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SYNERGY™ XD H7493941812220Recalls & reported problems

Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant

All models of SYNERGY XD (65)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
21
Deaths reported
1
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729980711), received between Nov 25, 2020 and May 1, 2026 — classified as 1 death, 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Advance10
  • Break7
  • Device Dislodged or Dislocated6
  • Difficult to Advance3
  • Material Deformation3
  • Adverse Event Without Identified Device or Use Problem2
  • Defective Device1
  • Nonstandard Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14
  • Chest Pain2
  • Foreign Body In Patient2
  • Cardiac Arrest1
  • Low Blood Pressure/ Hypotension1
  • No Consequences Or Impact To Patient1
  • Non specific EKG/ECG Changes1
  • Thrombosis1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 1, 2026Break; Difficult to Advance

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 2.25 X 12MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PHYSICIAN HAD DIFFICULTY TO NEGOTIATE THE BEND OF THE LESION AND NOTICED THAT THE HYPOTUBE WAS BROKEN. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25061017 ↗
  • MalfunctionMar 3, 2026Break; Nonstandard Device; Difficult to Advance

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE AND UNDERWENT CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN STATED THAT THE LESION WAS VERY DIFFICULT TO PREPARE. A 2.25 X 32 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE STENT FELT AS THOUGH IT WAS GETTING HUNG UP IN THE 6F GUIDEZILLA GUIDE EXTENSION CATHETER, AND THE STENT WAS UNABLE TO BE ADVANCED. ALL ACCESS WAS LOST AS THE STENT, THE GUIDEZILLA, AND THE GUIDEWIRE ALL CAME OUT TOGETHER. A NEW 2.25 X 12M SYNERGY XD DES WAS USED; BUT THE STENT WAS ALSO DIFFICULT TO ADVANCE AND ENDED UP BREAKING IN THE GUIDE. BOTH STENTS WERE REMOVED AND NO FOREIGN MATERIAL REMAINED IN THE PATIENT. THE LESION WAS FURTHER PREPPED, AND ANOTHER STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24496019 ↗
  • InjuryOct 29, 2025Failure to Advance; Failure to Advance

    IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED RESULTING IN PATIENT IMPACT. A 2.25 X 12 MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. SUBSEQUENTLY, THE PATIENT WAS OBSERVED TO HAVE BECOME HYPOTENSIVE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT.

    Patient problems: Low Blood Pressure/ Hypotension

    MAUDE report 23417256 ↗
  • MalfunctionOct 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT CAME OFF OF THE BALLOON BEFORE PLACING IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND PATIENT WAS IN GOOD CONDITION AND REMAINED STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23238958 ↗
  • MalfunctionOct 16, 2024Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 70-90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS VESSEL. FOLLOWING PRE-DILATION, A 2.25 X 12 MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED THROUGH A WATCHDOG HEMOSTASIS VALVE TO TREAT THE TARGET LESION. TORTUOSITY KEPT PUSHING ON THE STENT AND DAMAGED THE STRUTS. WHEN THE STENT WAS REMOVED, THE STRUTS STUCK IN THE WATCHDOG AND THE STENT FELL OFF THE DELIVERY SYSTEM. THE PROCEDURE WAS NOT COMPLETED BECAUSE OF THE PATIENT ANATOMY. THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20462218 ↗
  • InjuryJun 10, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. USING A CLS3.5 GUIDE CATHETER, A LUGE WIRE WAS PLACED IN THE LEFT CIRCUMFLEX ARTERY (LCX). ANGIOPLASTY WAS PERFORMED WITH A 2.5 X 12 BALLOON WITH MULTIPLE INFLATIONS FROM 6 ATMOSPHERES (ATM) UP TO 14 ATM. A SAMURAI WIRE WAS ALSO PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY AS A PRECAUTION. A 2.25 X 38 SYNERGY DRUG-ELUTING STENT (DES) WAS DEPLOYED AT 16 ATM FOR 20 SECONDS; AND ANOTHER UNSPECIFIED 2.50 X 20 STENT WAS DEPLOYED INTO THE LEFT MAIN IN THE LCX AT 18 ATM FOR 20 SECONDS. POST-DEPLOYMENT, ANGIOGRAM WAS PERFORMED WHICH SHOWED THAT THERE WAS A GAP BETWEEN TWO STENTS. A 2.25 X 16MM SYNERGY XD DES WAS THEN ADVANCED BUT FAILED TO CROSS THE LESION AND WAS DAMAGED, SO THE STENT WAS REMOVED. A 2.25 X 12MM SYNERGY XD DES WAS ALSO ADVANCED BUT STILL FAILED TO CROSS THE LESION. A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE EXTENSION CATHETER WAS THEN INTRODUCED; BUT AS THE 2.25 X 12MM STENT WAS REMOVED, IT WAS NOTED THAT THE STENT WAS LEFT IN THE LCX AREA. SINCE STENT WAS STILL ON THE WIRE, A 1.20 BALLOON WAS ADVANCED AND INFLATED DISTAL TO T

