionFeb 24, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT STRUTS WERE STICKING OUT. THE PROCEDURE WAS COMPLETED WITH A 3.5X22MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375721 ↗
• MalfunctionDec 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR USE BUT FAILED TO CROSS THE LESION. HOWEVER, AFTER THE ATTEMPT TO CROSS THE LESION, THE STENT WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11016219 ↗
• MalfunctionDec 15, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 20 MM SYNERGY STENT DELIVERY SYSTEM WAS USED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED AFTER CROSSING ATTEMPT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11015258 ↗
• MalfunctionDec 15, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 4.00 X 20 SYNERGY DRUG ELUTING STENT WAS LOADED ONTO THE WIRE. UPON ADVANCING THE STENT DELIVERY SYSTEM IT BECAME STUCK ON THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE DELIVERY SYSTEM COULD NOT BE ADVANCED PAST THE DISTAL END OF THE GUIDE CATHETER. THE PHYSICIAN NEEDED TO REMOVE BOTH THE STENT DELIVERY SYSTEM AND THE GUIDEWIRE FROM THE BODY AS A UNIT. A NEW GUIDEWIRE WAS ADVANCED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11014044 ↗
• MalfunctionOct 28, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 4.00 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WAS STUCK WHEN IT WAS BEING LOADED ONTO A NON-BOSTON SCIENTIFIC GUIDE WIRE. BOTH DEVICES WERE REMOVED TOGETHER FROM THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10749851 ↗
• MalfunctionSep 14, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY ADVANCING AND STENT DAMAGE OCCURRED. WHILE OUTSIDE THE PATIENT, A 4.00 X 20 SYNERGY II DRUG ELUTING STENT WAS ADVANCED THROUGH A WATCHDOG HEMOSTASIS VALVE, BUT IT WAS NOTICED THAT THE STENT HAD CRINKLED. IT WAS NOTED THAT THERE WAS RESISTANCE IN THE WATCHDOG WHILE ADVANCING THE STENT THROUGH THE TOUEY. THE STENT WAS ABLE TO ADVANCE THROUGH THE TOUEY, BUT THERE WAS TOO MUCH RESISTANCE TO ADVANCE FURTHER. THE STENT WAS PULLED BACK OUT OF THE TOUEY AND THE STENT BECAME MANGLED. IT WAS NOTED THAT THE STENT NEVER WENT INTO THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10528586 ↗
• InjurySep 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS DETACHED FROM THE INFLATABLE BALLOON. THE PHYSICIAN WAS UNABLE TO RECOVER THE STENT AND SO THE DEVICE WAS DEPLOYED IN THE SAPHENOUS VEIN GRAFT TO POSTERIOR DESCENDING ARTERY ZONE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10513866 ↗
• MalfunctionJul 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 76% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. AFTER IVUS WAS PERFORMED, THE PHYSICIAN ADVANCED DIRECTLY A 4.00 X 20MM SYNERGY DRUG-ELUTING STENT WITHOUT PRE-DILATING THE LESION. HOWEVER, DURING PROCEDURE THE BALLOON WAS NOT EXPANDING AS THE ATMOSPHERIC PRESSURE WAS GOING UP. IT WAS NOTED THEN THAT DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS THE BALLOON RUPTURED. THE STENT WAS PLACED BY USING A NON-COMPLIANT BALLOON TO FULLY EXPAND THE DEVICE AND MAKE SURE IT WAS WELL APPOSED. THE BALLOON THAT RUPTURED WAS COMPLETELY WITHDRAWN IN A FULLY DEFLATED STATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290001 ↗
• InjuryJun 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN MODERATELY TURTOUOS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS ADVANCED THROUGH ANOTHER DEPLOYED STENT, IT WOULD NOT ADVANCED. AS THE PHYSICIAN REMOVED THE DEVICE, THE STENT WAS DISLODGED ON THE PREVIOUSLY DEPLOYED STENT AND MIGRATED INTO THE AORTA. A SNARE WAS USED TO RETRIEVE THE STENT FULLY INTACT. THE PHYSICIAN DID NOT ATTEMPT TO PLACE ANOTHER STENT AFTER THAT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10148521 ↗
• MalfunctionJun 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS ADVANCED, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130578 ↗
• MalfunctionJun 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10111702 ↗
• InjuryMar 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 20MM SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE BALLOON SEPARATED AT THE CONNECTION WHERE THE WIRE EXITS THE RAPID EXCHANGE SYSTEM AND WAS DISLODGED INSIDE THE PATIENT. A SNARE WAS UTILIZED TO COMPLETELY REMOVE THE DEVICE FRAGMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Code Available

