SYNERGY™ H7493926008350Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729840008), received between Dec 2, 2016 and Aug 11, 2025 — classified as 3 deaths, 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Bent” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathAug 11, 2025Nonstandard Device; Off-Label Use; Failure to Advance; Defective Device; Nonstandard Device; Off-Label Use; Failure to Advance; Defective Device

  IT WAS REPORTED THAT THE PATIENT DIED. TWO SYNERGY? 3.50 X 8 MM STENTS WERE IMPLANTED FOR TREATMENT OF A PATENT DUCTUS ARTERIOSUS (PDA). HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO FUNCTION AS INTENDED WHICH LED TO CARDIAC ARREST AND THE PATIENT DIED. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH A SMALL, SOMEWHAT TORTUOUS PDA TO CONFLUENT BRANCH PULMONARY ARTERIES. THE SYNERGY STENTS WERE SELECTED AS TREATMENT TO ALLOW FOR A STABLE SOURCE OF PULMONARY BLOOD FLOW. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND ACCESS WAS OBTAINED VIA THE LEFT AXILLARY ARTERY. THE PDA WAS CROSSED WITH DIFFICULTY AND A SYNERGY? 3.50 X 12 MM WAS ADVANCED. THE STENT WAS UNABLE TO ADVANCE IT PAST THE PULMONARY END OF THE PDA. ANGIOGRAPHY SHOWED SPASM OF THE PDA WITH NO OPACIFICATION OF THE BRANCH PAS. THE PROXIMAL END OF THE STENT PROTRUDED SIGNIFICANTLY INTO THE AORTA. HIGH DOSE PROSTAGLANDIN E1 (PGE) INFUSION WAS INITIATED AND THE STENT WAS EXCHANGED FOR A SYNERGY? 3.50 X 8 MM. THE STENT WOULD ALSO NOT ADVANCE PAST THE PA END OF THE DUCTUS, BUT WAS DEPLOYED AT 16ATM IN HOPES OF EXPANDING THE PDA AND ALLOWING PGE FLOW TO REOPEN THE MORE DISTAL PDA. THE STENT WAS WELL EXPANDED, BU

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Respiratory Failure

  MAUDE report 22773417 ↗
• DeathApr 18, 2025Nonstandard Device; Off-Label Use; Defective Device; Nonstandard Device; Off-Label Use; Defective Device

  IT WAS REPORTED THAT THE PATIENT DIED. A SYNERGY? 3.50 X 8 WAS ADVANCED FOR TREATMENT OF A PATENT DUCTUS ARTERIOSUS (PDA). HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO FUNCTION AS INTENDED WHICH LED TO CARDIAC ARREST AND THE PATIENT DIED.

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Respiratory Failure

  MAUDE report 21869018 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH/MAUDE REPORT #(B)(4) THAT SHAFT BREAK OCCURRED. DURING INSERTION OF A 3.50 X 8 SYNERGY DRUG-ELUTING STENT INTO A GUIDE CATHETER, THE SHAFT SNAPPED IN HALF. THE DEVICE HAD NOT ENTERED THE PATIENT AND WAS EASILY PULLED BACK OUT OF THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10760193 ↗
• MalfunctionAug 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND ON THE DEVICE. A 3.50 X 8MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. THE DEVICE WAS OPENED IN A STERILE MANNER, HOWEVER, DURING PREPARATION, A FOREIGN OBJECT WAS OBSERVED. THE STENT WAS ADVANCED INTO THE GUIDE CATHETER BUT WOULD NOT PASS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10387960 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURED. DURING PREPARATION OF A 3.50 X 8 MM SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8917255 ↗
• 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 3.50 X 8 MM 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 OUT SIDE OF THE CATHETER. ANOTHER 3.50 X 12 MM 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 4.5 MM 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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8700907 ↗
• InjuryFeb 12, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. A 3.5X8MM SYNERGY II DRUG ELUTING STENT WAS DEPLOYED TO TREAT THE TARGET LESION. HOWEVER, TWO HOURS POST-DEPLOYMENT, THE PATIENT DEVELOPED CHEST PAIN AND ELECTROCARDIOGRAPHY (ECG) WAS PERFORMED. THROMBOSIS WITHIN THE PREVIOUSLY IMPLANTED STENT WAS NOTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY WAS PERFORMED AND A NON BSC HEART PUMP WAS PLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 8331599 ↗
• DeathJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2018-05803. (B)(6) STUDY. IT WAS REPORTED THAT THE SUBJECT DIED. IN (B)(6) 2018, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: 2) AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. TARGET LESION #1 WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 8 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 8 MM STUDY STENT. FOLLOWING, POST-DILATATION RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN DISTAL LAD WITH 80% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 20 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. SIXTEEN DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED DUE TO ACUTE ON CHRONIC CONGESTIVE HEART FAILURE. THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. TWENTY-EIGHT DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED IN RESPONSE TO ¿FOREIGN BODY REMOVAL: ESOPHAGUS.¿ AN INTERVENTIONAL PROCEDURE WAS PERFORMED IN RESPONSE TO THE EVENT. IN (B

