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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1550225-08
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Prolapse (2475)
Event Date 07/11/2019
Event Type  Injury  
Manufacturer Narrative
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. The stent remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2019, a 2. 25x8mm xience sierra stent was implanted in the proximal circumflex (cx) lesion without a device deficiency. During stent deployment, a plaque shift occurred from the proximal cx to the proximal left anterior descending (lad) coronary artery. Balloon angioplasty was performed as treatment and the event resolved. The patient was discharged from the hospital that same day. No additional information was provided regarding this issue.
 
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Brand NameXIENCE SIERRA
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
connie speck
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8860243
MDR Text Key153246601
Report Number2024168-2019-10572
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648226991
UDI-Public08717648226991
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/07/2020
Device Catalogue Number1550225-08
Device Lot Number9032841
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 Received08/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2019
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: 08/05/2019 Patient Sequence Number: 1
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