SYNERGY™ H7493926012270Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729840046), received between Jan 17, 2017 and Oct 4, 2021 — classified as 1 death, 13 injuries, 17 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2021Difficult to Remove; Material Rupture; Migration; Difficult to Remove; Material Rupture; Migration

  IT WAS REPORTED THAT BALLOON RUPTURE, STENT MIGRATION AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT WHEN THE BALLOON WAS FIRST INFLATED AT 9 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. WHEN THE BALLOON WAS REMOVED, THE STENT MOVED BACK WITH THE BALLOON. IT EVENTUALLY STOPPED AFTER 1-2 MM OF MOVEMENT AND WAS SUCCESSFULLY REMOVED. POST-DILATATION WAS PERFORMED WITH A 2.75X15 NC BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12570132 ↗
• MalfunctionMar 4, 2021Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.75 X 12MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS NOT MOVING SMOOTHLY ON THE WIRE AND THE SHAFT BROKE IN TWO PIECES. THE BROKEN PIECE WAS REMOVED FROM THE WIRE AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408980 ↗
• InjuryMar 1, 2021Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION OF A 2.5MM BALLOON CATHETER, A 2.75 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REPOSITIONED TWICE AND ON THE THIRD ATTEMPT TO REPOSITION, THE STENT BALLOON CAME BACK BUT THE STENT STAYED AT THE LESION. THE STENT BALLOON WAS ATTEMPTED TO ADVANCE BACK INTO THE STENT, HOWEVER, THE STENT WAS DEFORMED. THE STENT BALLOON WAS REMOVED AND A 1.0MM NON-BSC BALLOON CATHETER WAS USED TO INFLATE THE STENT. POST-DILATATION WAS PERFORMED WITH A 2.75MM NC BALLOON AND THE STENT CAME OFF THE BALLOON EXACTLY IN THE LESION WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396068 ↗
• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE MID SHAFT OF THE DELIVERY SYSTEM BROKE ON THE TABLE WHILE TRYING TO LOAD THE DEVICE ONTO THE WIRE. THE DEVICE NEVER ENTERED INTO THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10733880 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED AND THE PATIENT EXPERIENCED CHEST PAIN. THE PATIENT WAS PRESENTED WITH MYOCARDIAL INFARCTION. THE TARGET LESIONS WERE LOCATED IN THE TOTAL DISTAL RIGHT CORONARY (RCA) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES WITH 80% MID AND 90% DISTAL STENOSIS. A 2.5X24 SYNERGY DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE RCA AND A 2.75X12 SYNERGY DES WAS SUCCESSFULLY PLACED IN THE LAD. HOWEVER, ONE HOUR LATER POST PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AFTER ELECTROCARDIOGRAM CHANGES AND ACUTE STENT THROMBOSIS WAS NOTED ON THE DISTAL RCA WHERE STENT WAS IMPLANTED. ANGIOPLASTY WAS PERFORMED WITH EMERGE BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Chest Pain; Non specific EKG/ECG Changes

  MAUDE report 10727317 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, IT FAILED TO CROSS THE LESION AND THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880121 ↗
• MalfunctionFeb 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AS A 2.75 X 12 SYNERGY DRUG-ELUTING STENT WAS BEING LOADED ON THE WIRE, IT WAS NOTED THAT SOME STRUTS WERE NOT ALIGNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE NEVER WENT INSIDE THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9678743 ↗
• MalfunctionAug 12, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STENT WAS STUCK ON THE WIRE. A 2.75X12 SYNERGY DRUG ELUTING STENT AND A ROTAWIRE WERE USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, ABLATION WAS COMPLETED USING ROTAPRO IN A CHALLENGING LESION AND PRE-DILATION WAS THEN PERFORMED USING TWO NON- BSC BALLOONS. SUBSEQUENTLY, STENTING WAS DESIRED AND A SYNERGY STENT WAS LOADED INTO THE ROTAWIRE. HOWEVER, THE STENT BECAME STUCK ON THE WIRE. EXTREME MANIPULATION AND EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE STENT FROM THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882973 ↗
• MalfunctionJun 3, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.75 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT STRUT WAS STICKING UP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8664559 ↗
• MalfunctionMay 7, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER CROSSING THE LESION WITH A GUIDE WIRE, A 2.75X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE THE DEVICE WAS BEING ADVANCED, IT BECAME TWISTED WITH THE WIRE. THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT FURTHER OVER THE WIRE. BOTH THE WIRE AND THE STENT WERE REMOVED TOGETHER. A NEW WIRE AND A NEW STENT WERE ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586994 ↗
• MalfunctionMar 25, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.75 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PROXIMAL SHAFT FRACTURED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449237 ↗
• MalfunctionFeb 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 12 SYNERGY DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED IT WAS FOUND THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8321748 ↗
• MalfunctionDec 18, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. DURING A BSC SALES REPRESENTATIVE EXPIRED STENT SWAP AT THE WAREHOUSE, A 2.75 X 12 SYNERGY II STENT WAS NOTED TO HAVE ITS BOX RIPPED OPEN.

