Omnilink Elite 1012632-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648178542), received between Oct 11, 2016 and May 19, 2026 — classified as 10 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS CELIAC ARTERY LESION WITH 90% STENOSIS. A 9X29 MM OMNILINK ELITE BALLOON EXPANDING STENT WAS ADVANCED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO THE USE OF 0.014 INCH GUIDE WIRE. THE STENT THEN CAME OFF THE BALLOON WHILE ATTEMPTING TO CROSS THE LESION. A SNARE WAS USED TO RETRIEVE THE STENT AND EVERYTHING WAS PULLED OUT OF THE BODY TOGETHER. ACCESS WAS LOST AND THE PROCEDURE WAS ABORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220121 ↗
• MalfunctionJan 30, 2026Break; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT THE LEFT SUBCLAVIAN ARTERY. RESISTANCE WAS NOTED WHEN REMOVING THE STYLET/PROTECTIVE SHEATH OF THE 9.0X29MM OMNI ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES), FORCE WAS APPLIED AND THE BES DISLODGED WHEN THE YELLOW PROTECTIVE SHEATH WAS BEING REMOVED, PRIOR TO ENTERING THE BODY. IT WAS NOTED THAT ONE SIDE OF THE STENT APPEARED FRAYED. A NEW OMNILINK STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR 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 24223520 ↗
• MalfunctionSep 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, UPON UNSHEATHING A 9.0 X 29 MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES) SYSTEM, THE STENT WAS NOTED TO HAVE COMPLETELY COME OFF THE DELIVERY SYSTEM. A NEW 9.0 X 29 MM OMNILINK ELITE VASCULAR BES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR 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 23125362 ↗
• MalfunctionJan 31, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, COMMON ILIAC ARTERY. RESISTANCE WAS NOTED WHEN ADVANCING THE 9.0X29MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT (BES) SYSTEM THROUGH A 6F SHEATH, THE STENT DISLODGED BUT REMAINED IN THE SHEATH AND WAS SIMPLY WITHDRAWN WITH THE SHEATH. 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 21284235 ↗
• MalfunctionDec 23, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE LESION WAS PRE-DILATED AND THEN THE 9X29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED. THE LESION WAS TIGHTER THAN EXPECTED AND THE STENT DISLODGED. THE STENT WAS REMOVED WITH THE DEVICE AND BALLOON DILATATION WAS PERFORMED AGAIN. A NEW, SAME SIZE OMNILINK ELITE SDS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21007019 ↗
• MalfunctionMay 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN LOADING THE 9X29 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) ONTO THE GUIDE WIRE, THE STENT WAS NOTED TO BE LOOSE ON THE DISTAL SHAFT. THERE WAS NO RESISTANCE NOTED. THE STENT STAYED ON THE DELIVERY SYSTEM AND WAS THEN REMOVED BY HAND. THERE WAS NO RESISTANCE WHEN REMOVING THE PROTECTIVE SHEATH FROM THE SDS. A NEW SDS WAS USED TO COMPLETE THE PROCEDURE. 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 19321574 ↗
• InjuryFeb 15, 2024Difficult to Remove; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. THERE WERE TWO PREVIOUSLY IMPLANTED STENTS IN THE EXTERNAL ILIAC. THE 9X29MM OTW OMNI ELITE BALLOON-EXPANDABLE STENT (BES) WAS ADVANCED AND STRONG RESISTANCE WAS NOTED WITH THE 6F SHEATH. THE BES AND THE SHEATH MET STRONG RESISTANCE ADVANCING IN THE ANATOMY, AND THE BES FAILED TO CROSS TO THE TARGET LESION. THE BES WAS REMOVED FROM THE SHEATH TO DETERMINE THE CAUSE OF THE RESISTANCE; HOWEVER, DURING REMOVAL THE BES GOT STUCK WITH THE EDGE OF A PREVIOUSLY IMPLANTED STENT, THE OMNI ELITE STENT SEPARATED OFF THE BALLOON INTO THE LEFT COMMON ILIAC. ATTEMPTS WERE MADE FOR 2 HOURS TO SNARE THE STENT, BUT THIS WAS UNSUCCESSFUL AND THE PATIENT WAS SENT TO SURGERY. THE STENT WAS UNABLE TO BE REMOVED WITH SURGERY; THEREFORE, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE STENT WAS LATER EMBEDDED IN THE ARTERIAL WALL WITH A COVERED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18713035 ↗
