SYNERGY™ XD H7493941848300Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 08714729985228), received between Dec 15, 2020 and Aug 12, 2026 — classified as 2 deaths, 9 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229880 ↗
• MalfunctionMay 11, 2026Activation Failure

  IT WAS REPORTED THAT STENT MALAPPOSITION OCCURRED. IN (B)(6) 2026, THE TARGET LESION, LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), WAS PRE-TREATED USING A SEMI COMPLIANT BALLOON AND A NON-COMPLIANT BALLOON. AFTERWARDS, THE RCA WAS FURTHER TREATED USING A 3.00 X 48MM SYNERGY XD DRUG ELUTING STENT. DURING THE PROCEDURE, STENT MALAPPOSITION OCCURRED. POST-PROCEDURE A GRADE B DISSECTION WAS NOTED, HOWEVER NO INTERVENTION WAS PERFORMED TO TREAT THE EVENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH ASPIRIN AND TICAGRELOR.

  Patient problems: Vascular Dissection

  MAUDE report 25140026 ↗
• MalfunctionJan 2, 2026Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE PACKAGE, THE STENT FLARED OFF THE BALLOON INCORRECTLY. STENT WAS NOT USED DUE TO IT NOT BEING SAFELY ON THE BALLOON IT CAME ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE STENT WAS DAMAGED ON THE BALLOON AND NOT DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946154 ↗
• MalfunctionOct 8, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT MOVED ON BALLOON OCCURRED. DURING THE PROCEDURE, A 3.00 X 48MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, PRIOR TO INFLATION, A PORTION OF THE STENT WAS RAISED FROM THE BALLOON/DISPLACEMENT FROM ITS ORIGINAL POSITION ON THE BALLOON WAS OBSERVED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246712 ↗
• InjuryJul 11, 2025Inflation Problem; Difficult to Advance; Material Deformation; Inflation Problem; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED REQUIRING SURGICAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, DELIVERING THE STENT INTO THE LESION WAS DIFFICULT AND THE BALLOON INFLATION WOULD NOT GO BEYOND 2 ATMOSPHERES. AS PHYSICIAN BEGAN RETRACTING THE STENT, WHICH REMAINED ON THE BALLOON, THE STENT ACCORDIONED NEAR THE SHEATH, SO A RADIAL CUTDOWN WAS PERFORMED TO REMOVE THE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22483407 ↗
• InjuryJun 25, 2025Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUES, REMOVAL DIFFICULTY AND DEVICE DETACHMENT OCCURRED RESULTING IN SURGERY. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED. HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED AND RETRACTED HALFWAY INTO THE CATHETER, WHILE ITS DISTAL PORTION REMAINED INFLATED. WITH THE BALLOON STILL LEFT IN THE STENT, IT WAS UNABLE TO BE COMPLETELY REMOVED. THE PATIENT TURNED VERY ISCHEMIC WHILE THE BALLOON REMAINED INFLATED. DESPITE MULTIPLE ATTEMPTS TO GO UP AND DOWN ON THE STENT BALLOON, THE ENCORE 26 INFLATION DEVICE WAS UNABLE TO ACHIEVE FULL DEFLATION. AN ATTEMPT TO USE A DOUBLE-WIRE TECHNIQUE WAS MADE TO DEFLATE THE AFFECTED PORTION OF THE BALLOON. THE DISTAL TIP OF THE STENT CATHETER WAS THEN CUT, AND A GUIDE EXTENSION WAS PLACED OVER THE CATHETER; BUT THE EXTENSION COULD NOT BE ADVANCED OUTSIDE THE GUIDE CATHETER. ADDITIONALLY, THE PHYSICIAN HELD RETRACTION ON THE STENT CATHETER AND WIRE, WHEN THE CATHETER FRACTURED DISTALLY. FOLLOWING AN ATTEMPT TO PULL THE WIRE AND THE ENTIRE COMPLEX OUT, THE WIRE CAME BACK, AND POSITION WAS LOST. WITHOUT

