SYNERGY™ H7493926012350Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729840060), received between Feb 8, 2017 and Apr 2, 2021 — classified as 5 deaths, 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2021Failure to Advance; Device-Device Incompatibility; Material Deformation; Failure to Advance; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX AND LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 12 AND A 4.00 X 12 SYNERGY DRUG-ELUTING STENTS WERE ADVANCED FOR TREATMENT WITH THE INTENT TO DEPLOY THEM TOGETHER. HOWEVER, THE TWO STENTS CAME INTO CONTACT WITH EACH OTHER AND COULD NOT BE DEPLOYED. WHEN THE DEVICES WERE REMOVED, SIGNIFICANT DAMAGE WAS NOTED TO BOTH STENTS. THE PROCEDURE WAS COMPLETED USING TWO NON-BOSTON SCIENTIFIC STENTS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607499 ↗
• InjuryNov 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MAUDE REPORT MW5096781 THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON BEFORE INFLATION IN THE LESION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10823711 ↗
• MalfunctionSep 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 12MM SYNERGY II DRUG ELUTING STENT WAS ADVANCE, BUT COULD NOT PASS THE LESION INITIALLY. WHEN THE DEVICE WAS REMOVED TO DO MORE PRE-DILATATION, IT WAS NOTICED THAT A STENT STRUT WAS DAMAGE. THE PROCEDURE WAS COMPLETED WITH A NEW 3.5X12 STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10605022 ↗
• MalfunctionApr 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT A WAS SELECTED FOR USE, BUT THE STENT CAME OFF FROM THE DELIVERY SYSTEM OUTSIDE THE PATIENT'S BODY. A 3.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE STENT STRUTS GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962176 ↗
• MalfunctionJan 24, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION. 3.50 X 12 SYNERGY II DRUG-ELUTING STENT (DES) WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN TRIED TO INSERT THE CATHETER, THE SHAFT BROKE. THE DEVICE WAS REMOVED AND A NEW SYNERGY DES WAS DEPLOYED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9627740 ↗
• MalfunctionNov 29, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE HYPOTUBE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9391894 ↗
• InjuryNov 18, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT, SUB- ACUTE THROMBOSIS AND CHEST PAIN OCCURRED. THE TARGET LESION WAS LOCATED IN THE SIGNIFICANTLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS TREATED WITH PLACEMENT OF 3.00X24MM, 3.00X38MM AND 3.50X12MM SYNERGY II DRUG-ELUTING STENTS WHICH WERE POST DILATED. THREE DAYS LATER, THE PATIENT HAD SUB-ACUTE THROMBOSIS IN THE LAD WHICH NEEDED TO BE EXPANDED IN THE MID LAD. THE FOLLOWING DAY, THE PATIENT EXPERIENCED CHEST PAIN. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THAT THE STENTS WERE UNDER DEPLOYED. THE LAD WAS LASERED AND A QUANTUM BALLOON WAS INTRODUCED TO DILATE THE STENTS. IVUS REVEALED THE STENTS HAD APPROPRIATE APPOSITION AND EXPANSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 9336418 ↗
• MalfunctionOct 31, 2019Break; Break