• MalfunctionNov 7, 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 THE LEFT ILIAC ARTERY WITH 80% STENOSIS AND MILD CALCIFICATION. THE 9.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS INSERTED INTO THE 6FRENCH (FR) SHEATH WITH RESISTANCE AND DID NOT FEEL RIGHT SO THE SDS WAS REMOVED. IT WAS NOTED THE STENT WAS NOT CRIMPED TIGHTLY AND CAME OFF THE BALLOON AT THE DISTAL EDGE. ANOTHER OMNILINK ELITE 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 18085042 ↗
• MalfunctionJul 21, 2023Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE OMNILINK ELITE STENT CAME OFF OF THE BALLOON, ON THE BACK TABLE. THE DEVICE NEVER ENTERED THE PATIENT. IT WAS STATED THE TECH MAY HAVE FLUSHED THE WRONG PORT, CAUSING THE STENT TO FALL OFF THE BALLOON; POSSIBLE USE ERROR. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373514 ↗
• MalfunctionDec 22, 2022Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT IT WAS A BILATERAL PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY. THE 9.0X29MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) COLLAPSED WHILE ATTEMPTING TO BE INSERTED INTO A 6 FRENCH SHEATH. THE STENT CAME OFF OF THE BALLOON WHEN TRYING TO PUSH THE SDS INTO THE SHEATH. THE STENT WAS STILL TIGHTLY CRIMPED. THE SDS WAS SIMPLY REMOVED TOGETHER WITH THE STENT. ANOTHER SAME SIZE OMNILINK ELITE SDS 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 16034043 ↗
• InjuryDec 16, 2022Device Damaged by Another Device; Migration; Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 9.0 X 29 MM OMNILINK ELITE VASCULAR STENT DELIVERY SYSTEM WAS IMPLANTED WITHOUT ISSUE. AN ISSUE OCCURRED DURING USE OF ANOTHER DEVICE, REQUIRING USE OF A SNARE DEVICE, WHICH INADVERTENTLY PULLED THE OMNILINK STENT OUT OF POSITION. THE OMNILINK STENT WAS THEN SNARED AND REMOVED FROM THE ANATOMY. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE TARGET LESION. THE PLAN IS TO BRING THE PATIENT BACK ON A LATER DATE FOR TREATMENT OF THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000413 ↗
• MalfunctionSep 14, 2022Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ILIAC ARTERY. A 6X45MM NON-ABBOTT SHEATH WAS ADVANCED INSIDE THE PATIENT. THEN THE OMNILINK STENT WAS ADVANCED INSIDE THE SHEATH, BUT THE STENT BECAME STUCK INSIDE THE SHEATH. THE SHEATH AND STENT WERE COMPLETELY REMOVED FROM THE BODY AND WIRE ACCESS WAS MAINTAINED IN THE VESSEL AND PRESSURE WAS APPLIED AT THE ENTRY SITE. THEN TROUBLESHOOTING BEGAN OUTSIDE OF THE ANATOMY VIA THE HUB OF THE SHEATH WAS PURPOSELY UNSCREWED, AND REMOVED. THE STENT SYSTEM WAS THEN PULLED BACK BY THE VALVE OF THE SHEATH; HOWEVER, THE STENT CAME OFF THE DELIVERY SYSTEM,. THIS OCCURRED OUTSIDE OF THE PATIENT. A 9X19MM OMNILINK 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 15419882 ↗
• InjuryJul 6, 2022Off-Label Use; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Off-Label Use; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERIOR MESENTERIC ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON CATHETER AND THE 9.0X29MM OMNILINK ELITE WAS ATTEMPTED TO CROSS; HOWEVER, FAILED DUE TO ANATOMY. DURING REMOVAL THE STENT DISLODGED AS THE STENT BECAME CAUGHT IN THE TIP OF THE GUIDE CATHETER. THE DISLODGED STENT WAS RETRIEVED WITH FORCEPS FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. 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 14931279 ↗
• MalfunctionApr 8, 2022Difficult to Remove

