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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 11004-29
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2015
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a non-tortuous, mildly calcified lesion in the mid common iliac artery.No resistance was noted upon preparing the device for use.The introducer was a short 6f sheath.The omnilink elite was positioned at the target lesion and when the stent delivery system (sds) balloon was inflated a leak was detected at the proximal catheter (at the junction with the hub).There were difficulties inflating and the inflation was poor, but the stent still could be released at the lesion; however, with incomplete vessel wall apposition.The sds catheter was removed and a non-abbott 8 x 40 mm balloon catheter was used to complete the stent apposition at the target lesion.There was no clinically significant delay in the procedure reported and no adverse patient effects.No additional information was provided.
 
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.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 inflation issue and leak were able to be confirmed.Based on a visual and functional 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 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 Key4623475
MDR Text Key5572676
Report Number2024168-2015-01529
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 Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/26/2015
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? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Catalogue Number11004-29
Device Lot Number4112441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2015
Initial Date FDA Received03/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SHEATH: 6FR SHORT
Patient Outcome(s) Required Intervention;
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