Herculink Elite 1011487-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648077838), received between May 25, 2018 and Sep 8, 2026 — classified as 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (25 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  It was reported that out of packaging, the 4.0x15mm RX HERCULINK ELITE stent delivery system was prepped before the sheath/stylet removal. Resistance was met during removal of the sheath/stylet. The stent was loose and dislodged from the balloon. There was no patient involvement. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674579 ↗
• MalfunctionApr 22, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, HEAVILY TORTUOUS RENAL ARTERY THAT IS 85% STENOSED. ONCE AT THE LESION PRIOR TO DEPLOYMENT, RESISTANCE WAS MET WITH THE GUIDING CATHETER AND THE BALLOON DISLODGED FROM THE 4.0X15MM HERCULINK BALLOON-EXPANDABLE (BES) STENT DELIVERY SYSTEM. THE BES WAS SIMPLY WITHDRAWN, AND ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE DEVICE WAS HANDLED AND THE STENT WAS LOST DURING TRANSPORTATION, LEAVING ONLY THE DELIVERY SYSTEM. THERE WERE NO REPORTED 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 24956244 ↗
• MalfunctionSep 26, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE 4X15MM HERCULINK ELITE BALLOON EXPANDING STENT (BES) WAS BEING FLUSHED DURING PREPARATION, A LEAK WAS NOTED AS AIR BUBBLE COULD BE SEEN DURING AIR ASPIRATION. THE BALLOON WAS NOTED TO HAVE A HOLE AT THE TIP; THEREFORE, THE BES WAS NOT USED IN THE PROCEDURE. ANOTHER HERCULINK ELITE BES WAS USED TO CONTINUE THE PROCEDURE. 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 23159274 ↗
• MalfunctionMar 7, 2025Off-Label Use; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Off-Label Use; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT VERTEBRAL ARTERY. THE 9.0X39MM OMNILINK ELITE STENT WAS IMPLANTED WITHOUT ISSUE ON (B)(6) 2022. THE PATIENT RETURNED ON (B)(6) 2024 FOR ANOTHER PROCEDURE. THE 4.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER COULD NOT CROSS THROUGH THE PREVIOUSLY IMPLANTED OMNILINK ELITE STENT. THE SDS WAS REMOVED AND IT WAS NOTED THE STENT WAS DAMAGED AND MISLOCATED ON THE BALLOON. 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 21546255 ↗
• InjuryJan 28, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS STATED THAT THERE WAS RESISTANCE DURING PUSHING [ADVANCEMENT] AND THE DEVICE REACHED THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21259972 ↗
• MalfunctionJan 21, 2025Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT VERTEBRAL ARTERY. THE 4.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION HOWEVER IT WAS NOTED THE STENT WAS LOOSE ON THE BALLOON. THE SDS WAS REMOVED WITH THE STENT STILL ON THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. 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 21196115 ↗
• InjuryDec 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RENAL ARTERY. THE 4.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT DISLODGED FROM THE BALLOON. ANOTHER BALLOON CATHETER WAS USED TO IMPLANT THE DISLODGED STENT OUTSIDE OF THE TARGET LESION. ANOTHER HERCULINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20852227 ↗
• MalfunctionSep 26, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN REMOVING THE 4.0X15MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) FROM THE PACKAGING, THE STENT WAS NOTED TO BE MISLOCATED. THE DEVICE WAS PREPPED FOR USE PRIOR TO REMOVING THE PROTECTIVE SHEATH. 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 20308896 ↗
• InjurySep 19, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED LESION IN THE RENAL ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 4X15MM HERCULINK ELITE BALLOON EXPANDING STENT (BES) WAS BEING ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY WHEN THE STENT BECAME DISLODGED. THEREFORE, A 1.5X15MM CORONARY BALLOON WAS USED TO IMPLANT THE STENT INTO THE DISTAL VESSEL WALL. THERE WAS ADVERSE PATIENT SEQUELA. ANOTHER HERCULINK STENT WAS IMPLANTED AT THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20262549 ↗
