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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 1011710-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Arrhythmia (1721); Headache (1880); Weakness (2145); Dizziness (2194)
Event Date 01/19/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). On (b)(6) 2015, the patient experienced a headache after changing position and unstable angina was diagnosed. The patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2015, the patient experienced intermittent chest tightness and chronic coronary insufficiency was diagnosed. The patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2015, the patient experienced precordial discomfort, heart palpitations, and dizziness with no known cause. Unstable angina was diagnosed and the patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2015, the patient experienced intermittent precordial discomfort and unstable angina was diagnosed. The patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2015, the patient experienced precordial discomfort with heart palpitations and dizziness with no known cause. Unstable angina was diagnosed and the patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2016, the patient experienced heart palpitations and lower limb weakness with no known cause. Unstable angina was diagnosed. The patient was hospitalized and medication was provided. The event resolved. Per physician, the events were unknown if related to the xience prime stent. There was no device malfunction. There was no additional information provided regarding this issue. (b)(6) 2014: creatine kinase muscle and brain (ck-mb)
=
13 ng/ml,normal upper limit 24 (b)(6) 2014: (ck)
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150 u/l, normal upper limit 200 (b)(6) 2014: (ck-mb)
=
17 ng/ml, normal upper limit 24 (b)(6) 2014: troponin i
=
0. 05 ng/ml, upper reference limit 0. 4 (b)(6) 2014: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2014: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2014: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2014: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2014: (ck)
=
155 u/l, normal upper limit 170 (b)(6) 2014: (ck-mb)
=
8 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2015: ck-mb
=
11 ng/ml, normal upper limit 24 (b)(6) 2015: ck
=
186 u/l, normal upper limit 200 (b)(6) 2015: ck-mb
=
11 u/l, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2015: ck
=
311 u/l, normal upper limit 200 (b)(6) 2015: ck-mb
=
14 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2015: ck
=
153 u/l, normal upper limit 200 (b)(6) 2015: ck-mb
=
9 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2015: ck
=
177 u/l, normal upper limit 200 (b)(6) 2015: ck-mb
=
15 ng/ml, normal upper limit 24 (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2015: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2016: electrocardiogram(ecg)
=
no myocardial infarction (b)(6) 2016: ck-mb
=
0. 85 ng/ml, normal upper limit 2. 03 (b)(6) 2016: troponin i
=
0. 012 ng/ml, upper reference limit 0. 034 the device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. It should be noted that the reported patient effect of angina and arrhythmia are listed in the instructions for use xience prime everolimus eluting coronary stent systems as a known patient effect(s) of coronary stenting procedures. A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined. However, the reported treatments appear to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that on (b)(6) 2013, a 3. 5x18mm xience prime stent was successfully implanted in the distal right coronary artery (rca) lesion. The patient was discharged from the hospital on (b)(6) 2013. On (b)(6) 2014, the patient was hospitalized for sudden back pain and unstable angina was diagnosed. Medication was provided and the event resolved. On (b)(6) 2014, the patient experienced intermittent palpitations and unstable angina. The patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2014, the patient experienced precordial discomfort with intermittent activity and unstable angina was diagnosed. The patient was hospitalized and medication was provided. The event resolved. On (b)(6) 2014 the patient experienced intermittent precordial discomfort and unstable angina was diagnosed. The patient had been hospitalized both times and medication was provided. The events resolved. On (b)(6) 2014, coronary angiography noted no stenosis in the xience prime stent. On (b)(6) 2015, the patient experienced intermittent precordial discomfort and unstable angina was diagnosed. The patient was hospitalized and medication was provided. The event resolved.
 
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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 Key6671598
MDR Text Key78542652
Report Number2024168-2017-05431
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 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/26/2015
Device Catalogue Number1011710-18
Device Lot Number3011541
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 Received06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
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: 06/27/2017 Patient Sequence Number: 1
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