SUPERA S-50-120-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08717648211775), received between May 12, 2017 and Aug 11, 2026 — classified as 24 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (19 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Material Separation; Improper or Incorrect Procedure or Method

  It was reported this was a procedure to treat a heavily calcified, heavily tortuous, and 98% stenosed superficial femoral artery. A Supera 5.0x120 was inserted and placed at the target lesion. However, after the stent was released and the delivery system was withdrawn from the body, the distal tip was found detached and trapped on the guide wire. It was noted the thumb slide was not fully retracted, and the system lock and deployment lock were not rotated into the locked position. A snare was inserted to retrieve the detached fragment. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214011 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6) IT WAS REPORTED THAT ON (B)(6) 2025 TWO ABSOLUTE PRO STENTS (6.0X100 AND 6.0X80 MM) AND ONE 5.0X12 MM SUPERA STENT WERE IMPLANTED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (LSFA). ONE 6.0X100 MM, NON-ABBOTT STENT WAS ALSO IMPLANTED IN THE LSFA. IN (B)(6) 2025 THE PATIENT WAS FOUND TO HAVE THROMBUS (STENOSIS) WITHIN THE LSFA. BALLOON ANGIOPLASTY AND THROMBOLYSIS WERE PERFORMED. THE PHYSICIAN ASSESSED THAT THERE WAS LIKELY STENOSIS IN ALL FOUR IMPLANTED STENTS. THE PATIENT'S CONDITION HAS IMPROVED AND THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25881993 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT THE TIP OF A SUPERA STENT SYSTEM WAS FOUND TO HAVE FALLEN OFF [SEPARATED] WHEN REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436237 ↗
• MalfunctionFeb 11, 2026Premature Activation

  IT WAS REPORTED THAT DURING PREPARATION, UPON OPENING THE PACKAGE OF THE SUPERA SELF-EXPANDING STENT SYSTEM (SESS), THE STENT WAS OBSERVED EXPOSED AND NOT FLOWERED. THE SESS WAS NOT USED IN THE PATIENT AND ANOTHER SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317908 ↗
• MalfunctionJan 30, 2026Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION OVER A .014 GUIDE WIRE. AFTER APPROXIMATELY 5CM OF DEPLOYMENT, ADVANCEMENT USING THE THUMB SLIDE BECAME DIFFICULT AND DEPLOYMENT COULD NOT BE PERFORMED AS EXPECTED. DEPLOYMENT WAS THEREFORE ABANDONED, AND THE PARTIALLY DEPLOYED SUPERA WAS WITHDRAWN FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222565 ↗
• MalfunctionJan 5, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LOWER LIMB ARTERY WITH 80% STENOSIS. THE 5.0X120 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED. THE ROLLER BECAME STUCK AND THE STENT COULD NOT BE FULLY RELEASED. THE STENT WAS MANUALLY RETRACTED BACK INTO THE SHEATH AND REMOVED FROM THE BODY. A DRUG COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED CHINA REPORT IT WAS REPORTED THE STENT ONLY PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960790 ↗
• MalfunctionNov 5, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 70% STENOSED. THE VESSEL WAS PREPPED WITH A 5.0X150MM NON-ABBOTT BALLOON AT 7 ATMOSPHERES FOR 5 MINUTES. DURING DEPLOYMENT OF THE 5.0X120MM SUPERA SELF-EXPANDING STENT DIFFICULTLY WAS NOTED AS IT ONLY PARTIALLY DEPLOYED AND THE RELEASE LOCK WAS OPENED, BUT FAILED. AFTER REPEATED CAREFUL ROTATION OF THE CATHETER, THE STENT FINALLY FULLY RELEASED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480272 ↗
• InjuryNov 3, 2025Material Separation; Stretched; Patient-Device Incompatibility; Material Separation; Stretched; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL (SFA) ARTERY. THE 5.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED; HOWEVER A WAIST WAS NOTED IN THE PROXIMAL SEGMENT OF THE STENT. DURING RETRACTION OF THE SES THE NOSE CONE BECAME CAUGHT IN A VERY TIGHT LESION IN THE ANATOMY AND STRETCHED AND THEN SEPARATED, REMAINING ON THE 0.18 GUIDE WIRE IN THE ANATOMY. THE TIP OF A THROMBECTOMY CATHETER WAS USED TO SNARE THE NOSE CONE AND PULL IT BACK INTO THE CATHETER, REMOVING IT FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451836 ↗
• InjuryJun 11, 2025Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  USER FACILITY MEDWATCH REPORT (B)(4) RECEIVED THAT STATES. ¿DESCRIBE THE EVENT OR PROBLEM: THE STENT WAS DEPLOYED BUT IT APPEARS THAT THE DELIVERY DEVICE FAILED TO DETACH FROM THE STENT. WE TRIED SEVERAL ATTEMPTS TO MANIPULATE THIS, BUT IT WAS NOT POSSIBLE TO DETACH THE STENT FROM THE DELIVERY SYSTEM. THE STENT GOT PULLED PARTIALLY INTO THE SHEATH. SO, AT THIS POINT WE DECIDED TO PERFORM AN OPEN CUTDOWN TO SAFELY EXPLANT THIS STENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LEFT LEG ARTERIOGRAM WITH INTERVENTION WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN; "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190129 ↗
• MalfunctionMay 22, 2025Separation Failure