  Patient problems: Ischemia

  MAUDE report 22325419 ↗
• MalfunctionMay 23, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED VIA MEDWATCH MW5169412 THAT DEFLATION ISSUES AND REMOVAL DIFFICULTY OCCURRED. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS PLACED IN THE DISTAL LEFT MAIN INTO THE MID LEFT ANTERIOR DESCENDING ARTERY, OVERLAPPING WITH THE PREVIOUSLY PLACED STENT. HOWEVER, WHEN ATTEMPTING TO WITHDRAW THE STENT DELIVERY SYSTEM, THE BALLOON DID NOT FULLY DEFLATE. AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE THE BALLOON, THE GUIDE, WIRE AND BALLOON WERE CAREFULLY REMOVED AS A WHOLE UNIT FROM THE BODY. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078822 ↗
• DeathMay 6, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED, RESULTING IN PATIENT DEATH. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND PLACED IN THE PROXIMAL LAD. HOWEVER, THE DEVICE WOULD NOT DEFLATE. RE-INFLATION ATTEMPTS WERE MADE FOLLOWED BY DEFLATION ATTEMPTS, AND APPROXIMATELY 30 SECONDS TO ONE MINUTE OF WAIT TIME BEFORE ATTEMPTING TO REMOVE THE DEVICE. HOWEVER, PATIENT EXPERIENCED CHEST PAIN AND ALL EQUIPMENT WAS REMOVED. THE PATIENT WAS STABLE POST PROCEDURE WITH A NON-BOSTON SCIENTIFIC HEART PUMP IMPLANTED. UNFORTUNATELY, PATIENT DIED. IT IS UNKNOWN IF THE DEVICE OR PROCEDURE WERE A CAUSE OR CONTRIBUTION TO THE PATIENT DEATH.

  Patient problems: Chest Pain

  MAUDE report 21972325 ↗
• DeathMay 5, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED AND THE PATIENT LATER DIED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 48 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, POST DEPLOYMENT, THE BALLOON WOULD NOT DEFLATE AFTER 30-60 SECONDS. RE-INFLATION ATTEMPTS FOLLOWED BY DE-INFLATION ATTEMPTS WERE MADE. THE PATIENT EXPERIENCED CHEST PAIN AND THE DEVICE WAS REMOVED ALONG WITH THE GUIDE CATHETER AND GUIDEWIRE. THE PATIENT WAS STABLE POST PROCEDURE WITH A NON-BOSTON SCIENTIFIC HEART PUMP IMPLANTED. THE PATIENT SUBSEQUENTLY DIED OF UNKNOWN CAUSE SOMETIME DURING THE NEXT TWO DAYS.

  Patient problems: Chest Pain

  MAUDE report 21963569 ↗
• MalfunctionApr 9, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, PHYSICIAN NOTICED A KINK IN THE SHAFT OF THE STENT AND WHEN HE PULLED IT OUT, THE SHAFT BROKE. BOTH PIECES WERE REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809108 ↗
• MalfunctionApr 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. DURING PREPARATION OF A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT FELL OFF OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738631 ↗
• InjuryMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED REQUIRING A SURGICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT WAS DEPLOYED, THE BALLOON BECAME STUCK AND DETACHED FROM THE SHAFT, REMAINING IN THE RCA. THE PATIENT WAS TAKEN FOR SURGERY TO REMOVE THE BALLOON. THERE WERE NO COMPLICATIONS, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609854 ↗
• InjuryJan 29, 2025Break; Difficult to Remove; Device Dislodged or Dislocated; Break; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DETACHMENT AND REMOVAL DIFFICULTIES OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). AFTER A NON-BOSTON SCIENTIFIC GUIDE CATHETER PASSED THE OSTIUM OF THE RCA, A DISSECTION WAS NOTED IN THE PROXIMAL RCA. RIGHT AFTER THE DISSECTION WAS BALLOONED AND STENTED, A ROTAPRO AND SHOCKWAVE BALLOON WERE USED ON THE MID TO DISTAL RCA. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS THEN ADVANCED TO TREAT THE MID RCA. HOWEVER, THE STENT WAS NOTED TO BE STUCK IN THE LESION. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE, THE STENT AND STENT BALLOON SHEARED OFF FROM THE DELIVERY SYSTEM. AN ATTEMPT TO SNARE THE DETACHED PIECE, BUT THE SNARE WOULD NOT PASS THE GUIDE EXTENSION CATHETER. ANESTHESIA, INTUBATION, AND OPEN-HEART SURGERY WERE REQUIRED TO REMOVE THE DETACHED FRAGMENT. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS RECOVERED AND WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269904 ↗
• InjuryNov 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND PERFORATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AN IVUS WAS USED TO MEASURE THE DISTAL REFERENCE OF 2.5 MM, AND PRE-DILATATION WAS PERFORMED WITH A 3.0 MM SHOCKWAVE BALLOON. AFTER A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS PLACED, MULTIPLE POST-DILATATIONS WERE PERFORMED WITH A 4.0 MM, 4.5 MM AND 5.5 MM NON-BOSTON SCIENTIFIC BALLOON CATHETER. HOWEVER, DURING THE FINAL INFLATION, THE STENT SEEMED TO BE FLOATING IN THE ARTERY AND A SMALL PERFORATION WAS NOTED. IN RESPONSE TO THE PERFORATION, A COVERED STENT WAS PLACED, AND BALLOON TAMPONADE WAS APPLIED, WHICH SUCCESSFULLY DIMINISHED THE PERFORATION. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Perforation