  MAUDE report 9857541 ↗
• MalfunctionMar 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 20 SYNERGY DRUG- ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9803096 ↗
• MalfunctionMar 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS REMOVED, THE STENT WAS DAMAGED AND IT WAS DAMAGED IN THE TUOHY OR BEFORE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9795087 ↗
• MalfunctionJan 30, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATION WITH A 3.0X15MM EMERGE BALLOON CATHETER AT 12 ATMOSPHERES FOR 10 SECONDS, A 4.00 X 20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED AT 16 ATMOSPHERES FOR 20 SECONDS. HOWEVER, DURING DEFLATION, THE STENT BALLOON COULD NOT DEFLATE. THE DEVICE WAS PULLED BACK INTO A 3.5 GUIDE CATHETER BUT WAS STILL UNABLE TO DEFLATE. THE SYSTEM WAS REMOVED ALTOGETHER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648411 ↗
• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 20MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE UPON INTRODUCING IT IN THE GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460140 ↗
• MalfunctionDec 10, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL BRANCH OF THE CIRCUMFLEX ARTERY. A 4.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE STENT GOT DAMAGED. THE DEVICE WAS REMOVED AND 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 9444071 ↗
• MalfunctionNov 7, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18OCT2019. IT WAS REPORTED THAT STYLET REMOVAL DIFFICULTY WAS ENCOUNTERED AND CATHETER DAMAGE OCCURRED. DURING PREPARATION OF A 4.00 X 20 SYNERGY DRUG-ELUTING STENT, THE STYLET COULD NOT BE REMOVED FROM THE DEVICE AND THE CATHETER WAS RUINED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED INNER SHAFT POLYMER EXTRUSION BREAK.

  Patient problems: No Patient Involvement

  MAUDE report 9293639 ↗
• MalfunctionSep 20, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE HAD DIFFICULTY WITHDRAWING INTO THE SHEATH. A 4.00X20 SYNERGY II DRUG ELUTING STENT AND 190CM FILTERWIRE EZ WERE SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE SAPHENOUS VEIN GRAFT (SVG) PROCEDURE. DURING THE PROCEDURE, THE FILTER WAS DEPLOYED AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS DONE. HOWEVER, THE BALLOON OF THE SYNERGY II DES STENT DELIVERY SYSTEM WAS NOT ABLE TO PULL BACK THROUGH THE SHEATH AND WAS NOT ABLE TO BE RE-SHEATH AS THERE WAS SOMETHING WRONG WITH THE DEVICE. THE FILTER WIRE AND BALLOON OF THE SYNERGY WERE THEN PULLED OUT TOGETHER AS THE BALLOON COULD NOT BE PULLED OUT BY ITSELF OVER THE FILTER WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100304 ↗
• MalfunctionJul 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVE ON BALLOON OCCURRED. THE 80% STENOSED, 12MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.00X20MM SYNERGY DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS BEING PUT DOWN THE ARTERY THE STENT SEEMED TO BE LOOSE ON THE BALLOON. IT THEN STARTED TO COME OFF SO THE PHYSICIAN DECIDED TO REMOVE THE DEVICE FROM THE BODY BEFORE THE STENT CAME OFF ALL THE WAY FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8838172 ↗
• MalfunctionJul 18, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 4.00 X 20 SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS FRAYED UPON REMOVAL FROM THE HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00X20MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8804043 ↗
• MalfunctionJul 1, 2019Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE >70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4X20MM, 3X16MM, 3X20MM SYNERGY DRUG-ELUTING STENTS WERE ADVANCED FOR TREATMENT. HOWEVER, THE STENTS STRUTS WERE FRACTURED. THE PROCEDURES WERE COMPLETED WITH ANOTHER SYNERGY STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749430 ↗
• MalfunctionJun 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00MM X 20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STRUT AT THE DISTAL END WAS BENT AND COULD NOT BE DELIVERED. 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 8668964 ↗
• InjuryFeb 19, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT INADEQUATE APPOSITION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A 6F NON-BSC GUIDE CATHETER WAS INSERTED AND A FORTE MOD WITH MARKERS GUIDE WIRE WAS ADVANCED TO THE LESION. A 4.00 X 20MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE LESION; HOWEVER, IT WAS NOTED THAT THE MID PORTION OF THE STENT WAS NOT FULLY EXPANDED. A 4.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED TO POST DILATE THE IMPLANTED STENT. HOWEVER, DURING THE FOURTH INFLATION AT 25 ATMOSPHERES AFTER 36 SECONDS, THE BALLOON RUPTURED. DURING REMOVAL, THE BALLOON HUNG UP ON THE PROXIMAL EDGE OF THE STENT. THE DEVICE WAS REMOVED TOGETHER WITH THE FORTE WIRE. ONCE OUTSIDE OF THE PATIENT, IT WAS NOTED THAT THE BALLOON RUPTURED HORIZONTALLY AND A PORTION OF THE BALLOON WAS LEFT INSIDE THE PATIENT. ON THE NEXT CONTRAST INJECTION, THERE WAS A SLIGHT HAZY APPEARANCE ON THE PROXIMAL EDGE OF THE SYNERGY DES. IT WAS SUSPECTED TO BE A PORTION OF THE BALLOON MATERIAL. A NEW 4.0X12MM SYNERGY DES WAS ADVANCED AND DEPLOYED OVERLAPPING THE PROXIMAL PORTION OF THE PREVIOUS IMPLANTED STENT. THE STENT BALLOON WAS USED FOR POST DILATION FOLLOWING DEPLOYMENT. FI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351147 ↗