  THE STENT WAS DEPLOYED BUT IT APPEARS THAT THE DELIVERY DEVICE FAILED TO DETACH FROM THE STENT. WE TRIED SEVERAL ATTEMPTS TO MANIPULATE THIS, BUT IT WAS NOT POSSIBLE TO DETACH THE STENT FROM THE DELIVERY SYSTEM. THE STENT GOT PULLED PARTIALLY INTO THE SHEATH. SO, AT THIS POINT WE DECIDED TO PERFORM AN OPEN CUTDOWN TO SAFELY EXPLANT THIS STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069660 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED; HOWEVER, POST STENT IMPLANTATION THE PATIENT DEVELOPED STENT THROMBOSIS. THEREFORE, AN ASPIRATION DEVICE WAS USED TO TREAT THE THROMBUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21576790 ↗
• MalfunctionMar 4, 2025Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516767 ↗
• InjuryFeb 3, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A COMMON FEMORAL ARTERY. THE ARTERY WAS PREPPED WITH A 5.0X150MM UNSPECIFIED BALLOON AND 5.0X12MM SUPERA SELF-EXPANDING STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, DURING REMOVAL UNDER FLUOROSCOPY RESISTANCE WAS FELT WITH A PREVIOUSLY IMPLANTED STENT AND THE TIP OF THE DELIVERY SYSTEM SEPARATED. THE TIP WAS REMOVED VIA SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296408 ↗
• MalfunctionJul 29, 2024Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851479 ↗
• MalfunctionJun 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE FEMORAL AND POPLITEAL ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. DURING PREPARATION OF THE 5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), WHILE FLUSHING THE GUIDE WIRE PORT, THE TIP OF THE CATHETER SEPARATED. THEREFORE THE SESS WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AN NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538334 ↗
• MalfunctionJun 7, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 93% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE VESSEL DIAMETER WAS 5MM AND WAS PREPARED WITH A 5.0X100MM BALLOON WITH 10 RATED PRESSURE THAT LASTED 3 MINUTES. THE 5.0X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS NOT FULLY DEPLOYED AS THE PHYSICIAN FORGOT TO OPEN THE RELEASE LOCK AFTER RELEASING THE STENT ALSO WITHDRAWING THE STENT FROM THE ANATOMY DURING REMOVAL UNDER FLUOROSCOPY. THERE WAS NO PROBLEM WITH THE DEPLOYMENT MECHANISM. ANOTHER SUPERA STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490464 ↗
• MalfunctionMay 24, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY WITH CALCIFICATION. THE 5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS RELEASED FROM THE DELIVERY SYSTEM. THE STENT PLACEMENT WAS CONFIRMED; HOWEVER, WHEN PULLING THE DELIVERY SYSTEM BACK, THE STENT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THEREFORE, THE COMPLETE SESS WAS REMOVED FROM THE PATIENT WITH THE STENT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393126 ↗
• MalfunctionMar 18, 2024Premature Activation; Activation Failure; Premature Activation; Activation Failure

  SUBSEQUENT TO THE INITIAL FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE, INDICATING THAT THE SUPERA STENT DID NOT ENTER THE PATIENT ANATOMY; HOWEVER, IT CANNOT BE CONFIRMED THAT THE STENT DELIVERY SYSTEM WAS NOT ON THE GUIDE WIRE WHEN THE STENT PARTIALLY DEPLOYED AND FLOWERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921670 ↗
• MalfunctionMar 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE SUPERA STENT WAS USED IN THE PATIENT AND IT WAS FOUND THE DEVICE WAS EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842366 ↗
• MalfunctionDec 1, 2023Premature Activation; Premature Activation

