Omnilink Elite 1012624-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648179303), received between Aug 10, 2018 and Mar 25, 2026 — classified as 1 death, 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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.

• MalfunctionMar 25, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. ONCE THE SDS WAS REMOVED FROM THE PATIENT ANATOMY IT WAS NOTED THE STENT HAD SHIFTED ON THE BALLOON. A NEW DEVICE 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 24690087 ↗
• InjuryNov 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THROUGH AN ARTICLE OF AN INDIVIDUAL CASE REGARDING A PATIENT PRESENTED WITH A LEFT LEG INTERMITTENT CLAUDICATION WITH SEVERE CALCIFIED STENOSIS OF THE LEFT COMMON ILIAC ARTERY (CIA) AND THROMBOTIC OCCLUSION OF THE LEFT EXTERNAL ILIAC ARTERY ON (B)(6) 2024. THEREFORE, THROMBECTOMY WAS PERFORMED AND TWO OMNILINK ELITE STENTS (8.0X29MM / 8.0X39MM) WERE PLACED IN THE CIA. COMPUTED TOMOGRAPHY (CT) WAS OBTAINED ON POSTPROCEDURAL DAY 4 BECAUSE THE LEFT ANKLE-BRACHIAL PRESSURE INDEX (ABI) REMAINED LOW AT 0.85 COMPARED WITH 1.07 ON THE RIGHT. CT REVEALED THE OMNILINK STENTS HAD COLLAPSED WITHIN THE CIA AND IN-STENT STENOSIS WAS PRESENT. ON DAY 7 BALLOON ANGIOPLASTY WAS PERFORMED WITH ADDITIONAL PLACEMENT OF A NON-ABBOTT SELF-EXPANDING STENT. POSTPROCEDURAL CT CONFIRMED SATISFACTORY STENT EXPANSION. HOWEVER, ON (B)(6) 2024, CT OBTAINED FOR EVALUATION OF GASTROINTESTINAL BLEEDING AGAIN SHOWED STENT COLLAPSE WITHIN THE CIA. PER THE PHYSICIAN'S OPINION THE BLEEDING WAS NOT CAUSE BY THE OMNILINK STENTS. FLUOROSCOPY DEMONSTRATED SEVERE STENT COLLAPSE AT THE HEAVILY CALCIFIED SEGMENT. PRE-DILATATION WAS PERFORMED WITH A 7.0 MM NON-ABBOTT BALLOON AND A 7.5X60MM SUPERA SELF-EXPANDING

  Patient problems: Stenosis

  MAUDE report 23662653 ↗
• InjuryAug 19, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE RIGHT COMMON ILIAC ARTERY WITH 75-80% STENOSIS AND MODERATE CALCIFICATION. THE 8.0X39MM OMNILINK ELITE PERIPHERAL STENT SYSTEM WAS BEING ADVANCED WHEN RESISTANCE WAS NOTED DUE TO THE ANATOMY AND THE STENT CAME OFF THE BALLOON IN THE AORTIC BIFURCATION. A BALLOON WAS USED TO PUSH THE DISLODGED STENT ALL THE WAY TO THE BIFURCATION AND PARTIALLY IMPLANTED IN THE TARGET LESION. ANOTHER NON-ABBOTT STENT WAS USED TO COMPLETELY COVER THE TARGET LESION AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE. ALTHOUGH THERE WAS A SLIGHT DELAY IN THE PROCEDURE, THERE WAS NO PATIENT HARM; THEREFORE, THE DELAY WAS NOT SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843013 ↗
• MalfunctionAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN 8.0X39MM OVER-THE-WIRE OMNI ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM WAS OPENED, THE STENT DISLODGED WHEN REMOVING THE STENT SYSTEM FROM THE DISPENSER COIL AND WAS NOT LOCATED IN THE PROTECTIVE SHEATH. THE STENT DELIVERY SYSTEM WAS NOT PREPPED. 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 22733133 ↗
• InjuryJun 24, 2025Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 8.0X39MM OTW OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE SDS WAS REMOVED AND A NON-ABBOTT BALLOON CATHETER WAS USED TO FULLY APPOSE THE STENT TO THE VESSEL WALL. 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 22318778 ↗
