SYNERGY™ H7493926020220Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729840145), received between Nov 15, 2016 and Jul 14, 2022 — classified as 4 deaths, 12 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT MOVED ON BALLOON OCCURRED. DURING PREPARATION OF A 2.25 X 20 SYNERGY DRUG-ELUTING STENT, THE PHYSICIAN NOTICED A KINK IN THE DELIVERY SYSTEM CLOSE TO STENT AND THE STENT APPEARED TO BE LOSE ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15016202 ↗
• MalfunctionOct 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 20 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, DURING PREPARATION, THE STENT FELL OF THE BALLOON WHEN THE STYLET WAS BEING REMOVED FROM THE END OF THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12650675 ↗
• InjuryFeb 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WERE TWO LAYERS OF STENTS IN THE PROXIMAL LAD. A 2.25 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON REMOVAL OF THE DELIVERY SYSTEM, THE STENT COULD NO LONGER BE VISUALIZED. AT THIS POINT IN TIME, IT IS BELIEVED THAT THE STENT CAME OFF OF THE DELIVERY SYSTEM AND WAS LOST IN THE PATIENT. THE PATIENT WAS THEN SENT FOR A COMPUTED TOMOGRAPHY (CT) SCAN, AND UPON INSPECTION OF THE PATIENT ARTERIES, NO STENT WAS FOUND. IN AN ATTEMPT TO LOCATE THE STENT, THE GUIDE CATHETER AND HEMOSTASIS VALVE WERE OPENED BUT THE STENT COULD NOT BE FOUND. THE LESION DID NOT GET REVASCULARIZED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Insufficient Information

  MAUDE report 11306856 ↗
• MalfunctionSep 15, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20AUG2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.25 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT WAS KINKED AND COULD NOT BE USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Patient Involvement

  MAUDE report 10536517 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE DEVICE BROKE AND WAS UNABLE TO CROSS THE LESION. NO PATIENT COMPLCIATIONS WERE REPORTED. IT WAS FURTHER REPORTED THE TARGET LESION WAS 80% STENOSED AND WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE BREAK OCCURRED APPROXIMATELY 40CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144066 ↗
• MalfunctionFeb 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREAMENT. HOWEVER, THE STENT FELL OFF BALLOON MID PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9666852 ↗
• MalfunctionJan 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.25X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHILE ATTEMPTING TO DEPLOY THE STENT, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9555243 ↗
• InjuryDec 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN WITHDRAWING THE DEVICE FROM THE BODY, THE STENT CAME OFF AND ENDED UP IN THE RIGHT CORONARY ARTERY (RCA). THE STENT WAS THEN CRUSHED, CAUSING A DISSECTION IN THE DISTAL RCA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 9527012 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL BRANCH. A 2.25 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT THE BACK HALF OF THE SHAFT GOT KINKED AND WAS BROKEN. THE REST OF THE SHAFT WAS PULLED OUT AND 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 9521634 ↗
• MalfunctionDec 6, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PHYSICIAN ATTEMPTED TO PASS 2.25 X 20 SYNERGY DRUG-ELUTING STENT THROUGH AN INTERNAL MAMMARY GRAFT TO THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE STENT WAS UNABLE TO COMPLETELY ADVANCE AND IT WAS REMOVED SO THAT THE AREA OF THE VESSEL COULD BE PREDILATED. WHEN THE STENT WAS REMOVED IT WAS NOTED THAT ONE OF THE STENT STRUTS ON PROXIMAL PORTION OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A 2.25 X 16 SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9427683 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-HEAVILY CALCIFIED ARTERY. FOLLOWING PRE-DILATATION, A 2.25 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DETACHED PORTION CAME OUT WITH THE REMOVAL OF THE WIRE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216200 ↗
• MalfunctionOct 2, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN ATTEMPT TO INSERT THE STENT, THE SHAFT BROKE IN HALF. THE DEVICE WAS NEVER ENTERED INTO THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Patient Involvement