• InjuryAug 28, 2024Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED RIGHT RENAL ARTERY. A NON-ABBOTT STENT 3.0X15MM WOULD NOT CROSS AND ATTEMPTED 3 TIMES. THE 4.0X15MM HERCULINK STENT WAS SELECTED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WAS FELT WITH ANATOMY AND THE STENT DISLODGED. THE PHYSICIAN WAS ABLE TO SNARE THE STENT TO THE COMMON FEMORAL ARTERY; HOWEVER, COULD NOT REMOVE IT. THEREFORE, CUT DOWN WAS PERFORMED AND THE STENT WAS REMOVED. NO OTHER DEVICE WAS USED AS NO DEVICE WAS ABLE TO CROSS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090652 ↗
• MalfunctionMay 31, 2024Off-Label Use; Failure to Advance; Device Dislodged or Dislocated; Off-Label Use; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A VERTEBRAL ARTERY WITH 80% STENOSIS. THE 4.0X15MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE SDS WAS REMOVED FROM THE ANATOMY AND THE STENT DISLODGED. THE PROCEDURE WAS COMPLETED USING ANOTHER HERCULINK ELITE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436419 ↗
• InjuryJan 16, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT RENAL ARTERY WITH SEVERE CALCIFICATION AND 90% STENOSIS. THE LESION WAS PRE-DILATED WITH A 3.0X15 MM BALLOON AND THEN A 4.0X15 MM BALLOON. A 6FR GUIDING CATHETER WAS ATTEMPTED BUT COULD NOT CROSS THE LESION. THEN THE 4.0X15 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER AN .014 GUIDE WIRE ACROSS THE LESION AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE STENT REMAINED ON THE WIRE BUT CAME OFF OF THE BALLOON. THE DELIVERY SYSTEM WAS REMOVED AND A SMALLER BALLOON WAS USED TO PULL THE STENT OUT OF THE PATIENT. A 4.0 BALLOON WAS USED TO DILATE THE LESION AGAIN AND A GUIDING CATHETER WAS ADVANCED. A NEW 4.0X18 MM SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521690 ↗
• InjuryNov 14, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2023 WAS TO TREAT A 70% STENOSED LESION IN THE LEFT VERTEBRAL ARTERY OSTIUM. A GUIDE WIRE WAS PLACED AND PRE-DILATATION WAS PERFORMED. THE 4.0X15MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. WHEN THE SDS WAS BEING REMOVED TO PERFORM ADDITIONAL PRE-DILATATION, THE STENT DISLODGED AT THE OSTIUM OF THE VERTEBRAL ARTERY. THE HERCULINK SDS WAS REMOVED AND A 1.5X15MM BALLOON WAS USED TO ATTEMPT TO REMOVE THE STENT. THE STENT WAS RETRACTED BACK TO THE FEMORAL ARTERY, BUT WAS NOT ABLE TO BE REMOVED WITH THE BALLOON. THE PATIENT HAD NO DISCOMFORT AND BLOOD FLOW WAS SMOOTH. THE PATIENT WAS PLACED TEMPORARILY ON ANTI-PLATELET MEDICATION AND MONITORED. THEN, ON 10/03/2023 DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED AND A SURGICAL INCISION WAS MADE TO REMOVE THE STENT. THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132327 ↗
• MalfunctionOct 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DURING REMOVAL OF THE PROTECTIVE SHEATH WITHOUT RESISTANCE, THE 4.0X15MM HERCULINK ELITE STENT DISLODGED FROM THE BALLOON. ANOTHER SAME SIZE HERCULINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913791 ↗
• InjuryMay 31, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A CALCIFIED RENAL ARTERY. THE 4.00X15MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RENAL ARTERY; HOWEVER, DUE TO INTERACTION WITH PLAQUE DURING ADVANCEMENT THE STENT CAME OFF THE SHAFT. THE STENT HAD REACHED THE RENAL ARTERY, BUT WAS OBSERVED TO HAVE MIGRATED TO THE COMMON FEMORAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PROCEDURE WAS ABORTED AND ANOTHER PROCEDURE WILL BE ATTEMPTED AT AN UNSPECIFIED FUTURE DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 17034739 ↗
• MalfunctionSep 30, 2022Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE LEFT RENAL (LR) ARTERY. A 4X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS UNABLE TO BE ADVANCED INTO AN UNSPECIFIED 6F GUIDING CATHETER (GC) AFTER SEVERAL ATTEMPTS. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE BESS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. RETURNED DEVICE ANALYSIS NOTED THAT THE STENT MOVED, WAS DISLOCATED ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520480 ↗
• InjuryAug 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 80% STENOSED LESION IN THE RIGHT RENAL ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. A 6F GUIDE CATHETER WAS USED. THE 4.00X15MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT WAS OBSERVED TO HAVE MOVED ON THE BALLOON. THEREFORE, THE STENT WAS DEPLOYED IN THE VESSEL PARTIALLY IN HEALTHY TISSUE AND THE SDS WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER HERCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298916 ↗
