SYNERGY™ XD H7493941848250Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729985204), received between Apr 29, 2021 and Apr 1, 2026 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 2.50 X 48 MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. WHEN THE BALLOON PROTECTOR WAS REMOVED, THE STENT CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758531 ↗
• InjuryAug 5, 2025Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED FAILURE TO DEFLATE, DIFFICULT TO REMOVE, AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX ARTERY, EXTENDING TOWARD THE SECOND OBTUSE MARGINAL (OM) BRANCH. A 2.50 X 48 MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED AT THE INTENDED LESION SITE USING A 6FR GUIDE CATHETER. THE STENT WAS INFLATED TO 11 ATMOSPHERES AND HELD FOR 15 SECONDS. FOLLOWING DEPLOYMENT, THE BALLOON FAILED TO DEFLATE PROPERLY. THE PHYSICIAN WAITED FOR BALLOON DEFLATION BEFORE ATTEMPTING DEVICE WITHDRAWAL. UPON WITHDRAWAL, THE BALLOON BECAME STUCK ON THE DEPLOYED STENT. WHEN ADDITIONAL TRACTION WAS APPLIED, THE DELIVERY SYSTEM SHAFT BROKE. THE BROKEN PORTION OF THE SHAFT WAS RETRIEVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE PATIENT EXPIRED PRIOR TO HOSPITAL DISCHARGE DUE TO A PULMONARY EMBOLISM (PE) ARREST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722796 ↗
• MalfunctionJul 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A STENT ISSUE OCCURRED. A 2.50 X 48MM SYNERGY? XD DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, PRIOR TO ADVANCING THE STENT ONTO THE GUIDEWIRE, IT WAS NOTED THAT THE STENT STRUTS WERE EXPANDED AT THE DISTAL EDGE OF THE STENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22599272 ↗
• MalfunctionApr 17, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 48MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT PASS THROUGH THE LESION. HOWEVER, UPON INSERTION, IT WAS NOTICED THAT THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859051 ↗
• MalfunctionMar 10, 2025Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13FEB2025. IT WAS REPORTED THAT INFLATION ISSUE OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT HOWEVER, WHEN THE PHYSICIAN TRIED TO DEPLOY THE STENT, THE STENT WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE BODY WITH THE STENT STILL INTACT ONTO THE BALLOON. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT OUTER LUMEN OF SHAFT POLYMER EXTRUSION HAD A TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560619 ↗
• InjuryOct 10, 2024Material Rupture; Material Deformation; Activation Failure; Material Rupture; Material Deformation; Activation Failure