  IT WAS REPORTED WHEN REMOVING THE SUPERA SELF-EXPANDING STENT SYSTEM FROM THE PACKAGING IT WAS OBSERVED THE TIP OF THE STENT WAS FLOWERED. ANOTHER SAME SIZE SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS OBSERVED BLOOD IN THE DEVICE INDICATING THAT THE SUPERA SELF-EXPANDING STENT SYSTEM HAD BEEN ATTEMPTED TO BE ADVANCED. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THE DEVICE WAS ADVANCED ON THE GUIDE WIRE AND ATTEMPTED TO BE ADVANCED INTO THE SHEATH; HOWEVER, THE DEVICE DID NOT ENTER THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250238 ↗
• MalfunctionDec 22, 2022Stretched; Activation Failure; Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON AT 24 ATMOSPHERES (ATM) 3 TIMES FOR 60 SECONDS. THE 5.00X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE USED TO TREAT THE TARGET LESION; HOWEVER ONLY PARTIALLY DEPLOYED. THE STENT BECAME ELONGATED GREATER THAN 10% OF THE EXPECTED LENGTH. THEREFORE, THE SESS, INCLUDING THE STENT, WAS REMOVED FROM THE ANATOMY UNDER FLUOROSCOPY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040305 ↗
• MalfunctionDec 22, 2022Break; Failure to Advance; Deformation Due to Compressive Stress; Break; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO A HEAVILY CALCIFIED POPLITEAL ARTERY. THE 5.0X120 SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, MET RESISTANCE WITH ANATOMY. THE NOSE CONE (TIP) BECAME SEVERELY BENT AND THE DEVICE WAS WITHDRAWN WITHOUT ISSUE UNDER FLUOROSCOPY. OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT THE TIP WAS BARELY ATTACHED AND WAS DANGLING FROM THE DEVICE; HOWEVER, REMAINED ATTACHED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033629 ↗
• MalfunctionDec 13, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED FEMORAL ARTERY THAT IS 80% STENOSED. THE VESSEL WAS PRE-DILATED WITH A 5X150MM ARMADA 18 BALLOON DILATATION CATHETER FOR TWO MINUTES AT 8 ATMOSPHERES. THE 5.0X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) PARTIALLY DEPLOYED APPROXIMATELY 2 CENTIMETERS AS THE THUMBSLIDE WOULD NOT FURTHER DEPLOY THE STENT REGARDLESS BEING PRESSED REPEATEDLY. THE DEVICE WAS REMOVED UNDER FLUOROSCOPY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970479 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 5.0X120 MM SUPERA SELF EXPANDING STENT (SES) WAS IMPLANTED ON (B)(6) 2021 IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND ON (B)(6) 2022 THE PATIENT REQUIRED REVASCULARIZATION. THE PATIENT WAS TREATED WITH ATHERECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA).THE FINAL PATIENT OUTCOME WAS SUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 15651297 ↗
• InjuryMay 31, 2022Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT A RIGHT SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED VIA CSI ATHERECTOMY FIRST THEN BALLOON ANGIOPLASTY WITH A 4X200MM ARMADA 14 BALLOON. THE SUPERA STENT WAS ADVANCED TO THE LESION AND THE STENT WAS FULLY DEPLOYED. IT WAS THEN REALIZED THAT THE STENT IMPLANT DEPLOYED PARTIALLY IN THE INTRODUCER SHEATH AND THE VESSEL. DURING DEPLOYMENT, THE SUPERA STENT PARTIALLY DEPLOYED IN THE INTRODUCER SHEATH AND BECAME ELONGATED IN THE PROCESS. IT WAS NOTED THAT THE PHYSICIAN DEPLOYED THE SUPERA INCORRECTLY. THE INTRODUCER SHEATH WAS FAR AWAY TO THE PROXIMAL END OF THE STENT DURING DEPLOYMENT. THE 120 LENGTH STENT TURNED INTO A 300 LENGTH STENT BECAUSE OF THE USER ERROR. THE INTRODUCER SHEATH AND STENT WERE REMOVED TOGETHER AS A UNIT AND WIRE ACCESS REMAINED. A NEW SHEATH WAS PLACED AND BALLOON ANGIOPLASTY WAS PERFORMED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A SMALL DISSECTION NOTED AT THE LESION AT THE END OF THE PROCEDURE. THE DISSECTION WAS TREATED VIA CSI (ORBITAL ATHERECTOMY DEVICE) AND BALLOONING. THE CAUSE OF THE DISSECTION REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14552857 ↗