Omnilink Elite 1012631-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648178511), received between Jan 30, 2017 and May 15, 2026 — classified as 16 injuries, 11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS COMMON ILIAC ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 8.0X39MM OMNI ELITE OTW BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS MET WITH THE GUIDING CATHETER. UPON REMOVAL OF THE SDS, THE STENT DISLODGED FROM THE BALLOON BUT REMAINED TIGHTLY CRIMPED ON THE SDS CATHETER. A 7.0X39MM OMNILINK 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 25187565 ↗
• InjuryMay 11, 2026Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT COMMON ILIAC ARTERY LESION. THE 8X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS NOT PREPPED WITH NEGATIVE PRESSURE PRIOR TO USE. THE SDS WAS ADVANCED TO THE LESION VIA THE LEFT COMMON FEMORAL ARTERY THROUGH THE 7FR SHEATH. HOWEVER, WHILE PASSING THROUGH THE LEFT ILIAC ARTERY, SLIGHT RESISTANCE WAS NOTED AND THE STENT WAS STRIPPED FROM THE BALLOON. THE STENT THEN TRAVELED DOWN TO THE RIGHT COMMON FEMORAL ARTERY (RCFA). A 5X40 MM BALLOON WAS USED TO DEPLOY THE STENT IN THE RCFA. A NEW 8X59 MM OMNILINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25139742 ↗
• MalfunctionMay 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THE STENT DISLODGED FROM THE BALLOON. 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 25058717 ↗
• InjuryNov 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY AND A MILD TO MODERATELY CALCIFIED LEFT COMMON ILIAC ARTERY. THE FIRST 8.0X39MM OMNI ELITE BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO TREAT THE RIGHT COMMON ILIAC ARTERY. DURING REPOSITIONING THE SDS, THE STENT SLID OFF THE SDS. THE DISLODGED STENT WAS REMOVED VIA SNARE. A NEW OMNILINK STENT WAS USED TO TREAT THE RIGHT COMMON ILIAC ARTERY. THE SECOND 8.0X39MM OMNI ELITE SDS WAS ADVANCED TO THE LEFT COMMON ILIAC ARTERY. DURING REPOSITIONING, THE STENT SLID PARTIALLY OFF THE SDS DURING REPOSITIONING; HOWEVER, IT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION OF THE LEFT COMMON ILIAC ARTERY. 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 23599670 ↗
• MalfunctionNov 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY AND A MILD TO MODERATELY CALCIFIED LEFT COMMON ILIAC ARTERY. THE FIRST 8.0X39MM OMNI ELITE BALLOON-EXPANDABLE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO TREAT THE RIGHT COMMON ILIAC ARTERY. DURING REPOSITIONING THE SDS, THE STENT SLID OFF THE SDS. THE DISLODGED STENT WAS REMOVED VIA SNARE. A NEW OMNILINK STENT WAS USED TO TREAT THE RIGHT COMMON ILIAC ARTERY. THE SECOND 8.0X39MM OMNI ELITE SDS WAS ADVANCED TO THE LEFT COMMON ILIAC ARTERY. DURING REPOSITIONING, THE STENT SLID PARTIALLY OFF THE SDS DURING REPOSITIONING; HOWEVER, IT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION OF THE LEFT COMMON ILIAC ARTERY. 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 23599669 ↗
• InjuryOct 15, 2024Entrapment of Device; Stretched; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Stretched; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT DURING REMOVAL THE STENT HAD DISLODGED AS IT WAS HOOKED ON A PREVIOUSLY IMPLANTED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453848 ↗
• InjuryAug 21, 2024Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE PATIENT ANATOMY HOWEVER IT WAS NOTED THE STENT HAD STARTED TO DISLODGE FROM THE BALLOON AS IT WAS CAUGHT IN THE CALCIUM. THE SDS WAS PULLED BACK ALTHOUGH RESISTANCE WAS MET WITH THE 7FR SHEATH AND THE STENT CAME OFF THE BALLOON EVEN MORE. THE PHYSICIAN DECIDED THE BEST OPTION WAS TO DEPLOY IT IN A HEALTHY VESSEL IN THE LEFT COMMON ILIAC. ANOTHER OMNILINK ELITE WAS THEN SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20009195 ↗
• MalfunctionJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED LEFT COMMON FEMORAL ARTERY FOLLOWING AN ABDOMINAL AORTA ANEURYSM REPAIR. DURING PREPARATION OF THE 8X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS), NO RESISTANCE WAS NOTED WHEN REMOVING THE SDS FROM THE DISPENSER COIL OR WHEN REMOVING THE STYLET. IT WAS NOTED THAT THE STENT WAS NOTED TO BE LOOSE ON THE DELIVERY SYSTEM THEREFORE IT WAS NOT USED. ANOTHER OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559790 ↗
• InjuryMay 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE RIGHT ILIAC. THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION HOWEVER THE PHYSICIAN WANTED TO EXCHANGE THE GUIDE WIRE THEREFORE THE SDS WAS WITHDRAWN FROM THE ANATOMY. IT WAS NOTED THE STENT HAD DISLODGED FROM THE BALLOON AND REMAINED IN THE ARTERY. AN ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED THROUGH THE DISLODGED STENT AND ABLE TO PLACE THE STENT AT THE INTENDED LESION. THE BALLOON WAS INFLATED AND THE STENT DEPLOYED. 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 19330891 ↗
• InjuryMar 18, 2024Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT AND RIGHT ILIAC ARTERIES. A 8.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND PLACED IN THE LEFT ILIAC AND ANOTHER SAME SIZE OMNILINK ELITE PLACED IN THE RIGHT ILIAC. THE OMNILINK ELITE PLACED IN THE LEFT ILIAC WAS PRESSURIZED TO 10 ATMOSPHERES HOWEVER A LEAK WAS NOTED IN THE HUB OUTSIDE THE PATIENT ANATOMY. THE STENT WAS DEPLOYED HOWEVER WAS NOT FULLY EXPANDED. AFTER THE OMNILINK ELITE STENT ON THE RIGHT SIDE WAS DEPLOYED, THE SDS WAS MOVED AND USED TO FULLY EXPAND THE STENT ON THE LEFT SIDE. 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 18921374 ↗
• InjuryAug 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION. THE 8X39MM OTW OMNILINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, BEFORE REACHING THE TARGET LESION THE STENT SUDDENLY CAME OFF THE SHAFT AND WAS NOTED PARTIALLY DISLODGED WHEN WAS STILL ON THE DISTAL PORTION OF THE BALLOON. THEREFORE, AN UNSPECIFIED BALLOON WAS USED FOR POST-DILATATION TO FULLY DEPLOYED THE STENT AT THE LOCATION. PART OF THE DEVICE IS IN THE TARGET LESION AND PART IS IN HEALTHY TISSUE. THE OMNILINK BES WAS REMOVED WITHOUT ISSUES. A 8X59MM OMNILINK STENT AND A 8X29MM OMNILINK STENT WERE 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 17552723 ↗
• MalfunctionJun 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 8.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS), THERE WAS NO RESISTANCE REMOVING THE SDS FROM THE DISPENSER COIL AND DURING REMOVAL OF THE PROTECTIVE SHEATH, HOWEVER, THE DISTAL END OF THE STENT WAS SLIGHTLY OFF OF THE BALLOON BUT STILL ON DELIVERY SYSTEM. THERE WAS NO DAMAGE NOTED ON THE PACKAGING OF THE DEVICE. THE DEVICE WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). ANOTHER OMNILINK STENT WAS USED TO COMPLETE THE PROCEDURE THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. 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 17225946 ↗