  IT WAS REPORTED THAT BALLOON RUPTURE AND STENT INSUFFICIENT APPOSITION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT AND SUCCESSFULLY DELIVERED. HOWEVER, DURING THE INITIAL INFLATION USING A NON-BOSTON SCIENTIFIC INDEFLATOR AT FEW ATMOSPHERES FOR 20 TO 30 SECONDS, THE BALLOON WAS NOT HOLDING THE PRESSURE AND LEAKING CONTINUOUSLY. IT WAS POSSIBLE TO CONTINUE INFLATING UNTIL THE STENT MESH WAS EXPANDED ENOUGH FOR DEPLOYMENT. THE STENT DELIVERY SYSTEM WAS REMOVED, AND SHAFT KINK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL DILATATIONS USING AN NC EMERGE BALLOON CATHETER TO FULLY EXPAND AND APPOSE THE STENT MESH WITHOUT ANY FURTHER ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417961 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE MID-SHAFT OF THE HYPOTUBE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498644 ↗
• MalfunctionMay 28, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED. DURING PREPARATION, IT WAS OPENED, AND WHEN THE STENT WAS REMOVED FROM THE HOOP, THE STYLET GOT CAUGHT, ALONG WITH THE STENT STRUT, AS IT PULLED OR STRETCHED THE STENT AWAY FROM THE BALLOON. THE ATTACHED MEDIA ALSO INDICATED THAT THE STENT WAS STRETCHED, LIFTED, AND MOVED FROM THE BALLOON WHILE INSIDE THE POUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19406804 ↗
• MalfunctionApr 11, 2024Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. UPON REMOVAL OF A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT FROM THE BOX, THE DEVICE DROPPED, AND IT SNAGGED ON THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088417 ↗
• InjuryFeb 22, 2024Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED, THE DEVICE WAS UNRETRIEVED REQUIRING ADDITIONAL SURGERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50 X 48MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT TOGETHER WITH A NON-BSC GUIDE CATHETER. HOWEVER, UPON INSERTING THE SECOND 2.5 X 48MM SYNERGY, THE PHYSICIAN WAS USING A NON-BSC GUIDE CATHETER TO HELP ADVANCE THE STENTS, IT WAS NOTED THE SECOND STENT WAS NOT POSITIONED AS EXPECTED. UPON REPOSITIONING, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, IT WAS NOTED THE BALLOON WAS NOT INFLATING. A SECOND INDEFLATOR WAS OPENED AND UPON TRYING TO DEPLOY THE STENT AGAIN, IT WAS NOTED THE BALLOON WAS NOT INFLATING AND BLOOD WAS COMING BACK INTO THE INDEFLATOR. FLUOROSCOPY CONFIRMED THE STENT WAS NOT DEPLOYED AND THE NON-BSC GUIDE CATHETER WAS ADVANCED OVER THE PROXIMAL PORTION OF THE STENT TO RETRIEVE. UPON TRYING TO RETRIEVE THE STENT, THE HYPOTUBE AND SHAFT BROKE LEAVING THE STENT DEPLOYMENT SYSTEM WITH BALLOON IN THE PATIENTS LAD. IT WAS NOT ATTEMPTED TO SNARE THE SYSTEM OUT, INSTEAD IT WAS LEFT IN THE PATIENT AND TRANSFERAL OF

