SYNERGY™ H7493926012400Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729840077), received between Dec 16, 2016 and Apr 2, 2021 — classified as 3 deaths, 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Bent” (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 32 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 11607497 ↗
• MalfunctionApr 1, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT AFTER FLUSHING THE STENT, THE PROXIMAL END OF THE STENT STRUTS APPEARED TO BE EXPANDED LARGER THAN THE REST OF THE STRUTS.THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603189 ↗
• MalfunctionMar 26, 2021Failure 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 04MAR2021. IT WAS REPORTED THAT CROSSING DIFFICULTY OCCURRED. A 4.00 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT DELIVERY SYSTEM WAS RETUNED WITHOUT A STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574126 ↗
• MalfunctionOct 12, 2020Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-SEP-2020. IT WAS REPORTED THAT DAMAGED DEVICE OCCURRED. A 4.00 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE DEVICE WAS FOUND DEFECTIVE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT POLYMER EXTRUSION DETACHED/SEPARATED AND STENT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10661765 ↗
• InjuryAug 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE STENT CAME OFF THE BALLOON. A 4.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS USED. AT AN UNKNOWN TIMEPOINT, THE STENT CAME OFF OF THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10445618 ↗
• InjuryJul 15, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A GRAFT IN THE RIGHT CORNARY ARTERY. A 4.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON PLACEMENT, IT WAS NOTED THAT THE ONLY HALF OF THE STENT WAS DEPLOYED. THE STENT WAS COMPLETELY REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789556 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX (LCX) ARTERY. ROTABLATION WAS PERFORMED WITH A 1.75MM ROTABLATOR BURR AND CORONARY GUIDEWIRES WERE CROSSED THE LESION. PRE-DILATION WITH 1.5MM, 2.5MM AND 3.0X12MM EMERGE BALLOON CATHETERS IN THE PROXIMAL CIRCUMFLEX AND DISTAL LEFT MAIN ARTERY AND A 2.5X10MM WOLVERINE BALLOON CATHETER WAS DILATED IN THE PROXIMAL ARTERY. A 4.0X24MM SYNERGY DRUG-ELUTING STENT (DES) WAS THEN ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND A 3.0X12MM SYNERGY DES WAS ADVANCED TO THE PROXIMAL AND DEPLOYED FOLLOWED BY A 4.0X12MM STENT DEPLOYED IN THE DISTAL LEFT MAIN AND PROXIMAL CIRCUMFLEX ARTERY. HOWEVER, IT WAS OBSERVED VIA ANGIOGRAM THAT PERFORATION OCCURRED AT THE PROXIMAL CIRCUMFLEX ARTERY. ANOTHER BALLOON CATHETER FOLLOWED BY A 3.0X16MM GRAFTMASTER NON-BSC STENT WAS USED TO COVER MOST OF THE PERFORATION. ANOTHER 4.0X12MM SYNERGY DES WAS DEPLOYED AND POST-DILATED WITH A 5.0X8MM NC EMERGE BALLOON CATHETER LIMITING THE PERFORATION TO A SMALL TRICKLE. THE PATIENT'S ANTICOAGULATION WAS REVERSED WITH PROTAMINE TO FURTHER PROMOTE CLOSURE OF THIS PERFORATION. THE PATIENT WAS FOLLOWED CL