  MAUDE report 9147976 ↗
• MalfunctionJul 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 2.25 X 20 SYNERGY DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT STRUTS WERE DEFECTIVE UPON REMOVAL FROM THE HOOP. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8789530 ↗
• MalfunctionMay 16, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX. AFTER ABLATION WAS PERFORMED USING A 1.5MM ROTABURR A 3.0 X 20 SYNERGY DRUG-ELUTING STENT (DES) WAS PLACED. A 2.25 X 20 SYNERGY DES WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE 2.25 X 20 SYNERGY DES WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE STENT WAS DISLODGED ON THE BALLOON SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618043 ↗
• MalfunctionJan 28, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 20 SYNERGY STENT WAS SELECTED FOR TREATMENT. HOWEVER, STENT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT WAS FRACTURED. 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 8283892 ↗
• DeathOct 25, 2018Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Migration; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Migration

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. CORONARY ANGIOGRAPHY WAS PERFORMED OF THE LEFT CORONARY ARTERY AND RIGHT CORONARY ARTERY. LEFT VENTRICULOGRAPHY WAS PERFORMED OF THE LEFT VENTRICLE. AT THIS POINT, THE PATIENT WAS MADE READY FOR PERCUTANEOUS CORONARY INTERVENTION TO THE OSTIAL LEFT CIRCUMFLEX (LCX) AND POSSIBLE TO THE LESION MORE DISTAL IN THE 1ST OBTUSE MARGINAL (OM1). THESE LESIONS WERE HEAVILY CALCIFIED. BALLOON ANGIOPLASTY OF THE SECOND OM AND IMPROVED THE CHANNEL TO THE OM1. BALLOON ANGIOPLASTY WAS THEN PERFORMED OF THE OM1. ANGIOGRAPHY DEMONSTRATED 70-80% RESIDUAL STENOSIS WITH NO DISSECTION AND COMPLETE TIMI-3 FLOW DISTALLY. ADDITIONAL BALLOON ANGIOPLASTY WAS THEN PERFORMED OF THE OM1, RESULTING IN 60-70% RESIDUAL STENOSIS WITH NO DISSECTION AND COMPLETE TIMI-3 FLOW DISTALLY. ADDITIONAL DILATION PERFORMED ON THE DISTAL OM STENOSIS. THE BALLOON CATHETER WAS DEFLATED AND REMOVED. A 2.50X8MM SYNERGY STENT WAS THEN ADVANCED TO THE OSTIAL CIRCUMFLEX LESION AND COULD NOT BE ADVANCED FURTHER. THE STENT WAS DEPLOYED IN THE OSTIAL CIRCUMFLEX. FINAL ANGIOGRAPHY OF THE OSTIAL CIRCUMFLEX SHOWED EXCELLENT APPEARANCE OF

  Patient problems: Death

  MAUDE report 8005485 ↗
• InjuryJun 21, 2018Occlusion Within Device; Occlusion Within Device

  EVOLVE SHORT DAPT CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED AND THE PATIENT EXPERIENCED ANGINA. IN APRIL 2017, CLINICAL STATUS ASSESSMENT INDICATED THE PATIENT'S QUALIFYING CONDITION AS STABLE ANGINA AND WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 75% STENOSIS AND WAS 18MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25X20MM SYNERGY II STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL ON THE SAME DAY. IN (B)(6) 2018, THE PATIENT EXPERIENCED MID RETRO STERNAL CHEST PRESSURE. THE PATIENT STATED THAT SHE HAS HAD CHEST PAIN A COUPLE OF TIMES IN PAST FEW WEEKS THAT WOKE HER UP AND WERE RELIEVED WITH NITROGLYCERIN. THE PATIENT ALSO EXPERIENCED SHORTNESS OF BREATH. THE PATIENT WAS DECIDED TO PROCEED WITH CARDIAC CATHETERIZATION FOR FURTHER EVALUATION. FOUR DAYS AFTER, THE PATIENT PRESENTED TO THE HOSPITAL FOR PLANNED CARDIAC CATHETERIZATION. ON CARDIOVASCULAR EXAMINATIONS, THE PATIENT WAS NOTED TO HAVE CHEST PAIN AND PAROXYSMAL

