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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
Catalog Number 11004-19
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Cardiac Arrest (1762); Respiratory Failure (2484)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.A review of the electronic lot history record (elhr) revealed no nonconforming material records (ncmr).Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with r espect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the biliary duct artery.It was noted that other non-abbott devices were used in the procedure.An 8.0x19mm omnilink balloon-expandable stent (bes) was advanced to the target lesion, and the stent was successfully deployed.However, the patient experienced cardiac and respiratory failure and the patient went into anaphylactic shock.The patient was successfully treated with adrenaline medication.The physician stated that the stent or a non-abbott device used in the procedure caused the anaphylactic shock.The patient is stable and remains hospitalized.There was no clinically significant delay in the procedure.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 Key9506039
MDR Text Key176240557
Report Number2024168-2019-14860
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/20/2019
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? No
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue Number11004-19
Device Lot Number8080841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2019
Initial Date FDA Received12/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2018
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) Hospitalization; Required Intervention;
Patient Age3 YR
Patient Weight14
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