    Patient problems: Foreign Body In Patient

    MAUDE report 19498783 ↗
  • DeathMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. SIX SYNERGY XD DRUG ELUTING STENTS WERE IMPLANTED, A 2.25MM X 12MM, A 2.75MM X 12MM, A 3.00 X 16MM, A 3.00MM X 38MM, A 3.5MM X 28MM AND A 3.5MM X 48MM, WITH NO VISIBLE EDGE DISSECTIONS. TWENTY MINUTES AFTER ARRIVING IN THE RECOVERY UNIT, THE PATIENT COMPLAINED ABOUT CHEST PAIN AND DEVELOPED ST SEGMENT ELEVATION. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETERIZATION LABORATORY AND THE STENTS IN BOTH THE LAD AND LCX WERE THROMBOSED. THROMBECTOMY WAS PERFORMED IN AN ATTEMPT TO RE-OPEN THE ARTERIES. THE PATIENT CODED FOR SIXTY MINUTES AND EXPIRED.

    Patient problems: Cardiac Arrest; Chest Pain; Non specific EKG/ECG Changes; Thrombosis/Thrombus

    MAUDE report 19368007 ↗
  • MalfunctionFeb 15, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-JAN-2024. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS ARTERY. A 2.25 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED INTO THE LESION BUT FAILED TO CROSS. THE DEVICE WAS REMOVED , AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT METHOD. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT MOVED ON BALLOON.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18717601 ↗
  • MalfunctionSep 29, 2023Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING THE PROCEDURE, A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT PASS THOUGH THE LESION. HOWEVER, UPON ADVANCING THE STENT INTO THE PATIENT, IT WAS NOTICED THAT THE STENT WAS BROKEN. NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17843192 ↗
  • InjurySep 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED, REQUIRING SURGICAL INTERVENTION WITH PROLONGED HOSPITALIZATION. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN VESSEL. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. UPON ATTEMPTING TO ADVANCE THE STENT, THE STENT COMPLETELY CAME OFF FROM THE BALLOON AND DISLODGEMENT OCCURRED. A SNARE WAS USED, HOWEVER; IT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO A TERTIARY FACILITY AND UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. THERE WAS NO FURTHER INFORMATION AVAILABLE TO CONFIRM IF THE STENT WAS RETRIEVED. THE PATIENT WAS IN A FULLY RECOVERED STATE.

    Patient problems: Foreign Body In Patient

    MAUDE report 17703259 ↗
  • MalfunctionFeb 22, 2023Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT MAIN AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE CROSSING THE LESION, THE STENT SHAFT BROKE AT APPROXIMATELY 15CM FROM THE HUB. THE DEVICE WAS PULLED OUT INTACT, THEN BROKE COMPLETELY OUTSIDE OF PATIENT'S BODY. ANOTHER 2.25 X 12MM SYNERGY DES WAS USED AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16418333 ↗
  • InjuryJan 26, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN PLACING THE DEVICE IN THE LAD, THE STENT SLIPPED OFF THE BALLOON PROXIMAL TO THE LESION. SUBSEQUENTLY, THE DISLODGED STENT WAS INFLATED AND DEPLOYED IN PLACE. ANOTHER STENT WAS ADVANCED TO TREAT THE LESION BUT FAILED TO CROSS. THE PHYSICIAN DECIDED TO ADVANCE A NON-BOSTON SCIENTIFIC STENT AND WAS DEPLOYED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS INITIALLY UNABLE TO CROSS THE LESION. THERE WAS NO PRE-DILATATION DONE IN THE CIRCUMFLEX OR OBTUSE MARGINAL (OM). IT APPEARED CALCIFIED OSTIAL CIRCUMFLEX BUT STILL GOING TO STENT THE OBTUSE MARGINAL 1 (OM1). THE STENT CROSSED THE CIRCUMFLEX INTO OM1 BUT COULD NOT CROSS INITIALLY WITH SYNERGY STENT OVER NON-BOSTON SCIENTIFIC WIRE. WHEN PULLING THE STENT BACK, IT CAME OFF THE BALLOON OF THE STENT DELIVERY