  Patient problems: Perforation

  MAUDE report 8515999 ↗
• MalfunctionMar 13, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ENTERING THE CATHETER IT WAS NOTED THAT THE SHAFT GOT KINKED AND BROKE 120CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417653 ↗
• MalfunctionFeb 4, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. DURING PREPARATION OF A 4.00 X 12 SYNERGY STENT, IT WAS NOTED THAT THE SYSTEM BALLOON WAS ALREADY INFLATED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8302462 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE MAIN BODY WAS FRACTURED MORE THAN 15CM FROM THE HUB, RESULTING IN TWO SEPARATE PIECES OF THE STENT DELIVERY SYSTEM (SDS). IT WAS NOTED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE STENT NEVER EXITED THE GUIDING CATHETER AND SO THE ENTIRE FRACTURED SDS WAS REMOVED TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT HARM NOR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8138528 ↗
• DeathOct 15, 2018Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT A DEATH HAD OCCURRED. IN (B)(6) 2017 THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS FURTHER REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 95% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.00 X 20 STUDY STENT. FOLLOWING, POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY WITH 90% STENOSIS AND WAS 4 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.8MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00X12 STUDY STENT. FOLLOWING, POST DILATATION, THE RESIDUAL STENOSIS WAS 10%. THAT SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018 THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 7966594 ↗
• MalfunctionJun 27, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE IN-STENT RESTENOSED PREVIOUS NON-BSC STENT WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.0 X 38 STENT WAS DEPLOYED IN THE MID TO DISTAL PORTION OF THE PREVIOUS STENT AND THEN OVERLAPPED IT WITH A 4.00 X 12 SYNERGY II IN THE PROXIMAL PORTION. HOWEVER, UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE CATHETER BECAME STUCK ON THE WIRE. BOTH DEVICES WERE REMOVED TOGETHER. THE 4.00 X 12 SYNERGY II STENT WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643865 ↗
• MalfunctionJun 21, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 4.00 X 12 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT STRUTS WERE FRAYED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7627840 ↗
• MalfunctionMay 2, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT STRUT WAS FRAYED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7481959 ↗
• MalfunctionMar 28, 2018Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  SAME CASE AS MDR ID#: 2134265-2018-02329 AND 2134265-2018-03092. IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AFTER ENGAGING THE LESION WITH A NON-BSC GUIDE CATHETER AND A GUIDEZILLA GUIDE EXTENSION CATHETER, A 4.00X12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS NOT PLACED CORRECTLY AND THE PHYSICIAN THEN PULLED THE STENT BACK THROUGH BOTH DEVICES. AS THE PHYSICIAN PUT THE STENT BACK IN, THE STENT GOT STRIPPED OFF THE BALLOON AT THE TRANSITION, AT THE COLLAR OF THE GUIDEZILLA. THE STENT WAS REMOVED WITH THE BALLOON TOGETHER. FURTHERMORE, A 4.00X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED; HOWEVER AT SOME POINT DURING THE PROCEDURE, THE PHYSICIAN CLAIMED THAT WHEN THE DEVICE WAS REMOVED THE BALLOON LOOKED LARGER ON EITHER SIDE OF THE STENT. THUS, THE PHYSICIAN OPTED NOT TO USE THE DEVICE. 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 7376842 ↗
• MalfunctionMar 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER WAS PRESENT ON THE DEVICE. A 4.00 X 12MM SYNERGY II STENT WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE PHYSICIAN TOOK THE PROTECTIVE SHEATH OFF FROM THE DEVICE, IT WAS NOTED THAT THERE WAS SOMETHING "SUSPICIOUS" ON THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 7331403 ↗
• MalfunctionJan 10, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT HAD DIFFICULTIES ADVANCING THROUGH THE GUIDE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE MIDDLE OF THE STENT WAS FRAYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178999 ↗
• MalfunctionNov 8, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-OCT-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 4.00 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT MOVED ON BALLOON AND STENT DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7012442 ↗
• InjuryNov 2, 2017Material Rupture; Activation, Positioning or Separation Problem; Material Rupture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND PARTIAL DEPLOYMENT OF STENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00 X 12 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED TO TREAT THE LESION. DURING MID INFLATION, THE BALLOON RUPTURED RESULTING TO PARTIAL DEPLOYMENT OF THE STENT. MULTIPLE BALLOONS WERE THEN USED TO APPOSE THE SYNERGY STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6996808 ↗
• DeathSep 7, 2017Adverse 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) 2016, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 50% STENOSIS AND WAS 6MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF 4.00X12MM SYNERGY II STUDY STENT. FOLLOWING POST-DILATATION THE RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT DIED. SITE HAS REPORTED AN EVENT OF "CARDIAC ARREST; SHOCK FOR VENTRICULAR TACHYCARDIA; LEAD TO DEATH." AS PER INFORMATION RECEIVED FROM THE SITE, PATIENT WAS GIVEN SHOCK FOR THE VENTRICULAR FIBRILLATION EPISODES. THE FOLLOWING DAY, THE PATIENT'S WIFE WAS CONTACTED, SHE SAID THAT "SHOCK DIDN'T WORK".

  Patient problems: Cardiac Arrest; Death; Ventricular Fibrillation; Ventricular Tachycardia

  MAUDE report 6849785 ↗
• MalfunctionAug 7, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, BEFORE THE STENT COULD FULLY ADVANCE INTO THE GUIDE CATHETER, THE SHAFT WAS BENT AND BROKE AT APPROXIMATELY 25CM FROM THE HUB OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6772631 ↗
• InjuryJul 24, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 4.00 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON AND WAS CAUGHT UP IN THE LESION. THE DISLODGED STENT WAS THEN TRAPPED IN THE TOUHY AND WAS ABLE TO BE REMOVED FROM THERE WITHOUT ANY OTHER ADDITIONAL INTERVENTION PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.00 X 12 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6739023 ↗
• MalfunctionJun 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00MM X 12MM SYNERGY II STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, INSIDE THE PATIENT, IT WAS NOTED THAT THE STENT WAS NOT ATTACHED TO THE BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 6638549 ↗
• InjuryJun 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE CAUSE OF DISSECTION WAS "GUIDE INDUCED" AFTER THE STENT PLACEMENT AND NOT DUE TO THE STENT AS PREVIOUSLY REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 6619092 ↗
• InjuryJun 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE CAUSE OF DISSECTION WAS "GUIDE INDUCED" AFTER THE STENT PLACEMENT AND NOT DUE TO THE STENT AS PREVIOUSLY REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 6613150 ↗