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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
Model Number 1012630-29
Device Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported malposition of device (stent) appears to be related to the operational context 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 lesion located in the superior mesenteric artery.The 7x29mm otw omni elite stent was advanced to the lesion, but during deployment, the stent jumped distally and only partially covered the lesion.Another omnilink stent was implanted to fully cover the lesion.There was no adverse patient effect or a clinically significant delay in procedure.
 
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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 Key14366194
MDR Text Key291829123
Report Number2024168-2022-05173
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08717648178467
UDI-Public08717648178467
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1012630-29
Device Catalogue Number1012630-29
Device Lot Number1100841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/25/2022
Initial Date FDA Received05/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2021
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 Age79 YR
Patient SexFemale
Patient Weight69 KG
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