SYNERGY™ XD H7493941838300Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729981015), received between Dec 23, 2020 and Sep 22, 2026 — classified as 3 deaths, 15 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a grade C dissection occurred. The 3.0 mm x 36 mm target lesion located at the mid right coronary artery (mid RCA) was pretreated with a 3.0 x 15 mm non-compliant balloon angioplasty catheter resulting in 40% stenosis and TIMI flow 3. The target lesion was then treated with the 3.0 mm x 38 mm Synergy XD stent. During the stent placement a stent edge dissection caused by the stent placement occurred. The dissection was a type C that extended into the distal RCA and required placement of two stents to resolve the issue. The event was resolved and the patient discharged.

  Patient problems: Vascular Dissection

  MAUDE report 50860042 ↗
• MalfunctionApr 17, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 6F NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS PLACED AND A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS OBSERVED THAT THE STENT SHEARED OFF THE BALLOON AND WAS FOUND INSIDE THE GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915999 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE STENT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294342 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN (LM). A 3.00 X 38 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT DURING A PROCEDURE. HOWEVER, A PART OF THE STENT BROKE OFF WHILE BEING UTILIZED WITHIN THE LEFT MAIN CORONARY ARTERY. THE STENT HAD NOT BEEN DEPLOYED AT THE TIME OF THE INCIDENT. THE PHYSICIAN WAS ABLE TO SAFELY RETRIEVE THE BROKEN COMPONENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671810 ↗
• MalfunctionJun 25, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT CATHETER BROKE AT THE HUB WHILE REMOVING IT FROM THE PATIENT. THE BALLOON WAS FULLY DEFLATED PRIOR TO REMOVAL AND WAS REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333409 ↗
• MalfunctionMay 12, 2025Inflation Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Inflation Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND STENT MOVEMENT ON THE BALLOON OCCURRED. THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-TORTUOUS RIGHT CORONARY ARTERY (RCA). AN 8F NON-BOSTON SCIENTIFIC GUIDE CATHETER AND A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS USED. THE LESION WAS PRE-DILATED USING MULTIPLE BALLOONS, ALONG WITH ROTATIONAL ATHERECTOMY (ROTABLATOR) AND INTRAVASCULAR LITHOTRIPSY (SHOCKWAVE). A 3.00 X 38 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR DEPLOYMENT. DURING ADVANCEMENT, RESISTANCE WAS ENCOUNTERED AS THE STENT INTERACTED WITH THE 6F GUIDEZILLA II GUIDE EXTENSION CATHETER. THE STENT WAS ADVANCED PAST THE GUIDEZILLA HELIX COLLAR AND INSERTED INTO THE LESION. UPON ATTEMPTED DEPLOYMENT, THE BALLOON FAILED TO INFLATE, AND INFLATION WAS ABORTED. THE STENT COULD NOT BE RETRACTED INTO THE GUIDEZILLA II, AND THE ENTIRE SYSTEM WAS REMOVED TOGETHER. UPON REMOVAL, THE STENT WAS VISIBLY DAMAGED AND SMASHED ON THE BALLOON, WITH DAMAGE OCCURRING DURING BOTH ADVANCEMENT AND WITHDRAWAL. ADDITIONAL DAMAGE WAS NOTED ON THE GUIDEZILLA II. ALTHOUGH THE STENT REMAINED ON THE BALLOON, IT HAD SHIFTED FROM ITS ORIGINAL POSITION. THE SYSTEM WAS SUCCESSFULLY REMOVED US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001668 ↗
