SYNERGY™ XD H7493941832300Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729981008), received between Nov 3, 2020 and Jun 11, 2026 — classified as 1 death, 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 31 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED REQUIRING ADDITIONAL INTERVENTION. IN (B)(6) 2026, THE 2.75 MM X 26 MM MAIN BRANCH OF THE BIFURCATED TARGET LESION LOCATED AT THE MID LEFT ANTERIOR DESCENDING VESSEL WAS PRETREATED WITH A 2.5 MM X 15 MM SCORING BALLOON. THE LESION WAS THEN SUCCESSFULLY TREATED WITH 3.0 MM X 32 MM SYNERGY XD STENT REACHING A MAXIMUM INFLATION PRESSURE OF 12. IN ADDITION, THE 2.75 X 15 MM SIDE BRANCH OF THE BIFURCATED TARGET LESION LOCATED AT THE 1ST DIAGONAL VESSEL WAS PRETREATED WITH A 2.0 MM X 15 MM SCORING BALLOON. THE TARGET LESION WAS THEN SUCCESSFULLY TREATED WITH A NON-BOSTON SCIENTIFIC BALLOON. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IN (B)(6) 2026, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN RESULTING IN A PROLONGED HOSPITALIZATION. THE PATIENT WAS DISCHARGED THE NEXT DAY. LATER THAT MONTH THE PATIENT HAD AN INTERVENTIONAL PROCEDURE OF RIGHT AND LEFT HEART CATHETERIZATION. THE EVENT IS CONSIDERED ONGOING.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 25472283 ↗
• MalfunctionOct 21, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0 X 32MM SYNERGY XD DES BROKE ON A NON-BOSTON SCIENTIFIC WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351402 ↗
• MalfunctionAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH MW5173116 THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX CORONARY ARTERY. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THAT STENT CAME OFF INTO THE GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926676 ↗
• MalfunctionMar 31, 2025Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT FAILED TO CROSS THE LESION, CRUSHED, AND WAS COMPLETELY OFF FROM THE STENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731048 ↗
• InjuryNov 5, 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 LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT HAD DIFFICULTY CROSSING THE LESION. THE STENT GOT CAUGHT ON THE PREVIOUS STENT IN THE DIAGONAL BRANCH, DISLODGED, AND FLOATED DOWN TO THE ILIAC. THE PHYSICIAN WAS UNABLE TO SNARE THE STENT AND A VASCULAR SURGEON WAS CALLED. THE VASCULAR SURGEON SAID WHERE THE STENT LANDED WOULD BE OKAY SO THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20610510 ↗
• DeathFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACURATE IDE STUDY: IT WAS REPORTED THAT THE PATIENT DIED. ON (B)(6) 2023, THE SUBJECT WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH CHIEF COMPLAINTS OF ACUTE CHEST PRESSURE, CONFUSION WITH ALTERED MENTAL STATUS, DIZZINESS, AND NAUSEA/EMESIS. THE SUBJECT WAS DIAGNOSED WITH INFERIOR ST ELEVATION MYOCARDIAL INFARCTION. THE SUBJECT RECEIVED 324 MG ASPIRIN AS WELL AS HEPARIN BOLUS AND WAS REFERRED FOR IMMEDIATE PERCUTANEOUS CORONARY INTERVENTION (PCI). CORONARY ANGIOGRAPHY REVEALED A 99% STENOSED OSTIUM TO PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION. OWING TO THE NEED FOR RCA INTERVENTION, DUE TO BRADYCARDIA, HYPOTENSION AND HEART BLOCK, THE SUBJECT WAS IMPLANTED WITH A TEMPORARY PACER. THE VESSEL WAS PRE-DILATED WITH A 1.50 MM NON-BOSTON SCIENTIFIC (BSC), 2.00 MM EMERGE, 2.50 MM EMERGE, 2.50 MM NC EMERGE, AND 3.00 MM NC EMERGE BALLOONS. HOWEVER, THERE WAS EXTENSIVE RECOIL OF THE BALLOONS. WITH EACH BALLOONING, THE SUBJECT BECAME PROFOUNDLY HYPOTENSIVE RESULTING IN CARDIOGENIC SHOCK WHICH REQUIRED IV EPINEPHRINE, LEVODOPA. THE SUBJECT ALSO BECAME PROFOUNDLY HYPOXIC AND UNRESPONSIVE WHICH REQUIRED TRANSIENT CHEST COMPRESSION. THE SUBJECT WAS INTUBATED IN THE CATH LAB, AND A NON-BSC HEART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695835 ↗
• MalfunctionDec 13, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT (B)(4) THAT STENT FRACTURE OCCURRED. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE STENT WAS BENT/BROKEN IN THE MIDDLE WHEN REMOVED FROM THE BOX. THE STENT WAS NOT USED ON THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323740 ↗
• MalfunctionNov 20, 2023

