Omnilink Elite 1012631-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648178528), received between Dec 15, 2017 and May 19, 2026 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT COMMON ILIAC ARTERY LESION. AN 8X59 MM OMNILINK ELITE STENT WAS IMPLANTED WITHOUT ISSUE. THE OMNILINK BALLOON WAS THEN USED FOR POST-DILATION AT A HIGHER ATMOSPHERE; HOWEVER, THE DISTAL END OF THE STENT BECAME CRUSHED DURING ADVANCEMENT OF THE BALLOON CATHETER. AN ADDITIONAL OMNILINK STENT WAS USED TO COVER THE DAMAGED SECTION AND COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219850 ↗
• InjuryMar 31, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT HAS BEEN REPORTED THE PROCEDURE WAS TO TREAT 80% STENOSED LESIONS IN THE LEFT EXTERNAL ILIAC ARTERY AND LEFT COMMON ILIAC ARTERY WITH MODERATE CALCIFICATION. ON (B)(6) 2026 THE 8X59MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ADVANCED TO THE TARGET LESION AND THE WHILE REPOSITIONING THE BES WITH DIFFICULTY, THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM BALLOON. THEN, A 7X39MM OMNI ELITE BES WAS IMPLANTED; HOWEVER, POST STENT IMPLANTATION AN UNSPECIFIED GUIDE WIRE (GW) WAS BEING ADVANCED TO ACCESS THE PATIENTS LEFT SIDE WHEN THE GW BECAME ENTANGLED WITH THE IMPLANTED STENT. THEREFORE, ON (B)(6) 2026 CUTDOWN SURGERY WAS PERFORMED TO REMOVE BOTH THE STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743535 ↗
• MalfunctionFeb 20, 2026Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE OMNILINK ELITE BALLOON EXPANDING STENT (BES) WAS REMOVED FROM THE DISPENSER HOOP, SLIGHT RESISTANCE WAS NOTED. THEN THE STYLET AND THE PROTECTIVE SHEATH WERE REMOVED, BUT THE STENT CAME OFF WITH IT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402710 ↗
• InjuryJul 17, 2025Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY. THE 8.0X59MM OMNILINK STENT DELIVERY SYSTEM WAS ADVANCED AND WHEN ATTEMPTING TO DEPLOY THE BALLOON ON THE DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES. THE STENT WAS UNDER EXPANDED AND A 6.0 ARMADA BALLOON WAS ADVANCED AND USED TO FULLY EXPAND THE STENT. 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 22532825 ↗
• InjuryJun 24, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED CHRONIC TOTAL OCCLUSION OF THE LEFT DISTAL COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 8X59MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE BES FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE BES WAS ATTEMPTED TO BE REMOVED FROM THE PATIENT; HOWEVER, DURING REMOVAL THE STENT BECAME DISLODGED FROM THE BALLOON AND REMAINED IN THE RIGHT COMMON FEMORAL ARTERY. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. A LARGER OPENING WAS MADE AT THAT INTERVENTIONAL ACCESS SITE TO ADVANCE A HEMOSTAT DEVICE AND REMOVE THE STENT. THE PROCEDURE WAS ABORTED DUE TO THE PATIENT EXPERIENCING BLOOD LOSS, AND DISCOMFORT WHICH WAS TREATED WITH ADDITIONAL SEDATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 22322842 ↗
• MalfunctionFeb 24, 2025Difficult 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 EXTERNAL ILIAC ARTERY. THE 8X59MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED ON A VIPER GUIDE WIRE (GW) VIA THE LEFT COMMON FEMORAL ARTERY; HOWEVER, THE BES MET WITH RESISTANCE DURING ADVANCEMENT PRIOR TO ENTERING THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO SLIGHTLY PULL BACK THE BES AND THE READVANCE, BUT RESISTANCE WAS STILL NOTED WITH THE GW AND THE STENT BECAME LOOSE ON THE BALLOON AND MOVED FROM BETWEEN THE BALLOON MARKERS. THEREFORE, THE BES AND THE GW WERE REMOVED INDEPENDENTLY FROM EACH OTHER AND ANOTHER OMNI ELITE BES AND VIPER GW WERE USED TO CONTINUE THE PROCEDURE. THERE AS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453522 ↗
• InjuryOct 24, 2024Failure 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 ILIAC ARTERY. THE 8X59MM OMNI LINK BALLOON EXPANDING STENT (BES) WAS ATTEMPTED TO BE ADVANCED TO TARGET LESION; HOWEVER, THE BES MET WITH RESISTANCE WITH A DIFFERENT LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DURING ADVANCEMENT. THEREFORE, THE BES WAS REMOVED AND THE STENT BECAME DISLODGED IN THE POSTERIOR TIBIAL ARTERY DURING REMOVAL. A BALLOON WAS USED TO EMBED THE STENT IN THE POSTERIOR TIBIAL ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. ANOTHER OMNILINK STENT WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20526465 ↗