• MalfunctionFeb 19, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL LEFT CIRCUMFLEX CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A SMALL NC BALLOON. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS INTRODUCED FOR TREATMENT BUT EXPERIENCED ADVANCING DIFFICULTY THROUGH THE LEFT MAIN STENT. THE STENT CAME OFF OF THE STENT DELIVERY SYSTEM WITHIN THE VESSEL. A BALLOON WAS THEN ADVANCED TO THE DISTAL END OF THE STENT IN ATTEMPT TO REMOVE THEM AS ONE UNIT. THE STENT WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417343 ↗
• InjuryFeb 18, 2025Inflation Problem; Use of Device Problem; Inflation Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE, AND THE SLEEVE OF THE DEVICE WAS INADVERTENTLY LEFT IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED. THE PATIENT WAS REFERRED FOR A VASCULAR PROCEDURE POST MITRAL VALVE AREA (MVA) FOR VASCULAR ARTERIAL THROMBUS. A FLAP DISSECTION WAS FOUND IN THE TIBIOPERONEAL (TP) TRUNK. DURING THE INITIAL PROCEDURE ON (B)(6) 2024, A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, HOWEVER THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED, AND A DIFFERENT STENT WAS DEPLOYED WITHOUT ISSUE. HOWEVER, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM (OR) FOR THROMBUS FORMATION AND EXPLORATORY SURGERY. A. SURGERY REVEALED A FOREIGN BODY OF A PIECE OF PLASTIC COVER PRESENT ON ALL CORONARY STENTS AND BALLOONS ALONG WITH THE A STYLET, FOUND IN THE POPLITEAL ARTERY. IT IS BELIEVED THAT THE PLASTIC COVER/SLEEVE WAS LEFT IN THE BODY DURING WITHDRAWAL OF THE STENT DELIVERY SYSTEM. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT AFTER THE SURGERY, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 21401020 ↗
• MalfunctionNov 5, 2024Difficult or Delayed Positioning; Inflation Problem; Difficult to Remove; Material Deformation; Difficult or Delayed Positioning; Inflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT INFLATION ISSUES AND REMOVAL DIFFICULTIES OCCURRED RESULTING IN STENT DAMAGE POST-DEPLOYMENT. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION, THE MIDDLE OF THE BALLOON DID NOT FULLY INFLATE. THE STENT BECOME ELONGATED AND STRETCHED OUT BEYOND 38MM FROM ATTEMPTS TO REMOVE THE BALLOON FROM THE STENT. THE STENT WAS STILL DEPLOYED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADDITIONAL STENT USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606714 ↗
• InjurySep 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE CALCIFIED NODULE TARGET LESION WAS LOCATED IN A NON-TORTUOUS CORONARY ARTERY. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING INSERTION, THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT, HOWEVER, IT GOT STUCK AND CAME OFF IN THE VESSEL. THE PHYSICIAN DECIDED TO DEPLOY THE STENT AT THAT LOCATION. THE STENT DID NOT TRAVEL OR MOVE DOWN THE ARTERY AFTER IT WAS DETACHED FROM THE STENT BALLOON. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186580 ↗
• 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 19368001 ↗
• MalfunctionMar 13, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT COULD NOT PASS THROUGH THE LESION AND THE SHAFT BROKE UPON REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894364 ↗
• MalfunctionDec 15, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE DELIVERY SHAFT BROKE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336068 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS AND CHEST PAIN OCCURRED. TWO 3.00 X 38 MM SYNERGY XD DRUG-ELUTING STENTS WERE IMPLANTED IN THE PATIENT SUCCESSFULLY WITH NO ISSUES. