SYNERGY MEGATRON™ H7493942832350Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729985778), received between Jul 6, 2021 and Apr 18, 2026 — classified as 3 deaths, 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS ILIAC ARTERY. A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS LOADED ONTO THE UNKNOWN GUIDEWIRE AND ADVANCED TO THE NON-BOSTON SCIENTIFIC (BSC) GUIDELINER CATHETER, THE STENT SHAFT SNAPPED. THE DEVICE WAS THEN REMOVED FROM THE NON-BSC GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919435 ↗
• MalfunctionNov 4, 2025Nonstandard Device; Difficult to Remove; Failure to Deflate; Nonstandard Device; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESIONS WERE LOCATED IN THE CIRCUMFLEX (CX) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. A 3.50 X 32 MM SYNERGY MEGATRON? DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE CX ARTERY. FOLLOWING DEPLOYMENT, THE BALLOON FAILED TO DEFLATE AND WAS DIFFICULT TO REMOVE. THE PHYSICIAN ATTEMPTED TO APPLY ADDITIONAL NEGATIVE PRESSURE, BUT THIS WAS UNSUCCESSFUL. THE DEVICE HAD TO BE FORCIBLY WITHDRAWN, AND THE DISTAL END OF THE BALLOON REMAINED INFLATED. THE PHYSICIAN THEN PROCEEDED TO DEPLOY A STENT IN THE DISTAL LAD, FOLLOWED BY PLACEMENT OF A 4.50 X 24 MM SYNERGY? XD DES IN THE PROXIMAL LAD. DURING REMOVAL, SIMILAR DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS REMOVED WITH FORCE, AND THE GUIDEWIRE WAS INADVERTENTLY EXTRACTED ALONG WITH IT. ONCE OUTSIDE THE BODY, THE PHYSICIAN HAD TO PULL THE GUIDEWIRE FROM THE BALLOON CATHETER WITH FORCE. UPON INSPECTION, THE PROXIMAL PORTION OF THE STENT BALLOON WAS STILL INFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469217 ↗
• MalfunctionMay 22, 2025Leak/Splash; Difficult to Remove; Material Rupture; Difficult to Advance; Leak/Splash; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON RUPTURED, AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATIONS WITH 3.00 NON-BOSTON SCIENTIFIC BALLOON CATHETERS, A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED IN A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WITH TWO WIRES AND A 2.00 X 20 BALLOON, BUT IT FAILED TO ADVANCE THE LESION. THE STENT WAS REMOVED AND NOTED TO BE INTACT. THE 2.00 X 20 BALLOON WAS REMOVED, AND THE STENT WAS SUCCESSFULLY DELIVERED AGAIN ACROSS THE LESION. HOWEVER, FOLLOWING THE INITIAL INFLATION AT 3-4 ATMOSPHERES FOR MINIMAL SECONDS, AND DURING DEPLOYMENT, THE BALLOON RUPTURED. THE DEFLATION WAS INSTANTANEOUS AS THE BALLOON RUPTURED. CONTRAST WAS SEEN ON THE ANGIOGRAPHY, AND BLOOD CAME BACK INTO THE INSUFFLATOR. WHEN THE BALLOON WAS REMOVED, IT WOULD NOT RETRACT BACK INTO THE NON-BSC GUIDE. SUBSEQUENTLY, THE BALLOON WAS REMOVED IN ONE PIECE BY DEEP SEATING THE NON-BSC GUIDE INTO THE VESSEL. THE 1.50 X 8MM, 2.00 X12MM, AND 2.50 X12MM BALLOON CATHETERS WERE DELIVERED AND THE STENT WAS FULLY EXPANDED, POST-DILATED WITH A 3.50 X15 NON-COMPLIANT BALLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075394 ↗
• MalfunctionMay 7, 2025Entrapment of Device; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Entrapment of Device; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT BALLOON FAILURE TO DEFLATE AND ENTRAPMENT OF DEVICE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 32MM SYNERGY MEGATRON MONORAIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED FOR 13 ATM FOR 20 SECONDS. UPON DEFLATION FOR A COUPLE MINUTE OR LESS, THE MEGATRON BALLOON WOULD NOT FULLY DEFLATE. AN ATTEMPT TO REPULL NEGATIVE AND THE BALLOON WOULD NOT RETRACT BACK INTO THE GUIDEZILLA. THEN, AN EMPTY 20CC SYRINGE WAS ATTACHED AFTER DETACHING THE INDEFLATOR AND IT WOULD STILL NOT FULLY DEFLATE. FURTHERMORE, THE PHYSICIAN REATTEMPTED TO ADVANCE THE BALLOON, AND IT WOULD NOT SEPARATE. THE DEVICE WAS REMOVED IN ONE PIECE WITH GUIDEZILLA AND GUIDE AROUND 30 SECONDS AFTER DEFLATION. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976250 ↗
• InjuryApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT RESTENOSIS AND STENT FRACTURE OCCURRED. ON (B)(6)2021, IN STENT RESTENOSIS OCCURRED AT PROXIMAL RIGHT CORONARY ARTERY (RCA), IT WAS SUCCESSFULLY TREATED WITH A 3.50 MM X 32 MM SYNERGY MEGATRON DRUG ELUTING STENT. ON (B)(6) 2022, 99% IN STENT RESTENOSIS NOTED AT PROXIMAL RCA WITH STENT FRACTURE. ON (B)(6) 2022, CORONARY ANGIOGRAPHY REVEALED 99% IN-STENT RESTENOSIS AT PROXIMAL RCA, WAS NOTED WITH NEOINTIMAL HYPERPLASIA AND STENT RECOIL. HEPARIN OR OTHER ANTITHROMBOTIC MEDICATION WERE ADMINISTERED AT THE TIME OF INDEX PROCEDURE. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS) AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN (>= 72 HOURS) AT THE TIME OF INDEX PROCEDURE. THE TARGET LESION WAS LOCATED AT THE PROXIMAL RCA AND WAS 7 MM LONG WITH A REFERENCE VESSEL DIAMETER WAS 4.0 MM. THE TARGET LESION WAS PRE-DILATED WITH A 2.00 MM X 15 MM BALLOON WITH 30% RESIDUAL STENOSIS AND TIMI FLOW OF 3. THE TARGET LESION WAS TREATED WITH A 4.00 MM X 12 MM NC EMERGE STUDY DEVICE SUCCESSFULLY WITH 15% RESIDUAL STENOSIS AND TIMI 3. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2024, THE PATIENT WAS NOTED WITH SYMPTOMS ASSOCIATED WITH ANGINA DURING LENG