  Patient problems: Angina; Dyspnea; Reocclusion

  MAUDE report 7626103 ↗
• InjuryMay 8, 2018Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 20MM SYNERGY DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS ATTEMPTED TO BE RETRIEVED BACK TO THE GUIDE, THE STENT GOT STRIPPED OFF FROM THE BALLOON INTO THE VESSEL. THE PHYSICIAN KEPT THE WIRE IN POSITION AND DEPLOYED THE DISLODGED STENT IN THE LEFT MAIN. THE PHYSICIAN THEN TOOK A 2.50 AND A 3.0 BALLOON CATHETER TO POST-DILATE THE STENT AT ABOUT 4MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496930 ↗
• DeathApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED IN (B)(6) 2017, THE CAUSE OF DEATH WAS END STAGE RENAL DISEASE AND WAS NOT CONSIDERED RELATED TO THE STUDY DEVICE. PER DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS END STAGE RENAL DISEASE OR A CONSEQUENCE OF TYPE 2 DIABETES. OTHER SIGNIFICANT CONDITION CONTRIBUTING TO DEATH WAS CONGESTIVE HEART FAILURE. PER DEATH CERTIFICATE AUTOPSY WAS NOT PERFORMED AND THE MANNER OF DEATH WAS NATURAL. THE SUBJECT DIED AT HOME.

  Patient problems: Death

  MAUDE report 7466486 ↗
• MalfunctionApr 18, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-MARCH-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.25 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROXIMAL STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441843 ↗
• MalfunctionFeb 20, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, THE SHAFT BROKE WHILE ATTEMPTING TO INSERT THE DEVICE INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7283859 ↗
• MalfunctionSep 13, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 22-AUG-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED CIRCUMFLEX ARTERY. A 2.25 X 20 SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6862171 ↗
• InjurySep 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI). THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND A 90% STENOSED, 20MM LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED POSTERIOR DESCENDING ARTERY (PDA). A NON BSC GUIDE CATHETER AND GUIDEWIRE WERE SELECTED AND SUCCESSFULLY CROSSED THE LESION. THE 100% OCCLUDED LESION WAS SUCCESSFULLY PREDILATED WITH A 2.0X12MM NON BSC BALLOON CATHETER. A 2.0X20MM EMERGE WAS USED TO SUCCESSFULLY PREDILATE THE PDA. A 2.25X28 MM SYNERGY II WAS ADVANCED IN THE PDA USING A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER BUT FAILED TO CROSS THE LESION. ANOTHER PREDILATION WITH EMERGE WAS MADE AND THE SYNERGY WAS RE-ADVANCED BUT STILL FAILED TO CROSS THE MID RCA LESION. THE STENT WAS REMOVED AND A 2.25X20MM NON BSC BALLOON CATHETER WAS USED TO PREDILATE THE MID RCA LESION. SEVERAL ATTEMPTS WERE MADE TO ADVANCE A NEW 2.25X20 SYNERGY II STENT TO THE PDA THROUGH THE PROXIMAL RCA BUT THE STENT FAILED TO CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS REMOVED BUT THE STENT HAD DISLODGED IN THE RCA. AN ATTEMPT TO SNARE THE STENT FAILED. THE STEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849691 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE DELIVERY SHAFT SNAPPED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25X20 SYNERGY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON ADVANCING THE DEVICE THROUGH THE GUIDE CATHETER, THE SHAFT SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731761 ↗
• MalfunctionJul 20, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PATENT DUCTUS ARTERIOSUS (PDA). A 2.25 X 20 SYNERGY II DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. AFTER THE STENT WAS WELL DEPLOYED, THE BALLOON WAS SUCCESSFULLY DEFLATED; HOWEVER, THE BALLOON WAS UNABLE TO BE RELEASED FROM THE STENT. SUBSEQUENTLY, AFTER A SIGNIFICANT AMOUNT OF PRESSURE, THE DEVICE WAS REMOVED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6730060 ↗