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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 11003-59
Device Problems Positioning Failure (1158); Inflation Problem (1310); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the mid common iliac artery with mild tortuosity, mild calcification and 90% stenosis.A 7x59mm omnilink elite over the wire (otw) stent system was prepped outside the anatomy prior to use, the elite was inserted through the sheath and advanced toward the target lesion.An attempt was made to inflate the balloon three times but the balloon did not inflate.The stent was not deployed.Upon removal of the device from the patient anatomy, the elite was inspected, flushed and a hole was noted in the balloon between the tip and proximal part of the stent.Another elite stent was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Evaluation summary: (b)(4).Visual and functional inspection was performed on the returned device.The reported difficulties were confirmed.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
 
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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 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key5498258
MDR Text Key40268724
Report Number2024168-2016-01574
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P110043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/05/2016
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 Date08/31/2018
Device Catalogue Number11003-59
Device Lot Number5030241
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/10/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/18/2016
Initial Date FDA Received03/14/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
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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