• InjuryJun 19, 2023Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. AN ENDARTERECTOMY WAS PERFORMED ON THE LEFT COMMON FEMORAL ARTERY AND AN 11FR SHEATH WAS PLACED. A 7X100MM ABSOLUTE PRO SELF-EXPANDING STENT (SESS) WAS ADVANCED TO THE LEFT EXTERNAL ILIAC ARTERY AND DEPLOYED. THEN, THE 8X39MM OMNILINK STENT DELIVERY SYSTEM (SDS) WAS BROUGHT UP TO THE LEFT COMMON ILIAC ARTERY, THE PHYSICIAN THEN DECIDED NOT TO DEPLOY THE OMNILINK STENT AND REMOVE UNDEPLOYED FROM THE PATIENT. HOWEVER, DURING REMOVAL THE OMNILINK STENT BECAME CAUGHT ON THE ABSOLUTE PRO STENT AND THE STENT OF THE OMNILINK CAME OFF THE BALLOON. THE DELIVERY SYSTEM OF THE OMNILINK WAS REMOVED FROM THE PATIENT; HOWEVER, THE DISLODGE STENT FLOATED THROUGH ABSOLUTE PRO STENT WHERE IT BECAME ENTANGLED WITHIN THE DISTAL PORTION OF THE ABSOLUTE PRO. THEREFORE, PHYSICIAN REMOVED BOTH STENTS FROM THE PATIENT VIA A SMALL INCISION IN THE ENDARTERECTOMY PATCH WITH A SNIP TOOL. THERE WAS NO ADVERSE PATIENT SEQUELA. A 8X100 ABSOLUTE PRO STENT IN THE LEFT EXTERNAL ILIAC TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154188 ↗
• MalfunctionMay 22, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT ILIAC ARTERY. THE 8X39MM OMNILINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT MET RESISTANCE WITH THE CALCIFICATION AND BECAME STUCK. DURING REMOVAL RESISTANCE WAS FELT WITH ANATOMY. BALLOON DILATATION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973997 ↗
• InjuryJul 26, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT ILIAC ARTERY. THE 8.0X39MM OMNILINK ELITE STENT WAS ADVANCED THROUGH A 6FR SHEATH; HOWEVER, RESISTANCE WAS MET AND THE STENT DISLODGED. A SMALL UNSPECIFIED BALLOON WAS USED TO COMPLETELY DEPLOY THE STENT WHERE IT WAS NOT INTENDED TO BE IMPLANTED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15108026 ↗
• MalfunctionMay 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. THE 8.0X39MM OMNILINK ELITE STENT WAS FLUSHED AND PREPARED PER INSTRUCTIONS FOR USE (IFU) WITHOUT ISSUES. HOWEVER, WHEN THE STENT WAS ON THE TABLE BEING PREPARED AND AS IT WAS BEING ADVANCED ONTO THE GUIDE WIRE WHICH WAS ALREADY IN THE PATIENT, THE STENT CAME OFF THE BALLOON BUT IT NEVER CAME COMPLETELY OFF THE STENT DELIVERY SYSTEM. THERE WAS NO RESISTANCE FELT PRIOR TO THE STENT DISLODGEMENT. THE OMNILINK SYSTEM WAS REMOVED TOGETHER WITH THE DISLODGED STENT. ANOTHER DEVICE 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 14270112 ↗
• InjuryMar 8, 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 PERFORMED TO TREAT A DISSECTION IN THE DISTAL RIGHT ILIAC ARTERY. AN ATTEMPT WAS MADE TO ADVANCE A SHEATH TO THE TARGET SITE VIA LEFT ACCESS; HOWEVER, THE SHEATH COULD NOT BE ADVANCED TO THE RIGHT DISTAL ILIAC. THE 8.0 X 39 MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, AS THERE WAS NO SUPPORT FROM THE SHEATH, THE OMNILINK ELITE WAS UNABLE TO GET TO THE TARGET SITE. THE DEVICE WAS REMOVED; HOWEVER, WHEN PULLING THE STENT INTO THE SHEATH, THE STENT CAUGHT ON THE SHEATH AND DISLODGED, REMAINING IN THE SHEATH. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY. THE STENT REMAINED IN THE SHEATH AND AN ATTEMPT WAS MADE TO REMOVE THE SHEATH AND STENT. DURING REMOVAL, THE STENT EMBOLIZED TO THE LEFT PROFUNDA. A SECOND PHYSICIAN WAS CONSULTED, AND THE DECISION WAS MADE TO LEAVE THE STENT WHERE IT WAS, AS THE PATIENT DID NOT EXPERIENCE ANY ADVERSE PATIENT EFFECT. THE STENT REMAINED UNEXPANDED IN THE LEFT PROFUNDA AND NO ADDITIONAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 13694505 ↗
• MalfunctionDec 30, 2021Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. THE 8.0 X 39 MM OMNILINK ELITE VASCULAR STENT DELIVERY SYSTEM WAS PREPARED FOR USE WITHOUT NOTED ISSUE. THE OMNILINK STENT DELIVERY SYSTEM WAS ADVANCED INTO THE ANATOMY AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT. THE BALLOON WAS INFLATED AND IT WAS NOTED THAT THE STENT WAS MISSING. THE DISLODGED STENT WAS FOUND ON THE BACK TABLE. THE PROCEDURE ENDED WITH ONLY ANGIOPLASTY PERFORMED, USING THE STENT DELIVERY SYSTEM BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119229 ↗
