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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 1011711-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Edema (1820); Cardiac Enzyme Elevation (1838)
Event Date 07/02/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(6) 2014: ck
=
96 u/l, normal upper limit 195; (b)(6) 2014: ck-mb
=
16. 0 u/l, normal upper limit 25; (b)(6) 2014: troponin i
=
2. 30 ng/ml, upper reference limit 1. 7; (b)(6) 2015: ck
=
175 u/l, normal upper limit 195; (b)(6) 2015: ck-mb
=
18. 3 u/l, normal upper limit 25; (b)(6) 2015: troponin i
=
0. 96 ng/ml, upper reference limit 1. 7. There was no reported device malfunction and the product was not returned. 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 effect of angina and edema are listed in the instructions for use xience prime everolimus eluting coronary stent systems as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
It was reported that on (b)(6) 2014, the patient underwent a coronary stenting procedure with implantation of a 4. 0 x 15 mm xience prime stent in the left main coronary artery. On (b)(6) 2014, the patient began to experience chest tightness and was re-hospitalized. Medication was administered. The chest tightness resolved on (b)(6) 2014. On (b)(6) 2014, the patient began to experience chest tightness and was re-hospitalized. Cardiac enzymes were elevated. Medication was administered and the event resolved on (b)(6) 2014. On (b)(6) 2015, the patient was re-hospitalized with edema in the lower limbs. Medication was administered and the event resolved on (b)(6) 2015. No additional information was requested.
 
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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 Key6673811
MDR Text Key78601653
Report Number2024168-2017-05469
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 06/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2015
Device Catalogue Number1011711-15
Device Lot Number3041841
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 Received06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
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: 06/28/2017 Patient Sequence Number: 1
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