  Patient problems: Angina; Restenosis; Vasoconstriction

  MAUDE report 21741125 ↗
• MalfunctionJun 3, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION AND THE SHAFT WAS BROKEN. ALL COMPONENTS WERE COMPLETELY REMOVED AND CAME OUT ON WIRE. 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 19448439 ↗
• MalfunctionMay 15, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON LOADING THE STENT INTO THE WIRE, IT WAS NOTICED THAT THE SHAFT WAS BENT. WHEN ATTEMPTED TO BEND IT BACK TO MAKE IT STRAIGHT, THE MID SHAFT WAS BROKEN. THE DEVICE WAS SIMPLY PULLED OUT TO REMOVE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321151 ↗
• InjuryMar 27, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED WHICH REQUIRED ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 32MM SYNERGY MEGATRON DRUG ELUTING STENT WAS ADVANCED FOR DILATION. THE STENT SHAFT WAS BENT WHILE LOADING ONTO THE WIRE DOWN INTO THE LAD. THE SHAFT BROKE WHILE ADVANCING THE DEVICE THROUGH THE GUIDE. THE STENT AND DELIVERY SYSTEM EXITED THE GUIDE, BUT THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM WAS WITHIN THE GUIDE. THE PHYSICIAN USED A SMALL BALLOON TO TRACK BEYOND THE STENT AND INFLATED IT TO PULL BACK THE STENT DELIVERY SYSTEM. ONCE THE BALLOON WAS INFLATED AND PULLED, THE PHYSICIAN WAS ABLE TO REMOVE THE STENT AND THE STENT DELIVERY SYSTEM THROUGH THE GUIDE. THE PHYSICIAN REWIRED THE LAD AND CONTINUED THE PROCEDURE, PLACING A 3.5 X 38MM SYNERGY STENT IN THE DISEASED PORTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988903 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, WHEN A STENT WAS INSERTED IN THE PROXIMAL PORTION OF THE GUIDING CATHETER, THE PROXIMAL PART OF THE SHAFT BROKE OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS COMPLETELY REMOVED BUT DAMAGED, AND 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 18838991 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CATHETER WAS BROKEN. THE DEVICE WAS REMOVED COMPLETELY INTACT FROM THE PATIENT, 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 18764021 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV CLINICAL STUDY. IT WAS REPORTED THAT ANGINA RECURRED. IN (B)(6) 2021, THE SUBJECT QUALIFYING CONDITION WAS STABLE ANGINA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE NEXT DAY. THE FIRST TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.50 MM X 16MM STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. THE SECOND TARGET LESION WAS LOCATED IN THE MID RCA WITH 80% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.50 MM X 32 MM STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 20% WITH TIMI FLOW 3. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS OF RECURRENT CLASS III ANGINA. THE ANGINAL SYMPTOMS HAD BEEN PROGRESSIVE OVER THE PAST SEVERAL WEEKS. THE SUBJECT HAD CHEST BURNING RADIATING TO THE JAW WITH EXERTION. THE SUBJECT HAD ELEVATED BLOOD PRESS