  REPORTED VIA VOLUNTARY MEDWATCH # (B)(4). IT WAS REPORTED THAT SHAFT BREAK OCCURRED THE TARGET LESION WAS LOCATED IN CIRCUMFLEX ARTERY. A 3.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED OVER A 180CM NON BSC GUIDEWIRE BUT FAILED TO CROSS THE LESION. A SECOND NON BSC GUIDEWIRE WAS ADDED AS A "BUDDY WIRE" AND ANOTHER ATTEMPT WAS MADE TO CROSS THE LESION BUT WAS UNSUCCESSFUL. THE SYNERGY DEVICE WAS REMOVED FROM THE PATIENT AND LAID OUT STRAIGHT ON THE TABLE OFF TO THE SIDE. A 6FR GUIDE LINER WAS INSERTED FOR MORE SUPPORT AND THE BUDDY WIRE WAS REMOVED. THE SYNERGY DEVICE WAS THEN LOADED BACK ON THE GUIDEWIRE BUT DURING ADVANCEMENT, IT WAS NOTICED THAT THE SHAFT OF THE CATHETER DID NOT LOOK RIGHT. UPON REMOVING THE STENT, THE DISTAL 60% OF THE STENT SHAFT SEPARATED FROM THE REST OF THE CATHETER, LEAVING APPROXIMATELY 40% IN THE PATIENT WITH ABOUT 12 INCHES STICKING OUT OF THE HUB OF THE ACCESS SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE REMAINING PORTION OF THE STENT CATHETER COMPLETELY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260422 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS PULLED OUT OF THE PACKAGE AND WAS NOTED TO UNWRAP FROM BOTH ENDS OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 9251352 ↗
• MalfunctionAug 20, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INFLATION, THE INDEFLATOR WOULD NOT HOLD PRESSURE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT'S BODY WITH THE STENT UNDEPLOYED AND STILL CRIMPED ON THE BALLOON CATHETER. THE PHYSICIAN FOUND A RUPTURE IN THE BALLOON CATHETER AND IT BROKE IN HALF ABOUT 55 CM FROM THE HUB AFTER REMOVING IT OUT OF THE BODY. ANOTHER 3.50 X 12 SYNERGY DRUG-ELUTING STENT WAS THEN USED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910212 ↗
• InjuryJun 14, 2019Positioning Problem; Migration; Positioning Problem; Migration

  IT WAS REPORTED THAT STENT MIGRATION AND POSITIONING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN AN OSTIUM OF THE RIGHT CORONARY ARTERY. A 3.50X8MM SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN THE OSTIUM. HOWEVER, IT WAS OBSERVED THAT THE STENT WAS POSITIONED IN THE AORTA AND THE NON-BSC GUIDE CATHETER SLIPPED INSIDE OF IT. SINCE THE GUIDE CATHETER WAS SMALLER THAN THE STENT, THE STENT BECAME STUCK ON THE OUTSIDE OF THE CATHETER. ANOTHER 3.50 X 12MM SYNERGY DRUG-ELUTING STENT WAS ATTEMPTED TO DEPLOY IN THE OSTIUM; HOWEVER, THE WHOLE SYSTEM WAS MOVING IN AND OUT OF OSTIAL AND THE GUIDE ALSO KEPT ENGAGING AND DISENGAGING. THE STENT WAS INFLATED INSIDE THE AORTA AND IT GOT SET AGAIN ON THE OUTSIDE OF THE GUIDE CATHETER. THE TWO STENTS WERE KIND OF SITTING ON THE OUTSIDE OF THE GUIDE CATHETER. SUBSEQUENTLY, A 4.5MM BALLOON WAS ADVANCED AND INFLATED OUT THE OUTSIDE OF THE GUIDE CATHETER TO CAPTURE BOTH STENTS AND WOULD NOT SLIDE OFF IN THE MOMENT OF PULLING THEM BACK INTO THE RIGHT RADIAL SHEATH. HOWEVER, UPON PULLING THE STENTS BACK, IT SEEMED THAT BOTH STENTS WERE STUCK AROUND THE BRACHIAL REGION OF THE ARM AN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8700908 ↗
• DeathMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE SHORT DAPT CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT HAD CARDIO-RESPIRATORY ARREST AND DIED. IN (B)(6) 2018, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS FURTHER REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS IN THE PROXIMAL LEFT ANTERIOR CIRCUMFLEX (LCX) ARTERY WITH 95% STENOSIS, 7MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X12MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE SAME DAY ON DUAL ANTI-PLATELET THERAPY. IN (B)(6) 2019, 385 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT INTUBATED AFTER SUFFERING A CARDIAC ARREST. THE ARREST WAS LIKELY PRIMARY RESPIRATORY WITH SECONDARY CARDIAC. THE PATIENT WAS PLACED WITH CENTRAL LINE FOR VASCULAR ACCESS. THE PATIENT WAS INITIALLY FOUND IN ASYSTOLE AND ACHIEVED RETURN OF SPONTANEOUS CIRCULATION AFTER EPINEPHRINE ADMINISTRATION AND 4 ROUNDS OF COMPRESSIONS. MULTIPLE ELECTROCARDIOGRAPHY (ECG) TESTING WAS PERFORMED ALONG WITH COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA), ECHOCARDIOGRAM AND CHEST X RAYS. T