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION AND RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATHETERIZATION. THE SYNERGY STENT WAS BENT/BROKEN IN THE MIDDLE WHEN REMOVED FROM THE BOX. STENT NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY XD (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169088 ↗
• MalfunctionOct 13, 2023Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00MM X 32MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. THE STENT BECAME STUCK AND WOULD NOT ADVANCE. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE; THE BALLOON WAS PARTIALLY PULLED OFF. EVENTUALLY THE DEVICE WAS SNARED AND SUCCESSFULLY REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936501 ↗
• MalfunctionAug 29, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. A 3.00 X 32MM SYNERGY XD DRUG -ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE PACKAGE WAS OPENED AND INSPECTED, GRIT ON THE CATHETER WAS NOTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644077 ↗
• MalfunctionApr 11, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT STENT UNABLE TO LOAD THE GUIDEWIRE. A 3.00 X 32MM SYNERGY XD STENT WAS SELECTED FOR USE. HOWEVER, DURING INSERTION THE DEVICE FAILED TO LOAD THE 0.014 GUIDEWIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW 3.0X32 SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE DETACHMENT AND STENT WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714658 ↗
• MalfunctionJan 9, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE DEVICE FAILED TO CROSS THE LESION AND THE HYPOTUBE DISCONNECTED FROM THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125217 ↗
• MalfunctionDec 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT STENT NARROWING OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. BED PREPARATION WAS PERFORMED WITH AN OPTICROSS IMAGING CATHETER, A 3.0 NON-BOSTON SCIENTIFIC INTRAVASCULAR LITHOTRIPSY CATHETER, AND A 3.0 NONCOMPLIANT (NC) BALLOON CATHETER WHICH WERE EACH ADVANCED INTO THE LESION WITHOUT ANY ISSUES. A 3.00 X 32MM SYNERGY XD DRUG ELUTING-STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, A NARROWING IN THE MID PART OF THE STENT WAS NOTED. THE STENT WAS POST-DILATED WITH A 3.0 NC EMERGE BALLOON, HOWEVER, THE LESION WAS STILL PRESENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039854 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING CROSSING THE LESION, THE PROXIMAL PART OF THE STENT SHAFT TOWARDS THE HUB OF THE CATHETER WAS BROKEN. THE DEVICE WAS REMOVED INTACT, AND NO FRAGMENTS LEFT INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00 X 32MM SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931216 ↗
• MalfunctionOct 19, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY (CT) TURN DOWN COMPLEX MULTIVESSEL PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. DURING WITHDRAWAL, THE STENT WAS DISLODGED OFF THE BALLOON IN THE RADIAL ARTERY AND THE ENTIRE SYSTEM WAS PULLED FROM RADIAL ACCESS. THE PATIENT FELT DISCOMFORT AND PAIN. EVENTUALLY, A 2.5 X 24 SYNERGY XD/ 3.0 X 38 SYNERGY XD AND A 4.5 X 16 SYNERGY XD DES WERE USED TO TREAT MULTIVESSEL DISEASE AND THE PROCEDURE WAS COMPLETED WITH A 3.0 X 38 SYNERGY XD DES. THE PATIENT WAS DOING WELL AND FULLY RECOVERED POST-PROCEDURE.

  Patient problems: Discomfort; Pain

  MAUDE report 15631616 ↗
• MalfunctionSep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT ON THE BALLOON OCCURRED. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON HALFWAY. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366046 ↗
• MalfunctionJun 7, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-MAY-2022. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE PHYSICIAN CONNECTED THE INFLATION DEVICE AND PULLED NEGATIVE. SUBSEQUENTLY, PROCEEDED TO INFLATE THE BALLOON AT 11 ATMOSPHERES FOR 15 SECONDS AND NOTICED THE BALLOON AND/OR THE STENT WAS NOT INFLATED. HE THEN DIALED DOWN THE INFLATION TO 0 AND PULLED NEGATIVE ON THE STENT DELIVERY SYSTEM AND CONFIRMED THAT THERE WAS CONTRAST IN THE INFLATION DEVICE UNDER FLUOROSCOPY. UPON CONFIRMATION, TRIED TO INFLATE THE STENT BALLOON AGAIN AND STILL WOULD NOT INFLATE. WHEN THE PHYSICIAN PULLED NEGATIVE, THERE WAS SOME BLOOD COMING BACK INTO THE INFLATION DEVICE. HE THEN REMOVED THE STENT DELIVERY SYSTEM FROM THE BODY AND THE STENT WAS INTACT ON THE DELIVERY DEVICE. ANGIOGRAM WAS PERFORMED TO CHECK THE RCA AND THE PROCEDURE WAS COMPLETED WITH A 3,00X32 SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14623790 ↗
• MalfunctionMay 12, 2022Contamination; Difficult to Open or Remove Packaging Material; Contamination; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH# (B)(4) THAT DEVICE CONTAMINATION OCCURRED. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING THE OPENING OF THE PACKAGE IT WAS NOT RIPPED DOWN THE ONE SIDE ALL THE WAY. THE DEVICE WAS CAUGHT IN THE PACKAGING AND THE STENT WAS DROPPED AND CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379348 ↗
• InjuryMar 17, 2022Material Rupture; Defective Device; Device Dislodged or Dislocated; Material Integrity Problem; Material Rupture; Defective Device; Device Dislodged or Dislocated; Material Integrity Problem

