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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 1550350-15
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Prolapse (2475)
Event Date 12/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The stent remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional xience sierra device referenced is being filed under a separate medwatch report.
 
Event Description
It was reported that the patient had presented with a recent non-st elevated myocardial infarction (nstemi) and with long or multiple coronary artery lesions. A 3. 0x33mm xience sierra stent was implanted in the mid right coronary artery (rca) lesion. Post implantation, the angiographic appearance of the stent was not acceptable due to stent underexpansion, intra-stent protrusion and thrombus, and a distal edge dissection. As treatment, balloon angioplasty was performed with a non-complaint balloon and a 3. 5x15mm xience sierra stent was implanted as treatment. Following implantation of the 3. 5x15mm xience sierra stent, proximal stent underexpansion and an intra-stent plaque protrusion were noted. Balloon dilatation was performed using a non-compliant balloon. The procedure end diameter stenosis was 0%. Reportedly the pci result after additional treatment was acceptable. No additional information was provided regarding this issue.
 
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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)
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 Key8636761
MDR Text Key145951299
Report Number2024168-2019-04051
Device Sequence Number1
Product Code NIQ
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,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/09/2019
Device Catalogue Number1550350-15
Device Lot Number8090341
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 Received05/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
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: 05/23/2019 Patient Sequence Number: 1
Treatment
GUIDE CATH: 5 FRHEPARINXIENCE SIERRA STENT
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