Herculink Elite 1011487-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648077821), received between Dec 8, 2016 and Nov 20, 2025 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT VERTEBRAL ARTERY. THE 4.0X12MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT DISLODGED FROM THE BALLOON. DURING RETRACTION OF THE SDS THE RIGHT RADIAL ARTERY WAS INJURED. AN INCISION WAS MADE AND THE DISLODGED STENT WAS REMOVED FROM THE ANATOMY. THE PROCEDURE WAS ABORTED AT THIS TIME. THE PATIENT WAS BROUGHT BACK AT A LATER DATE TO TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23605945 ↗
• MalfunctionJan 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE RENAL ARTERY. THE 4.0X12MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING DEPLOYMENT IT WAS NOTED THE STENT WAS NOT ON THE BALLOON. THE SDS WAS REMOVED AND THE DISLODGED STENT WAS LOCATED IN THE GUIDING CATHETER; THEREFORE THE GUIDING CATHETER WAS SIMPLY REMOVED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178346 ↗
• MalfunctionDec 3, 2024Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT RENAL ARTERY WITH 85% STENOSIS. AFTER THE VESSEL WAS PREPPED, THE 4.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE FELT FROM AN UNSPECIFIED GUIDING CATHETER. AN ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, IT WOULD ONLY PARTIALLY DEPLOY. T HE SDS AND STENT WERE WITHDRAWN, AND A NEW 4.0X12MM HERCULINK STENT WAS IMPLANTED, WITH ANGIOGRAPHY CONFIRMING PATENCY. 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 20839003 ↗
• InjuryNov 27, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT RENAL ARTERY WITH 80% STENOSIS. THE 4.0X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE GUIDING CATHETER, AND IT WAS SEEN ANGIOGRAPHICALLY THAT THE STENT HAD DISLODGED FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND THE STENT WAS RETRIEVED BY INFLATING A BALLOON TO PULL THE STENT BACK. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE HERCULINK SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799027 ↗
• MalfunctionOct 31, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING FLUSHING OF THE 4.0X12 MM HERCULINK STENT DELIVERY SYSTEM (SDS) BALLOON WAS FOUND TO BE LEAKING AIR. THEREFORE THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW HERCULINK SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578831 ↗
• MalfunctionOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 4.0X12 MM HERCULINK ELITE STENT CAME OFF [DISLODGED] IN THE REWRAP TIP [SHEATH]. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569163 ↗
• MalfunctionOct 23, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE FLUSHING PROCESS OF THE 4X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), THE STENT WAS NOTED TO HAVE MOVED ON THE DELIVERY SYSTEM. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. IT WAS NOTED THAT FORCE WAS USED TO REMOVE THE SHEATH/STYLET DUE TO RESISTANCE. ANOTHER HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516838 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE RENAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4X12MM HERCULINK BALLOON EXPANDING STENT (BES) WAS ADVANCED ON A COMMAND 14 GUIDE WIRE (GW) TO THE TARGET LESION; HOWEVER, THE STENT BECAME DISLODGED. THEREFORE, THE SHEATH WAS TO BLOCK THE STENT AND STENT WAS ABLE TO BE REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281207 ↗
• MalfunctionAug 26, 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 PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE RENAL ARTERY. A 4X12MM RX HERCULINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED INTO THE ANATOMY, HOWEVER FAILED TO REACH THE LESION. THE BES WAS REMOVED WITH RESISTANCE NOTED WITH THE GUIDING CATHETER AND THE STENT DISLODGED. THE STENT WAS SIMPLY REMOVED AND ANOTHER HERCULINK BES 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064581 ↗
• MalfunctionJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT RENAL ARTERY. THE 4X12MM HERCULINK ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE USED IN A PROCEDURE; HOWEVER, THE STENT DISLODGED WHILE IN THE GUIDE CATHETER. THEREFORE, THE GUIDE CATHETER WAS REMOVED WITH THE DISLODGED STENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER HERCULINK BES WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767581 ↗
