SYNERGY™ H7493926020300Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 08714729840176), received between Dec 2, 2016 and Apr 30, 2025 — classified as 9 deaths, 20 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 90 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2019, A 2.50 MM X 20 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 3.00 MM X 20 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PROXIMAL LAD. ON (B)(6) 2025, THE SUBJECT STARTED EXPERIENCING SYMPTOMS ASSOCIATED WITH UNSTABLE ANGINA. AT THE TIME OF THE EVENT THE SUBJECT WAS ON ASPIRIN AND TICAGRELOR. CORONARY ANGIOGRAPHY REVEALED 50 TO 60% IN STENT RESTENOSIS (ISR) AT THE LAD. ON (B)(6) 2025, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS ADMITTED TO HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. TTE REVEALED 50-55% LVEF. ON (B)(6) 2025, THE 100% STENOSIS AT THE LEFT MAIN WAS TREATED WITH A DES AND BALLOON ANGIOPLASTY CATHETER. TARGET VESSEL REVASCULARIZATION WAS ALSO PERFORMED AND THE LEFT CIRCUMFLEX ARTERY WAS STENTED. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE EVENT WAS CONSIDERED AS RESOLVED AND SUBJECT WAS DISCHARGED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE SUBJECT STARTED EXPERIENCING SYMPTOMS ASSOCIATED WITH CHEST PAIN. ON (B)(6) 2025, THE SUBJECT PRESENTED TO HOSPITAL WITH CHEST PAIN AND WAS HOSPITALIZED F

  Patient problems: Angina; Chest Pain; Myocardial Infarction; Restenosis

  MAUDE report 21933308 ↗
• DeathMar 17, 2022Obstruction of Flow; Obstruction of Flow

  SAME CASE AS PR ID# (B)(4). EVOLVE_LV_XLV IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT INDEX PROCEDURE WAS PERFORMED AND QUALIFYING CONDITION WAS UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE SUBJECT WAS ENROLLED IN THE 4.5/5.0 COHORT OF THE EVOLVE LV XLV STUDY. TARGET LESION 1 WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.50 MM X 28 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. ADDITIONALLY, NON-TARGET LESION WAS ALSO TREATED. THE NON-TARGET LESION 1 WAS LOCATED IN RIGHT- POSTERIOR DESCENDING ARTERY (R-PDA) WAS TREATED WITH PLACEMENT OF 2.25 MM X 32 MM SYNERGY STENT AND 3.00 MM X 28 MM SYNERGY STENT IN DISTAL RCA. ELECTROCARDIOGRAM (ECG) REVEALED SINUS RHYTHM, BORDERLINE PROLONGED PR INTERVAL, RIGHT BUNDLE BRANCH BLOCK AND IN (B)(6) 2021, REVEALED SINUS RHYTHM, LEFT ATRIAL ENLARGEMENT, LEFT VENTRICULAR HYPERTROPHY, NON-SPECIFIC T ABNORMALITY. ON THE SAME DAY, SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2021, POST INDEX PROCEDURE

  Patient problems: Anemia; Chest Pain; Fever; Ischemia; Myocardial Infarction; Respiratory Failure; Restenosis; Thrombosis/Thrombus

