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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 11011-29
Device Problems Inflation Problem (1310); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2014
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a lesion located in the iliac artery.The 8.0 mm x 29 mm omnilink 35 stent delivery system was advanced to the lesion with some resistance felt; however, the balloon failed to inflate for deployment of the stent.The case was abandoned.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
 
Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported failure to inflate was not confirmed.The reported resistance was not tested as it was based on case circumstances.Based on a visual and dimensional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
 
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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 Key4274527
MDR Text Key5297417
Report Number2024168-2014-07731
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/03/2014
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 Date09/30/2017
Device Catalogue Number11011-29
Device Lot Number4042541
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/06/2015
Initial Date FDA Received11/24/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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