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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011710-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Fatigue (1849); Dizziness (2194); Stenosis (2263)
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effects of restenosis and angina are listed in the xience prime everolimus eluting coronary stent system instructions for use as a known patient effects of coronary stenting procedures. Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported that on 11/07/2013, the patient presented with unspecified stent restenosis of 70% in the mid-right coronary artery (rca). 90% stenosis was noted in the proximal rca de novo lesion. A 3. 5x12mm xience prime stent was successfully implanted in the mid rca and a 3. 5x23mm xience prime stent was successfully implanted in the proximal rca. On (b)(6) 2018, the patient was hospitalized for unstable angina, dizziness, and fatigue. The dizziness and fatigue were experienced for three days prior to hospitalization. Medication was provided. On (b)(6) 2018, an angiogram was performed, and restenosis was noted in the mid rca. Another stent was implanted at the mid rca. The event resolved without sequela. No additional information was provided regarding this issue.
 
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Brand NameXIENCE PRIME 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 Key8698217
MDR Text Key147996828
Report Number2024168-2019-04694
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/11/2015
Device Catalogue Number1011710-12
Device Lot Number3060441
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 Received05/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
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: 06/13/2019 Patient Sequence Number: 1
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