  Patient problems: Cardiopulmonary Arrest; Death

  MAUDE report 8649943 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE LESION WAS PRE-DILATED AGAIN AND WHEN THE STENT WAS INSERTED, THE SHAFT KINKED AND SUBSEQUENTLY SNAPPED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION NOR BLOOD LOSS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566635 ↗
• MalfunctionMar 28, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC GUIDE EXTENSION CATHETER WAS ADVANCED, A 3.50X12MM SYNERGY II DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, RESISTANCE WAS MET AT THE COLLAR OF THE GUIDE EXTENSION CATHETER AND IT KINKED THE SHAFT OF THE STENT OUTSIDE THE PATIENT'S BODY. ANOTHER 3.50X12MM SYNERGY II DES WAS ADVANCED THROUGH THE GUIDE TO THE COLLAR OF THE GUIDE EXTENSION CATHETER HOWEVER, IT WAS NOTED THAT THE PROXIMAL END OF THE STENT STRUTS WERE RAISED. THE DEVICE WAS REMOVED WITH THE GUIDE EXTENSION CATHETER AND USED A 3X16MM SYNERGY DES AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462753 ↗
• InjuryOct 2, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT CHEST PAIN AND STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED FOR DIAGNOSTIC HEART CATHETERIZATION. THE TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY AND LEFT ANTERIOR DESCENDING ARTERIES. THREE SYNERGY STENTS SIZED 3.50 X 38, 3.50 X 20, AND 3.50 X 12 WERE IMPLANTED TO TREAT THE LESIONS AND THE PROCEDURE WAS COMPLETED. HOWEVER, AN HOUR LATER, THE PATIENT CAME BACK HAVING CHEST PAIN AND ACUTE THROMBOSIS ON ALL OF THE STENTS. SUBSEQUENTLY, THE STENTS WERE RE-BALLOONED AND THE PATIENT WAS PLACED ON DIFFERENT MEDICATIONS. THE PATIENT WAS ON BABY ASPIRIN AND PLAVIX. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 7927612 ↗
• MalfunctionSep 27, 2018Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50X12 SYNERGY STENT WAS ADVANCED IN A GUIDE CATHETER. THE PHYSICIAN FELT RESISTANCE AND REMOVED THE DEVICE. THE BALLOON EDGES (PROXIMAL AND DISTAL) APPEARED LARGER THAN WHAT THEY WERE SUPPOSED TO BE AND WEREN'T TIGHTLY CRIMPED OR WRAPPED, IT APPEARED TO BE ALMOST PRE-DILATED. THE PHYSICIAN STATED THAT THE STENT LOOKED DAMAGED. ANOTHER 3.5X12 SYNERGY MR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INJURY REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916199 ↗
• DeathAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2017, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 3) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 95% STENOSIS AND WAS 6 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 12 MM STUDY STENT. FOLLOWING, POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE SUBJECT WAS HOSPITALIZED DUE TO ACUTE NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE CARDIAC ENZYME WAS FOUND TO BE ELEVATED (PEAK TROPONIN I: 1.815 NG/ML; ULN: 0.028 NG/ML). THE PATIENT WAS TREATED WITH MEDICATION AND A 2.75 X 16 MM PROMUS STENT WAS IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. TWENTY-THREE DAYS FOLLOWING THE INITIAL HOSPITALIZATION, THE PATIENT DIED. PRIMARY CAUSE OF DEATH IS ACUTE NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK.