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED THE MID LEFT ANTERIOR DESCENDING (LAD) VESSEL MEASURED 3.5 MM AND THE FIRST STENT WAS IMPLANTED ABOUT 20 MM FROM THE OSTIUM. THE STENT BALLOON WAS TAKEN UP TO 16 ATM WHICH PUT THE STENT AT A 3.25 MM. THE RAMUS ARTERY MEASURED AT 3.00 MM AND THE SECOND STENT WAS IMPLANTED. IVUS ALSO SHOWED THE STENT TOUCHING ALL THE WALLS OF THE MID LAD DUE TO PLAQUE BUILDUP IN THE AREA STENTED. LATER THAT NIGHT THE PATIENT HAD CHEST PAIN, AND ELECTROCARDIOGRAM (EKG) CHANGES. THEY WERE DEEMED A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND TAKEN BACK TO THE CATHETERIZATION LAB WHERE THEY FOUND THE STENTS WERE THROMBOSED. THEY WERE BALLOONED AND FLOW WAS RESTORED. THE NEXT DAY, THE PATIENT HAD ANOTHER STEMI AND HAD TO BE TAKEN BACK TO THE CATHETERIZATION LAB WHERE THE STENTS WERE THROMBOSED A SECOND TIME. THE THIRD TIME THE PATIENT WAS TAKEN BACK TO THE CATHETERIZATION LAB, IVUS WAS PERFORMED, AND THE STENTS LOOKED FULLY EXPANDED WITH NO DISSECTION, NOTHING WAS VISUALLY APPARENT TO HAVE C

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 18051923 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS AND CHEST PAIN OCCURRED. TWO 3.00 X 38 MM SYNERGY XD DRUG-ELUTING STENTS WERE IMPLANTED IN THE PATIENT SUCCESSFULLY WITH NO ISSUES. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED THE MID LEFT ANTERIOR DESCENDING (LAD) VESSEL MEASURED 3.5 MM AND THE FIRST STENT WAS IMPLANTED ABOUT 20 MM FROM THE OSTIUM. THE STENT BALLOON WAS TAKEN UP TO 16 ATM WHICH PUT THE STENT AT A 3.25 MM. THE RAMUS ARTERY MEASURED AT 3.00 MM AND THE SECOND STENT WAS IMPLANTED. IVUS ALSO SHOWED THE STENT TOUCHING ALL THE WALLS OF THE MID LAD DUE TO PLAQUE BUILDUP IN THE AREA STENTED. LATER THAT NIGHT THE PATIENT HAD CHEST PAIN, AND ELECTROCARDIOGRAM (EKG) CHANGES. THEY WERE DEEMED A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND TAKEN BACK TO THE CATHETERIZATION LAB WHERE THEY FOUND THE STENTS WERE THROMBOSED. THEY WERE BALLOONED AND FLOW WAS RESTORED. THE NEXT DAY, THE PATIENT HAD ANOTHER STEMI AND HAD TO BE TAKEN BACK TO THE CATHETERIZATION LAB WHERE THE STENTS WERE THROMBOSED A SECOND TIME. THE THIRD TIME THE PATIENT WAS TAKEN BACK TO THE CATHETERIZATION LAB, IVUS WAS PERFORMED, AND THE STENTS LOOKED FULLY EXPANDED WITH NO DISSECTION, NOTHING WAS VISUALLY APPARENT TO HAVE C

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 18051921 ↗
• InjuryApr 24, 2023Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT A ST ELEVATION MYOCARDIAL INFARCTION (STEMI) PROCEDURE OF THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. UPON INSPECTION OF THE DEVICE PRIOR TO USE, THERE WAS NO DAMAGE NOTICED ON THE DEVICE. DURING ADVANCEMENT OF THE DEVICE OVER THE GUIDEWIRE, THERE WAS NO NOTICEABLE RESISTANCE NOTED. THE STENT WAS DEPLOYED SUCCESSFULLY AND WAS WELL-APPOSED. HOWEVER, PRIOR TO DEPLOYMENT, IT WAS NOTED THAT THE BALLOON MARKERS WERE NOT IN PROXIMITY TO THE STENT AND ANGIOGRAM SHOWED THAT THE BALLOON WAS LONGER THAN THE STENT. IT WAS NOTED THAT THERE WAS ROUGHLY 10-12MM OF BALLOON OVERHANG BETWEEN THE PROXIMAL MARKER AND THE PROXIMAL EDGE OF THE STENT. THE PHYSICIAN DECIDED TO DEPLOY THE STENT AS THE PROCEDURE WAS TIME SENSITIVE AND THE PATIENT WAS IN CRITICAL CONDITION. ALTHOUGH THERE WERE NO ISSUES WITH THIS STENT, THE PHYSICIAN DECIDED THAT THEY NEEDED TO PLACE A 3.50 X 12MM SYNERGY XD DRUG-ELUTING STENT PROXIMAL TO THE PREVIOUSLY PLACED STENT DUE TO THE BALLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16800016 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THE PHYSICIAN TRIED TO INSERT THE STENT, HOWEVER, THE MID SHAFT SNAPPED IN TWO OUTSIDE OF THE PATIENT'S BODY. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549734 ↗