• InjuryJun 23, 2022Off-Label Use; Difficult to Advance; Device Dislodged or Dislocated; Off-Label Use; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT VERTEBRAL ARTERY THAT IS 80% STENOSED. THE 4.0X15MM RX HERCULINK ELITE STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE NON-ABBOTT GUIDING CATHETER. THE DEVICE WAS REMOVED AND THE STENT WAS FOUND TO BE DISLODGED WHEN THE DELIVERY SYSTEM WAS WITHDRAWN. A CUT DOWN WAS PERFORMED TO RETRIEVE THE STENT. ANOTHER SAME SIZE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791023 ↗
• InjuryJun 23, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INFERIOR MESENTERIC ARTERY WITH AT LEAST 90% STENOSIS, HEAVILY CALCIFIED AND PROBABLY 140 DEGREE TORTUOSITY. THE 4.0X15MM HERCULINK STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. UPON REMOVAL, THE MID PART OF THE STENT WAS CAUGHT IN THE GUIDE CATHETER AND THE SDS TOGETHER WITH THE GUIDE CATHETER WERE REMOVED, HOWEVER, THE STENT DISLODGED AND WAS WITHIN THE SOFT TISSUE IN THE FEMORAL AREA. THERE WERE NO ATTEMPTS TO RETRIEVE THE STENT AND THE STENT BECAME EMBEDDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14788159 ↗
• MalfunctionDec 20, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY. WHEN ADVANCING THE 4X15MM HERCULINK ELITE DELIVERY SYSTEM RESISTANCE WAS MET WITH ANATOMY AND THE STENT IMPLANT DISLODGED. THE HERCULINK ELITE DELIVERY SYSTEM (THAT WAS ALREADY IN THE ANATOMY) WAS ADVANCED THROUGH THE DISLODGED STENT IMPLANT, INFLATED THE HERCULINK BALLOON AT THE FRONT END OF THE DISLODGED STENT TO CAPTURE IT, AND BOTH THE STENT IMPLANT AND DELIVERY SYSTEM WERE REMOVED ALTOGETHER. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 13046918 ↗
• MalfunctionOct 29, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Off-Label Use; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT VERTEBRAL ARTERY THAT IS 90% STENOSED. THE PHYSICIAN DECIDED TO USE A 4.0X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT AS IT MATCHED THE SIZE OF THE LESION. THE HERCULINK WAS ADVANCED AND AFTER THE BALLOON WAS INFLATED NO STENT WAS FOUND UNDER ANGIOGRAPHY. THE STENT DELIVERY SYSTEM WAS WITHDRAWN AND THE STENT WAS FOUND IN THE PROTECTIVE SHEATH. A NEW 4.5X12MM HERCULINK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720308 ↗
• MalfunctionJun 9, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 65% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE LEFT VERTEBRAL ARTERY. FOLLOWING PRE-DILATATION, AN ATTEMPT TO ADVANCE A 4.0X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS MADE; HOWEVER, IT FAILED TO CROSS. THE BESS WAS REMOVED AND RESISTANCE WITH THE GUIDE CATHETER WAS FELT. ONCE OUTSIDE THE ANATOMY IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED/FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4.0X15MM HERCULINK ELITE STENT. 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 11970305 ↗
• MalfunctionApr 12, 2021Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 4.0X15MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS PREPARED BEFORE THE PROTECTIVE SHEATH WAS REMOVED. THE STENT DISLODGED OFF THE BALLOON PRIOR TO USE. THE BESS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 4.5X12MM HERCULINK STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653974 ↗
• InjuryFeb 24, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, HEAVILY TORTUOUS AND 90% STENOSED LESION IN THE RIGHT RENAL ARTERY. THE HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT AFTER SEVERAL ATTEMPTS, FAILED TO CROSS THE LESION. WHEN THE SDS WAS REMOVED FROM THE BODY, IT WAS FOUND THAT THE STENT HAD DISLODGED AND WAS LEFT IN THE PATIENT'S DEEP FEMORAL ARTERY. THE STENT WAS EMBEDDED IN THE VESSELS. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER 4X15 CORONARY STENT WAS USED TO FINISH THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11376316 ↗
• MalfunctionNov 20, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY TORTUOUS DE NOVO LESION IN THE LEFT VERTEBRAL ARTERY. THE 4.0X15 MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED WITHOUT ANY ISSUES. ONCE OUTSIDE THE PATIENT ANATOMY THE STENT DISLODGED. ANOTHER 4.0X15MM RX HERCULINK ELITE SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10876826 ↗