  Patient problems: Death

  MAUDE report 7647822 ↗
• MalfunctionApr 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50 X 8 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. THE DEVICE WAS ADVANCED OVER A GUIDE WIRE, THROUGH THE GUIDE CATHETER; HOWEVER, A STENT "FLOATING" ON THE SHAFT OF THE DELIVERY SYSTEM WAS NOTED. THE DELIVERY SYSTEM WAS REMOVED FROM THE WIRE. HOWEVER, UPON INSPECTION, THERE WAS THE CRIMPED STENT ON THE BALLOON ALONG WITH THE "FLOATING" STENT. THE DEVICE WAS NEVER USED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429079 ↗
• MalfunctionAug 18, 2017Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX (CX) ARTERY. A 3.50 X 8 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS ADVANCED IN THE GUIDE CATHETER. HOWEVER, THE STENT STRUTS WAS DAMAGED BY THE SHAFT OF THE BALLOON THAT WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE STENT WAS REMOVED FROM THE GUIDE, THE WIRES WERE MANIPULATED, AND A NEW 3.50 X 8 STENT WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID GREAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6804152 ↗
• MalfunctionAug 3, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED WITH A 3.0 X 8 APEX BALLOON CATHETER, A 3.50 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE STENT STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50 X 8 SYNERGY II DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765329 ↗
• MalfunctionFeb 21, 2017Bent; Device Damaged Prior to Use; Device Dislodged or Dislocated; Bent; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. A 3.50 X 8 SYNERGY II DRUG ELUTING STENT (DES) WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON BUT WAS FOUND ON THE STYLET AFTER THE STYLET HAD BEEN REMOVED FROM THE CATHETER. IT WAS ALSO NOTICED THAT THE STENT LOOKED ELONGATED AND WRAPPED UP. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6345339 ↗
• InjuryDec 2, 2016Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  SAME CASE AS MDR ID: 2134265-2016-11190, 2134265-2016-11285. IT WAS REPORTED VIA FACILITY MEDWATCH# MW5065811 THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION. SUBSEQUENTLY, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WITH PERCUTANEOUS INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATION WAS PERFORMED USING A 2.5X12MM BALLOON, A 3.5X16MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. THE PROXIMAL PORTION OF THE RCA WAS TREATED WITH A 3.5X8MM SYNERGY II DRUG-ELUTING STENT OVERLAPPING THE 3.5X16MM SYNERGY II STENT. A 3.0X8MM SYNERGY II DRUG-ELUTING STENT WAS ALSO IMPLANTED DISTALLY AND OVERLAPPING THE 3.5X16MM SYNERGY II STENT. THE STENTS WERE POSTDILATED WITH A 3.5MM NON COMPLIANT BALLOON CATHETER FOLLOWED BY A 4.0MM NON COMPLIANT BALLOON CATHETER. ANGIOGRAPHY WAS PERFORMED AND REVEALED THAT THE STENTS APPEARED TO BE WELL-EXPANDED WITH NO EVIDENCE OF DISSECTIONS AND TIMI 3 FLOW THROUGHOUT THE CORONARY ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE NON-BSC GUIDEWIRE FOR FINAL ANGIOGRAPHY UNDER FLUOROSCOPY. AFTER INITIAL WITHDRAWAL OF THE GUIDEWIRE, THE VERY DISTAL PORTION OF THE RADIOPAQUE TIP OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6141614 ↗