  Patient problems: Foreign Body In Patient

  MAUDE report 18763746 ↗
• MalfunctionDec 13, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO TRACK THE LESION. HOWEVER, THE STENT BALLOON GOT STUCK AND COULD NOT BE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323755 ↗
• MalfunctionNov 30, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 2.50 X 48MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT FAILED TO CROSS THE LESION AND HUNG UP ON THE GUIDE DURING REMOVAL. THE DEVICE WAS SUCCESSFULLY REMOVED INTACT, AND THE STENT MESH WAS FOUND TO BE STRETCHED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY XD. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237250 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, WHEN ATTEMPTED TO PASS THROUGH THE GUIDE CATHETER, THE SHAFT SNAPPED INTO TWO PIECES. THE BROKEN PIECES WERE RETRIEVED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039564 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING THE CATHETER THROUGH THE GUIDE, IT WAS OBSERVED THAT THE MIDDLE OF THE SHAFT BROKE. BOTH PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703981 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE PREPARING, THE STENT SHAFT BROKE OUTSIDE OF THE PATIENT'S BODY. ANOTHER SYNERGY DRUG-ELUTING STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381317 ↗
• MalfunctionApr 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT LEFT HEART CATHETERIZATION (LHC). A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED AT 4-6 ATMOSPHERES. THE STENT WAS THEN REMOVED UNDEPLOYED AND WAS STILL ON THE STENT BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE STENOSED TARGET LESION WAS 90%, LOCATED IN THE NON-TORTUOUS AND MODERATE TO SEVERELY CALCIFIED MID AND DISTAL LEFT ANTERIOR DESCENDING ARTERY. INITIAL INFLATION WAS ATTEMPTED BUT THE BALLOON RUPTURED BEFORE THE STENT WAS EVEN ABLE TO BE EXPANDED. THE DEVICE WAS REMOVED FROM THE BODY AND THE STENT WAS STILL WRAPPED ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707651 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE STENT WAS NOTICED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457762 ↗
• MalfunctionAug 22, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NOT VERY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED INTACT, AND UPON SECOND ATTEMPT TO CROSS THE DEVICE TO THE LESION, THE DEVICE FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED A 2.25 X 28 SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266103 ↗
• MalfunctionAug 12, 2022Break; Device Difficult to Setup or Prepare; Material Deformation; Break; Device Difficult to Setup or Prepare; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE PHYSICIAN FELT IT WAS CHALLENGING TO REMOVE IT FROM THE SLEEVE. WHEN THE DEVICE WAS PULLED FROM THE RING, THE END OF THE STENT CATHETER BENT AND BROKE OFF. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218344 ↗
• MalfunctionJun 13, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE AND WAS PREPARED TO LOAD ON THE WIRE. HOWEVER, UPON INSPECTION, IT WAS NOTICED THAT THE STENT LOOKED DAMAGED. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 2.75 X 48 SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681279 ↗
• MalfunctionApr 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STRUTS OF THE STENT WERE DAMAGED DUE TO CALCIFICATION OF THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079479 ↗
• MalfunctionMar 15, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10MAR2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. FOLLOWING PRE-DILATION WITH AN NC QUANTUM APEX BALLOON, A 2.5X48MM SYNERGY XD DRUG ELUTING STENT WAS INTRODUCED FOR TREATMENT. THE DEVICE WAS UNABLE TO CROSS THE TARGET LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776493 ↗
• InjuryMar 3, 2022Fracture; Obstruction of Flow; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT STENT FRACTURE AND STENT THROMBOSIS OCCURRED; PATIENT EXPERIENCED ARRHYTHMIA. THE PATIENT PRESENTED WITH CHEST PAIN THROUGH EMERGENCY ROOM. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, DISEASE IN MIDDLE AND DISTAL, PROXIMAL CIRCUMFLEX (CX), AND CHRONIC TOTALLY OCCLUDED OBTUSE MARGINAL OF CX. RIGHT CORONARY ARTERY WAS PATENT WITH DISTAL FOCAL LESION WHICH ALSO GAVE COLLATERAL TO LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN PLACED 2.50 X 48MM SYNERGY XD STENTS IN PROXIMAL, MID, AND DISTAL LAD AND COMPLETED THE PROCEDURE. THE PATIENT CAME BACK WITHIN A TWO-HOUR WINDOW FOR STENT THROMBOSIS (ST) IN PROXIMAL LAD, WAS OCCLUDED. THE 48MM SYNERGY STENT WAS ALSO FRACTURED AT PROXIMAL PORTION AND THE PATIENT EXPERIENCED ARRHYTHMIA. THE PHYSICIAN THEN BALLOONED THE PROXIMAL, MID, AND DISTAL LAD. WENT IN WITH NON-BOSTON SCIENTIFIC CATHETER, PATIENT CODED WHILE IN ROOM AND ON TABLE DURING PROCEDURE. THE PATIENT WAS STARTED ON AGGRESTAT FOR CLOT. ANGIOMAX WAS GOING PRIOR TO INTERVENTIONAL WIRE BEING INTRODUCED. ENDED UP USING A 2.50 X 48 STENT IN BETWEEN THE MID AND DISTAL STENTS TO COVER.

  Patient problems: Arrhythmia; Thrombosis/Thrombus

  MAUDE report 13664849 ↗
• MalfunctionFeb 2, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JAN2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND COMPLEX VESSEL. A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13426508 ↗
• InjuryJan 19, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL, SHAFT BREAK, AND PERFORATION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 2.50 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS PLACED IN THE MID RCA. HOWEVER, THE STENT BALLOON WOULD NOT PULL BACK. THE PHYSICIAN TRIED TO REMOVE THE BALLOON BUT THE SHAFT BROKE 25CM FROM THE HYPOTUBE AT THE FLEXIBLE DISTAL PORTION. A BALLOON WAS PLACED DISTAL TO THE BROKEN SHAFT, INFLATED AND DRAGGED THE BROKEN DEVICE BACK INTO THE GUIDE. FURTHERMORE, A PERFORATION WAS NOTED AT THE MID RCA. THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED CHEST PAIN. THE PERFORATION WAS TREATED WITH BALLOON TAMPONADE. THE PROCEDURE WAS PROLONGED BUT WAS ABLE TO BE COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT BUT THEY WERE COMPLICATIONS WERE REPORTED.

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 13295492 ↗