• InjuryJan 8, 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 THE ILIAC ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. ACCESS WAS VIA THE RADIAL ARTERY. PRE-DILATATION WAS PERFORMED; HOWEVER, IT WAS NOT ENOUGH. THERE WAS DIFFICULTY WITH THE ANATOMY DURING ADVANCEMENT OF THE 8X59 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) AND DURING REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY AND THE STENT CAME OFF OF THE BALLOON. THE STENT WAS ULTIMATELY DEPLOYED WHERE IT DISLODGED IN THE BRACHIAL ARTERY. THE TARGET LESION WAS TREATED WITH ADDITIONAL BALLOON DILATATION AND ANOTHER OMNILINK ELITE STENT. THERE WAS A DELAY IN THE PROCEDURE BUT NO REPORTED HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18465359 ↗
• MalfunctionJun 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ONCE THE 8.0X59MM OMNI ELITE WAS REMOVED FROM ITS PACKAGING AND THE STENT LOOKED LIKE IT WAS COMING OFF OF THE BALLOON ON THE PROXIMAL END. ANOTHER SAME SIZE OMNI ELITE WAS USED TO SUCCESSFULLY COMPLETE 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 17242829 ↗
• InjuryJun 5, 2023Difficult to Remove; Failure to Advance; Difficult or Delayed Activation; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Difficult or Delayed Activation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED DISTAL RIGHT ILIAC ARTERY. AFTER CROSSING WITH AN UNSPECIFIED WIRE THE 8.0X59MM, THE OMNILINK ELITE STENT DELIVERY SYSTEM FAILED TO FULLY CROSS LESION DUE TO RESISTANCE WITH ANATOMY; THEREFORE, IT WAS ATTEMPTED TO PULL BACK THE DELIVERY SYSTEM INTO SHEATH. RESISTANCE WAS MET AND THE STENT BEGAN TO COME OFF THE BALLOON. THE OMNILINK ELITE WAS ADVANCED BACK INTO THE ILIAC ARTERY AND DEPLOYED NOTING THAT IT WAS ALSO, PARTIALLY DEPLOYED IN THE PROXIMAL RIGHT ILIAC ARTERY. A SMALLER UNSPECIFIED BALLOON WAS ADVANCED INTO THE PORTION OF THE STENT THAT WAS DEPLOYED AND BALLOONED ENOUGH TO USE ANOTHER OMNILINK STENT TO FULLY DEPLOY THE FIRST STENT, WHILE ALSO STENTING THE REST OF THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AN NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062967 ↗
• MalfunctionApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUBCLAVIAN ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. THE 8.0X59MM OTW OMNI ELITE BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED TO THE LESION; HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM. THE BESS WAS REMOVED FROM THE PATIENT ANATOMY. THE TARGET LESION WAS IMAGED, AND IT WAS NOTED THAT THE STENT HAD DISLODGED AND WAS AT THE TIP OF THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS REMOVED WITH THE DISLODGED STENT. THERE WAS NOT RESISTANCE MET DURING ADVANCEMENT. ANOTHER 8X29MM OTW OMNI 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 16725848 ↗
• MalfunctionNov 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 8.0X59MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE STENT WAS LOOSE UPON REMOVAL OF THE PROTECTIVE SHEATH. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER SAME SIZE OMNILINK 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 15886144 ↗
• InjuryApr 18, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ILIAC ARTERY. WHEN ADVANCING THE OMNILINK TO THE LESION, RESISTANCE WAS MET WITH THE ANATOMY AND THE STENT IMPLANT DISLODGED. THE STENT IMPLANT WAS BALLOONED AND EMBEDDED TO THE VESSEL WALL. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND IMPLANT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14138317 ↗
• MalfunctionDec 6, 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 WITH NO TORTUOSITY AND HEAVY CALCIFICATION IN THE RIGHT COMMON ILIAC ARTERY. PRE-DILATATION WAS PERFORMED SUCCESSFULLY. THE 8.0 X 59 MM OTW OMNI ELITE STENT DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE TARGET LESION, BUT ONCE AT THE LESION THE STENT COULD NOT BE SEEN UNDER FLUOROSCOPY. THE SDS WAS REMOVED, AND IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT WAS FOUND ON THE BACK TABLE. IT WAS SUSPECTED IT MIGHT HAVE DISLODGED DURING PREPARATION OF THE SDS AND NOT NOTICED. A NEW SDS WAS USED SUCCESSFULLY IN 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 12934594 ↗