• InjuryFeb 23, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS REQUIRING INTERVENTION OCCURRED. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED AND POST DILATED WITH NO ISSUES. HOWEVER, THREE HOURS POST-PROCEDURE, THE PATIENT RETURNED TO THE CARDIAC CATHETERIZATION LAB WHERE A STENT THROMBOSIS WAS DISCOVERED. POST-DILATION WAS PERFORMED AGAIN WITH 3.0 X 20 BALLOON. THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16428775 ↗
• MalfunctionNov 21, 2022Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-NOV-2022. IT WAS REPORTED THAT HUB BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE RIGHT CORONARY ARTERY (RCA). A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. AFTER ATTEMPTING A STENT PLACEMENT IN DISTAL RCA AND HAVING THAT ONE BREAK, A GUIDEZILLA WAS PUT DOWN AND TRIED TO DEPLOY THE STENT. HOWEVER, IT BROKE AGAIN IN THE SHAFT NEAR THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SHAFT DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834471 ↗
• MalfunctionNov 18, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS UNABLE TO DEPLOY DUE TO CALCIUM AND WHEN THE DEVICE WAS TRIED TO PULL BACK, THE STENT CAME OFF FROM THE BALLOON IN LEFT MAIN ARTERY. THE STENT BALLOON WAS REINFLATED TO REMOVE THE DISLODGED STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825854 ↗
• InjuryAug 22, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT SHAFT WAS BROKE INSIDE THE NON-BOSTON SCIENTIFIC GUIDE CATHETER AND HAD TO SNARE THE ENTIRE PORTION OF THE DEVICE TO REMOVED OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD OR DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15268332 ↗
• InjuryApr 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT A BALLOON RUPTURE AND DISSECTION OCCURRED. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WITH CHEST PAIN AND ST ELEVATION MYOCARDIAL INFARCTION. THE 100% STENOSED TARGET LESION WITH A SIGNIFICANT BEND OF 45 DEGREES WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER ONE STENT WAS IMPLANTED, THE 3.00 X 38MM SYNERGY XD WAS ADVANCED TO THE TARGET LESION. UPON INITIAL INFLATION, THE STENT DELIVERY SYSTEM (SDS) BALLOON WOULD NOT INFLATE AND WHEN THE BALLOON WAS DEFLATED, THERE WAS EVIDENCE OF BLOOD IN THE INDEFLATOR CONSISTENT WITH A RUPTURED BALLOON. AS THE SDS WAS BEING REMOVED FROM THE PATIENT, A SMALL DISSECTION OCCURRED WHICH REQUIRED A THIRD STENT TO REPAIR. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION WAS STABLE BUT THEY REQUIRED CONTINUED OBSERVATION IN THE HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 14058331 ↗
• InjuryMar 15, 2022Positioning Failure; Difficult to Remove; Material Rupture; Positioning Failure; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AS THE STENT WAS BEING DEPLOYED, THE BALLOON BURST AND PULLED BLOOD INTO THE INFLATION DEVICE. THE PHYSICIAN NOTICED THAT THE PROXIMAL AND DISTAL EDGES OF STENT EXPANDED BUT THE REST DID NOT. THE STENT COULD NOT BE REMOVED OR INFLATED. THE HUB WAS CUT AND A GUIDEZILLA2 GUIDE EXTENSION CATHETER WAS INTRODUCED TO SUCCESSFULLY RECAPTURE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  MAUDE report 13766602 ↗
• MalfunctionFeb 24, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-FEB 2022. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO LOAD THE DEVICE INTO THE WIRE, IT WAS NOTICED THAT THE BALLOON WAS SLIGHTLY INFLATED AND NOT FULLY WRAPPED. IT WAS ALSO NOTED THAT THERE WAS ACCIDENTAL PRESSURE APPLIED TO THE BALLOON DURING PREPARATION. A NEW STENT WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595350 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS BROKE. THE DETACHED PORTION OF THE DEVICE WAS PULLED OUT AND 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 13535565 ↗