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16246802 ↗
  • InjuryJan 20, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE STENT DETACHMENT OCCURRED. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND HAD DIFFICULTY CROSSING THE LESION. HOWEVER, THE STENT CAME OFF OF SYSTEM PRIOR TO DEPLOYING OR NEGATIVE. ALL BEFORE THE LESION. THE PHYSICIAN BALLOONED THE STENT TO STAY IN CORONARY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. DURING INSERTION OF THE DEVICE THE STENT CAME OFF INSIDE THE PATIENT. THE DEVICE STAY IN THE CORONARY AND 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 16216393 ↗
  • MalfunctionOct 18, 2022Defective Device; Defective Device

    IT WAS REPORTED THAT A STENT PROFILE ISSUE OCCURRED. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. THE 90% STENOSED TARGET LESION WITH A BEND OF >45 DEGREES WAS MILDLY TORTUOUS AND HEAVILY CALCIFIED IN MIDDLE TO DISTAL RIGHT CORONARY ARTERY. FOLLOWING PRE DILATION WITH 2.25 X 12 EMERGE AND A 2.5 X 12 EMERGE BALLOON CATHETER, A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE SIZE OF THE DEVICE WAS THE SAME AS THE SIZE OF THE LESION. THE DEVICE WAS ADVANCED AND PUSH A LITTLE BIT DOWN TO THE LESION. THE PLAQUE WAS A MIXTURE OF FIBROTIC AND CALCIFICATION WHICH WAS VISIBLE UNDER FLUOROSCOPY BEFORE CONTRAST. TO AVOID HARMING THE VESSEL, THE PHYSICIAN DECIDED TO LET THE STENT ENDOTHELIALIZE AND COME BACK ANOTHER TIME TO TREAT THE CALCIUM AND PLANT ANOTHER STENT NEXT TO THE 2.25 X 12MM WHICH HAD JUST BEEN IMPLANTED AND WAS UNDERSIZED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15621096 ↗
  • MalfunctionJul 14, 2022Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE MID SHAFT BROKE WHILE INSIDE THE GUIDE CATHETER. THE DEVICE WAS PULLED OUT AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15016923 ↗
  • InjuryMay 31, 2022Failure to Advance; Failure to Advance

    IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED CORONARY ARTERY. TWO SYNERGY XD DRUG-ELUTING STENTS, A 2.25 X 12MM AND A 2.25 X 28MM, WERE ADVANCED FOR TREATMENT. THE DEVICES HAD DIFFICULTY CROSSING THE LESION AND DISSECTION OCCURRED. THE PATIENT WAS FLOWN OUT FOR CORONARY ARTERY BYPASS GRAFT SURGERY.

    Patient problems: Vascular Dissection

    MAUDE report 14552233 ↗
  • MalfunctionAug 23, 2021Break; Failure to Advance; Break; Failure to Advance

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED CIRCUMFLEX ARTERY. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS RECENTLY DEPLOYED PROXIMAL STENT. THE PHYSICIAN PUSHED AND PUSHED UNTIL THE HYPOTUBE OF THE DELIVERY SYSTEM FRACTURED. ALL OF THE DEVICE COMPONENTS WERE REMOVED WITHOUT ISSUE. THE PHYSICIAN ELECTED TO STOP THE PROCEDURE AFTER FRACTURE AND END THE CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12356910 ↗
  • MalfunctionJul 3, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS THE LESION. THE STENT WAS OBSERVED TO BE DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12114111 ↗
  • MalfunctionMar 29, 2021Break; Break

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. WHILE A 2.25 X 12MM SYNERGY XD DRUG ELUTING STENT WAS BEING ADVANCED TO CROSS A CALCIFIED LESION, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE 70% STENOSED AND SEVERELY CALCIFIED ARTERY. IT WAS NOTED THAT THE BREAK WAS 3-5 CM FROM THE HUB AND WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY MANUALLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11583090 ↗
  • MalfunctionDec 7, 2020Difficult to Advance; Difficult to Advance

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 27 NOV 2020. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ATTEMPTED TO BE DELIVERED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE BUT THE GUIDEWIRE DID NOT EXIT THE GUIDEWIRE PORT ON THE MONORAIL PORTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10960526 ↗
  • InjuryNov 25, 2020Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THAT STENT THROMBOSIS AND CHEST PAIN OCCURRED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL BRANCH. A 2.25 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND SUCCESFULLY IMPLANTED. HOWEVER, 2 HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. STENT THROMBOSIS WAS NOTED IN THE DIAGONAL BRANCH. INTRAVASCULAR ULTRASOUND SHOWED THE VESSEL WAS 3.25MM. A 3.0 NON-COMPLIANT BALLOON CATHETER WAS USED TO OPEN THE VESSEL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FULLY RECOVERED.

    Patient problems: Chest Pain; Thrombosis

    MAUDE report 10901906 ↗

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