• InjuryMay 30, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT ILIAC ARTERY, SUPERFICIAL FEMORAL AND TIBIAL ARTERIES. THE 8X39MM OMNI ELITE BALLOON EXPANDING STENT (BES) WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL RIGHT ILIAC ARTERY; HOWEVER, THE PATIENT WAS EXPERIENCING HYPOTENSION, NOT DUE TO THE IMPLANTED STENT, THEREFORE, THE PROCEDURE WAS ABORTED. ON, (B)(6) 2025 THE PROCEDURE WAS PERFORMED TO TREAT THE SUPERFICIAL FEMORAL AND TIBIAL ARTERIES WHEN THE OMNI ELITE STENT WAS NOTED TO HAVE EMBOLIZED TO THE COMMON ILIAC ARTERY. THEREFORE, A 9MM BALLOON USED TO REPOSITION THE STENT. THE TARGET LESION WAS TREATED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 22115700 ↗
• MalfunctionOct 3, 2024Difficult or Delayed Activation; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Difficult or Delayed Activation; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THIS WAS A NON-TORTUOUS, MODERATELY CALCIFIED DISTAL EXTERNAL ILIAC ARTERY. REPORTEDLY, WHEN THE STARCLOSE VESSEL LOCATOR WINGS WERE OPENED THEY BECAME STUCK ON THE OMNILINK STENT THAT HAD BEEN PLACED IN THE EXTERNAL ILIAC ARTERY. THE RED SAFETY RELEASE BUTTON WAS USED TO CLOSE THE VESSEL LOCATOR WINGS AND THE STARCLOSE SE DEVICE WAS REMOVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE OMNILINK STENT WAS DAMAGED (STRETCHED/ELONGATED AND THE DISTAL END OF STENT WAS NO LONGER WELL APPOSED TO THE VESSEL WALL) BY THE STARCLOSE SE DEVICE; HOWEVER, IT REMAINED IN THE ARTERY AND NO OTHER INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362161 ↗
• MalfunctionJul 26, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. REPORTEDLY DIFFICULTY WAS MET INSERTING THE 8X39MM OTW OMNILINK ELITE BALLOON EXPANDABLE STENT (BES) INTO THE 6 X 23 NON-ABBOTT SHEATH, AND AFTER FURTHER INSPECTION IT WAS NOTED THAT THE STENT HAD BECOME DISLODGED AND WAS LOCATED ON THE SHAFT OF THE CATHETER. ANOTHER OMNILINK BES WAS USED, AND THE PROCEDURE WAS COMPLETED. 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 19844548 ↗
• MalfunctionJun 17, 2024Difficult to Remove; Stretched; Difficult to Advance; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON ILIAC ARTERY WITH 50% STENOSIS. A 6FR SHEATH WAS ENTERED INTO THE LEFT COMMON FEMORAL ACCESS SITE AND A VIPERWIRE WHICH WAS USED WITH A NON-ABBOTT ATHERECTOMY DEVICE WAS ALREADY PRESENT AT THE TARGET LESION. THE 8X39 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ON THE GUIDE WIRE BUT THERE WAS RESISTANCE AT THE SHEATH AND THE DEVICE COULD NOT BE ADVANCED. THERE WAS SOME RESISTANCE AT THE SHEATH DURING REMOVAL AND THE STENT ELONGATED. A NEW NON-ABBOTT GUIDE WIRE AND NON-ABBOTT STENT WERE 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 19548815 ↗
• MalfunctionMay 3, 2023Difficult 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 LESION IN THE RIGHT AND LEFT COMMON LILAC ARTERY WITH MODERATE CALCIFICATION AND 100% STENOSIS. THE 8.0X39MM AND 8.0X59MM OMNILINK ELITE BALLOON EXPANDABLE STENT (BES) WERE ADVANCED TO BE IMPLANTED AT THE SAME TIME; HOWEVER, THE 8.0X39MM OMNILINK ELITE MET RESISTANCE PROXIMAL TO THE LESION. AN ATTEMPT WAS MADE TO BE REMOVE THE BES, BUT THE STENT EDGE BECAME CAUGHT IN THE SHEATH AND THE STENT DISLODGED. THE DISLODGED STENT REMAINED ON THE GUIDEWIRE AND WAS REMOVED SUCCESSFULLY. DURING REMOVAL, RESISTANCE WAS ALSO MET WITH THE SHEATH. ANOTHER 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 16861913 ↗