• InjuryFeb 24, 2021Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT ILIAC ARTERY. THE KISSING STENT TECHNIQUE WAS ATTEMPTED. A NON-ABBOTT CATHETER WAS ADVANCED FIRST. THE 8.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER WHEN PUSHING UP PAST THE TARGET LESION, RESISTANCE WAS MET WITH THE CALCIFIED LESION AND THE SDS CAME OFF THE GUIDE WIRE AND WENT UP INTO THE AORTA, THEN DOUBLE BACKED DOWN AND TIED ITSELF INTO A KNOT. THE SDS COULD NOT BE MOVED AT THIS POINT; THEREFORE A CUT DOWN WAS PERFORMED WHERE THE PHYSICIAN WAS ABLE TO UNTIE THE SDS SHAFT. THE PROCEDURE WAS CONTINUED WITH THE SAME DEVICE AND THE OMNILINK STENT WAS ABLE TO BE DEPLOYED IN THE TARGET LESION. THERE WAS A CLINICALLY SIGNIFICANT DELAY DUE TO THE CUT DOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11373827 ↗
• InjuryOct 15, 2019Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 60% STENOSED, MILDLY TORTUOUS, AND HEAVILY CALCIFIED DE NOVO LESION IN THE COMMON ILIAC ARTERY. AN 8X39MM OTW OMNI ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION BETWEEN 6 TO 8 ATMOSPHERES DURING DEPLOYMENT. AN UNSPECIFIED BALLOON CATHETER WAS USED TO POST-DILATE THE STENT TO ACHIEVE WALL APPOSITION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193432 ↗
• InjurySep 19, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED RIGHT ILIAC LESION. THE 8.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED WITH RESISTANCE NOTED WITH A 6F GUIDING CATHETER. THE STENT DISLODGED FROM THE BALLOON IN THE LEFT ILIAC AND WAS IMPLANTED IN HEALTHY TISSUE USING A NEW UNSPECIFIED BALLOON. A NEW UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9086688 ↗
• MalfunctionJan 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE 8.0X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290363 ↗
• InjurySep 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED MODERATELY CALCIFIED PERIPHERAL ARTERY. AN 8.0 X 39 MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM WAS USED AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. HOWEVER, THE STENT DISLOCATED FROM THE STENT SYSTEM; THEREFORE, IT WAS IMPLANTED IN HEALTHY TISSUE. ANOTHER UNSPECIFIED OMNILINK ELITE STENT SYSTEM WAS THEN 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: Foreign Body In Patient

  MAUDE report 7903107 ↗
• MalfunctionMar 1, 2018Difficult or Delayed Positioning; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED, DE NOVO, RIGHT COMMON ILIAC THAT WAS 100% STENOSED. PRE-DILATATION WAS PERFORMED WITH A 3.0 X 40 MM NON ABBOTT BALLOON CATHETER AND THEN WITH A 5.0 X 40 MM NON ABBOTT BALLOON CATHETER. AN ATTEMPT WAS MADE TO DEPLOY A 8.0 X 39 MM OMNILINK ELITE STENT, BUT THE DISTAL END OF THE BALLOON STARTED TO INFLATE FIRST AND AS A RESULT THE STENT IMPLANT SHIFTED AND MOVED PROXIMAL ON THE BALLOON. THE STENT WAS DEPLOYED PARTIALLY OUT OF THE LESION BECAUSE IT HAD MOVED PROXIMALLY ON THE BALLOON. IN ORDER TO FULLY COVER THE LESION, A NEW 7.0 X 29MM OMNILINK WAS ADVANCED AND DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308407 ↗
• InjuryDec 14, 2017Difficult or Delayed Positioning; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED, AND DE NOVO RIGHT COMMON ILIAC ARTERY. AN 8.0 X 39 OMNILINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED TO THE TARGET LESION. THE BES WAS INFLATED AT 6 ATMOSPHERES AND BEFORE THE BALLOON FULLY INFLATED (ONLY THE PROXIMAL PART OF THE BALLOON HAD INFLATED), THE STENT JUMPED APPROXIMATELY 1 CM AND LANDED OUTSIDE THE LESION. A LEAK FROM THE INFLATION PORT WAS CONFIRMED. A NON-ABBOTT BALLOON WAS ADVANCED TO MOVE THE STENT TO THE TARGET LESION. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7119448 ↗