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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PRIME DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1011710-23
Device Problems Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Event Date 06/19/2018
Event Type  Injury  
Manufacturer Narrative

The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. 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

Patient id: (b)(6). It was reported that on (b)(6) 2014, a 3. 5x23mm xience prime stent was successfully implanted in the mid right coronary artery (rca) 90% stenosed lesion. On (b)(6) 2018, the patient was hospitalized for unstable angina and neck pain. As treatment, medications was provided and another percutaneous intervention, with stent placement, was performed in the mid rca. The event resolved. No additional information was provide regarding this issue.

 
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Brand NameXIENCE PRIME
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
cashel road
clonmel tipperary
EI 
Manufacturer Contact
connie speck
26531 ynez rd.
temecula , CA 92591-4628
9519143996
MDR Report Key8794104
Report Number2024168-2019-10086
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,S
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/01/2015
Device Catalogue Number1011710-23
Device LOT Number3032141
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 Received07/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/02/2013
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: 07/16/2019 Patient Sequence Number: 1
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