• MalfunctionOct 20, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  HOLD SM 10.24IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LEFT COMMON FEMORAL ARTERY. A 6FR 11CM SHEATH WAS USED WITH THE OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) AND THE SDS WAS ATTEMPTED TO BE ADVANCED UP AND OVER THE ILIAC BIFURCATION WHEN THERE WAS RESISTANCE WITH THE HEAVY CALCIFICATION. THE STENT DISLODGED FROM THE BALLOON. THE STENT, DELIVERY SYSTEM, SHEATH AND GUIDE WIRE WERE ALL REMOVED TOGETHER AND NOTHING WAS LEFT IN THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT CAME BACK ON (B)(6) 2022 TO HAVE THE PROCEDURE RE-DONE, WITH ACCESS FROM THE OTHER GROIN [DUE TO THE CALCIFICATION ON THE LEFT] AND THEY ARE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640596 ↗
• InjuryJul 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY. AN 8X39MM OVER THE WIRE (OTW) OMNI ELITE BALLOON-EXPANDABLE STENT SYSTEM WAS ADVANCED TO THE TARGET LESION AND DEPLOYMENT WAS INITIATED WHEN THE STENT BECAME DISLODGED FROM THE BALLOON BUT REMAINED ON THE GUIDE WIRE (GW). A SURGICAL CUT DOWN WAS PERFORMED TO REMOVE THE GUIDE WIRE WITH THE DISLODGED STENT TO PREVENT THE STENT FROM DISLODGING FROM THE GW. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE DUE TO THE SURGICAL CUT DOWN. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958630 ↗
• InjurySep 10, 2020Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE ILIAC ARTERY. AN 8X39MM OMNI ELITE BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS PREPARED WITHOUT ISSUES. THE BESS WAS ADVANCED; HOWEVER, THE BALLOON RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. AN UNSPECIFIED ARMADA BALLOON CATHETER WAS USED TO FULLY APPOSE THE STENT TO THE VESSEL WALL. 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 10517815 ↗
• InjuryAug 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS AN OMNILINK ELITE (OLE) PROCEDURE TO TREAT THE RIGHT COMMON ILIAC (RCI) ARTERY. THE OLE WAS POSITIONED AT THE RCI WHEN IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE DELIVERY CATHETER. A BALLOON DILATATION CATHETER WAS USED TO DEPLOY THE DISLODGED STENT IN AN AREA THAT DID NOT NEED INTERVENTION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10468637 ↗
• InjuryMay 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS ILIAC ARTERY. REPORTEDLY, THE 8X39 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WITHOUT RESISTANCE AND THE STENT DISLODGED. THE SDS BALLOON WAS INFLATED RIGHT AWAY EVEN THOUGH THE STENT WAS NOT IN THE CORRECT POSITION AND THE STENT WAS DEPLOYED OUTSIDE THE TARGET LESION. A NEW OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10094148 ↗
• InjuryMar 13, 2020Failure 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 HEAVILY TORTUOUS RIGHT COMMON ILIAC ARTERY. AN 8X39MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) FACED RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY. THEN THE STENT DISLODGED, SO AN UNSPECIFIED BALLOON WAS USED TO SLIGHTLY DILATE THE DISLODGED STENT AND REMOVE IT WITH THE BALLOON. THE PATIENT HAS ANOTHER APPOINTMENT TO TREAT THE SAME LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829784 ↗