  STENT CAME OFF OF STENT BALLOON IN THE RIGHT COMMON ILIAC ARTERY AND WAS PARTIALLY REMOVED USING BALLOON TRAPPING, BUT WAS UNABLE TO BE REMOVED FROM THE LEFT FEMORAL ARTERIOTOMY SITE REQUIRING SURGICAL EXPLORATION AND FOREIGN BODY EXTRACTION FOLLOWED BY DIRECT REPAIR OF THE LEFT FEMORAL ARTERIOTOMY SITE WITH PROBABLE PERIOPERATIVE BLOOD LOSS ANEMIA. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14074344 ↗
• InjuryApr 1, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. DURING ADVANCING OF THE FIRST OMNILINK STENT DELIVERY SYSTEM (SDS) (1012632-39, 1050441), THE STENT DISLODGED, AND A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT SUCCESSFULLY. A SECOND OMNILINK SDS (1012632-29, 1030941) WAS ADVANCED INTO THE VESSEL AND THE STENT DISLODGED AS WELL. THE DISLODGED STENT WAS ABLE TO BE RETRIEVED WITH THE DELIVERY SYSTEM BUT A CUT DOWN OF THE VESSEL WAS PERFORMED TO REMOVE THE SECOND DISLODGED STENT. THERE WAS SOME RESISTANCE NOTED DURING ADVANCEMENT DUE TO A SHARP ANGLE IN THE VESSEL. A THIRD OMNILINK SDS WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978528 ↗
• MalfunctionJul 8, 2021Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TO TREAT THE BILATERAL ILIAC ARTERIES. WHEN THE 9.0X29 MM OMNILINK ELITE WAS BEING REMOVED FROM THE PACKAGING HOOP, THE STENT FELL OFF OF THE STENT DELIVERY SYSTEM ON THE BACK TABLE; THERE WAS NO PATIENT INVOLVEMENT. ANOTHER 9.0X29 MM OMNILINK ELITE WAS PREPARED AND INSERTED INTO THE 6 FRENCH SHEATH, BUT WAS NOT ABLE TO COME OUT OF THE SHEATH TO USE IN THE PATIENT. THE SHEATH HAD TO BE REMOVED FROM THE PATIENT SO THE OMNILINK ELITE COULD BE REMOVED FROM THE SHEATH. A NEW 6 FRENCH SHEATH OF THE SAME BRAND WAS USED IN THE PATIENT WITH TWO 8.0X29 OMNILINK ELITE STENTS WITHOUT FURTHER INCIDENT. THE PHYSICIAN FELT THAT THE FIRST TWO OMNILINK ELITE STENTS WERE NOT CRIMPED ON THE BALLOON DELIVERY SYSTEM PROPERLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136246 ↗
• MalfunctionJul 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TO TREAT THE BILATERAL ILIAC ARTERIES. WHEN THE 9.0X29 MM OMNILINK ELITE WAS BEING REMOVED FROM THE PACKAGING HOOP, THE STENT FELL OFF OF THE STENT DELIVERY SYSTEM ON THE BACK TABLE; THERE WAS NO PATIENT INVOLVEMENT. ANOTHER 9.0X29 MM OMNILINK ELITE WAS PREPARED AND INSERTED INTO THE 6 FRENCH SHEATH, BUT WAS NOT ABLE TO COME OUT OF THE SHEATH TO USE IN THE PATIENT. THE SHEATH HAD TO BE REMOVED FROM THE PATIENT SO THE OMNILINK ELITE COULD BE REMOVED FROM THE SHEATH. A NEW 6 FRENCH SHEATH OF THE SAME BRAND WAS USED IN THE PATIENT WITH TWO 8.0X29 OMNILINK ELITE STENTS WITHOUT FURTHER INCIDENT. THE PHYSICIAN FELT THAT THE FIRST TWO OMNILINK ELITE STENTS WERE NOT CRIMPED ON THE BALLOON DELIVERY SYSTEM PROPERLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136225 ↗
• MalfunctionDec 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER DEVICE PREPARATION AND WHILE LOADING THE OMNILINK ELITE ONTO THE GUIDE WIRE, IT WAS OBSERVED THAT THE STENT WAS LOOSE ON THE BALLOON, SO THE DEVICE WAS REMOVED AND NOT USED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER OMNILINK STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10950479 ↗
• InjuryApr 3, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE COMMON ILIAC ARTERY. A 9.0X29MM OTW OMNI ELITE STENT DELIVERY SYSTEM WAS ADVANCED THROUGH A 6FR SHEATH; HOWEVER, IT WAS PULLED BACK TO TAKE MORE PICTURES AND THE STENT MET RESISTANCE WITH THE SHEATH AND THE STENT DISLODGED. THE STENT REMAINED ON THE GUIDE WIRE; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED. A SMALLER UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND WAS ABLE TO ADVANCE THE DISLODGED STENT TO THE TARGET LESION AND DEPLOY THE STENT AGAINST THE VESSEL WALLS. THE SMALLER BALLOON CATHETER WAS REMOVED AND THE OTW OMNI ELITE DELIVERY SYSTEM WAS RE-ADVANCED TO FULLY DEPLOY THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 9923226 ↗
