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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

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ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 11005-39
Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified common iliac artery that is 70% stenosed.The 9.0mmx39mm omnilink elite 35 stent was attempted to advance with the 6fr sheath; however, resistance was felt with the sheath and the stent was noted to slightly off the delivery system.The device was simply withdrawn with the stent and another omnilink elite stent with a 7f sheath was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported stent dislodgement was confirmed.The reported difficulty to advance could not be confirmed due to the condition the device was received for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified common iliac artery that is 70% stenosed.The 9.0mmx39mm omnilink elite 35 stent was attempted to advance with the 6fr sheath; however, resistance was felt with the sheath and the stent was noted to slightly off the delivery system.The device was simply withdrawn with the stent and another omnilink elite stent with a 7f sheath was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
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Brand Name
OMNILINK ELITE PERIPHERAL STENT SYSTEM
Type of Device
PERIPHERAL STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI  
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key18006497
MDR Text Key326529506
Report Number2024168-2023-11846
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11005-39
Device Lot Number3012441
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6FR SHEATH.
Patient Age70 YR
Patient SexFemale
Patient Weight56 KG
Patient RaceWhite
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