• InjuryDec 2, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THIS WAS A PERIPHERAL PERCUTANEOUS INTERVENTION TREATING THE BILATERAL ILIAC ARTERIES, MODERATELY CALCIFIED LESIONS. TWO OMNILINK ELITE STENTS WERE SUCCESSFULLY PLACED. IMAGING WAS PERFORMED WITH AN UNSPECIFIED CATHETER, WHEN THE CATHETER SNAGGED THE LEFT ILIAC, 8X39MM OMNILINK ELITE STENT. THE STENT WAS DRAGGED DOWN TO THE BIFURCATION AT THE COMMON FEMORAL WITH IMAGING CATHETER REMOVAL. THE SAME IMAGING CATHETER WAS USED TO PUSH THE STENT BACK TO THE DESIRED IMPLANTATION SITE. THE STENT WAS SUCCESSFULLY RE-EXPANDED AND WAS IMPLANTED AT THE DESIRED LOCATION. THERE WAS NO STENT DAMAGE OBSERVED, HOWEVER, AS A PRECAUTION, ANOTHER STENT WAS SUCCESSFULLY IMPLANTED, OVERLAPPING THE 8X39MM OMNILINK ELITE STENT. REPORTEDLY, THE PROCEDURE ENDED WITH GOOD RESULTS NOTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397610 ↗
• MalfunctionOct 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY WITH NO TORTUOSITY. NO RESISTANCE WAS NOTED DURING ADVANCEMENT AND THE BALLOON OF THE 8X39 MM OMNILINK STENT DELIVERY SYSTEM (SDS) WAS INFLATED TWICE AND RUPTURED AT NOMINAL PRESSURE. THE STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ISSUE REMOVING THE BALLOON AND THERE WERE NO ADVERSE PATIENT EFFECTS. 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 9227443 ↗
• DeathJul 25, 2019Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE OMNILINK ELITE STENT WAS IMPLANTED IN THE SUBCLAVIAN ARTERY AND THE XACT STENT WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. REPORTEDLY, 8 DAYS LATER, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS REPORTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 8828885 ↗
• MalfunctionJun 28, 2019Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS NOTED THAT THE TIP OF AN 8.0 X 39 MM OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM WAS KINKED. THEREFORE, THE STENT SYSTEM WAS REPLACED WITH AN UNSPECIFIED DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT HAD MOVED FROM ITS POSITION ON THE BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 8744935 ↗
• InjuryAug 10, 2018Failure 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 RIGHT ILIAC ARTERY WITH NO TORTUOSITY AND HEAVY CALCIFICATION. A NON-ABBOTT STENT WAS PREVIOUSLY IMPLANTED IN THE LEFT ILIAC ARTERY. AN 8.0 X 39 MM OTW OMNI-LINK BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCING UP AND OVER THE LEFT ILIAC ARTERY, BUT THE BESS COULD NOT CROSS TO THE TARGET LESION DUE TO TIGHTNESS AROUND THE PREVIOUSLY IMPLANTED STENT AND HEAVY CALCIFICATION. THE OMNILINK STENT BECAME STUCK WITH THE NON-ABBOTT STENT DURING ADVANCEMENT AND THE OMNILINK STENT DISLODGED. THE DISLODGED STENT WAS STUCK IN THE CALCIUM, JUST PROXIMAL OF THE PREVIOUSLY IMPLANTED STENT. THE DELIVERY SYSTEM WAS REMOVED AND THE PATIENT WAS IMMEDIATELY SENT TO SURGERY. THE STENT WAS SURGICALLY REMOVED WITHOUT COMPLICATIONS. THE TARGET LESION WAS TREATED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7772436 ↗