  MAUDE report 20620902 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS CAUGHT ON SOME CALCIUM AND IT WAS NOTICED THAT THE STENT LOOKED BROKEN. THE DEVICE WAS COMPLETELY REMOVED WITH THE STENT STILL ON THE BALLOON AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928809 ↗
• MalfunctionJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING PREPARATION, THE STENT APPEARED TO BE NOT CRIMPED PROPERLY ON BALLOON. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829823 ↗
• MalfunctionJun 24, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, AFTER PULLING OUT THE STENT FROM THE CARRIER HOOP, IT UNRAVELED FROM THE STENT BALLOON, APPEARING PARTIALLY EXPANDED ON THE PROXIMAL EDGE WITH THE STENT STRUTS SLIGHTLY MANGLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594662 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON CROSSING THE LESION, THE MID SHAFT OF THE STENT WAS BROKEN. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460610 ↗
• MalfunctionMay 28, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT DIFFICULTIES IN CROSSING THE LESION WAS ENCOUNTERED. HOWEVER, WHEN PUSHING THE STENT FURTHER, THE SHAFT BROKE IN HALF OUTSIDE THE WATCHDOG DEVICE. THE DEVICE WAS PULLED OUT AND WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19406534 ↗
• MalfunctionFeb 23, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 48MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE STENT WAS REMOVED, IT CAUGHT ON CALCIUM, AND THE DISTAL PORTION OF THE STENT PULLED OFF THE DELIVERY BALLOON BUT REMAINED ON THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772370 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RE-OCCLUSION OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS DIAGONAL ARTERY. ON (B)(6) 2023, A 2.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS PLACED IN THE DIAGONAL ARTERY AND A 3.00 X 48MM SYNERGY XD DRUG ELUTING STENT WAS PLACED IN THE LAD USING A CULOTTE BIFURCATION TECHNIQUE. THE STENTS WERE POST DILATED INDIVIDUALLY AND USING A KISSING BALLOON TECHNIQUE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH CHEST PAIN AND ELEVATED TROPONINS. CARDIAC CATHETERIZATION SHOWED THAT THE 3.00 X 48MM SYNERGY XD WAS OCCLUDED. THE STENTS HAD TO BE BALLOONED TO OPEN FOR FLOW AND THE PATIENT WAS DISCHARGED TO CARDIAC REHABILITATION.

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Obstruction/Occlusion

  MAUDE report 18193598 ↗
• MalfunctionOct 16, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. A 3.00 X 48MM SYNERGY XD WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, IT WAS NOTICED THAT THE STENT BUNCHED UP ON THE DELIVERY BALLOON AND CATHETER UNDER FLOURO. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939599 ↗
• InjuryJun 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT A STENT FRACTURE AND THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH PERCUTANEOUS CORONARY INTERVENTION. THE RIGHT CORONARY ARTERY (RCA) WAS TOTALLY OCCLUDED, MILDLY TORTUOUS AND SEVERELY CALCIFIED. A 2.75 X 38 SYNERGY STENT WAS USED IN THE DISTAL RCA AND DEPLOYED AT 14ATM. THE 3.0 X 48 SYNERGY STENT WAS MOVED PROXIMAL MAKING SURE IT WAS OVERLAPPING, AND WAS DEPLOYED AT 14ATM. FINALLY, A 3.0 X 12 STENT WAS PLACED. THE STENT WAS POST DILATED USING A 3.0 X 20 NC BALLOON AT 14-20 ATM. THE WIRES AND TEMPORARY PACER WERE REMOVED. HOWEVER, AFTER A MONTH, THE PATIENT RETURNED WITH STENT THROMBOSIS. IT WAS NOTED THE 3.0 X 48 SYNERGY STENT WAS FRACTURED AT THE DISTAL PORTION, WHICH WAS CONFIRMED VIA ANGIOGRAM. THE DEVICE WAS NOT ATTEMPTED TO BE REMOVED, AND THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER STENT. THE PATIENT WAS FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17138099 ↗
• MalfunctionJun 14, 2023Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.00 X 48MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED OVER WIRE FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE DEVICE WOULD NOT CROSS THE LESION AND THE DISTAL SHAFT OF THE DELIVERY SYSTEM BENT AND THEN BROKE OUTSIDE THE PATIENT. THE DEVICE WAS PULLED OUT OVER WIRE AND WAS REMOVED INTACT. ANOTHER SYNERGY STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124958 ↗
• MalfunctionJun 6, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION PROBLEM AND REMOVAL DIFFICULTY WERE ENCOUNTERED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION OF THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND DEPLOYED SUCCESSFULLY. DURING WITHDRAWAL, THE PHYSICIAN FELT THAT THE BALLOON TOOK LONGER TO DEFLATE THAN IT SHOULD AND FELT THAT THE BALLOON WAS "STICKING". THE BALLOON WAS ATTEMPTED TO BE DEFLATED FOR 30 SECONDS AND WAS REMOVED IN A FULLY DEFLATED STATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074940 ↗