  Patient problems: Cardiogenic Shock; Chest Pain; Death; Dyspnea; Myocardial Infarction

  MAUDE report 7762281 ↗
• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, WHILE INSERTING THE DEVICE INTO THE SHEATH, IT WAS NOTED TO BE BROKEN AT THE JOINT OF STENT AND SHAFT. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724097 ↗
• MalfunctionMar 16, 2018Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH# 000023009-2018-0001 THAT BALLOON DEFLATION FAILURE AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY. A 3.50X12MM SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED TO TREAT THE LESION. HOWEVER, UPON WITHDRAWAL, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE ALL THE WAY AND BECAME STUCK AT THE END OF A NON-BSC GUIDE CATHETER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7345205 ↗
• MalfunctionFeb 22, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.50 X 12 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS KINKED AS THE DEVICE WAS PULLED OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7288699 ↗
• MalfunctionNov 29, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT INSERTION DIFFICULTIES WERE ENCOUNTERED. DEVICE WOULD NOT FEED THRU THE GUIDE CATHETER SO DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT STRUT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068174 ↗
• DeathJun 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2017-06291. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 75% STENOSIS AND WAS 9MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 32MM AND 3.50 X 12MM STUDY STENTS WITH RESIDUAL STENOSIS OF 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT WAS HOSPITALIZED AT ANOTHER HEALTHCARE CENTER WITH ACUTE CHRONIC DIASTOLIC HEART FAILURE AND NON ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. TWO DAYS LATER, THE PATIENT WAS PLACED ON CRITICAL CARE. THE FOLLOWING DAY, THE PATIENT HAD SOME HEMATEMESIS AND ENDOSCOPY WAS PERFORMED WITH NEGATIVE RESULTS. DURING THE COURSE OF HOSPITALIZATION, THE PATIENT DEVELOPED WORSENING RENAL INSUFFICIENCY AND WAS SENT FOR NEPHROLOGY CONSULTATION. THE PATIENT WAS DIURESED SECONDARY TO PULMONARY EDEMA. THE PATIENT ALSO DEVELOPED WORSENING SHORTNESS OF BREATH AND AN EPI

  Patient problems: Anemia; Cardiac Arrest; Cardiac Enzyme Elevation; Chest Pain; Congestive Heart Failure; Death; Dyspnea; Heart Failure; Hypoxia; Myocardial Infarction; Renal Failure; Respiratory Failure

  MAUDE report 6654740 ↗
• DeathApr 11, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS: 2134265-2017-03311. IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED AND THE PATIENT EXPIRED. TWO SYNERGY II STENTS; A 3.50 X 12 AND A 2.25 X 16 WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING THE PROCEDURE, STENT THROMBOSIS OCCURRED AND THE PATIENT EXPIRED SHORTLY THEREAFTER.

  Patient problems: Chest Pain; Death; Thrombosis

  MAUDE report 6479505 ↗
• MalfunctionMar 28, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT DELIVERY SYSTEM FRACTURED AS THE DEVICE WAS ADVANCING THROUGH THE GUIDE CATHETER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50 X 12 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438963 ↗
• DeathMar 9, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS: 2134265-2017-01774 AND 2134265-2017-01776. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THROMBOSIS, CHEST PAIN, ST ELEVATIONS AND EXPIRED. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE (B)(6) STENOSED, MILDLY TORTUOUS AND MILD TO MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THREE SYNERGY II STENTS WERE IMPLANTED OVERLAPPING IN THE RCA; A 3.00 X 38 IN THE PROXIMAL TO MID RCA, ANOTHER 3.00 X 38 IN THE MID RCA, AND A 3.50 X 12 IN THE DISTAL RCA. THE PROCEDURE WAS COMPLETED AND HEPARIN BIVALIRUDIN, AND CLOPIDOGREL BLOOD THINNING MEDICATION WAS ADMINISTERED. THE PATIENT WAS IN RECOVERY FOR 2-3 HOURS WHEN CHEST PAIN AND ST ELEVATIONS OCCURRED. THE PATIENT WAS TRANSFERRED BACK TO THE CARDIAC CATH LAB FOR TREATMENT. THE FOLLOWING DAY ALL 3 STENTS HAD COMPLETE THROMBOSIS AND ANGIOJET THROMBECTOMY WAS PERFORMED, HOWEVER THE PATIENT EXPIRED.

  Patient problems: Chest Pain; Death; ST Segment Elevation; Thrombosis

  MAUDE report 6393880 ↗