  MAUDE report 13791994 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20 SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS DAMAGED AND DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS UNHARMED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12209666 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 28 SYNERGY II DRUG ELUTING CORONARY STENT SYSTEM WAS ADVANCED, HOWEVER, DURING THE STENT INSERTION TO THE GUIDE CATHETER THE STENT SHAFT BROKE. NO PATIENT COMPLICATIONS OR ISSUES THAT HE IS AWARE OF AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203889 ↗
• MalfunctionJul 14, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. FOLLOWING PRE-DILATION WITH A 3.00 X 12 NON-BOSTON SCIENTIFIC NONCOMPLIANT BALLOON DILATATION CATHETER, A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT FRAYED AT DISTAL TIP. THE PROCEDURE WAS COMPLETED BY USING A 3.0X12 NON-BSC CORONARY BALLOON INTRAVASCULAR LITHOTRIPSY AND PLACEMENT OF 2.5X15, 2.5X18 AND 3.0X15 NON-BSC STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167950 ↗
• MalfunctionJun 21, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION AND THE STRUTS WERE DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, SEVERELY TORTUOUS AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.0X20 EMERGE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035627 ↗
• MalfunctionMay 10, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, THE STENT STRUTS WERE NOTED TO BE DEFECTIVE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795767 ↗
• MalfunctionApr 21, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01APR2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.00 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704477 ↗
• MalfunctionFeb 10, 2021Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND STENT DISLODGMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH ANOTHER MANUFACTURES 2.5X12 BALLOON. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED THROUGH A NON-BSC GUIDE EXTENSION CATHETER TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN TRIED TO PUT THE STENT THROUGH THE EXTENSION CATHETER, THE STENT WOULD NOT GO. THE GUIDELINER, THE GUIDE WIRE AND THE STENT WERE REMOVED AS A WHOLE FROM THE PATIENT'S BODY AND IT WAS NOTICED THAT THE STENT WAS DAMAGED AND OFF THE BALLOON. IT APPEARED THAT THE STENT WAS INTACT AND NOTHING WAS LEFT IN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH BALLOON DILATION. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAS MODERATE CALCIUM AND TORTUOUSITY WAS SITED. A 6F GUIDELINER WAS USED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309608 ↗
• MalfunctionSep 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATION OF A 3.0 NC EMERGE BALLOON CATHETER, A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT IT FAILED TO DELIVER AND SO, A 6F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS USED. HOWEVER, IT FELT LIKE THE CATHETER WAS HUNG UP ON SOMETHING. AFTER REMOVAL, IT WAS NOTICED THAT THE STENT WAS COMPLETELY DISLODGED FROM THE BALLOON AND WAS FURTHER PROXIMAL ON THE CATHETER. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 3.0X12 NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567489 ↗
• MalfunctionAug 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 3.00 X 20MM SYNERGY DRUG ELUTING STENT, IT WAS NOTED THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10436995 ↗
• MalfunctionAug 6, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10375040 ↗
• MalfunctionJul 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT HAD A SECTION NEAR ONE END OF THE BALLOON THAT WAS OFF THE BALLOON AND HAD A SEGMENT STICKING UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE STENT WAS STICKING UP AFTER WITHDRAWAL FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264632 ↗
• MalfunctionMay 26, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED VESSEL. FOLLOWING PRE-DILATATION WITH A 2.5 X 15MM APEX BALLOON CATHETER, A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS. UPON REMOVAL, IT WAS NOTED THAT THE STENT DEVELOPED A BURR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086845 ↗
• MalfunctionMay 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT A STENT STRUT STUCK OUT AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10048428 ↗
• InjuryApr 1, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURED. A 3.00X20MM SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, IN LESS THAN AN HOUR, STENT THROMBOSIS OCCURRED. THE PATIENT HAD PLAVIX AND HEPARIN ON BOARD AND WAS BROUGHT BACK TO THE LAB. BALLOONING WAS PERFORMED FOLLOWED WITH INTRAVASCULAR ULTRASOUND WHICH REVEALED STENT WAS EXPANDED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Code Available; Thrombosis

  MAUDE report 9910408 ↗
• MalfunctionFeb 4, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20 SYNERGY II DRUG-ELUTING STENT SELECTED FOR USE. HOWEVER, WHILE INSERTING THE DEVICE INTO THE GUIDE, THE STENT CATHETER SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 9664168 ↗
• MalfunctionJan 27, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED WITH A 3.00X20 EMERGE BALLOON CATHETER, A 3.00X20MM SYNERGY II DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. RESISTANCE WAS ENCOUNTERED DUE TO SOME MINOR CALCIFICATION AND SEVERE TORTUOSITY OF THE VESSEL AND THE CATHETER SNAPPED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY DES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633723 ↗
• InjuryJan 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT EXPERIENCED HYPOTENSION AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER ADVANCING THE 300CM MARVEL GUIDEWIRE, A 3.00 X 20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. THE STENT WAS REMOVED AND THE WIRE WAS REPOSITIONED. IT WAS THEN NOTICED THAT THE STENT WAS UNABLE TO ADVANCED OVER THE WIRE AND THE TIP WAS DRAGGING THE COATING MATERIAL OFF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Injury; Low Blood Pressure/ Hypotension; Respiratory Failure

  MAUDE report 9570731 ↗
• MalfunctionDec 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS FLARED. THE DEVICE WAS NEVER USED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 9517380 ↗
• MalfunctionDec 4, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE DEVICE WOULD NOT DELIVER OVER A NON-BSC GUIDE WIRE AND WHEN THE STENT CAME BACK THROUGH A 6F NON-BSC GUIDE CATHETER, A STENT STRUT LIFTED WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410523 ↗
• MalfunctionNov 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, AFTER PREPARATION WHILE INSPECTING THE PRODUCT, IT WAS NOTICED THAT THE STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9380050 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125878 ↗
• MalfunctionSep 18, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 27-AUG-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED CORONARY VESSEL. A 3.00X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO THE CROSS LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082837 ↗
• MalfunctionSep 13, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT GROIN ARTERY. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN TRIED TO INSERT THE DEVICE, THE STENT GOT CAUGHT INSIDE THE NON-BSC DEVICE AND WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE EDGE OF THE STENT STRUTS WERE ROLLED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038681 ↗