  Patient problems: Angina; Obstruction/Occlusion

  MAUDE report 17711731 ↗
• DeathJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT A SUBJECT DEATH OCCURRED. (B)(6) 202, REVEALED SUBJECT QUALIFYING CONDITION WAS MYOCARDIAL INFARCTION AND STABLE ANGINA (CCS CLASSIFICATION: HENCE, THE SUBJECT WAS REFERRED TO CARDIAC CATHETERIZATION. THE SAME DAY THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION 1 WAS LOCATED IN LEFT MAIN CORONARY ARTERY WITH 95% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM. TARGET LESION 1 WAS TREATED WITH PRE DILATION AND PLACEMENT OF 3.50 MM X 32 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. ADDITIONALLY A NON-TARGET LESION WAS ALSO TREATED. NON-TARGET LESION 1 WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND WAS TREATED WITH PLACEMENT OF 3.00 MM X 38 MM SYNERGY STENT. ON 09JULY2021, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON 15MARCH2022, 251 DAYS POST INDEX PROCEDURE, SUBJECT EXPIRED DUE TO UNKNOWN CAUSE OF DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776619 ↗
• DeathNov 29, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ROTABLATED WITH A 1.5 BURR FOLLOWED BY A 3.5 BALLOON. A 3.50 X 32MM SYNERGY MEGATRON IMPLANTED TO TREAT THE LESION AND POST DILATED WITH A NC EMERGE BALLOON. ANGIOGRAPHY SHOWED PATENT FLOW POST STENTING. AS THE PATIENT WAS LEAVING THE CATH LAB, THEY BEGAN TO CODE AND THE STAFF BEGAN IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR). THE PATIENT WAS BROUGHT BACK TO THE CATH LAB WITH AN AUTOMATIC CPR MACHINE. REPEATED ANGIOGRAM REVEALED A CLOTTED LAD. THE LAD WAS WIRED AND BALLOONED TO RESTORE FLOW. CPR CONTINUED AND VENTRICULAR ASSIST DEVICE WAS INSERTED AS WELL AS A TEMPORARY PACEMAKER. TWO HOURS AFTER CPR WAS INITIATED, TIME OF DEATH WAS CALLED. IT WAS FURTHER REPORTED THAT THE STENTED VESSEL CLOTTED OFF SOON AFTER THE PATIENT LEFT THE CATH LAB.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 12884162 ↗
• MalfunctionSep 21, 2021Deflation Problem; Difficult to Remove; Material Integrity Problem; Deflation Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DEFLATION AND REMOVAL DIFFICULTY OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50 X 32MM SYNERGY MEGATRON WAS ADVANCED TO THE LESION, THE BALLOON WAS INFLATED ONE TIME AT 12 ATMOSPHERES FOR 8 TO 10 SECONDS, AND WAS DEPLOYED IN THE RCA. HOWEVER, THE BALLOON WOULD NOT DEFLATE. A DOUBLE NEGATIVE WAS PERFORMED USING A 3-WAY BUT IT DID NOT DO MUCH AND THE DEVICE HAD TO BE REMOVED WITH A LOT OF EFFORT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT AFTER THE STENT WAS IMPLANTED, THE BALLOON TOOK A LOT OF TIME TO DEFLATE AND WHEN IT WAS FINALLY ABLE TO BE REMOVED IT WAS NOTED TO BE DEFORMED. IT WAS FURTHER REPORTED THAT RESISTANCE WAS ENCOUNTERED ONLY WHILE WITHDRAWING THE STENT DELIVERY SYSTEM INTO THE 7F GUIDE CATHETER. IT WAS NOTED THAT MORE THAN A MINUTE WAS ALLOWED FOR BALLOON DEFLATION BEFORE PULLING BACK THE DEVICE AND THAT THERE WAS AN ATTEMPT TO DEFLATE THE BALLOON MANUALLY WITH A 20 CC SYRINGE. THERE WAS ALWAYS CONTRAST INSIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511092 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY. IT WAS REPORTED THAT A PERFORATION OCCURRED. ON (B)(6) 2021, THE INDEX PROCEDURE WAS PERFORMED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING TO THE FIRST RIGHT POSTEROLATERAL BRANCH (1ST RPL) AND WAS 90MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 4MM. THE TARGET LESION WAS PREDILATED WITH 2.5MM LARGEST BALLOON WITH MAXIMUM INFLATION PRESSURE OF 14MM USING IVUS. THE LESION WAS TREATED WITH THE PLACEMENT OF A 3.50 MM X 32 MM STUDY STENT. POST DILATATION WAS PERFORMED WITH A 4MM BALLOON INFLATED TO MAXIMUM PRESSURE OF 18MM. TIMI FLOW WAS 0, WITH A 100% RESIDUAL STENOSIS. A PERFORATION WAS NOTED. HOWEVER, NO THROMBUS AND ABRUPT CLOSURE WERE NOTED POST PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

