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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

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AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 1012624-29
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.The omnilink referenced is being filed under a separate manufacturing report number.
 
Event Description
It was reported that the procedure was to treat a common iliac artery.An 8.0 x 19 mm omnilink elite was prepped according to the instructions for use (ifu) and was being loaded onto the guide wire; however, before entering the patient the stent dislodged off the balloon onto the wire.The device was removed and an 8.0 x 29 mm omnilink elite was again prepped per the ifu and advanced to the lesion.During deployment, a non-abbott inflation device could not maintain pressure; although the omnilink elite was successfully deployed.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
 
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Brand Name
OMNILINK ELITE PERIPHERAL STENT SYSTEM
Type of Device
PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key3803566
MDR Text Key21165539
Report Number2024168-2014-02998
Device Sequence Number1
Product Code NIO
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 Health Professional
Remedial Action Other
Type of Report Initial
Report Date 04/16/2014
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 Expiration Date05/31/2017
Device Catalogue Number1012624-29
Device Lot Number3121241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2014
Initial Date FDA Received05/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
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
INFLATION: BARD
Patient Age76 YR
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