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AND THE PATIENT EXPERIENCED VASOSPASMS AND PAIN. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS DELIVERED IN THE NORMAL MANNER WITH NO ISSUES. WHEN THE PHYSICIAN STARTED TO DIAL PRESSURE ON THE INDEFLATOR AND GOT TO 11-12 ATMOSPHERES, NO CONTRAST COULD BE SEEN ON FLUOROSCOPY. THE PHYSICIAN PULLED NEGATIVE AND TRIED TO RE-INFLATE BUT WAS UNSUCCESSFUL AND IT WAS NOTICED THAT THERE WAS BLOOD IN THE INDEFLATOR. IT WAS UNKNOWN IF THE BALLOON HAD RUPTURED OR IF THERE WAS A HOLE IN THE SHAFT. THE DEVICE WAS PULLED BACK OUT OF THE CORONARY ARTERY AND HALFWAY INTO ANOTHER MANUFACTURERS 6FR EBU 3.75 GUIDE CATHETER. AFTERWARDS THE GUIDE CATHETER, GUIDEWIRE AND THE STENT WERE PULLED BACK INTO THE RADIAL ARTERY. HOWEVER, THE STENT CAME OFF THE BALLOON AND HAD TO BE SNARED AND REMOVED FROM THE RADIAL ARTERY THROUGH THE RADIAL SHEATH. AT THIS TIME THAT PATIENT EXPERIENCED RADIAL ARTERY VASCOSPASMS AND PAIN IN THEIR RIGHT ARM. THE PHYSICIAN WAS UNABLE TO COMPLETELY RETRIEVE THE DEVICE. THE ST

  Patient problems: Discomfort; Pain; Vasoconstriction

  MAUDE report 13802944 ↗
• InjuryNov 17, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 80% IN STENT STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. AN ATTEMPT WAS MADE TO USE A DIFFERENT BRAND STENT BUT IT ALSO FAILED TO CROSS THE LESION. WHEN THE SECOND STENT WAS REMOVED, IT WAS NOTED THAT THE FIRST STENT, THE SYNERGY XD, HAD CAME OFF THE BALLOON AND WAS STUCK IN THE LEFT MAIN ARTERY. IT TOOK THREE HOURS BUT THE STENT WAS FINALLY SNARED OUT OF THE LEFT MAIN. THE PATIENT WAS STABLE THE ENTIRE TIME. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831413 ↗
• MalfunctionOct 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT LEFT HEART PERCUTANEOUS CORONARY INTERVENTION. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, DURING THE INITIAL INFLATION TO DEPLOY THE STENT, THE BALLOON OF THE STENT DELIVERY SYSTEM RUPTURED. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-COMPLIANT BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657985 ↗
• MalfunctionSep 9, 2021Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. DURING INTRODUCTION OF A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT, THE STENT FELL OFF FROM THE DELIVERY SYSTEM. THE STENT GOT CAUGHT INTO CO PILOT AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451548 ↗
• InjuryAug 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON IN THE LEFT MAIN. A 6F NON- BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS USED TO REMOVE THE DISLODGED STENT. DURING REMOVAL OF THE STENT, THE INITIAL WIRING WAS THREADED THROUGH A STRUT ON THE LEFT CIRCUMFLEX STENT (LCX) AND RESULTED IN THE UNINTENDED REMOVAL OF THE LCX STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367804 ↗
• InjuryJul 9, 2021Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. FOLLOWING DEPLOYMENT OF A 3.00 X 16MM SYNERGY XD DRUG ELUTING STENT IN THE OSTIAL CIRCUMFLEX ARTERY, A 3.00 X 32MM SYNERGY XD STENT WAS INTRODUCED. THE 3.00 X 32 STENT EMBOLIZED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND BECAME ENTANGLED IN THE 3.00 X 16MM STENT AND WHEN THE EMBOLIZED STENT WAS REMOVED, BOTH STENTS CAME OUT TOGETHER. THE LAD WAS PRE-DILATED. TWO SYNERGY XD STENTS WERE IMPLANTED OVERLAPPING IN THE MID AND PROXIMAL LAD AND ANOTHER SYNERGY XD STENT WAS IMPLANTED IN THE OSTIAL CIRCUMFLEX TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142840 ↗
• MalfunctionMay 13, 2021Entrapment of Device; Difficult to Advance; Material Deformation; Entrapment of Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 3.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, THE STENT WOULD NOT MOVE OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE STRUT WAS BENT AND THE DEVICE WAS NOT STUCK ON WIRE AS WHAT WAS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822630 ↗