• InjuryJun 16, 2021Difficult 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 LEFT SUBCLAVIAN ARTERY VIA BRACHIAL ACCESS. THE PATIENT ANATOMY INCLUDED A PREVIOUSLY IMPLANTED THORACIC STENT GRAFT. THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE GUIDE WIRE TO THE TARGET LESION; HOWEVER THE SDS WAS ADVANCED PAST THE TARGET LESION AND INTERACTED WITH THE STENT GRAFT. THE OMNILINK SDS WAS ADVANCED THROUGH THE STENT GRAFT STRUTS AND DURING REMOVAL OF THE OMNILINK SDS, THE STENT DISLODGED FROM THE DELIVERY SYSTEM, BUT REMAINED ON THE GUIDE WIRE. A SNARE WAS ADVANCED TO RETRIEVE THE DISLODGED STENT. THE PHYSICIAN WAS UNABLE TO SNARE THE STENT. DURING REMOVAL OF THE SNARE DEVICE, THE PHYSICIAN INADVERTENTLY PULLED THE GUIDE WIRE, WHICH CAUSED THE STENT TO COME OFF THE GUIDE WIRE. THE OMNILINK STENT THEN EMBOLIZED TO THE DESCENDING AORTA, WHERE IT BECAME CAUGHT IN THE THORACIC STENT GRAFT. THE PHYSICIAN ADVANCED A SNARE DEVICE, VIA GROIN ACCESS, AND WAS ABLE TO SNARE THE STENT FROM BELOW. THE STENT WAS THEN PULLED TO THE LEFT EXTERNAL ILIAC ARTERY, BUT WAS UNABLE TO BE PULLED INTO THE SHEATH. A CUT DOWN PROCEDURE WAS PERFORMED TO REMOVE THE STENT. A SECOND OMNILINK ELITE SDS

  Patient problems: Embolism/Embolus

  MAUDE report 12013258 ↗
• MalfunctionOct 13, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY WITH NO CALCIFICATION OR TORTUOSITY NOTED. AN 8X59MM OMNILINK ELITE BALLOON EXPANDABLE STENT (BES) WAS ADVANCED TO THE AORTA WITHOUT ISSUE, HOWEVER, THERE WAS RESISTANCE WITH THE ANATOMY ADVANCING FROM THE BRACHIAL TO THE COMMON ILIAC, AND THE DEVICE DID NOT REACH THE TARGET LESION. THE BES WAS REMOVED WITH RESISTANCE NOTED, AND IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER OMNILINK ELITE SUCCESSFULLY COMPLETED THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10673841 ↗
• InjuryApr 2, 2020Difficult 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 CALCIFIED LESION IN THE LEFT ILIAC. THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WOULD NOT CROSS THE MILD TO SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). DURING REMOVAL OF THE DEVICE, RESISTANCE WAS FELT AND THE STENT SLID OFF THE BALLOON. A BALLOON CATHETER WAS ADVANCED THROUGH THE DISLODGED STENT AND INFLATED, DEPLOYING THE STENT OUTSIDE THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9917526 ↗
• MalfunctionMar 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE 8.0X59MM OMNILINK ELITE STENT DISLODGED FROM THE CATHETER. THERE WAS NO PATIENT INVOLVEMENT. A NEW UNSPECIFIED DEVICE WAS USED TO CONTINUE THE PROCEDURE. 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 9805377 ↗
• InjuryJun 28, 2018Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A LESION IN THE EXTERNAL ILIAC ARTERY. AN UNKNOWN GUIDE WIRE WAS ADVANCED INTO THE INTERNAL ILIAC ARTERY AND AN 8X59MM OTW OMNI ELITE STENT SYSTEM WAS ADVANCED OVER THE WIRE. LOSS OF SUPPORT WITH THE SHEATH WAS FELT SO IT WAS ADVANCED AND AT THE SAME TIME THE STENT SYSTEM WAS ALSO ADVANCED ABOUT 8MM INTO THE INCORRECT ARTERY. THE INTERNAL ILIAC ARTERY WAS HEAVILY DISEASE AND CAUSED THE STENT TO BECOME STUCK. FORCE WAS USED TO REMOVE THE STENT SYSTEM, BUT THE STENT DISLODGED AND ONLY THE STENT SYSTEM WAS REMOVED. AN ATTEMPT TO SNARE THE STENT WAS MADE, BUT IT WAS LODGED IN THE ARTERY. THE RIGHT COMMON FEMORAL ARTERY WAS ACCESSED AND THE STENT WAS CRUSHED AGAINST THE VESSEL WALL. AN UNSPECIFIED OTW OMNI ELITE STENT WAS PLACED OVER THE CRUSHED STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF AN UNSPECIFIED ABSOLUTE PRO STENT IN THE EXTERNAL ILIAC ARTERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7648912 ↗
• MalfunctionDec 20, 2017Difficult to Insert; Unstable; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE UNSPECIFIED VESSEL, THE OMNILINK STENT DELIVERY SYSTEM (SDS) FAILED TO ENTER THE 6 FR NON-ABBOTT SHEATH. AFTER REMOVAL OF THE DEVICE THE STENT IMPLANT WAS NOTED TO BE INTACT ON THE BALLOON BUT HAD MIGRATED ABOUT 2MM, DEFORMED IN THE MID TO DISTAL AREA, SLIGHTLY BENT AND RAISED CIRCUMFERENTIALLY IN THE SAME AREA. THE DEVICE WAS NOT USED. A DIFFERENT SAME SIZE OMNILINK 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 7136327 ↗
• MalfunctionDec 15, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS PRESSURIZED TO 11 ATMOSPHERES FOR 20 SECONDS WHEN CONTRAST LEAKAGE AT THE BALLOON AREA WAS OBSERVED UNDER ANGIOGRAPHY. THE STENT WAS DEPLOYED AND THE SDS WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. NO POST-DILATATION WAS NEEDED. 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 7123300 ↗