  Patient problems: Perforation of Vessels

  MAUDE report 12454737 ↗
• DeathJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT ABRUPT CLOSURE, CARDIAC ARREST, AND PATIENT DEATH OCCURRED. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED IN THE STUDY AND THE INDEX PROCEDURE WAS PERFORMED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX). THE LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 3.50 MM X 32 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. POST PROCEDURE ABRUPT CLOSURE WAS NOTED WITH TIMI FLOW OF 3. HOWEVER, NO PERFORATION AND THROMBUS WERE NOTED. ON (B)(6) 2021, THE SUBJECT VISITED THE HOSPITAL WITH SYMPTOMS RELATED TO CARDIAC ARREST AND WAS HOSPITALIZED ON THE SAME DAY. THE SUBJECT UNDERWENT DIAGNOSTIC TEST OF ECHOCARDIOGRAM AND IN RESPONSE TO THE EVENT, MEDICATIONS WERE GIVEN. TWO DAYS LATER, THE SUBJECT PASSED AWAY.

  Patient problems: Cardiac Arrest; Obstruction/Occlusion

  MAUDE report 12204925 ↗
• InjuryJul 6, 2021Difficult to Insert; Difficult to Remove; Device Damaged by Another Device; Difficult to Insert; Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE POST DEPLOYMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION OF THE 70% STENOSED AND SIGNIFICANTLY CALCIFIED PROXIMAL SAPHENOUS VEIN GRAFT (SVG) WAS PERFORMED. A 3.50 X 32MM SYNERGY MEGATRON WAS ADVANCED TO THE TARGET LESION, INFLATED AT 14 ATMOSPHERES, AND DEPLOYED, BUT DIFFICULTY REMOVING THE DELIVERY SYSTEM OCCURRED. THE BALLOON WAS DEFLATED AND BECAUSE THE DEVICE WAS A LARGER SIZE AND LONGER SIZE, EXTRA TIME WAS GIVEN BEFORE REMOVING THE STENT DELIVERY SYSTEM (SDS). DURING REMOVAL, THE DEVICE WAS PULLED NEGATIVE, AND LEFT IT IN THAT POSITION. A GUIDEZILLA WAS MOVED FORWARD IN AN ATTEMPT TO REMOVE THE SDS, BUT WAS UNABLE TO RETRIEVE IT IN THE GUIDE EXTENSION OR THE GUIDE. THERE WAS NO GUIDE SUPPORT DUE TO THE TAKEOFF OF THE SVG FROM THE AORTA, WHICH WAS NOTED TO HAVE DEFINITELY CONTRIBUTED TO THE RESISTANCE. IT WAS NOTED THAT IT FELT STICKY. THE GUIDE WAS PULLED TO A MORE SUPERIOR ORIENTATION AND AT THAT POINT, THE PROXIMAL PART OF THE STENT STRETCHED A FEW MILLIMETERS INTO THE AORTA. IT WAS NOTED THAT BY MOVING THE ORIENTATION OF THE GUIDE, WITH THE SDS MOST LIKELY STILL IN THE VESSEL AND JUST A LITTLE BIT OUT IN THE AORTA, IT CREATED A LOT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122321 ↗