  Patient problems: No Patient Involvement

  MAUDE report 8174255 ↗
• MalfunctionSep 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN WAS TRYING TO DELIVER THE DEVICE, IT WAS OBSERVED THAT THE DISTAL STRUTS WERE FLARED BACKWARDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844752 ↗
• InjuryAug 6, 2018Obstruction of Flow; Obstruction of Flow

  SAME CASE AS MDR ID: 2134265-2018-07228 AND 2134265-2018-07229. IT WAS REPORTED THAT PATIENT EXPERIENCED CHEST PAIN AND ACUTE THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75X12 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD. THE MID LAD WAS TREATED WITH 2.25 X 16MM AND A 2.25 X 12MM SYNERGY II DRUG-ELUTING STENTS. THE FINAL ANGIOGRAM LOOKED GREAT. WHILE THE PATIENT WAS BEING REMOVED FROM THE TABLE, THE PATIENT EXPERIENCED NAUSEA AND CHEST PAIN. THE PHYSICIAN HAD ORDERED THE PATIENT TO BE LOADED WITH ASPIRIN AND PLAVIX BUT THE PATIENT REFUSED TO TAKE ANY MEDICATION. SOME TIME LATER, THE PATIENT DID RECEIVE ASPIRIN AND PLAVIX. THE PATIENT CONTINUED TO HAVE CHEST PAIN AND SOME ST ELEVATION. AN ECHO WAS PERFORMED WHICH CAME BACK CLEAR BUT THE PATIENT STARTED TO SHOW MORE PROMINENT ST ELEVATION. ANOTHER ANGIOGRAM WAS PERFORMED WHICH REVEALED THE STENTED AREA HAD STENT THROMBOSIS. THE PATIENT WAS LOADED WITH AN INTEGRILIN BOLUS AND STARTED ON AN INTEGRILIN DRIP. A SECOND INTEGRILIN BOLUS WAS GIVEN DIRECTLY IC AND THE STENTED AREA DILATED WITH A 2.0X12 BALLOON. THE PATIENT'S ST ELEVATION DISAPPEARED,

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

  MAUDE report 7753520 ↗
• InjuryMay 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A RELATIVELY TORTUOUS AND NON-CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION, PREDILATION WAS PERFORMED AND A 2.75 X 12 MM SYNERGY II DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON REMOVAL, IT WAS NOTED THAT THE STENT FELL OFF THE BALLOON. MULTIPLE ATTEMPTS AND VARIOUS TECHNIQUES WERE TRIED TO RETRIEVE THE STENT BUT IT WAS UNSUCCESSFUL. A 2.75 X 15 MM NON-BSC STENT WAS ADVANCED AND CRUSHED THE DISLODGED STENT INTO THE PROXIMAL CIRCUMFLEX ARTERY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490142 ↗
• InjuryFeb 13, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-00981 AND 2134265-2018-00876. IT WAS REPORTED THAT STENT THROMBOSIS AND CHEST PAIN OCCURRED. THE PATIENT PRESENTED WITH AN ACUTE ST ELEVATED MYOCARDIAL INFARCTION AND RECEIVED BIVALIRUDIN THERAPY (BLOOD THINNER). TARGET LESION #1 WAS LOCATED IN THE CIRCUMFLEX ARTERY. FOLLOWING PREDILATION USING A 2.50 MM X 20 MM EMERGE BALLOON, A 2.50 X 24 MM SYNERGY II STENT WAS SUCCESSFULLY DEPLOYED. TARGET LESION #2 WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS PERFORMED WITH A 2.50 MM X 15 MM EMERGE BALLOON. A 2.75 X 12 MM SYNERGY II STENT SYSTEM DEPLOYED IN THE LAD AND A 2.75 X 20 MM SYNERGY II EVEROLIMUS STENT WAS DEPLOYED IN THE DISTAL LAD. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS THEN TRANSFERRED FROM CATH LAB HOWEVER, THE PATIENT STARTED HAVING CHEST PAIN. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND IT WAS NOTED THAT A FOCAL CLOT WAS PRESENT IN BOTH THE MID CIRCUMFLEX AND MID LAD. A 2.50 MM X 15 MM EMERGE BALLOON WAS USED TO DILATE THE CLOT PRESENT INSIDE THE SYNERGY STENTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS LATER.

