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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR OMNILINK ELITE; PERIPHERAL STENT DELIVERY SYSTEM Back to Search Results
Model Number 1012623-39
Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 02/24/2020
Event Type  Injury  
Manufacturer Narrative
The incident information was reviewed; however, the product was not returned to abbott vascular 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 other similar incidents reported from this lot.The investigation determined the reported difficulties of difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, the selected device size chosen for the procedure was too short to cover lesion.During retraction, the sds encountered resistance with the anatomy and/or other devices used causing the stent to dislodge on the wire.Manipulation during attempt to retrieve the stent using a snare device caused the stent to get stuck on the previously implanted stent.Additionally, the treatment appears to be related to the operational context of the procedure as a non-abbott covered stent was used to cover the entire area and embed the dislodged stent to the vessel wall.There is no indication of a product quality issue with respect to the design, manufacture.
 
Event Description
It was reported that the patient arrived emergently with a groin bleed from a previous procedure.The physician cut down to the femoral/popliteal artery to bypass directly.Imaging was taken and the bleed was visualized and an 8fr sheath was inserted to attempt bypass.A 7.0x39 mm omnilink elite stent was implanted without issue.An abdominal angiogram was performed and tight stenosis on the left iliac was noted.The physician called for another 7.0x39 mm omnilink elite stent and it was advanced up and over the iliac crest only on a guide wire as the sheath was only on the right side.Once the omnilink reached the lesion it was found that the stent was too short.During removal of the omnilink elite sds the stent dislodged and was not noted until the delivery system was pulled out.The stent remained on the guide wire.A snare was used to bring the stent to the right side; however, the stent became stuck on the previously implanted omnilink elite stent.A non-abbott covered stent was then used to cover the entire area and embed the dislodged stent to the vessel wall.There was a delay in the procedure.There were no adverse patient sequela.No additional information was provided.
 
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Brand Name
OMNILINK ELITE
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 Key9845440
MDR Text Key186761599
Report Number2024168-2020-02569
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08717648179266
UDI-Public08717648179266
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model Number1012623-39
Device Catalogue Number1012623-39
Device Lot Number9032641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2020
Initial Date FDA Received03/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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