• MalfunctionMay 8, 2024Failure 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 WITH 80% STENOSIS. THE 4.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED AND THE STENT DISLODGED INSIDE THE CATHETER BEFORE IT REACHED THE LESION. THE SDS WAS WITHDRAWN WITH THE STENT ATTACHED AND ANOTHER HERCULINK SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270247 ↗
• MalfunctionFeb 16, 2024Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RENAL ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 4.0X12 MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS FLUSHED AS NORMAL AND WAS ADVANCED ALONG THE GUIDE WIRE TO THE LESION. IT WAS NOTED THAT THE STENT WAS DISLODGED ON ANGIOGRAPHY AS IT WAS NOT ON THE DELIVERY SYSTEM. THE STENT DISLODGED INSIDE THE GUIDING CATHETER AND WHEN THE GUIDING CATHETER WAS REMOVED, THE STENT WAS REMOVED WITHOUT ISSUE. ANOTHER SAME SIZE HERCULINK ELITE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE DEVICE WAS INFLATED AND THEN IT WAS NOTED THE STENT WAS NOT ON THE BALLOON. AN ADDITIONAL HERCULINK ELITE SDS WAS RECEIVED BY THE RETURNED GOODS LAB AND THE DEVICE WAS NOT USED; HOWEVER, THE STENT WAS FOUND TO BE INSIDE THE SHEATH WHICH WAS RETURNED SEPARATELY FROM THE REST OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723092 ↗
• MalfunctionNov 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RENAL ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. DURING ADVANCEMENT OF THE HERCULINK ELITE DELIVERY SYSTEM TO THE LESION, THE STENT DISLODGED IN THE SHEATH. THE STENT IMPLANT WAS FOUND IN THE SHEATH AFTER THE SHEATH WAS REMOVED FROM THE ANATOMY. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18162715 ↗
• InjurySep 22, 2023Off-Label Use; Failure to Advance; Device Dislodged or Dislocated; Off-Label Use; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT VERTEBRAL ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) HAD NO RESISTANCE BUT FAILED TO CROSS AND THE STENT THEN DISLODGED FROM THE BALLOON AND WAS BROUGHT INTO THE LATERAL THORACIC ARTERY BY BLOOD FLOW. ATTEMPTS IN REMOVAL OF THE STENT WERE MADE BUT WERE DIFFICULT. SURGICAL REMOVAL WAS NOT PERFORMED WITH GREATER TRAUMA TO THE LATERAL THORACIC ARTERY SO THE STENT WAS LEFT IN THE ANATOMY STUCK IN THE WALL OF THE BRACHIAL ARTERY. ANGIOGRAPHY SHOWED SMOOTH BLOOD FLOW IN THE ARTERY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE. ALTHOUGH THERE WAS A DELAY IN THE PROCEDURE, THERE WAS NO PATIENT HARM, THEREFORE; THIS IS NOT CLINICALLY SIGNIFICANT. CLOSE FOLLOW-UP OBSERVATION WAS RECOMMENDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17803389 ↗
• InjuryAug 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RENAL ARTERY THAT WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. THE 4.0X12MM HERCULINK ELITE STENT DISLODGED AS IT PASSED THROUGH THE STENOSIS. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL THE DEVICE. THE STENT WAS SNARED INTO THE SHEATH AND REMOVED FROM THE PATIENT. A NEW HERCULINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17559323 ↗
• MalfunctionJun 9, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RENAL ARTERY WITH 80% STENOSIS, MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT AND THE STENT DISLODGED FROM THE BALLOON. THE STENT TOGETHER WITH THE GUIDEWIRE AND STENT DELIVERY CATHETER WERE SIMPLY WITHDRAWN AS A UNIT. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER SAME SIZE HERCULINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100609 ↗
• MalfunctionJan 6, 2022Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Twisted/Bent; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF A 4X12MM HERCULINK ELITE RENAL BALLOON EXPANDABLE STENT SYSTEM (BESS), FORCE WAS APPLIED WITH THE REMOVAL OF THE PROTECTIVE COVERING AND THE STENT MOVED ON THE BALLOON, EXPOSING THE PROXIMAL BALLOON AND RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE HERCULINK WAS PREPARED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178914 ↗
• MalfunctionSep 2, 2021Product Quality Problem; Device Dislodged or Dislocated; Material Deformation; Product Quality Problem; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING UNPACKING OF A 4X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS), THE BALLOON WAS NOTED TO BE PARTIALLY INFLATED AND THE STENT PARTIALLY RELEASED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE 4X12MM HERCULINK ELITE STENT WAS ACTUALLY FLARED RATHER THAN PARTIALLY RELEASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415181 ↗