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 7268012 ↗
• InjuryFeb 7, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-00655. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2017, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA AND THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 95 % STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE TARGET LESION #1 WAS TREATED WITH DIRECT PLACEMENT OF A 2.50 X 16MM SYNERGY II STUDY STENT WITH 0 % RESIDUAL STENOSIS. THE TARGET LESION #2 WAS LOCATED IN THE PROXIMAL RCA WITH 90 % STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION #2 WAS TREATED WITH DIRECT PLACEMENT OF A 2.75 X 12MM SYNERGY II STUDY STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS NOTED TO BE 0 %. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON ANTIPLATELET THERAPY. IN (B)(6) 2018, PATIENT WAS PRESENTED TO THE EMERGENCY ROOM FOR UPCOMING KIDNEY TRANSPLANT FOLLOW-UP. THE PATIENT WAS SUFFERING FROM END-STAGE CHRONIC RENAL DISEASE. ON ARRIVAL, ELECTROCARDIOGRAM (ECG) REVEALED SINUS BRADY

  Patient problems: Bradycardia; Myocardial Infarction; Reocclusion

  MAUDE report 7249440 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. IN (B)(6) 2017, PATIENT'S CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA AND SILENT ISCHEMIA. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 25.0MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00X28MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 80% STENOSIS AND WAS 70MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.75X12MM SYNERGY II STENT, HOWEVER, FOLLOWING STENT DEPLOYMENT VESSEL PERFORATION WAS NOTED. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

  Patient problems: No Consequences Or Impact To Patient; Perforation of Vessels

  MAUDE report 7204612 ↗
• InjuryNov 1, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75X12MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT MIGHT BE KINKED WHEN TAKEN OUT FROM THE HOOP. WHEN THE PHYSICIAN PLACED THE DEVICE INTO THE TUOHY AND ADVANCED IT INTO THE GUIDE CATHETER, THE SHAFT BROKE IN HALVES. THE BROKEN SHAFT THAT WAS STILL HANGING OUTSIDE THE TUOHY WAS PULLED AND THE DEVICE WAS THEN REMOVED FROM THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6992563 ↗
• MalfunctionAug 21, 2017Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75X12MM SYNERGY II DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE PROXIMAL END OF THE STENT STRUTS WERE PEELED BACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS OKAY.

  Patient problems: No Patient Involvement

  MAUDE report 6808248 ↗
• MalfunctionJul 31, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE HYPOTUBE SNAPPED IN HALF. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6754762 ↗
• MalfunctionJun 29, 2017Stretched; Device Damaged Prior to Use; Stretched; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION, A 2.75X12MM SYNERGY II STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT STENT STRUTS WERE STRETCHED TO THE TIP OF THE BALLOON DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6677989 ↗
• InjuryJun 19, 2017Material Rupture; Material Rupture

  SAME CASE AS MEDWATCH #MW5069717 IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. WHILE DEPLOYING A 2.75 X 12 SYNERGY II DRUG-ELUTING STENT, THE PRESSURE ATMOSPHERES WERE UNABLE TO BE OBTAINED. THE STENT WAS DEPLOYED, HOWEVER, THE BALLOON RUPTURED. IT WAS REPORTED THAT INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6651109 ↗
• MalfunctionMay 22, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON INFLATION, IT WAS SUSPECTED THAT THE BALLOON MIGHT HAVE RUPTURED AS IT DID NOT HOLD ANY PRESSURE AND IMMEDIATE BLEED BACK WAS NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582841 ↗