• MalfunctionJan 10, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSIS IN THE TORTUOUS COMMON ILIAC ARTERY. THE 9X29 MM OMNILINK ELITE STENT WAS ADVANCED BUT THE STENT MOVED AND WAS LIKELY TO DISLODGE DUE TO RESISTANCE WITH THE ANATOMY SO IT WAS CAREFULLY REMOVED. NEXT, A 7X29 MM OMNILINK ELITE STENT WAS ATTEMPTED BUT FAILED TO CROSS DUE TO THE ANATOMY. THE STENT DELIVERY SYSTEM WAS REMOVED. AN UNSPECIFIED SELF EXPANDING STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578451 ↗
• InjuryOct 25, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY TORTUOUS AND MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY. THE OMNILINK STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT RESISTANCE, BUT THE STENT DISLODGED, REMAINING ON THE GUIDE WIRE, BUT OUTSIDE THE SHEATH. AN ATTEMPT WAS MADE TO ADVANCE AN UNSPECIFIED DILATATION CATHETER TO THE DISLODGED STENT, TO EXPAND THE STENT TO THE VESSEL WALL, BUT THE DILATATION CATHETER COULD NOT BE ADVANCED THROUGH THE STENT. THE DECISION WAS MADE TO PUSH THE SHEATH AND STENT INTO THE EXTERNAL ILIAC ARTERY AND A SECOND STENT WAS IMPLANTED, CRUSHING THE DISLODGED STENT TO THE VESSEL WALL. AN ADDITIONAL SAME SIZE OMNILINK STENT WAS IMPLANTED TO TREAT THE TARGET LESION. A PROCEDURE DELAY WAS REPORTED, DUE TO THE AMOUNT OF TIME TO TREAT THE DISLODGED STENT; HOWEVER, NO ADVERSE PATIENT EFFECTS OCCURRED DUE TO THE DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9242413 ↗
• InjurySep 12, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE OF THE MILDLY CALCIFIED, NON-TORTUOUS, DE NOVO RIGHT COMMON ILIAC AFTER PRE-DILATATION THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AREA. DUE TO LIMITED VISIBILITY DURING A CONTRAST INJECTION UNRELATED TO THE SDS; THE SDS WAS BEING REMOVED BUT THE STENT IMPLANT BECAME DISLODGED FROM THE BALLOON. THERE WAS NO REPORTED RESISTANCE. THE SHEATH WAS UPSIZED TO 7F TO SNARE THE STENT AND REMOVE IT FROM THE ANATOMY. A DIFFERENT STENT WAS USED SUCCESSFULLY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6859986 ↗
• InjuryJun 15, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND SEVERELY STENOSED LEFT COMMON ILIAC ARTERY. A 9.0 X 29 MM OMNI ELITE STENT DELIVERY SYSTEM WAS BEING ADVANCED WHEN THERE WAS RESISTANCE WITH THE ANATOMY AND THE STENT IMPLANT DISLODGED AND MIGRATED TO THE TIBIAL PERONEAL TRUNK. A BALLOON CATHETER WAS ADVANCED TO THE DISLODGED STENT AND CAPTURED THE STENT AND PULLED IT BACK TO THE ILIAC ARTERY WHERE IS WAS IMPLANTED IN THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643605 ↗
• MalfunctionMar 23, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT COMMON ILIAC ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF THE 9.0 MM/29 MM OMNILINK STENT AT THE LESION SITE, RESISTANCE WAS FELT DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) WITH THE 6FR TAPERED NON-ABBOTT INTRODUCER SHEATH. THE STENT DELIVERY SYSTEM BALLOON WAS CONFIRMED TO BE FULLY DEFLATED PRIOR TO ATTEMPTED RETRACTION. THE INTRODUCER SHEATH AND THE SDS WERE REMOVED TOGETHER AS ONE UNIT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429307 ↗
• InjuryOct 11, 2016Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE OF THE NON-TORTUOUS, NON-CALCIFIED, ILIAC ARTERY A 6 FR SLENDER SHEATH WAS USED AND AFTER PRE-DILATATION OF THE VESSEL THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED BUT FAILED TO CROSS THE LESION. DURING REMOVAL OF THE SDS, THE STENT DISLODGED IN THE ARM AT THE DISTAL END OF THE SHEATH. THE PROCEDURE WAS CONTINUED WITH A SMALLER SIZE STENT SUCCESSFULLY DEPLOYED IN THE TARGET LESION. A BALLOON CATHETER WAS THEN ADVANCED DISTAL TO THE DISLODGED STENT, BUT WAS UNSUCCESSFUL IN REMOVAL AND THE STENT WAS EXPANDED TO THE VESSEL WALL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6017310 ↗