• InjuryAug 24, 2021Failure to Advance; Malposition of Device; Material Deformation; Failure to Advance; Malposition of Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS DE NOVO RIGHT RENAL ARTERY THAT IS 70% STENOSED. THE 4.0X12MM HERCULINK ELITE BALLOON-EXPANDABLE STENT SYSTEM (BESS) FAILED TO CROSS THE LESION DUE TO ANATOMY. THE BESS WAS DEPLOYED IN THE ANATOMY AT AN UNINTENDED SITE DUE TO FLARED STENT STRUTS AS THE PHYSICIAN THOUGHT THE STENT MIGHT DISLODGE IF THE DEVICE KEPT ATTEMPTING TO BE ADVANCED. ANOTHER UNSPECIFIED DEVICE 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: Foreign Body In Patient

  MAUDE report 12360393 ↗
• MalfunctionAug 19, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED AND MILDLY CALCIFIED LESION IN THE RIGHT RENAL ARTERY. A 4.0X12MM HERCULINK ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED AND PRESSURIZED TO 8 ATMOSPHERES; HOWEVER, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED 4.0X12MM 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 12345599 ↗
• InjuryAug 13, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT RENAL ARTERY THAT IS 90% STENOSED. THE 4.0X12MM HERCULINK BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE BESS WAS REMOVED AND AN UNSPECIFIED 2.0X15MM CORONARY BALLOON WAS USED TO DILATE THE LESION. THE SAME BESS WAS RE-INSERTED BUT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, DUE TO THE ANGLE OF THE UNSPECIFIED GUIDE CATHETER THE BESS MET RESISTANCE WITH IT AND THE STENT DISLODGED. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE FLOATING STENT BY INSERTING AN UNSPECIFIED BALLOON IN THE STENT AND PARTIALLY DEPLOY IT IN AN ATTEMPT TO SNARE THE STENT WITH THE BALLOON; HOWEVER, THE STENT GOT CAUGHT WITH AN UNSPECIFIED WIRE AND THE TIP OF THE UNSPECIFIED WIRE SEPARATED. BOTH THE TIP OF THE WIRE AND THE STENT WERE FREE FLOATING IN THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT WAS PUT UNDER ANESTHESIA AND A CUT DOWN WAS PERFORMED. THE STENT AND TIP OF THE UNKNOWN WIRE WERE SUCCESSFULLY REMOVED, AND THE PATIENT IS DOING WELL. ADDITIONALLY, THE EVENT DID CAUSE THE PATIENT'S HOSPITALIZATION TO BE PROLONGED AND A CLINICALLY SIGNIFICANT DELAY WAS NOTED. N

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12320184 ↗
• InjuryJul 22, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED RIGHT RENAL ARTERY. A 4X12MM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) FACED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT, AND PRIOR TO CROSSING THE LESION, THE STENT DISLODGED COMPLETELY OUTSIDE THE TARGET LESION. THE STENT WAS RETRIEVED WITH A SNARE, AND A SAME SIZED HERCULINK ELITE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215020 ↗
• MalfunctionSep 13, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE STENT WAS MISSING OFF A 4.0X12MM RX HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) AFTER OPENING THE PACKAGE. THE SDS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO RESISTANCE FELT WHEN REMOVING THE SDS FROM THE DISPENSER COIL AND NO RESISTANCE FELT WHEN REMOVING THE PROTECTIVE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED HERCULINK SDS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9050652 ↗
• InjuryDec 8, 2016Difficult To Position; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION (PCI) TREATING A SMALL RIGHT RENAL ARTERY LESION. A HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) ADVANCED OVER AN UNSPECIFIED GUIDEWIRE THOUGH THE GUIDE CATHETER. ONCE AT THE GUIDE CATHETERS DISTAL END, RESISTANCE WAS MET DURING ADVANCEMENT. REPORTEDLY, THE RESISTANCE WAS DUE TO THE GUIDE CATHETER AND ANATOMY. THE DEVICE HAD FAILED TO CROSS THE LESION AND IT WAS THEN NOTED THAT THE STENTS PROXIMAL END WAS FLARED. ALL WAS ATTEMPTED TO BE REMOVED AS A SINGLE UNIT; HOWEVER, DURING REMOVAL, RESISTANCE WAS MET WITH THE GUIDE CATHETER AND THE STENT DISLODGED. THE DISLODGED STENT TRAVELED TO THE RIGHT COMMON FEMORAL ARTERY, EMBEDDED IN CALCIUM. THE PHYSICIAN DECIDED TO WAIT FOR THE FUTURE PLANNED RIGHT GROIN ENDARTERECTOMY TO SURGICALLY REMOVE THE DISLODGED STENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6156350 ↗