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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1550250-12
Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: dilatation cath: 2. 5 x 15 apex, guide wire: mailman, guide catheter: al1. 6f jl-4, jr-4. The device was not returned for evaluation. A review of the lot history record and complaint history could not be conducted because the lot number was not provided. The investigation was unable to determine a conclusive cause for the reported difficult to deploy; however, the reported physical resistance and subsequent treatment appear to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device. Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period.
 
Event Description
The patient presented with a history or recurrent chest pain and the procedure was performed to treat lesions in the previously stented and clipped saphenous vein graft to circumflex marginal coronary artery. Two guide wires were placed and balloon angioplasty with a non-abbott balloon catheter was performed distally. Advancement was difficult due to the previously stented and clipped part of the graft. A 2. 5 x 12 mm xience sierra was deployed in the distal lesion; however, adequate post dilatation with a non compliant balloon was not possible. An aneurysm was noted in the mid graft region and therefore a 4. 00 x 19 mm graftmaster cover stent was attempted to be deployed. The graftmaster failed to cross the difficult anatomy despite numerous attempts and replacing the guide wires. The graftmaster did not cause or contribute to complications or adverse events. Some slow flow was noted as a result of the anatomy and as the graft was old the physician decided not to continue with further treatment attempts. The patient was reported to be stable post procedure and transferred back to his room for standard post procedure care. No additional information was provided.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key8772004
MDR Text Key150420013
Report Number2024168-2019-05457
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227080
UDI-Public08717648227080
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1550250-12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/09/2019 Patient Sequence Number: 1
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